Archive 2017-HCV Genotypes/Treatment

Archive 2017 - HCV Genotypes/Treatment
Offered on this page is 2017 research articles with a focus on treating HCV according to genotype using FDA approved and investigational medicines. Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, research manuscripts and interactive learning activities.

Research Articles: Genotypes 2018
 2017 - Archive
2016 

2017 December
Dec 29, 2017
Genotype 1
Efficacy and safety of Harvoni in Japanese patients aged 75 years or over with hepatitis C genotype 1
Compared with younger patients, elderly patients had a similar virological response and tolerance to SOF/LDV therapy.

Dec 23, 2017
December: Blog Updates & Reports
Check out a few blog updates and reports released this week on the topic of viral hepatitis.

Dec 19, 2017
Genotype 4, 5, and 6
Shared by Henry E. Chang on Twitter

Dec 18, 2017
Genotype 1
SVR in HCV genotype 1 improves insulin resistance
Patients with hepatitis C genotype 1 who achieved sustained virologic response after direct-acting antiviral treatment had significant improvement or reversal of insulin resistance, according to a recently published study.

Dec 15, 2017
All Genotypes
Médecins Sans Frontières (MSF) has filed a legal patent challenge in China against US pharmaceutical corporation Gilead’s patent application for the combination of two crucial oral hepatitis C medicines, sofosbuvir and velpatasvir

Dec 14, 2017
8-week Harvoni cost-effective alternative to 12-week regimen
An 8-week course of Harvoni for hepatitis C virus infection in both black and nonblack patients was a cost-effective alternative to a 12-week course, according to…

Dec 12, 2017
Genotype 1
Retreatment of patients with treatment failure of direct-acting antivirals: Focus on hepatitis C virus genotype 1b
The recent development of direct-acting antiviral agents (DAAs) against hepatitis C virus (HCV) infection could lead to higher sustained virological response (SVR) rates, with shorter treatment durations and fewer adverse events compared with regimens that include interferon. However, a relatively small proportion of patients cannot achieve SVR in the first treatment, including DAAs with or without peginterferon and/or ribavirin. Although retreatment with a combination of DAAs should be conducted for these patients, it is more difficult to achieve SVR when retreating these patients because of resistance-associated substitutions (RASs) or treatment-emergent substitutions....... 
Retreatment regimens for patients with hepatitis C virus infection for whom the initial combination of direct-acting antivirals has failed.

Dec 11, 2017
Inclusive criteria, generic drugs effective for HCV in limited resource nations
Researchers from the University of Cairo analyzed the rates of sustained virologic response among patients with hepatitis C in Egypt since the…

Dec 7, 2017
Watch - Breaking News On HCV Regimens
AASLD Symposium
Released Online December 7, 2017
Great program for savvy patients to learn more about the treatment of hepatitis C.

Dec 6, 2017
Genotype 1 and 4
HCV Patients SVR with Mavyret After Previous DAA Failure
An international team of researchers studied 91 individuals with chronic HCV — 87 with genotype 1, and 4 with genotype 4. These patients had prior failures when treated with direct-acting antiviral (DAA) therapies that consisted of at least 1 NS3/4A protease and/or NS5A inhibitor-containing medication.

Dec 1, 2017
Summary from AASLD 2017 for Hepatitis C HCV: Game over?

Genotype 1
8 vs 12-weeks Ledipasvir/Sofosbuvir in Treatment-Naive HCV
In treatment-naïve HCV genotype 1 patients, SVR was 95% in those treated for either 8 weeks or 12 weeks with ledipasvir and sofosbuvir. 8 week ledipasvir and sofosbuvir can reduce costs without compromising outcomes for those patients who qualify for such regimen.

Genotype 2
Sofosbuvir Plus Ribavirin for HCV Genotype 2 Infection
In this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection

2017 November
Nov 29, 2017
Genotype 4
Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: real-world results from 18 378 patients in Egypt
Real-world experience of generic SOF-DCV in patients with chronic HCV-G4 proved to be safe and associated with a high SVR12 rate, in patients with different stages of fibrosis.

Nov 27, 2017
Genotype 3
Dramatic response of HCV patients with genotype 3 to sofosbuvir-based therapies in Punjab, Pakistan: A prospective study
We found an outstanding response rate of SOF in hepatitis C patients infected with genotype 3 of hepatitis C virus. These findings revealed that with SOF we may eliminate hepatitis C from our population.

Nov 22, 2017
Genotype 3a
Intrapatient viral diversity & treatment outcomes in patients with genotype 3a HCV infection on SOF-containing regimens

Nov 17, 2017
Of Interest
Vosevi & Mavyret: The Impact of New Options for DAA-Experienced Patients With HCV

Genotype 3
Effectiveness of current and future regimens for treating genotype 3 hepatitis C virus infection: a large-scale systematic review

Nov 16, 2017
Cost-effectiveness of DAAs for Hepatitis C Genotypes 2-6
Alimentary Pharmacology & Therapeutics

Nov 15, 2017
Of Interest
Blog Updates Around The Web: Does an SVR to Therapy for HCV-associated Cirrhosis Reduce Portal Pressure?
Topic Highlights
Meeting Shed Light on the Clinical Benefits of HCV DAAs
The Cochrane Review Conclusion for Hepatitis C DAA Therapies Is Wrong
What’s new with the flu shot?

Nov 13, 2017
Review - Labeling for Several HCV Drugs Updated With New Drug Interactions
Updated to include information pertaining to changes in International Normalized Ratio (INR) values in patients receiving warfarin.

Nov 9, 2017
Genotype 1
Shortening Duration of Therapy With DAAs for HCV Genotype 1
Journal of Viral Hepatitis, November 9, 2017

Genotype 1 & 4

Full-text articles shared by @HenryEChang via Twitter

Of Interest - Video

 Challenges in Treating Genotype 3 Hepatitis C Virus
According to the IDSA/AASLD guidelines, sofosbuvir/daclatasvir is an acceptable alternative to Mavyret and Epclusa.8 The combination achieves similar rates of SVR12 after 12 weeks of treatment. Daclatasvir is an NS5A inhibitor, and studies have identified baseline and acquitted genetic alterations of NS5A that confer resistance to daclatasvir....

2017 October
Oct 31, 2017
VA's Updated - Chronic Hepatitis C Virus Infection:Treatment Considerations
This revision ( October 18 , 2017 ) incorporates updates to treatment regimens for chronic hepatitis C virus (HCV) infection, genotype s 1 -4, including re-treatment of patients who previously failed direct -acting antiviral therapy...The Panel continues to recommend that HIV/HCV-coinfected patients receive the same HCV antiviral regimen s as HCV - monoinfected patients unless ledipasvir/sofosbuvir is being considered, in which case a 12 -week regimen should be used (instead of an 8 -week regimen).....

Oct 30, 2017
Fatty Liver Common After Direct-Acting Antivirals for Hep C
WASHINGTON, DC — Evidence of steatosis is found in almost half the patients with hepatitis C who achieved a sustained virologic response after treatment with direct-acting antivirals, results from a prospective study show.

Mean age of the participants was 60 years and mean body mass index (BMI) was 28 kg/m². In addition, 36% of the patients were white, 25% were Hispanic, and 90% had diabetes. The hepatitis C infection was genotype 1 in 86% of the patients, genotype 2 in 13%, and genotype 4 in 1%. People with genotype 3 infection were excluded from the analysis because the etiology of hepatic steatosis is different in this population...

Genotype 3
HCV Cirrhosis - Liver-related morbidity and mortality with and without sustained virologic response

Oct 28, 2017
Genotype 1
Impact of LDV/SOF on the work productivity of genotype 1 chronic HCV patients in Asia

Of Interest
Sustained virological response halts fibrosis progression: A long-term follow-up study of people with chronic hepatitis C infection

Oct 24, 2017
HCV in the Older Patient - Natural history, extrahepatic disorders, safety and efficacy of treatment regimens


Oct 23, 2017
Genotype 3
Mavyret (Glecaprevir/Pibrentasvir) for Treatment-Naive Patients With HCV Genotype 3
Glecaprevir/pibrentasvir was well-tolerated and resulted in high virologic response rates in treatment-naive patients with hepatitis C virus (HCV) genotype 3 infection, according to a study presented here at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

Genotype 3
Is Ribavirin Really Needed for Patients With HCV Genotype 3 on Sofosbuvir/Velpatasvir
“We could confirm the high SVR12 rates [sustained virologic response at 12 weeks] from the clinical phase 3 studies with sofosbuvir/velpatasvir, [but] in our cohort, it seems like the addition of ribavirin in cirrhotic patients did not have further benefit for those patients,”

Conference Coverage - NATAP
Efficacy and Safety of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Treatment-naïve Patients with Chronic HCV Genotype 3: An Integrated Phase 2/3 Analysis

Adherence to Pangenotypic Glecaprevir/Pibrentasvir Treatment and SVR12 in HCV-infected Patients: An Integrated Analysis of the Phase 2/3 Clinical Trial Program 

Do resistance associated substitutions (RAS) or Ribavirin (RBV) use influence treatment success of Sofosbuvir (SOF)/Velpatasvir (VEL) in chronic hepatitis C genotype 3 (GT 3) infection? - Results from the GErman hepatitis C COhort (GECCO) 

Conference Coverage - NATAP
Genotype 1
A Pragmatic Approach to Optimizing the Efficacy of Elbasvir/Grazoprevir Using Baseline Viral Load in Participants With Hepatitis C Virus Genotype 1a Infection: A Post Hoc Analysis of 11 Clinical Trials 

 Real-World Cost-Effectiveness of Elbasvir/Grazoprevir (EBR/GZR) in Treatment-Naïve (TN) Patients With Chronic Hepatitis C (CHC) Virus Genotype 1 (GT1) in the United States (US)

A Phrase 3, French Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve HCV GT1b-Infected Patients with non-severe Fibrosis: STREAGER study




Conference Coverage - NATAP
Genotype 1-6
Efficacy, Safety, and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis

C-BREEZE-2: Efficacy and Safety of a Two-Drug Direct-Acting Antiviral Agent Regimen Ruzasvir 180 mg and Uprifosbuvir 450 mg for 12 Weeks in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 3, 4, 5, or 6 

Conference Coverage - NATAP
Genotype 1 and 4

Mark Sulkowski, MD Highlights Each Day From The Liver Meeting® 2017: What you need to know in 5-minutes
First clip released; treatment in liver transplant patients HCV genotype 1 - 4, what happens after a patient is cured and more...

