2016-HCV Genotypes/Treatment 

2016 Archives
HCV Genotypes and Treatment
Offered on this page is research updates 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. 

December 2016
AbbVie Awaits NDA Approval For Hepatitis C Treatment
A New Drug Application (NDA) by AbbVie Inc (NYSE:ABBV) that will be used for the treatment of Hepatitis C is at the mercy the U.S. Food and Drug Administration. Glecaprevir/pibrentasvir (G/P), which will be in direct competition with another treatment from Gilead Sciences, Inc. (NASDAQ:GILD), has been submitted for an investigational pan-genotypic regimen. The application was supported by encouraging results that had been collected from over 2,300 patients in 27 countries who had used glecaprevir/pibrentasvir (G/P) regimen on trial basis.

Dec 14
Genotype 2
Longer Treatment Duration Cures More Patients with Hepatitis C Genotype 2 and Cirrhosis
Caitlyn Fitzpatrick
Increasing the duration of sofosbuvir/ribavirin treatment can cure more patients with hepatitis C genotype 2 with cirrhosis.

Dec 12
Genotype 1-6​
Sofosbuvir/velpatasvir: a pangenotypic drug to simplify HCV therapy

Dec 8
Genotype 1-6​
Gilead Submits New Drug Application to U.S. Food and Drug Administration for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir ​
- If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available as a Salvage Therapy for Patients Infected with HCV Genotype 1-6 Who Have Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors -

VIDEO: Pangenotypic regimen leads to high SVR in all HCV genotypes
December 2, 2016
Genotype 1 to 6
BOSTON — In this exclusive video at The Liver Meeting, Tom Podsadecki, head of antiviral research and development at AbbVie, discusses high sustained virologic…

Genotype 1
A phase 3, open-label study of daclatasvir plus asunaprevir in Asian patients with chronic hepatitis C virus genotype 1b infection who are ineligible for or intolerant to interferon alfa therapies with or without ribavirin
Daclatasvir plus asunaprevir achieved a SVR24 rate of 91.2%, rising to 98.6% in patients without baseline NS5A RAVs, and was generally well tolerated in interferon (±ribavirin)-ineligible or -intolerant patients with genotype 1b infection from mainland China, Korea, and Taiwan.

Full Text Article
​Nov 30
​Genotype 4
Simeprevir in combination with sofosbuvir in treatment-naïve and -experienced patients with hepatitis C virus genotype 4 infection: a Phase III, open-label, single-arm study (PLUTO)

​Nov 28
Genotype 1, 2, 4, 5, and 6 infection
Janssen has initiated phase IIb study of simeprevir, odalasvir and AL-335
The objectives of the phase IIb study are to investigate the efficacy, safety and pharmacokinetics of JNJ-4178/ AL-335 (800mg QD), odalasvir (25mg QD), and simeprevir (75mg QD) in treatment-naive and treatment-experienced non-cirrhotic subjects with chronic hepatitis C virus genotype 1, 2, 4, 5, and 6 infection.

​Of Interest
Mylan to produce and market a generic version of Bristol-Myers Squibb's DAKLINZA™ (daclatasvir) for low and middle income countries

Nov 28

Nov 22
Genotype 1 to 6
POLARIS-2: Voxilaprevir safe, effective with Epclusa in multiple HCV genotypes
BOSTON — A novel pangenotypic protease inhibitor, voxilaprevir, yielded encouraging outcomes when administered with Epclusa, regardless of HCV genotype or cirrhosis status, but remained non-inferior to the combination direct-acting antiviral, according to findings presented at The Liver Meeting 2016.
“Sof/vel/vox for 8 weeks resulted in a 95% SVR rate in DAA-naïve genotype 1 to 6 patients with or without cirrhosis,” Ira M. Jacobson, MD, chair of the department of medicine at Mount Sinai Beth Israel Medical Center and co-Chief Medical Editor for HCV Next, said during his presentation. “The regimen did not meet noninferiority as compared to the 98% SVR12 rate with sof/vel for 12 weeks and the difference between the regimens was largely attributed to more relapses amongst patients with genotype 1a infection in the sof/vel/vox group.”.......