Oct 21, 2017
Genotype 1 or 4 who have chronic kidney disease
The Liver Meeting® 2017 - ZEPATIER® High SVR In HCV Patients with Kidney disease

Oct 20, 2017
Liver Meeting® 2017 - Gilead Announces Multiple Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients
WASHINGTON-Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C.

TGIF HCV Rewind - Seasonal Flu, Liver Disease & Blog Updates Around The Web
People older than 65, those with certain chronic medical conditions, such as liver disease, COPD, diabetes, weakened immune systems, pregnant women and young children are most vulnerable for developing flu-related complications.

Oct 18, 2017
Genotype 4
Efficacy of Ravidasvir Plus Sofosbuvir for Chronic Hepatitis C Genotype 4
Patients with chronic hepatitis C virus-genotype-4 (HCV-GT4) in countries with limited resources may have a new treatment option with the combination of ravidasvir (an NS5A inhibitor) plus sofosbuvir, with or without ribavirin, according to a phase 3 study published in the Journal of Hepatology.

Oct 17, 2017
The changing HCV treatment cascade
Although the IDSA/AASLD guidelines provide the map to managing HCV, they do not identify the ideal interferon-free regimen to begin with, nor have they given a clear path to treating genotype 3 and those with decompensated cirrhosis. This ever-changing field will require collaboration among health care providers, including those specializing in infectious diseases, hepatology and gastroenterology, as well as pharmacists, to optimize treatment strategies. As the landscape of HCV continues to update with new literature and new medications, this subspecialty continues to be dynamic.

Oct 14, 2017
NPR-Ed Silverman & Dr. William Carey Discuss: New Pan-genotypic HCV Drugs: Cost & Cure

Oct 13, 2017
Of Interest
TGIF! HCV-related diseases and How hepatitis C wages guerrilla warfare
TGIF! Welcome to a review of this week's news, research and updates around the web.

Oct 12, 2017
Impact of hepatitis C virus genotype-4 eradication following direct acting antivirals on liver stiffness measurement
Successful HCV genotype-4 eradication results in significant  liver stiffness measurement (LSM)  improvement; the best improvement occurs in F4 patients. But as the majority of cirrhotics are still at risk for liver decompensation and hepatocellular carcinoma development despite achieving SVR-24, early detection and treatment are highly recommended.

Oct 11, 2017
In Case You Missed It
Hepatitis C Treatment With Direct-Acting Antivirals Confers Survival Benefit
Today over at Infectious Disease Advisor, media coverage on the study; Effect of Paritaprevir/Ritonavir/Ombitasvir/Dasabuvir and Ledipasvir/Sofosbuvir Regimens on Survival Compared With Untreated Hepatitis C Virus–Infected Persons: Results From ERCHIVES, is highlighted, the full-text article shared by @HenryEChang via Twitter, can be reviewed, here.

October 9, 2017
Genotype 1

Oct 7, 2017
Articles provided by @HenryEChang via Twitter
Treatment of HCV with 8 weeks of LDV/SOF: Highly effective in a predominately black male patient population

High sustained virological response rates using imported generic direct acting antiviral treatment for hepatitis C

Oct 6, 2017
Of Interest

Oct 5, 2017
Healio - Viekira Pak safe for patients with HCV, Child-Pugh A cirrhosis
Patients with hepatitis C and Child-Pugh A cirrhosis had similar rates of treatment-related adverse events and lower rates of hepatic decompensation after treatment with Viekira Pak compared with untreated patients...

Genotype 4
Real-life results of sofosbuvir based therapy in chronic hepatitis C -naïve and -experienced patients in Egypt
In the real-life setting, Sofosbuvir based regimens for 24 weeks has established an efficacious and well tolerated treatment in naïve and experienced patients with chronic HCV genotype 4 infection; although shorter treatment durations may be possible. However, patient follow up should extent to at least 6 months post-treatment and verifying viral load on yearly basis is warranted to track any late relapse.

2017 September
Sep 29, 2017
TGIF HCV Review - Merck Discontinues MK-3682B and MK-3682C Development Programs

Sep 27, 2017
Japan - AbbVie Announces Approval of MAVIRET™ (glecaprevir/pibrentasvir) of Chronic Hepatitis C in All Major Genotypes (GT1-6)

Genotype 1 & 3
New Treatment-Naïve & Treatment-Experienced
HCV Guidance Updates - Recommendations Reflecting Vosevi and Mavyret
Updated references have been provided throughout the guidance.

Sept 26, 2017
Most patients with HCV genotypes 2, 4, 5, 6 achieve SVR with Mavyret
Most patients with hepatitis C genotype 2, 4, 5 or 6 who received Mavyret for 8 weeks achieved sustained virologic response with a high safety profile, according to results from three phase 3 studies. The rate of virologic failure was less than 1%.

Sep 25, 2017
Genotype 3
Full Text Article
Glecaprevir/Pibrentasvir for HCV Genotype 3 Patients with Cirrhosis and/or Prior Treatment Experience
Patients with HCV GT3 infection with prior treatment experience and/or compensated cirrhosis achieved high SVR12 rates following 12 or 16 weeks of treatment with G/P. The regimen was well tolerated

Sept 15, 2017

Sept 14, 2017
HCV NEXT September/October Issue - Two Approvals Offer Even More Options for HCV Treatment
Two Approvals Offer Even More Options for HCV Treatment:The approval of two new regimens for treating hepatitis C comes as a very welcome development in the field. It is great news for patients and providers because both regimens offer new options for therapy.Ira M. JacobsonFor patient populations that we have been accustomed to treating with high levels of efficacy and tolerability, we now have new features like shorter duration of therapy. For those who previously failed direct- acting antiviral therapy who previously had no treatment, we now have an approved regimen.

Sept 12, 2017
Genotype 3
The fixed-dose combination of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) (Technivie, AbbVie), which is approved to treat HCV genotype 4, was combined with the pangenotypic DAA, sofosbuvir (SOF) (Sovaldi, Gilead), in addition to ribavirin for 12 weeks in patients having genotype 3 with cirrhosis, and with or without ribavirin in type 3 patients without cirrhosis. In addition, the regimen with ribavirin was administered for either 6 or 8 weeks to genotype 2 patients without cirrhosis. If the regimen without ribavirin proves efficacious, Shafran explained, it would offer a treatment option for many patients unable to tolerate it.

Sept 8, 2017
September 8, 2017
In summary, our study found that successful treatment of chronic HCV with DAA therapy is associated with improvement in liver stiffness, assessed by VCTE measured serially over the first 12 months after treatment. Continued improvement in VCTE scores between EOT and12 months post-treatment suggests possible early regression of fibrosis in addition to resolution of inflammation that occurs soon after starting HCV therapy. Longer-term data are needed to determine whether improvement in liver stiffness continues beyond 1 year, and larger studies are needed to elucidate factors associated with rapidity and magnitude of improvement.

In patients with advanced fibrosis, pretreatment LS significantly reduced during DAA therapy. SVR was the only independent factor associated with the regression in LSM. However, irrespective of achieving SVR, liver damage still persisted in a substantial proportion of patients. Thus, early treatment of HCV-infected patients can significantly prevent residual liver damage.

Genotype 1
Small case series of 5 patients - Viral load at the end of HCV treatment may not always imply therapeutic failure

Genotype 2
Full Text
Sofosbuvir plus ribavirin treatment of HCV genotype 2: results of the real-world, clinical practice HCV-TARGET study

Genotype 4
Effect of DAA therapy on type 2 diabetes patients with HCV genotype 4 infection.

2017 August
Genotypes 1, 2, 3, or 4
Aug 29, 2017
Treatment Of HCV Infection with New Drugs: Real World Experience in Southern Brazil
The aim of this historical cohort study is to describe the sustained virologic response (SVR) rate among real-world compensated chronic hepatitis C patients in three hepatology centers from Southern Brazil

All genotypes
Aug 26, 2017
The new paradigm in the treatment of chronic hepatitis C disease: Faster, Higher and Stronger

Systematic review: cost-effectiveness of DAAs for treatment of HCV genotypes 2-6

Articles provided by @HenryEChang via Twitter

Aug 24
Genotype 1
Harvoni in adolescents 12-17 years old with HCV genotype 1
All adolescent patients available for follow-up after treatment with Harvoni for chronic hepatitis C genotype 1 achieved sustained virologic response at 12 weeks with no serious adverse events, further supporting its approval in this population.

Aug 18, 2017
(grazoprevir-ruzasvir-uprifosbuvir)
"Results from the current studies support further investigation of grazoprevir, ruzasvir, and uprifosbuvir as a pan-genotypic regimen in individuals infected with HCV with and without cirrhosis, and suggest that this combination has the potential to provide a safe, single-duration regimen in most populations, including individuals with cirrhosis infected with genotype 3 who had previously received treatment with pegylated interferon and ribavirin," the researchers conclude.

Nearly all patients with chronic hepatitis C virus (HCV) infection treated with glecaprevir-pibrentasvir achieved sustained virologic response after 12 weeks of therapy, according to results of an industry-funded, phase 3 trial in the Lancet Infectious Diseases
Link To Full Text Articles:
New anti-HCV drug combinations: who will benefit? and....
Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial

Aug 17, 2017
All Genotypes
AbbVie's MAVIRET Approved by Health Canada
Health Canada has granted approval for MAVIRET™ (glecaprevir/pibrentasvir tablets), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVIRET is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment,* who make up a large portion of HCV patients in Canada.

Aug 17, 2017
See press release for genotypes
VOSEVI is the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment, and Completes Gilead’s Portfolio of Sofosbuvir-Based HCV Direct-Acting Antiviral Treatments
Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance for VOSEVI™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a pan-genotypic single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1, 2, 3 or 4 previously treated with sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies that evaluated 12 weeks of VOSEVI in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.

Aug 15
Genotype 1, 2, or 3
Blogs & Updates: Triple Drug Regimen Succeeds Against Treatment-Resistant HCV

Aug 11
Genotype 3
Hepatitis C Genotype 3 Infection Pathogenesis and Treatment Horizons
Hepatitis C genotype 3 infection is associated with increased late-stage liver events, accelerated hepatic fibrosis, and hepatocellular carcinoma.
provided by @HenryEChang via Twitter

Shortening the duration of therapy for chronic HCV
Lancet Published online August 9, 2017
provided by @HenryEChang via Twitter

Link to additional PDF full text articles @HenryEChang via Twitter

In Case You Missed It
Genotype 1
Full Text
Effectiveness of 8- or 12-weeks of ledipasvir and sofosbuvir in real-world treatment-naïve, genotype 1 hepatitis C infected patients
Dr Curry's team concludes, "In treatment-naïve HCV genotype 1 patients, sustained virological response was 95% in those treated for either 8 weeks or 12 weeks with ledipasvir and sofosbuvir."

Of Interest
Aug 10
Video
Watch ASCEND Documentary: Patients, Providers, and Hepatitis C
An inside view of Hepatitis C treatment in an urban community health care setting.
The ASCEND study has been published in the Annals of internal medicine...

Combination of sofosbuvir and daclatasvir in the treatment of genotype 3 chronic hepatitis C virus infection in patients on maintenance hemodialysis

Aug 5
Cured HCV patients - Still at risk for reinfection, even by the same genotype

Of Interest
AbbVie’s new, cheaper hepatitis C drug could launch the drug world’s own Hunger Games

Aug 4
Of Interest
The changing HCV treatment cascade
The shift in the HCV treatment paradigm is now heavily patient-centric and dependent on genotype, presence of cirrhosis, HIV coinfection, potential drug interactions, previous treatment failure, and renal impairment. In its simplest form, the backbone of HCV treatment requires a combination DAA with or without the addition of ribavirin and duration varies on the presence of cirrhosis.

Aug 3
FDA APPROVED MAVYRET™ (glecaprevir/pibrentasvir)
AbbVie Receives U.S. FDA Approval of MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT 1-6) in as Short as 8 Weeks

Aug 2
Genotype 3
Hepatitis C Cure Rate Tops 90% in Hard-to-Treat Genotype 3 Patients
Hepatitis C patients with hard-to-treat genotype 3 showed sustained virologic response (SVR) of greater than 90% in a real-life study of a therapy based on the direct-acting antiviral (DAA) drug sofosbuvir (Sovaldi, Gilead Sciences Inc.)

FDA Approves Expanded Labeling for Epclusa® for Hepatitis C in Patients Co-Infected with HIV

Liver International
SOF/VEL in patients with HCV GT 1-6 & compensated cirrhosis or advanced fibrosis

Curr Hepatology Rep
Next-generation direct-acting antiviral drug-based regimens for HCV

Of Interest
Viral Hepatitis: The Search for a Cure

Link to PDF full text articles provided by @HenryEChang via Twitter

 2017 July
July 28
Vosevi
Gilead's Vosevi® European Commission Grants Marketing Authorization

New At Hepatitis C Online - Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi)
View clinical trial data in either slide decks, in your browser or download PDF.

MAVIRET
European Commission Grants AbbVie's MAVIRET® (glecaprevir/pibrentasvir) Marketing Authorization for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

July 26, 2017
Diplomat Now Dispensing VOSEVI™ to Treat Chronic Hepatitis C Virus

July 22
Genotype 1 and 4
Grazoprevir/elbasvir
Objective: Evaluate the cost-effectiveness of all recommended therapies for treatment of genotypes 1 and 4 chronic HCV.

July 21
All Genotypes
BVHG/BASL/BSG/BHIVA/BIA/CVN Guidelines for management of chronic HCV infection

July 21
Free Registration May Be Required
The full journal article is available to read for free on MedPage Today
Genotype 4
Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection

July 20
LETTER TO EDITOR
Towards supporting greater and lower cost access to direct acting antiviral treatment for hepatitis C for all patients
At the Sultan Qaboos University Hospital, using the EASL 2016 guidelines,[8] we have treated 58 HCV patients [28% genotype 3, 26% cirrhotic with 40% of them decompensated, and 3% severe chronic kidney disease (CKD)] with generic DAAs including (sofosbuvir, ledipasvir, and daclatasvir). Sustained virological response was achieved in 57 patients (98%), the remaining one patient with severe CKD discontinued treatment due to worsening renal function. All patients with decompensated cirrhosis were delisted from transplantation.

In chronic HCV infection, oral DAAs have high sustained virologic response
In patients with chronic hepatitis C virus (HCV) infection, what are the efficacy and safety of oral direct-acting antiviral (DAA) regimens?
Main results - The main results for HCV genotype 1 and 3 are in the Table;

SVR varied according to treatment experience, cirrhosis status, and addition of ribavirin. SVR rates for genotypes 2, 4, 5, and 6 were > 90%. Rates of serious adverse events were < 10%.
Download PDF Provided by Henry E. Chang via Twitter 

July 19
Cost - Gilead Vosevi’s (Sofosbuvir/Velpatasvir/Voxilaprevir) price at $24,920 per bottle

July 18
FDA APPROVED VoseviTM
Genotype 1, 2, 3, 4, 5 or 6 - Re-treatment of chronic hepatitis C virus
Gilead's VoseviTM (Sofosbuvir/Velpatasvir/Voxilaprevir) FDA Approved for Re-Treatment of Adults with HCV
- Vosevi is the First Once-daily Single-Tablet HCV Regimen Approved as Salvage Therapy for Certain Patients and Completes Gilead's Portfolio of Sofosbuvir-based HCV Direct-acting Antiviral (DAA) Treatments -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 18, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved VoseviTM (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies, which evaluated 12 weeks of Vosevi in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.

July 14
Geno 3
HCV genotype 3: Work through virtual case study with Dr Doug Dieterich
The HCV Virtual Patient program is an interactive, case-based program featuring real-world case scenarios discussed by HCV thought leaders.

Genotype 3
Extrahepatic manifestations of HCV & Treatment
Collection of full text articles on conditions related to HCV:
Neurologic, rheumatologic, skin, depression, metabolic steatosis which is associated with features of metabolic syndrome and insulin resistance in patients infected with nongenotype 3....

July 13
Genotype 3
Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections—A Scandinavian real-life study
We found that sofosbuvir based treatment in a real-life setting could offer SVR rates exceeding 90% in patients with HCV genotype 3 infection and advanced liver disease.

Watch - Individualizing Initial HCV Therapy
Led by Tram T. Tran, MD, a panel of experts discusses their approach to individualizing initial HCV therapy based on key disease and patient characteristics that have an impact on treatment choice, including HCV genotype, race, cirrhosis, comorbidities, and comedications

July 12
Genotype 1
Retrospective Study - Eight-week ledipasvir/sofosbuvir in non-cirrhotic, treatment-naïve hepatitis C genotype-1 patients with hepatitis C virus-RNA real world effectiveness and safety
Aim - To evaluate sustained viral response (SVR) of 8-wk ledipasvir/sofosbuvir therapy among non-cirrhotic, genotype-1 hepatitis C virus (HCV) patients with RNA < 6 million IU/mL.

Of Interest
Hepatitis C Blog Update - How to Keep Your Liver Healthy

July 7
Of Interest
About The Cochrane Review of DAAs by Jakobsen and Colleagues
How to explain these apparently contradictory results? An important difference between the studies reviewed by Jakobsen and colleagues is the duration of follow-up, which was short at an average of 34 weeks compared with an average of more than 5 years in the other reviews..

July 5
Genotype 3
Sofosbuvir, Velpatasvir and Voxilaprevir combination for the treatment of hepatitis C- Review Article
Expert commentary
Voxilaprevir, a second-generation HCV protease inhibitor, in combination with the already approved combination of sofosbuvir and velpatasvir, was evaluated in the POLARIS trials and found to be a safe and effective regimen. Patients with prior DAA treatment failure, genotype 3, cirrhosis and/or unfavorable resistance profiles all achieved cure rates of 96% or greater. The most distinctive role for this potent regimen may prove to be as a salvage regimen for patients who have failed previous DAA therapy

July 3
Hepatitis C Therapies Perform Well in Challenging Patients
William F. Balistreri, MD
At this year's Digestive Disease Week, several studies looked into the nuances of treating hepatitis C virus (HCV)infection. Of particular interest were new data regarding difficult-to-treat groups and the validation of shorter, simpler regimens..