Genotype 1 or 4
Treatment With Ledipasvir–Sofosbuvir for 12 o r24Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection

Genotype 3
(Epclusa) Sofosbuvir plus velpatasvir “best options” for HCV G3
An analysis of published studies on direct acting antivirals (DAAs) found that regimens containing sofosbuvir and velpatasvir were the best option for patients with HCV genotype three (G3).
The analysis indicated that ribavirin significantly increased rates of SVR and should be considered if tolerated.

Pan-genotypic treatment regimens for hepatitis C virus: Advantages and disadvantages in high- and low-income regions
This review considers key data and treatment guidelines for DAA therapies, including pan-genotypic combination regimens, in the context of regional differences in HCV genotype and socio-economic factors.​

Nov 18
AASLD 2016 Review - Watch Advances in Chronic Hepatitis C: Management and Treatment
The review and discussion will focus on HCV therapeutic options and developments, including: current treatment and management strategies, algorithms and recommendations; therapies in development; epidemiology; and diagnosis and clinical management of specific patient populations, including HCV/HIV co-infected and cirrhotic patients.

Upcoming hepatitis C clinical trial - Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

Nov 17
​Genotype 3
Adding Voxilaprevir to Sofosbuvir/Velpatasvir Effective for HCV Genotype 3: Presented at AASLD
​BOSTON -- November 17, 2016 -- Adding voxilaprevir to the combination tablet containing sofosbuvir and velpatasvir (Epclusa) for 8 weeks shows similar efficacy to sofosbuvir/velpatasvir alone for 12 weeks in the treatment of patients with hepatitis C virus (HCV) genotype 3 and cirrhosis.

Genotype 3
AASLD 2016 Grazoprevir/elbasvir (Zepatier) plus sofosbuvir (Sovaldi) highly effective for hard-to-treat genotype 3 hepatitis C patients
A triple regimen of grazoprevir/elbasvir (Zepatier) plus sofosbuvir (Sovaldi) without ribavirin cured 96% of previously untreated and 97% of treatment-experienced people with hepatitis C virus (HCV) genotype 3 and liver cirrhosis, matching

Genotype 3
NATAP ​- Reported by Jules Levin review slides​

Genotypes 1
Nov 16
VIDEO: ENDURANCE-1 shows 99% SVR in patients with HCV/HIV
November 16, 2016
In this exclusive video from The Liver Meeting, Stefan Zeuzem, MD, chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany, discusses results of the ENDURANCE-1 clinical trial where a treatment regimen of glecaprevir/pibrentasvir (G/P) yielded high sustained virologic response rates in patients with hepatitis C genotype 1 after 8 weeks of treatment.​

Nov 15
Genotype 1,2, or 3
VIDEO: C-CREST-1 trial shows fixed-dose combo effective at 8 weeks for HCV
BOSTON — In this exclusive video from The Liver Meeting, Eric J. Lawitz, MD, vice president of scientific and research development at The Texas Liver Institute and clinical professor of medicine at the University of Texas Health Science Center, discusses results of the C-CREST-1 clinical study where treatment-naive patients with hepatitis C genotype 1, 2 and 3 infection showed high sustained virologic response rates after treatment with MK-3682, MK-8408 and grazoprevir.

​Genotype 1
NATAP ​- Reported by Jules Levin review slides​
Final Results From Phase 3 Portion in Phase 2/3 Study of Elbasvir/Grazoprevir in Hepatitis C Genotype 1-Infected Japanese Patients - (11/14/16)

NATAP ​- Reported by Jules Levin review slides​​
High Efficacy in Patients With Chronic Hepatitis C Virus (HCV) Genotype 1b Infection Treated with Elbasvir/Grazoprevir for 12 Weeks: An Integrated Analysis - (11/14/16)

​Genotype 1 or 4
AASLD 2016 Merck Presentation - New Findings for ZEPATIER (Elbasvir and Grazoprevir) in Patients with Chronic Hepatitis C
Merck announced results from multiple analyses at The Liver Meeting® 2016, which provide additional evidence supporting the use of ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg tablets in chronic hepatitis C virus (HCV) genotype (GT) 1- or GT4-infected patient populations, including those who receive opioid agonist therapy (OAT), are infected with chronic HCV GT1b, use proton pump inhibitors (PPIs) or have moderate kidney disease.