2017 June
June 30
All Genotypes
Pangenotypic regimens and the next generation hepatitis C virus therapy (pages 131–133)
Nancy S. Reau
Version of Record online: 29 JUN 2017 | DOI: 10.1002/cld.635
Three new antiviral therapies for viral hepatitis C are anticipated in the next several months: GP, glecaprevir (protease inhibitor [PI])/pibrentasvir (NS5A inhibitor); SOF/VEL/VOX, sofosbuvir (NS5B inhibitor)/velpatasvir (NS5A)/voxilaprevir (NS3); and MK3, grazoprevir (NS3) + MK-3682 (NS5B) + NS5A inhibitor (elbasvir or Ruzasvir).  Each is a pangenotypic all-oral fixed dose combination (FDC) with high potency and efficacy against common NS3 and NS5A polymorphisms. Multiple safety and efficacy abstracts were presented at the 67th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in November 2016. In this article, I will address why we need new therapies as well as what is still unaddressed in the arsenal against hepatitis C.
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Genotype 1
Harvoni - Effectiveness and safety of ledipasvir/sofosbuvir ± ribavirin in the treatment of HCV infection: The real-world HARVEST study
Treatment with LDV/SOF ± RBV is an effective and safe option for patients with HCV, including those with advanced liver disease or a history of non-response to PEG-IFN-based therapy.

June 26
Genotype 4
Response Tailored Protocol Versus the Fixed 12 Weeks of Dual Sofosbuvir/Daclatasvir Treatment in Egyptian Patients With Chronic Hepatitis C Genotype-4 Infection
The decision of shortening the duration of therapy of non-cirrhotic chronic hepatitis C genotype-4 patients with dual sofosbuvir plus daclatasvir to 8 weeks instead of the recommended 12 weeks, if based on achieving viral negativity in serum at week 2 as an on-treatment qualifier, could provide a prudent basis to avoid unnecessary long treatment courses. This could not only reduce the drug exposure and the risk of adverse drug reactions, but also cut the cost of full treatment course with such expensive medications by one third.

Genotype 1,3 and 4
Impact of Direct Acting Antiviral therapy for treatment of hepatitis C genotypes 1,3 and 4: A Real life experience from India

June 23
Genotype 1-6
AbbVies MAVIRET (glecaprevir/pibrentasvir) and Gilead’s Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) Receives CHMP Positive Opinion
Two new medicines recommended for the treatment of chronic hepatitis C
Maviret and Vosevi evaluated under accelerated assessment
The European Medicines Agency has recommended granting marketing authorisations in the European Union (EU) for Maviret and Vosevi, two new medicines indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Both Maviret and Vosevi are active against all genotypes of the virus and, with some differences between the two medicines, may be specifically useful in some patients who failed or cannot use previously available therapies.

June 22
Listen Or Watch: Mark Sulkowski, MD discuss current treatment options for all HCV genotypes
Topics include; HCV screening, diagnosis, noninvasive tests for assessing liver fibrosis and current treatment options for all HCV genotypes (1-6)

 June 6
This study evaluates the real-world treatment effectiveness of these three most widelyprescribed DAA combination regimens used to treat HCV patients within the VHA using anintent-to-treat analysis which included both initial and secondary treatment episodes.  Wecontrol for the impact of various patient, disease, and treatment characteristics on treatmenteffectiveness when comparing effectiveness across the regimens.

The pill -- which contains the antiviral drugs sofosbuvir (Sovaldi), velpatasvir and voxilaprevir -- was nearly 100 percent effective in curing hepatitis C in patients whose disease returned after treatment with other antiviral drugs, the researchers said.

2017 May
May 30
Genotype 3
Ledipasvir-Sofosbuvir Plus Ribavirin in Treatment-Naive Patients With Hepatitis C Virus Genotype 3 Infection: An Open-Label Study
In this multicenter trial involving treatment-naive patients with genotype 3 HCV, 12 weeks of ledipasvir-sofosbuvir provided a high level of SVR in those without cirrhosis.

May 27
May 2017 - Hepatitis C in a New Era: A Review of Current Therapies
Review of recommended HCV regimens according to genotype or comorbid patient conditions.

 May 26
Genotype 4
Two DAA regimens produce high SVR12 rates in HCV genotype 4
May 26, 2017
Treatment with Technivie plus ribavirin or Harvoni plus ribavirin were effective in patients with hepatitis C genotype 4, according to a recently published study.

May 26
All genotypes
Current therapy for chronic hepatitis C: The role of direct-acting antivirals.
Antiviral Res. 2017 Jun;142:83-122. doi: 10.1016/j.antiviral.2017.02.014. Epub 2017 Feb 24.
Highlights
• HCV genotype-specific drugs evolve to pan-genotypic drugs.
• Drug potency increases from moderate (∼60%) to high (>90%) levels of sustained virologic response.
• Treatment durations are shortened from a 48-week to 12-week or 8-week period.
• HCV therapies based upon multiple pills per day are simplified to a single pill per day.
• HCV therapies are administered orally regardless of prior treatment history and cirrhotic status.

May 26
Of Interest
We assessed the broadly used, off-label combination of sofosbuvir, daclatasvir, simeprevir, and ribavirin in direct-acting antiviral–experienced patients, as recommended in current guidelines despite scarce data. After 24 weeks’ treatment, sustained virological response 12 weeks after the end of treatment was achieved in 6 patients (60%). Two cirrhotic patients relapsed and 2 discontinued treatment due to serious adverse events.

May 24
Genotype 1,2,3,4
Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting
Simeprevir; Sofosbuvir;  Daclatasvir; Ledipasvir; Ombitasvir; Paritraprevir/ ritonavir; Dasabuvir.

May 23
Genotype 1
Treatment with generic ledipasvir-sofosbuvir for 8 to 12 weeks was affective in Chinese patients with HCV genotype 1b
Treatment with generic ledipasvir-sofosbuvir for 8 to 12 weeks was affective in Chinese patients with hepatitis C genotype 1b, according to a recently published study.

Updated - HCV Guidance website
Initial Treatment:
  • Includes new recommendation to shorten the duration of ledipasvir (90 mg)/sofosbuvir (400 mg) in patients without cirrhosis to 8 weeks for non-black, HIV-uninfected, and whose HCV RNA is <6 million IU/mL
  • Updated grading of sofosbuvir/velpatasvir for genotypes 5 and 6
  • Language added related to recent data regarding 8 weeks of PrOD for genotype 1b with early stage fibrosis
     
Retreatment:
  • Updated recommendations in Genotype 3 sections
     
Decompensated:
  • Extrapolation of data from patients with compensated cirrhosis to patients with decompensated cirrhosis in genotypes 5 and 6

May 18
The Changing HCV Landscape: Pangenotypic Regimens
DAAs for HCV infection have all but replaced IFN as the foundation of treatment for HCV across all genotypes. Among the major advantages of these oral regimens, beyond their remarkable efficacy, has been their relatively clean safety profile. Adverse effects are common but generally mild, including headache, fatigue, and insomnia—and are trivial relative to the effects of earlier regimens, reflected by a low rate of discontinuation for adverse events. Clinicians must be aware of potential drug–drug interactions, and should prescribe these medications with a commitment toward mastering these and/or consulting the numerous published and online references, including package inserts, containing this information.

Of Interest
British and Irish Gastroenterology Meeting
Change needed in HCV treatment, hears BIG conference
Despite hopes that it will soon be eradicated, hepatitis C will remain a challenge for many years, especially as patients are reluctant to come forward for treatment.

16 May 2017 - 2017 Post-EASL Report
Multiple abstracts for HCV therapies were also presented as AbbVie, Merck & Co, and Johnson & Johnson attempted to demonstrate differentiation in a highly-competitive market with few unmet needs remaining. AbbVie presented data from multiple Phase III studies which highlighted glecaprevir/pibrentasvir’s pan-genotypic efficacy in non-cirrhotic genotype 3 (GT-3) patients (ENDURANCE-3) and cirrhotic GT-1/2/4/5/6 patients (EXPEDITION-1), as well as its maintenance of competitive cure rates in direct-acting antiviral-experienced GT-1/4 patients (MAGELLAN-1) and posttransplant patients (MAGELLAN-2). Merck & Co presented data from the Phase II C-SURGE study in DAAexperienced patients which demonstrated that its triple combination of uprifosbuvir/grazoprevir/ruzasvir was an effective salvage regimen in DAA-experienced patients with resistance-associated substitutions, and future studies will investigate the regimen in both DAA-naïve and DAA-experienced patients. Finally, Johnson & Johnson suffered a setback as its triple combination of AL-335/odalasvir/simeprevir failed to demonstrate competitive efficacy in GT-3 patients, prompting the company to discontinue development for this subgroup and putting an end to the company’s hopes of marketing a pan-genotypic regimen. While AL-335/odalasvir/simeprevir is still being developed for the remaining GTs and could shorten treatment duration to just six weeks in non-cirrhotic GT-1 patients, it is likely that Johnson & Johnson will be forced to offer significant discounts to compensate for its late entry to the market.

Genotype 3
EASL 2017: Emerging Therapies for Genotype 3 HCV
Nancy Reau MD, FAASLD, AGAF - 5/12/2017
Genotype 3 HCV infection is concerning, not just because of its natural history but also because of its potential role in reinfection. New data from EASL offer promise for the treatment of this challenging patient population.

May 5
Genotype 3
SVR rates 92% to 100% with daclatasvir- or velpatasvir-based regimens
Source: 2017 Annual Meeting of the European Association for the Study of the Liver*

2017 April
April 29
Genotype 1
China FDA Approves Daklinza® (daclatasvir) in Combination with Sunvepra® (asunaprevir) for Chronic Hepatitis C
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the China Food and Drug Administration (CFDA) has approved a direct-acting antiviral regimen comprised of Daklinza® (daclatasvir) and Sunvepra® (asunaprevir), for the treatment of treatment-naive or -experienced patients, with or without compensated cirrhosis, infected with genotype 1b chronic hepatitis C virus (HCV).

April 26
Genotype 6
Abstract
HCV Genotype 6 Increased the Risk for Hepatocellular Carcinoma Among Asian Patients With Liver Cirrhosis.

April 25
Genotype 3
Effectiveness and Safety of Sofosbuvir-based Regimens Plus an NS5A Inhibitor for Patients With HCV Genotype 3 Infection and Cirrhosis Results of a Multicenter Real-life

 International Liver Congress (ILC 2016)
Check Back For Updates
Hep C 5-minute videos - Summary Of The International Liver Congress™ (ILC) 2017
On this page of the blog visitors are provided with an index of links pointing to comprehensive coverage of the meeting.  Start by viewing a short video series over at Practice Point presented by Dr. Tran, highlights include clinical studies on new antiviral therapy, data on drug toxicity/adverse events, drug interactions, and strategies for HCV management. On May 1, ViralEd will launch: The Advances in Chronic Hepatitis C: Management and Treatment, a comprehensive program featuring HCV experts reviewing and discussing the most important studies on chronic hepatitis C presented at EASL 2017. Other videos include EASL press conference, and opening ceremony.

April 24
Genotype 3
Combo Drug Beats Tough-to-Treat HCV Genotype 3
Anti-viral led to sustained virological response in 95% of trial patients

April 23
Genotype 3
Shortened duration triple therapy fails in genotype 3 HCV
AMSTERDAM — Six weeks of triple combination therapy induced sustained virologic response in a cohort of patients with genotype 1 HCV but not genotype 3, according to data presented at the International Liver Congress.

April 21
Genotype 3
Glecaprevir/pibrentasvir 95% SVR12 in HCV Geno 3 treatment naïve, non-cirrhotic patients
Study results presented today demonstrate that the oral, once-daily treatment regimen of glecaprevir/pibrentasvir (G/P) resulted in 95% sustained virologic response rates at 12 weeks post treatment (SVR12) in patients with Hepatitis C virus (HCV) genotype 3. In the ENDURANCE-3 study, presented at The International Liver Congress™ 2017 in Amsterdam, The Netherlands, patients infected with HCV genotype 3 without cirrhosis and who had no previous treatment history were treated with the new regimen for eight or 12 weeks, which was well tolerated. G/P had a similar safety profile to the commonly used combination of sofosbuvir and daclatasvir for 12 weeks, to which G/P was actively compared in the study.

An investigational dosage of an oral interferon-free treatment regimen can cure chronic Hepatitis C virus in children
A study presented today that evaluated an investigational dosage of once-daily ledipasvir 45 mg/sofosbuvir 200 mg (LDV/SOF) in children aged six to 11 years infected with the Hepatitis C virus (HCV), found that 99% of children (n=89/90) had undetectable levels of HCV-RNA 12 weeks after treatment. The study, presented at The International Liver Congress™ 2017 in Amsterdam, The Netherlands, also showed that the fixed-dose combination of LDV/SOF was well-tolerated, and no patients experienced a serious adverse event considered related to the study drug.

April 20
genotype 1, 2, 4, 5 or 6
glecaprevir/pibrentasvir (G/P)
AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved 99 Percent SVR(12) Rate in Chronic Hepatitis C Patients with Compensated Cirrhosis
99 percent (n=145/146) of chronic hepatitis C virus (HCV) infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). These high SVR12 rates were seen following 12 weeks of G/P treatment without ribavirin. Patients with specific virus strains associated with resistance or with a high quantity of the virus in their bloodstream before treatment initiation were not excluded from the study. These new data, from the Phase 3 EXPEDITION-1 study, will be featured as an oral presentation today at The International Liver Congress™ (ILC) 2017 in Amsterdam, The Netherlands.

sofosbuvir/velpatasvir with or without voxilaprevir
ILC 2017: SOF/VEL with or without VOX- High efficacy with investigational direct-acting antiviral treatment combination is accompanied with substantial gains in patient-reported outcomes
Patients with Hepatitis C and cirrhosis experience the greatest improvements in patient-reported outcomes with sofosbuvir/velpatasvir with or without voxilaprevir compared to those without cirrhosis -  Continue to article...

International Liver Congress - Updates On This Blog

April 19
All genotypes
Direct-acting antivirals: the endgame for hepatitis C?

April 17
Special Report
Free registration required - View All Topics here.....
Newer Hepatitis C Drugs Mean Direct Action
Covers approved HCV treatment for all genotypes
The “modern era” of treatment features multiple DAAs that target specific steps within the HCV life cycle. Register here, and Begin here.....

Glecaprevir and Pibrentasvir Yield High response Rates in Patients with HCV Genotype 1-6 without Cirrhosis

Of Interest

April 7
genotype 1, 4, 5 or 6
FDA Approves HCV Sovaldi and Harvoni For Children Ages 12 to 17
FDA approves two Hepatitis C drugs for pediatric patients

Today, April 7, 2017 the FDA approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17 or weighing at least 35 kilograms.

These approvals provide pediatric treatment options for six major genotypes, or strains, of the HCV virus. Harvoni is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with HCV genotype 1, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. Sovaldi in combination with ribavirin is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with genotype 2 or 3 HCV infection without cirrhosis or with compensated cirrhosis.

Of Interest
Hepatitis C Blog, Journal and Newsletter Update For April 2017

April 4
Genotype 1,4,or 6
Elbasvir, grazoprevir in patients with HCV infection and compensated cirrhosis
Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis

Persons with hepatitis C virus (HCV) infection are at risk of progressive liver disease, cirrhosis, and decompensation. We analyzed the effects of the direct-acting antiviral agents elbasvir and grazoprevir in patients with HCV infection and compensated cirrhosis, combining data from 6 clinical trials.

Link to Media Coverage Of This Study; Elbasvir, grazoprevir beat HCV despite compensated cirrhosis with full text article, here

2017 March
Mar 31
Genotype 1-4
High Cure Rates for HCV Patients Undergoing Liver Transplant with New DAAs
Although the guidelines recommend sofosbuvir/velpatasvir (Epclusa) for non-transplant patients with all HCV genotypes, there is not enough data about how well it works in the post-transplant setting, especially with regard to interactions with immunosuppressant drugs. The same holds for the grazoprevir/elbasvir (Zepatier) combination.

Doubt expressed about potential of any single regimen to treat all hep C
“There is no current therapy in my opinion that allows for one combination, for one length of treatment, without consideration of any patient characteristics,” Dr. Brown said at the meeting. Although several newer combination drugs with pangenotypic properties are likely to be approved for HCV in 2017, Dr. Brown believes that the one-size-fits-all ideal is not going to be fulfilled “anytime soon.”

Of Interest
Mar 29

Mar 20
Genotype 1-6
2017 Hepatitis C: Down but Not Out - Oral Direct-Acting Agent Therapy for HCV
Summary - NEJM Journal Watch
Researchers examined 42 randomized trials of oral hepatitis C treatments that included at least two direct-acting antivirals. Among the findings:
  • For genotype 1 infection, the most common HCV type, sustained virologic response rates were above 95% for six regimens.
  • For patients with HCV genotype 3 and without cirrhosis, sofosbuvir plus velpatasvir or daclatasvir for 12 weeks seemed to be most effective.
  • For genotype 3 with cirrhosis, velpatasvir-sofosbuvir had higher response rates. That drug combination was also highly effective (99% response rate) for genotypes 2, 4, 5, and 6.
  • Patient groups traditionally considered difficult to treat — including those with HIV, severe kidney disease, or liver transplant — had high response rates and limited adverse events.

Genotype 1-6
Quebec Broadens Access for Patients with Less Advanced Disease Who Have Other Health Conditions

Mar 19
Genotype 1, 2, 3, and 4
New HCV Tx Works Well for Severe Liver Disease
New therapies safe and effective in patients with decompensated cirrhosis
As discussed in the article, DAAs have now changed the treatment paradigm by facilitating an option beyond simply liver transplantation or palliative care in HCV patients with decompensated cirrhosis. Among currently available DAAs, pharmacologic therapy may be tailored to the underlying HCV genotype as guided by the recent AASLD/IDSA guidelines.
*Free registration may be required.

Decreasing racial disparity with the combination of ledipasvir–sofosbuvir for the treatment of chronic hepatitis C
African Americans (AA) in the US are twice as likely to be infected with hepatitis C virus (HCV) compared to the non-Hispanic-white US population (Cau). They are also more likely to be infected with HCV genotype 1, more likely to develop hepatocellular carcinoma, and, in addition, have a lower response rate to interferon-based therapies. With the increase in response rates reported for combinations of direct-acting antivirals, the possibility that racial disparity would be eliminated by agents that directly inhibit virus replication has become a reality. The objective of this review is to evaluate the literature from clinical studies and retrospective analysis with respect to the response of AA to the most prescribed antiviral combination sofosbuvir plus ledipasvir. While few studies have focused on AA patients, sufficient information is availed from the literature and studies in our predominately AA clinic population to confirm that ledipasvir–sofosbuvir has a similar effectiveness in AA as compared to Cau.

In Case You Missed It
Listen to Dr. Dieterich review and discuss Sofosbuvir/Velpatasvir/Voxilaprevir, in this short in-depth ten minute segment, over at ViralEd.

Highlights Include
POLARIS-2 Study
Genotype 1–6
A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevirfor 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1–6 HCV Infected Patients

Genotype 3
The POLARIS-3 Study
A Randomized, Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients with Genotype 3 HCV Infection and Cirrhosis

View the program with Dr. Dieterich, here......
Download Slides from the presentation, here.....
Watch the entire presentation; The Advances in Chronic Hepatitis C: Management and Treatment

Full Text Now Online - Mar 9
Genotype 3
Daclatasvir plus sofosbuvir, with or without ribavirin, for hepatitis C virus genotype 3 in a French early access programme
Daclatasvir+sofosbuvir achieved high SVR12 rates and was well tolerated in this large real-world cohort of GT3-infected patients with advanced liver disease, without benefit of ribavirin in those treated 24 weeks.