​Genotype 4,5, and 6
Glecaprevir/Pibrentasvir Achieves High SVR12 Rates in Non-cirrhotic HCV GT 4-6
By Debra Hughes, MS
The all-oral, ribavirin-free glecaprevir/pibrentasvir regimen achieved high SVR12 rates in non-cirrhotic patients with hepatitis C virus (HCV) genotype (GT) 4, 5, and 6 infection, the phase 3 ENDURANCE-4 study concluded at The Liver Meeting® 2016.

Genotype 4
SOF-based Regimens Offer New Options for Patients with HCV GT4
By Bryant Furlow
The sofosbuvir/ribavirin, ledipasvir/sofosbuvir, and sofosbuvir/velpatasvir regimens “may offer important new therapeutic options” for patients with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection, according to an integrated analysis reported at The Liver Meeting® 2016. Globally, GT4 HCV accounts for nearly 15% of all HCV infections and is the dominant genotype in Egypt and some regions of sub-Saharan Africa.

Nov 14
​Genotypes 1 - 6
SOF/VEL/VOX Effective as Retreatment for Non-NS5A DAA Failures
By Debra Hughes, MS November 14, 2016
Treatment with single tablet sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for 12 weeks "is a highly effective salvage therapy" for patients who did not previously achieve sustained virologic response (SVR) following treatment with non-NS5A inhibitor-containing direct-acting antivirals (DAAs), results from the POLARIS-4 study presented at The Liver Meeting® 2016 have shown. The investigators conducted an open-label, randomized, active-comparator Phase 3 study to evaluate SOF/VEL/VOX compared to SOF/VEL in DAA-experienced patients with hepatitis C virus (HCV) infection with genotypes 1-6 who had not previously received an NS5A inhibitor. The contribution of the components of the three-drug regimen was also explored.

NATAP ​- Reported by Jules Levin review slides
Sofosbuvir/Velpatasvir/Voxilaprevir or Sofosbuvir/Velpatasvir
A Randomized, Controlled, Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir or Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Patients With Genotype 1-6 HCV Infection: The POLARIS-4 Study - (11/14/16)​

Nov 13
Genotype 1,2, or 3
AASLD 2016 Merck's HCV Triple-Combination High Rates of SVR In Genotypes 1, 2 or 3 Infection
Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced the presentation of results from three Phase 2 clinical trials evaluating MK-3682B (MK-3682/grazoprevir/ruzasvir1), the company’s investigational all-oral, triple-combination regimen for the treatment of chronic hepatitis C (HCV) infection (informally referred to as MK3).​

Genotype 2,4,5, and 6
Glecaprevir/Pibrentasvir: High SVR Rates in HCV GT 2, 4, 5, 6 Without Cirrhosis
By Debra Hughes, MS
Patients with chronic hepatitis C virus (HCV) genotypes (GT) 2, 4, 5, or 6 infection without cirrhosis had SVR12 rates of 97% after 8 weeks of treatment with co-formulated glecaprevir/pibrentasvir, investigators from the SURVEYOR-II, Part 4, concluded at The Liver Meeting® 2016.

Nov 12
​Genotype 2 and 3
Sofosbuvir + Ribavirin Effective in Teens With HCV GT 2/3
For adolescents with chronic hepatitis C virus (HCV) infection, treatment with sofosbuvir (SOF) and ribavirin (RBV) led to a 98% SVR12 rate with no virologic failures, reported Kathleen B. Schwarz, MD, a professor of pediatrics at Johns Hopkins University School of Medicine, Baltimore, MD, at The Liver Meeting® 2016.

​Genotype 1
Significant QoL Improvement With LDV/SOF in Adolescents With HCV GT1
Ledipasvir plus sofosbuvir treatment improved HCV-positive adolescents' quality of life during and after achieving sustained virologic response.
​Genotype 1
6-Week SOF/LDV Therapy Found Effective in Acute HCV Genotype 1
At The Liver Meeting® 2016, scientists reported that treatment with ledipasvir/sofosbuvir (LDV/SOF) for 6 weeks was well tolerated and highly effective in patients with acute hepatitis C virus (HCV) GT 1 infection.

Nov 11
All Genotypes
Update AbbVie's Glecaprevir/Pibrentasvir (G/P) Acheive High SVR12 Rates at 8 Wks Genotypes 1-6
Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates Across All Major Genotypes of Chronic Hepatitis C

- 97.5 percent of chronic HCV infected patients without cirrhosis and new to treatment across all major genotypes (GT1-6) achieved SVR12 with 8 weeks of G/P

- Across the 8-week arms of three registrational studies, no patients discontinued treatment due to adverse events

- G/P is an investigational, pan-genotypic, once-daily, ribavirin-free regimen for the treatment of chronic HCV​

Nov 10
Genotype 1
Commentary Is stronger better in curing hepatitis C virus infection?
Thanks to a better understanding of the hepatitis C virus (HCV) life-cycle, HCV direct-acting antiviral agents (DAAs) targeting the viral proteins implicated in the virus replication have been developed: they inhibit specifically the NS3/4A protease, the NS5B polymerase and the multifunctional NS5A replication complex (1). DAAs have revolutionized the treatment of HCV infection over the last 5 years. Oral interferon-free combinations of at least two DAAs showed high antiviral efficacy, easy dosing, fair tolerance, and manageable drug-drug interactions, whatever the combination for treatment duration of 8, 12 or 24 weeks according to the patients profile.

Of Interest
Meeting Coverage AASLD: HCV Outcomes Under Scrutiny Treatment now 'predictably' good in trials but what about real world?

All Genotypes
IDWeek 2016: New Triple DAA Combo Cures 96%-99% of People with Genotype 1-6 Hepatitis C
​Gilead Sciences is testing a new 3-drug regimen combining agents from 3 different classes: the previously approved HCV polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the investigational protease inhibitor voxilaprevir (formerly GS-9857).

Of Interest
Nov 8
Watch - An Introduction to Access to Generic Hepatitis C Medicines
The webinar explored the generics landscape for hepatitis C with discussions on legalities, quality and performance of generics medicines as well as providing examples of how people across the globe are accessing them.​

​Nov 7
​All Genotypes​
Concise review: Interferon-free treatment of hepatitis C virus-associated cirrhosis and liver graft infection
Chronic hepatitis C is a major reason for development of cirrhosis and a leading cause for liver transplantation. The development of direct-acting antiviral agents (DAA) offered new therapeutic options for patients with advanced cirrhosis and liver graft recipients. This review gives a high topical summary of most current therapeutic options of DAA-based antiviral therapy in patients with hepatitis C virus associated cirrhosis before and after liver transplantation.

Nov 4
​All Genotypes​
Reported by Jules Levin
IDWeek Oct 26-30
New Orleans 2016
Sofosbuvir/Velpatasvir Plus Voxilaprevir for 6, 8, or 12 Weeks in Genotype 1-6 HCV-infected Patients: An Integrated Analysis of Safety and Efficacy from Two Phase 2 Studies

October Oct 27
Of Interest
All Genotypes​
Generic hepatitis C drugs purchased online achieve high cure rates
27 October 2016

Oct 26
​All GenotypesGastroenterology & Endoscopy News
The Changing HCV Landscape: Update on Treatment
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.

Oct 24
​Genotype 1 and 3
Short-duration Treatment With Elbasvir/Grazoprevir and Sofosbuvir for Hepatitis C: A Randomized Trial
This clinical study is the first to examine the treatment of patients infected with HCV GT1 or GT3 with or without cirrhosis with short durations of a novel regimen of EBR/GZR + SOF. Our data confirm that cirrhotic and noncirrhotic patients with HCV GT1 infection can be cured with 6–8 weeks of treatment, and that an 8–12 week regimen of EBR/GZR + SOF is safe and effective in cirrhotic and noncirrhotic patients with HCV GT3 infection, commonly regarded as one of the
most challenging patient populations to treat..