Of Interest
Mar 15
Genotype 3
Hepatitis C-related hepatocellular carcinoma in the era of new generation antivirals
Hepatitis C virus infection is a major cause of hepatocellular carcinoma worldwide. Interferon has been the major antiviral treatment, yielding viral clearance in approximately half of patients. New direct-acting antivirals substantially improved the cure rate to above 90%. However, access to therapies remains limited due to the high costs and under-diagnosis of infection in specific subpopulations, e.g., baby boomers, inmates, and injection drug users, and therefore, hepatocellular carcinoma incidence is predicted to increase in the next decades even in high-resource countries.

Moreover, cancer risk persists even after 10 years of viral cure, and thus a clinical strategy for its monitoring is urgently needed. Several risk-predictive host factors, e.g., advanced liver fibrosis, older age, accompanying metabolic diseases such as diabetes, persisting hepatic inflammation, and elevated alpha-fetoprotein, as well as viral factors, e.g., core protein variants and genotype 3, have been reported. Indeed, a molecular signature in the liver has been associated with cancer risk even after viral cure. Direct-acting antivirals may affect cancer development and recurrence, which needs to be determined in further investigation.

Mar 13
Of Interest
Manuscript Title: Augmentation of HCV specific immunity and Sustained virological response (SVR)
Combination therapy of SOF combined with ledipasvir (LDV, an NS5A inhibitor) for 12weeks demonstrated high SVR rates (95% to 99%) in treatment-naive patients with HCV GT-1 infection (14). We have demonstrated that 14 HCV GT-1 patients who had virologic relapse after treatment with SOF plus RBV for 24 weeks in the SPARE study were able to be successfully re-treated with SOF plus LDV for 12 weeks (15). Therefore, in the present study, we hypothesize that the retreatment of these relapsers with SOF plus LDV lead to a potent suppression of HCV replication, reversal of T cell exhaustion, and augmentation of HCV-specific protective immunity with viral clearance. We aimed to evaluate the HCV-specific immune responses in these patients and specifically investigated the phenotypic and functional changes in peripheral blood T cells pre- and post-treatment to identify immune responses associated with viral clearance

APASL:Asian Pacific Association for the Study of the Liver
Conference Coverage @ NATAP
Genotype 3
Elbasvir/Grazoprevir + Sofosbuvir ± Ribavirin in Treatment-Naive and Treatment-Experienced Patients with Hepatitis C Virus Genotype 3 Infection and Compensated Cirrhosis: The C-ISLE Study 

Genotype 1, 4, and 6
EFFICACY AND SAFETY OF ELBASVIR/GRAZOPREVIR IN TREATMENT-NAïVE PATIENTS WITH CHRONIC HCV GT 1, GT 4 AND GT 6 INFECTION (C-CORAL): A PHASE III RANDOMIZED MULTINATIONAL CLINICAL TRIAL 

Genotype 1, 4, and 6
Impact of a 12-Week Oral Regimen of Elbasvir/Grazoprevir (EBR/GZR) On Health-Related Quality of Life (HRQOL) and Fatigue in Treatment-Naïve Patients With Chronic Hepatitis C Virus (HCV) Genotype (GT) 1, 4, or 6 Infection: Data From the C-CORAL Study -

Genotype 4
Ledipasvir/Sofosbuvir in Egyptian Patients With Chronic Genotype 4 HCV Infection

Cirrhosis - Sofosbuvir Based
Long-term Follow-up of Patients With Chronic HCV Infection and Compensated or Decompensated Cirrhosis Following Treatment With Sofosbuvir-Based Regimens -

Genotype 1
ONYX-I: Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Asian Adults with Genotype 1b Chronic Hepatitis C Virus Infection - A Randomized, Double-Blind, Placebo-Controlled Study 

GARNET: High SVR Rates Following 8-Week Treatment With Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir in Patients With HCV Genotype 1b Infection  

Safety, Efficacy, and Clinical Outcomes in Hepatitis C Virus Genotype 1-Infected Patients Receiving Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir ± Ribavirin in the TOPAZ-I and TOPAZ-II Trials
Mar 6
Rarer HCV Types Still Need Attention
Genotype 1 HCV infection accounts for 75% of all HCV infection globally and was traditionally difficult to treat in the era of interferon. For these reasons, new direct-acting agents (DAAs) have mostly targeted genotype 1 infection. With the high cure rates afforded for genotype 1 HCV infection, we are now focusing attention on other genotypes. In particular, genotype 3 infection remains more challenging to treat as there may be baseline resistance to NS5A inhibitors, a type of DAA. Recently the first pan-genotypic agent effective against HCV genotypes 1-6 was approved. As more pan-genotypic agents become available, the specific HCV genotype may factor less into the treatment recommendations. For HCV genotypes that are more rare, such as genotypes 5 or 6, the experience with DAAs has been limited and more data are needed.

March 2
Clinical Care Options
Overview of treating HCV, a great starting point for anyone considering treatment.
In this module, Jordan J. Feld, MD, MPH, and Hemant Shah, MD, MScCH HPTE, review optimal strategies for managing patients with hepatitis C virus infection.            
Released: 3/2/2017
*Free registration is required to view updates

March 1
Genotype 3
Watch - Genotype 3 Infection - Identification of the Best Direct-Acting Antiviral Regimen for Patients With Hepatitis C Virus
Drs. Drenth and Berden discuss their manuscript Drs. Drenth and Berden discuss their manuscript "Identification of the Best Direct-Acting Antiviral Regimen for Patients With Hepatitis C Virus Genotype 3 Infection: A Systematic Review and Network Meta-analysis."

2017 February
Feb 27
Genotype 1
AbbVie Receives CHMP Positive Opinion for eight-week regimen of VIEKIRAX + EXVIERA for HCV genotype 1b
European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for a shorter, eight-week treatment of VIEKIRAX®

FDA
Genotype 4
On February 27, 2017 the TECHNIVIE  (fixed-dose combination of ombitasvir, paritaprevir, and ritonavir) label was updated to  expand the indication to patients with genotype 4 chronic hepatitis C virus infection (HCV) with compensated cirrhosis

Feb 24
Genotype 3
Hepatitis C Virus in mainland China with an emphasis on genotype and subtype distribution
The associations between HCV GTs and patients group, severity of illness and antiviral treatment efficacy were also discussed in this review

Feb 22
Genotype 1-6
Ontario Becomes First Province To List EPCLUSA™ On Public Drug Plan To Treat All Six Genotypes Of Chronic Hepatitis C Infection
Deal reduces price of life-saving hepatitis C drugs for Canadians
The list cost to the health system for hepatitis C treatment has ranged from $45,000 to over $100,000 per patient, depending on the drug and disease progression.  Agreements with the pCPA were reached with Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada to provide several hepatitis C drugs at an improved cost:
Daklinza (daclatasvir) – new
Epclusa (sofosbuvir/velpatasvir) – new
Harvoni (ledipasvir/sofosbuvir)
Sovaldi (sofosbuvir)
Sunvepra (asunaprevir) – new
Zepatier (elbasvir/grazoprevir) – new

PharmaCare is expanding the criteria in March 2017 to provide coverage to more patients living with hepatitis C. Physicians can apply for coverage of the new drugs on behalf of their patients on or around March 21, 2017. Starting in 2018-19, PharmaCare will provide coverage for any British Columbian living with chronic hepatitis C, regardless of the type or severity of their disease
Read it here.....

Download Accepted Article
Genotype 3
HIV infected & uninfected adults with non–GT 3 HCV have less hepatic steatosis than adults with neither infection

Feb 21
Genotype 1-6
Direct-acting combination antiviral therapies expected to be approved in 2017
Pangenotypic
Novel emerging treatments for hepatitis C infection: a fast-moving pipeline
This update reviews some upcoming therapies for the treatment of chronic hepatitis C

Genotype 1
HCV Genotype 1 No Longer a Treatment Bugbear
Treating patients with genotype 1 hepatitis C (HCV) can be rewarding because of a simple fact: modern direct-acting agents (DAAs) have a nearly 100 percent cure rate. Yet only four years ago, genotype 1 was considered the most difficult-to-treat type of HCV.
Back then, interferon regimens were used, and cure rates for genotype 1 hovered around 50 percent, while genotypes 2 and 3 were considered better treatment successes stories.

Feb 16
Genotype 1-6
Pan-genotypic Treatment Regimens for Hepatitis C Virus: Advantages and Disadvantages in High- and Low-income Regions
This review examines the challenges of developing pan-genotypic HCV direct-acting antiviral regimens, focusing on the context of regional differences in HCV genotype and socioeconomic factors.

Genotype 2
The Effectiveness of Ledipasvir/Sofosbuvir in the Treatment of Genotype 2 HCV
Atif Zaman, MD, MPH reviewing Gane EJ et al. Gastroenterology 2017 Jan 27.
In a phase II study, a 12-week course — but not an 8-week course — of LDV/SOF achieved a sustained viral response of greater than 90% at 12 weeks post-treatment.
Ledipasvir/sofosbuvir (LDV/SOF) is currently FDA approved for the treatment of genotypes 1 and 4 hepatitis C virus (HCV). Its effectiveness in genotype 2 HCV-infected patients is unknown, since reduced in vitro activity of LDV against genotype 2 HCV has hindered large-scale studies in this population (about 13% of HCV-infected patients globally).

In this phase II, manufacturer-sponsored, open-label study, investigators evaluated the efficacy of LDV/SOF in genotype 2 HCV-infected patients at two centers in New Zealand. An initial cohort was to receive daily LDV/SOF for 12 weeks, and if at least 90% achieved a sustained viral response (SVR; HCV RNA <15 IU/mL) at 4 weeks after therapy, a second cohort was enrolled to receive 8 weeks of daily LDV/SOF. The primary endpoint for both cohorts was an SVR 12 weeks after therapy (SVR12).