Oct 17
Genotype 3
Infection With Hepatitis C Virus Genotype 3 is an Independent Risk Factor for End-stage Liver Disease, Hepatocellular Carcinoma, and Liver-related Death.Clin Gastroenterol Hepatol. 2016 Oct 17. pii: S1542-3565(16)30929-6. doi: 10.1016/j.cgh.2016.10.012.
[Epub ahead of print]
McMahon BJ1, Bruden D2, Townshend-Bulson L3, Simons B3, Spradling P4, Livingston S3, Gove J3, Hewitt A3, Plotnik J3, Homan C3, Espera H3, Negus S3, Snowball M3, Barbour Y3, Bruce M2, Gounder P2.Abstract
​Few studies have examined factors associated with disease progression in hepatitis C virus (HCV) infection. We examined the association of 11 risk factors with adverse outcomes in a population-based prospective cohort observational study of Alaska Native/American Indian persons with chronic HCV infection.
We collected data from a population-based cohort study of liver-related adverse outcomes of infection in American Indian/Alaska Native persons with chronic HCV living in Alaska, recruited from 1995 through 2012. We calculated adjusted hazard ratios (aHR) and 95% CIs for end-stage liver disease (ESLD; presence of ascites, esophageal varices, hepatic encephalopathy, or coagulopathy), hepatocellular carcinoma (HCC), and liver-related death using a Cox proportional hazards model.
We enrolled 1080 participants followed for 11,171 person-years (mean, 10.3 years); 66%, 19%, and 14% were infected with HCV genotypes 1, 2, and 3, respectively. On multivariate analysis, persons infected with HCV genotype 3 had a significantly increased risk of developing all 3 adverse outcomes. Their aHR for ESLD was 2.1 (95% CI, 1.5-3.0), aHR for HCC was 3.1 (95% CI, 1.4-6.6), and aHR for liver-related death was 2.4 (95% CI, 1.5-4.0) compared to genotype 1. Heavy alcohol use was an age-adjusted risk factor for ESLD (aHR, 2.2; 95% CI, 1.6-3.2), and liver-related death (aHR: 2.9; 95% CI, 1.8-4.6). Obesity was a risk factor for ESLD (aHR, 1.4; 95% CI, 1.0-1.9, and diabetes was a risk factor for ESLD (aHR, 1.5; 95% CI, 1.1-2.2). Male sex was a risk factor for HCC (aHR, 3.6; 95% CI, 1.6-8.2).
In a population-based cohort study of American Indian/Alaska Native persons with chronic HCV infection, we found those infected with HCV genotype 3 to be at high risk for ESLD, HCC, and liver-related death.
Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.
KEYWORDS: AK-HEPC; American Indian/ Alaska Native; Hepatitis C Outcome; liver cancer risk
PMID: 27765729
DOI: 10.1016/j.cgh.2016.10.012

Oct 20
Genotype 1-6
Gilead SVR12 Rates SOF/VEL/VOX; (GS-9857), Treatment-Naïve/Treatment-Experienced HCV Geno 1-6
Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients
- If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available for Salvage for Patients Who Have Failed Prior HCV Therapy with Oral Direct-Acting Antiviral Agent Regimens -
- U.S. NDA Planned for Q4 2016 -
Gilead Sciences, Inc. (NASDAQ: GILD) today announced topline results from four international Phase 3 clinical studies (POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4) evaluating an investigational, once-daily, fixed-dose combination of sofosbuvir (SOF), a nucleotide analog NS5B polymerase inhibitor; velpatasvir (VEL), a pangenotypic NS5A inhibitor; and voxilaprevir (VOX; GS-9857), an investigational pangenotypic NS3/4A protease inhibitor, for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.

Oct 18
​Genotype 2
​Full Text ArticleSafety, Tolerability, and Efficacy of Sofosbuvir Plus Ribavirin in Elderly Patients Infected with Hepatitis C Virus Genotype 2
AbstractBackground: An interferon-free regimen including sofosbuvir and ribavirin (RBV) for patients with hepatitis C virus (HCV) genotype 2 (G2) infection leads to a drastic improvement of sustained virological response (SVR). However, the safety, tolerability, and efficacy in patients aged 75 or older have not been completely understood.Summary: Fifty-six patients with HCV G2 infection who were treated with sofosbuvir and weight-based dose of RBV were enrolled. Thirty-seven patients aged ≥75 and 19 patients aged ≤74 were classified as the aged and non-aged groups, respectively. The aged group was characterized by significantly more number of women, history of hepatocellular carcinoma, low serum albumin (ALB) level, low hemoglobin (Hb) concentration, low estimated glomerular filtration rate (eGFR), and high fibrosis-4 index (p = 0.0029). Forty-one patients were evaluated for SVR at 12 weeks after the end of therapy (SVR12); of them, all but one completed the treatment scheduled for 12 weeks. The aged group showed lower SVR12 rate than the non-aged group (81.3% for aged and 96.0% for non-aged groups). Although the Hb concentration and eGFR are significantly lower in the aged group throughout the clinical course, all patients in the aged group completed the 12-week treatment with a gradual increase of serum ALB level.Key Messages: The combination of sofosbuvir plus RBV is tolerable and beneficial in patients aged >75. However, intensive management of anemia by dose reduction of RBV is necessary, which could lead to a low SVR12 rate compared to that observed in patients younger than 75 years.
Dig Dis 2016;34:632-639
Download Full Text Article, here....

Oct 6
Genotype 1, 4 and 6
Effectiveness of Elbasvir and Grazoprevir, With or Without Ribavirin, Treatment-Experienced Patients with Chronic Hepatitis C Infection
The combination tablet of elbasvir and grazoprevir, with or without ribavirin, was highly efficacious in inducing an SVR12 in patients with HCV genotype 1, 4, or 6 infection failed by previous treatment with peg-interferon and ribavirin, including patients with cirrhosis and/or a prior null response

Zepatier less costly, more effective than Harvoni, Epclusa for Hepatitis C
​According to recent research presented at AMCP Nexus 2016, hepatitis C genotype 1 treatment with Zepatier (elbasvir/grazoprevir; Merck) was more effective and less expensive when compared to Harvoni (ledipasvir/sofosbuvir; Gilead) and Epclusa‎ (sofosbuvir/velpatasvir; Gilead).

New hepatitis C product covers all six genotypes
When asked about the current HCV market and evidence-based treatment recommendations to manage this disease, C. Wayne Weart, PharmD, BCPS, FASHP, FAPhA, a professor of clinical pharmacy and outcome sciences at South Carolina College of Pharmacy, told Pharmacy Today that, based upon the updated guidelines from July 2016 and the new FDA-approved hepatitis C once-a-day, single-pill medications, “I am suggesting that the following agents replace ledipasvir and sofosbuvir (Harvoni—Gilead), which costs approximately $95,000 for 12 weeks of therapy and even more if you need 24 weeks of therapy. The most cost-effective therapy for patients who are candidates for and can take it would be Merck’s elbasvir and grazoprevir tablets (Zepatier).” According to Weart, the cost is approximately $55,000 for 12 weeks of therapy.Weart recommended that treatment-naive patients with no cirrhosis and genotype 1a infection undergo testing for virus with NS5A resistance–associated variant polymorphisms (RAVs) to determine the best therapy. If no baseline NS5A RAVs are present, monotherapy for 12 weeks with elbasvir and grazoprevir should be given, but if baseline NS5A RAVs are present, ribavirin should be added to 16 weeks of treatment with elbasvir and grazoprevir. Patients with genotype 1b or 4 should receive elbasvir and grazoprevir once daily for 12 weeks.
“For those with genotypes 2, 3, 5, and 6, I would recommend this new therapy, sofosbuvir and velpatasvir, to be given for 12 weeks, which comes in at an approximate cost of $75,000,” said Weart.
Continue reading..

Hepatitis C drugs now effective for most genotypes
There are two or three options for the treatment of genotypes one and four. Currently, one treatment is preferred for genotype 3 (sofosbuvir and daclatasvir are used — with or without ribavirin depending on whether the patient has cirrhosis). Newer agents held out the prospect of further options, said Dr Feeney.