The study cohort included a total of 53 patients (77% HCV treatment naive), of whom 26 received 12 weeks of therapy. Only two participants had cirrhosis. All patients receiving 12 weeks of therapy achieved SVR12 except for one patient who received only one dose of drug before withdrawing consent. Among patients receiving 8 weeks of therapy, the SVR12 rate was only 74%. The most common adverse events were headache and fatigue, and none led to drug discontinuation.

Comment
This small phase II study demonstrates high efficacy of a 12-week course of LDV/SOF for the treatment of genotype 2 HCV-infected patients. Eight weeks of therapy appears to be inadequate, and it is unclear if 12 weeks will produce similar SVR rates among cirrhotic patients. If these results are replicated in phase III trials and the drug is determined to be effective in patients with cirrhosis as well, one of the most widely used and safe regimens for the treatment of HCV infection could be available to a large new population.

Abstract - Gane EJ et al. Efficacy of ledipasvir plus sofosbuvir for 8 or 12 weeks in patients with hepatitis C virus genotype 2 infection. Gastroenterology 2017 Jan 27; [e-pub]. (http://dx.doi.org/10.1053/j.gastro.2017.01.017)

 Feb 12
Case Report
Mixed Genotype 1 and 2
Successful Treatment of Mixed Hepatitis C Genotypes in a Cirrhotic Patient With an All-Oral, Interferon-Free Regimens
We present a case of mixed HCV genotype 1a and 2 infection in a decompensated cirrhotic patient treated successfully with sofosbuvir, ledipasvir, and ribavirin.

Feb 9
Genotype 3
Accepted manuscript online:
Daclatasvir+Sofosbuvir, With or Without Ribavirin, for HCV GT 3 in a French Early Access Programme
DCV+SOF achieved high SVR12 rates and was well tolerated in this large real-world cohort of GT3-infected patients with advanced liver disease, without benefit of ribavirin in those treated 24 weeks.
Now Online - Mar 9
Daclatasvir plus sofosbuvir, with or without ribavirin, for hepatitis C virus genotype 3 in a French early access programme

Of Interest
Generic ledipasvir-sofosbuvir for patients with chronic hepatitis C: a real-life observational study
The expensiveness of Harvoni® led to restrictions and access limitations in many developing and even developed countries with limited healthcare budgets. Gilead approved generic ledipasvir-sofosbuvir costs far less than Harvoni® and presents similar cure rate for patients with chronic hepatitis C.

Feb 8
All Genotypes - New Fact Sheets
New HCV fact sheets at TAG - Epclusa, HCV Genotypes, with updates on Viekira XR and Technivie

Feb 6
Genotype 1
Accepted manuscript online: 27 January 2017
Glecaprevir and Pibrentasvir for 12 Wks HCV Genotype 1 and Prior Direct-acting Antiviral Treatment
Media Coverage of this Article
Glecaprevir/pibrentasvir was highly effective and well tolerated for the treatment of hepatitis C virus genotype 1 infection in patients who previously failed treatment with direct-acting antivirals, according to the results of the phase 2 open-label MAGELLAN-1 study.

Genotype 3
Accepted author version posted online: 27 Jan 2017
Clinical characteristics, healthcare costs, and resource utilization in hepatitis C vary by genotype
These results suggest that liver disease progression varies by genotype and that CHC patients with GT3 appear to have more severe liver disease. These findings highlight the importance of effective HCV treatment for all patients and support guidelines for treatment of high-risk patients, including those with GT3.
Media Coverage of this Article

Feb 3
Full Text Article - Alimentary Pharmacology & Therapeutics.
All-oral direct-acting antiviral therapy in HCV-advanced liver disease is effective in real-world practice: observations through HCV-TARGET database
Media Coverage of this Article
DAA therapy effective in advanced liver disease in real-world study   
An all-oral, sofosbuvir-based therapy is a good option for hepatitis C virus (HCV) patients in genotype 1 or genotype 2 with advanced liver disease, according to a large observational, real-world study.... “Hepatitis C virus infection in those with advanced liver disease can be treated effectively with all-oral medications that are well tolerated and have high efficacy rate...  Successful treatment of HCV has led to a decrease in all-cause mortality and hepatocellular carcinoma, but it remains unknown whether this leads to improved liver function in those with advanced or decompensated liver disease.  
Continue Reading...

Feb 2
Genotype 1
Real-world Effectiveness for 12 Weeks of Ledipasvir-Sofosbuvir for Genotype 1 Hepatitis C
Does real-world experience with ledipasvir-sofosbuvir for genotype 1 HCV mirror the sustained viral response rates observed in clinical trials?

 Good Results for Real-World Treatment of Hep C in Those With Advanced Liver Disease
However, people with genotype 3 of the virus and advanced liver disease have particularly poor treatment results.

Genotype 1-6
U.S. FDA Grants Priority Review to AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P)

Newsletters
2017 February Hepatitis Newsletters - AbbVie's Glecaprevir/Pibrentasvir

January
Full Text Articles - Genotype 1, 4, and 6
Journal of Viral Hepatitis
January 2017

Jan 30
Genotype 4 - Fibrosis Progression
Prediction of Fibrosis Progression Rate in Patients with Chronic Hepatitis C Genotype 4: Role of Cirrhosis Risk Score and Host Factors

Genotype 6
Abstract
January 2017 Journal of Viral Hepatitis
Community-based real-world treatment outcomes of sofosbuvir/ledipasvir in Asians with chronic hepatitis C virus genotype 6 in the United States.
Media Coverage of this Article
Real-world DAA therapy shows gains in community setting
A combination of sofosbuvir and ledipasvir -- the first all-oral ribavirin-free treatment approved for chronic hepatitis C virus (HCV) genotype 6 -- offers a safe, highly efficacious treatment option even in a community-based, “real-world” setting, according to a new study.
Continue reading...

Genotype 3
Abstract
Week 4-response predicts sustained virologic response to all-oral direct-acting antiviral-based therapy in cirrhotic patients with hepatitis C virus genotype 3 infection

Jan 29
Genotype 1
Hepatitis C Treatment From “Response-guided” to “Resource-guided” therapy in the transition era from IFN-containing to IFN-free regimens
Accepted manuscript online: 26 January 2017

Jan 27
Genotype 3
New Genotype 3 Treatments - New HCV Treatments

Genotype 4
Full Text
Sofosbuvir in Combination with Simeprevir +/- Ribavirin in Genotype 4 Hepatitis C Patients with Advanced Fibrosis or Cirrhosis: A Real-World Experience from Belgium
Media Coverage of this Article
Combination Therapy Deemed Effective for Hepatitis C Genotype 4
Sofosbuvir and simeprevir, either with or without ribavirin, appears to be a safe and effective treatment for patients with hepatitis C genotype 4, according to a recent study.

Jan 26
Genotype 4
Hepatitis C Virus Genotype 4: Genotype 1's Little Brother
2017 Jan;24(1):4-12. doi: 10.1111/jvh.12620. Epub 2016 Dec 1.

Jan 24
Genotype 1-6
EMA grants accelerated assessment, validates marketing authorization application for AbbVie's HCV Regimen Glecaprevir/Pibrentasvir (G/P) for Major Genotypes (GT1-6)

Genotype 1 or 4
Treatment With Ledipasvir–Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection

Genotype 1-6
What's Hot in Gastroenterology - New Drug Classes Seek to Further Improve Already Favorable Outcomes in Hepatitis C

Jan 20
Genotype 1-6
EMA validates Gilead's marketing authorization application for Sofosbuvir/Velpatasvir/Voxilaprevir
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 20, 2017-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients has been fully validated and is now under assessment by the European Medicines Agency (EMA).

Genotype 3
Sovaldi-based regimens lead to high SVR rates in Egypt
Patients with hepatitis C virus infection in Egypt achieved rates of sustained virologic response at week 12 with Sovaldi-based regimens that were comparable to those demonstrated in phase 3 clinical trials, according to real-world study data.

HCV is one of the most significant health problems in Egypt, and accordingly, the country’s Ministry of Health National Treatment Programme “ensured that [Sovaldi; sofosbuvir, Gilead Sciences] became available in 2014 at prices appropriate for the scale of the epidemic of HCV and for the economic situation in Egypt,” investigators wrote. “Our aim was to assess the clinical effectiveness of the [sofosbuvir]-based treatment regimens,” — both dual and triple therapies — “and to demonstrate the predictors of response in our chronic HCV genotype 3 Egyptian patients.”

Jan 17
Genotype 3
Epclusa
Sofosbuvir with velpatasvir beat other HCV GT3 regimens
Publish date: January 30, 2017
By: Amy Karon Family Practice News
Regimens containing sofosbuvir and velpatasvir were most effective for treating both cirrhotic and noncirrhotic genotype 3 hepatitis C virus infection (HCV GT3), according to a meta-analysis reported in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.10.03).

Epclusa Most Effective for HCV Genotype 3 vs. Other DAAs
Researchers in the Netherlands found that Sovaldi plus velpatasvir, known as Epclusa in the United States, was the most effective regimen for the treatment of hepatitis C genotype 3 infection compared with other direct-acting antiviral regimens, according to published findings.

Jan 13
Genotype 3
Real-world use, effectiveness, safety of anti-viral treatment in chronic hepatitis C genotype 3
To validate the use, effectiveness and safety of anti-viral treatment in chronic hepatitis C genotype 3 infection under real-word conditions.

Genotype 1
Investigational HCV regimen highly effective in Japanese genotype-1 patients
Eight weeks of treatment with an investigational, ribavirin-free regimen of glecaprevir and pibrentasvir resulted in high rates of 12-week sustained virologic response…

Jan 11
Genotype 4
Full Text/Original Article Sofosbuvir-based treatment regimens: real life results of 14 409 chronic HCV genotype 4 patients in Egypt
To assess the clinical effectiveness and predictors of response to SOF-based treatment regimens, either dual therapy, with SOF/ribavirin (RBV) for 6 months or triple therapy with SOF/peg-IFN-alfa-2a/RBV for 3 months, in a cohort of patients treated in National Treatment Programme affiliated centres in Egypt.

Jan 9
Genotype 1
AbbVie's Regimen of Glecaprevir/Pibrentasvir (G/P) for HCV Achieved High SVR[12] Rates in Genotype 1
- 99 percent (n=105/106) of genotype 1 (GT1) chronic HCV-infected Japanese patients without cirrhosis achieved SVR[12] with 8 weeks of G/P

- Japan has one of the highest rates of hepatitis C infection in the industrialized world affecting approximately 1 million people, 60 to 70 percent of those GT1[1,2,3]

- Results demonstrated in CERTAIN-1 study are consistent with recently announced 8-week, GT1 data from the global registrational studies for G/P

Genotype 1,4, or 6
Healio - Zepatier highly effective for inducing SVR in HCV patients with prior treatment failure
Zepatier treatment for 12 weeks, with or without ribavirin, was highly effective for induction of sustained virologic response in patients infected with hepatitis C genotypes 1, 4 or 6, who failed prior peg-interferon and ribavirin treatments, according to the results of the C-EDGE Treatment Experienced trial. SVR12 was also achieved by patients with cirrhosis or a null response to previous treatment in this trial, and the treatment was generally well tolerated.

Genotype 1
Full Text
The effectiveness of daclatasvir based therapy in European patients with chronic hepatitis C and advanced liver disease
Received: 28 May 2016 Accepted: 10 December 2016 Published: 7 January 2017

Related Article
New Hope for Patients with Advanced Hepatitis C
Daclatasvir with sofosbuvir is an effective treatment for patients with hepatitis C who have a life expectancy of less than a year, according to a collaborative team of researchers.

Genotype 1
Short-term cost of interferon-free therapies for all HCV patients high yet cost-effective
A recent cost-effective analysis evaluating the value of interferon-free therapies for the treatment of hepatitis C virus infection genotype 1 revealed that administering less expensive regimens to non-cirrhotic patients and expensive yet more effective regimens to cirrhotic patients resulted in optimal outcomes for patients and insurers. Meanwhile, limiting treatment only to those with more advanced disease often resulted in poor outcomes, according to researchers.

Jan 8
Genotype 3
HCV: Fatty liver disease and genotype 3
In this post a collection of journal articles and videos reviewing HCV and fatty liver disease is offered; with a focus on individuals afflicted with both conditions. In addition given the development of steatosis (abnormal levels of fat in your liver) is higher in people with HCV and genotype 3, links are provided to current therapies in this difficult to cure genotype. Finishing off with several tips to help keep your liver healthy.

Jan 5
Genotype 1,3, and 4
Hepatitis C: efficacy and safety in real life
Key points
-Current real-world experience supports the use of either LDV/SOF±RBV or OBV/PTV/r±DSV±RBV in genotype 1 and 4 infected patients whatever the severity of fibrosis.
-HCV treatment history, HIV coinfection and previous liver or kidney transplantation do not influence the efficacy and safety of these two regimens.
-The efficacy of the SOF+SMV±RBV regimen was relatively low in real-world results.
-There is still not enough real-world data in patients infected with genotype 3 and other genotypes.

Jan 4
Genotype 1 or 2
All-Oral DAA Therapy in HCV-Advanced Liver Disease
Alimentary Pharmacology & Therapeutics, January 4, 2017
In summary, all-oral, sofosbuvir-based HCV therapy in GT1 or GT2 patients with advanced liver disease presents a good option. Real-life data on SVR are encouraging and helps in improvement in severity of liver disease in most patients. It is unclear, based on short follow-up period, what the long-term benefits might be, and what baseline and on-treatment predictors might address potential benefit vs. harm. Long-term follow-up is needed to more convincingly address the benefits of eradicating HCV infection in those with advanced liver disease. While ledipasvir, an NS5A inhibitor and sofosbuvir combination has been the treatment of choice in GT1 patients, this combination is unfortunately not available in several countries. Ledipasvir and sofosbuvir have worked effectively in patients with decompensated liver disease.[16,26] However, in some countries such as Brazil with a large hepatitis C population, sofosbuvir and simeprevir are available while ledipasvir is not and thus sofosbuvir and simeprevir combination serves as an effective therapeutic option. Furthermore, with the wide spread use of the NS5A and sofosbuvir combination, there has been the emergence of NS5A resistance, thus making the protease inhibitor, simeprevir and sofosbuvir a viable rescue strategy. Also these data are relevant to regions of the World, where generic sofosbuvir is available and potentially simeprevir can be used in combination with success

Jan 3
Genotype 1
Cost-Effectiveness of Treating Hepatitis C with Sofosbuvir/Ledipasvir in Germany
Our aim was to assess the long-term cost-effectiveness of treating hepatitis C genotype 1 patients with sofosbuvir/ledipasvir (SOF/LDV) treatment in Germany

Jan 1
Genotype 1
Ledipasvir-Sofosbuvir Effective for Chronic HCV in Adolescents
Dec. 30, 2016 (HealthDay News) -- For adolescents with chronic hepatitis C virus (HCV) genotype 1 infection, ledipasvir-sofosbuvir is highly effective, according to a study published online Dec. 20 in Hepatology.

Genotype 4
Efficacy of Sofosbuvir Plus Simeprevir for HCV Genotype 4
Journal of Viral Hepatitis, December 26, 2016
Discussion Only - Full Text Available @ Medscape
Free registration required
In real life, 92% of HCV genotype 4 patients with advanced fibrosis/compensated cirrhosis treated with SMV and SOF for 12 weeks achieved SVR. Real-life data on treatment with SMV and SOF in HCV genotype 4 patients are limited. Our data confirm that treatment with a combination of SMV and SOF for 12 weeks is a good option in HCV genotype 4 patients with advanced fibrosis or compensated cirrhosis. In our cohort, the four patients with virological failure did not receive RBV. Three of four failures were nonresponders to previous interferon-based therapy, and three of four were cirrhotic patients. Although the number of failures was very low, the addition of RBV could be considered in patients with cirrhosis and nonresponse to previous interferon-based therapy. Earlier studies in HCV genotype 1 patients to assess treatment success of a 12-week treatment regimen of SMV and SOF showed SVR rates of 83%–86%[4,15] in patients with advanced fibrosis/compensated cirrhosis. Recently, a real-world study showed similar SVR rates in HCV genotype 1 patients with cirrhosis treated with 12 weeks of SMV and SOF and no additional effectiveness of RBV.[16] Whether the addition of RBV in cirrhotic patients leads to a higher SVR rate in genotype 4 patients is not known. In our study cohort, all 12 patients who were treated with SMV, SOF and RBV achieved SVR, whereas the four patients with a viral relapse did not receive RBV. Although this difference was not statistically significant, there might be a place for the use of RBV in treatment-experienced HCV genotype 4 patients with advanced fibrosis/cirrhosis. Findings from a recent study in cirrhotic genotype 1 CHC patients treated with SOF/SMV showed a lower SVR rate of 79% in treatment-experienced patients compared to 88% in treatment-naïve patients.[15] There were no differences in comorbidity and comedication between the patients with and without SVR. Whether adherence to therapy may have been a factor remains the question, as we did not assess compliance in our study. A difference in SVR rates between patients with HCV/HIV co-infection and patients with HCV mono-infection with genotype 4 could not be assessed in our study cohort as only a small number of patients (n=4) had an HCV/HIV co-infection, of which all achieved SVR.
Limitations of our study are the relatively small number of included patients and the fact that the use of RBV was not randomized. As the addition of RBV was determined according to the discretion of the physician, there may be a bias towards RBV use in more severe cirrhotic patients and/or treatment-experienced patients. As a result, a reliable comparison between SVR rates in patients treated with or without RBV cannot be made.
Although there are currently more all-oral treatment options with DAAs available for genotype 4 HCV infection (such as ledipasvir/sofosbuvir, daclatasvir/sofosbuvir or paritaprevir/ombitasvir/ritonavir/ribavirin), it is worthwhile to have the combination of SMV and SOF (± RBV) as an efficacious treatment option. In various countries, not all of the mentioned combinations are registered or available and pricing upon which treatment regimen choices are made might differ.
In conclusion, in our real-life cohort, we showed that combination therapy for 12 weeks with SMV and SOF in patients with HCV genotype 4 infection and advanced fibrosis/compensated cirrhosis was an effective regimen, with an overall SVR rate of 92%. The effectiveness of adding RBV was unclear, but could be considered, as is recommended in recent AASLD and EASL guidelines for treatment-experienced and advanced cirrhosis patients.
Full Text Available

Genotype 1
Faldaprevir–Deleobuvir - Hepatitis C Virus Genotype-1b-Infected Patients w-Cirrhosis and Moderate Hepatic Impairment
In conclusion, in this small study in treatment-naïve and treatment-experienced patients with chronic HCV genotype-1b infection and mild or moderate hepatic impairment, the response to 24 weeks of treatment with faldaprevir, deleobuvir and ribavirin was not durable, with 74% of patients achieving SVR4 but only 57% achieving SVR12. Since this study was initiated, the HCV field has changed rapidly with the advent of new DAAs and all-oral DAA combinations. Because of this and based on the results of the phase 3 HCVerso1 and HCVerso2 trials [16], the development of the faldaprevir–deleobuvir combination has been terminated.

 Of Interest
Nov 28, 2016
Breakdown of Hepatitis C Genotype Distribution Around the World
Some of the different hepatitis C genotypes are more prominent in certain areas than others, and researchers specified where they're found around the world in people who inject drugs.

Take a look back at the top HCV news stories of 2016. Sit back and review a collection of hepatitis C research articles, guideline updates, conference reports, learning activities, and news from around the web.

 2016 Treating HCV according to genotype
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