Oct 5
Of Interest
European regulator limits some Gilead hep C patent claims
By Ed Silverman @Pharmalot
In a setback for Gilead Sciences, European regulators decided not to uphold all of its patent claims for the best-selling Sovaldi hepatitis C treatment, a move that could lead to generic versions of the medicine becoming available four years sooner than had been expected.

Oct 4
​Genotype 1-4 and 6
Hepatitis C Therapy: Game Over!
Alessio Aghemo, Maria Buti
DOI: http://dx.doi.org/10.1053/j.gastro.2016.09.034
Publication stage: In Press Accepted Manuscript
Published online: October 1, 2016
NS5B polymerase inhibitor sofosbuvir, NS5A inhibitor velpatasvir, and the new protease inhibitor GS-9857 (voxilaprevir)Download PDF

​Genotype 1
Strategy-based approach to treatment of genotype 1 chronic hepatitis C
The most recent issue of the Journal of Gastroenterology & Hepatology examines the cost-effectiveness of a strategy-based approach to treatment of genotype 1 chronic hepatitis C.September

Sept 29
Genotype 4
Review article on management of hepatitis C genotype 4 in the DAA
Genotype 4 chronic hepatitis C (G4 HCV) accounts for 13% of worldwide HCV infections; with 10 million people infected with the virus across the world. Up to the end of 2013, the only treatment option for G4 HCV was treatment with pegylated interferon and ribavirin for 24–48weeks. Since late 2013, treatment of G4 HCV has been transformed by the licensing of many directly acting antiviral agents (DAA). It is an exciting time to be involved in the management of HCV generally and G4 particularly. Interferon-free DAA regimens are now a reality for G4 HCV. This review will highlight these developments and discuss the data behind the use of these drugs. It will also highlight future regimens that are likely to be available over the coming years.

​Genotype 1
Targeted HCV patients improve on sofosbuvir/daclatasvir combination
Author: Heidi Splete
A combination of sofosbuvir/daclatasvir yielded sustained virological responses at 12 weeks after the last treatment in 95...

​Sept 28
Hepatitis C Treatment and Barriers to Eradication
Although current therapies are highly efficacious, simple, and well-tolerated for most patients, there are gaps in existing therapies. These include suboptimal SVR rates in patients with HCV genotype 3 infection and patients with child C cirrhosis of any genotype. Fortunately, the recent approval of SOF/velpatasvir has in large part addressed gaps in efficacy for patients with genotype 3 infection.11, 12 Patients with end-stage renal disease had until recently remained a subgroup with very limited treatment options, but the approval of daclatasvir and EBR/GZR has been a significant breakthrough for patients with genotype 1 and 4 infections. Impaired renal function remains a significant limitation in therapeutic treatment options for patients with genotype 2, 3, 5, or 6. Treating patients with decompensated cirrhosis remains complex, given their baseline tenuous hepatic function; therefore, it is recommended that they are managed in a liver transplant center.1 Therapeutic options are more restricted for patients with decompensated cirrhosis because several DAAs (simeprevir, dasabuvir, GZR, and EBR) are not approved for use in patients with child B or C cirrhosis, and there is a Food and Drug Administration warning against the use of paritaprevir/ritonavir/ombitasvir. These additional complexities have led to a debate whether treatment should be deferred until after liver transplant as several DAA combination regimens with minimal drug interactions with calcineurin inhibitors are available. On the other hand, SVR has been associated with improvement in liver function and decrease in model for end-stage liver disease score in patients with decompensated cirrhosis, raising the possibility that treatment in the pretransplant setting may obviate the need for transplant.

Sept 27
Genotype 6
Community-based real-world treatment outcomes of sofosbuvir/ledipasvir in Asians with chronic hepatitis C virus genotype 6 in the United States.
Among the largest U.S. community-based real-world cohort of Asian chronic HCV genotype 6 patients treated with all-oral SOF/LDV without ribavirin, SVR12 was similar to SVR12 reported in clinical trials, confirming the safety and effectiveness of this regimen and validating current HCV genotype 6 treatment guideline recommendations.

​Sept 26
Six weeks sofosbuvir plus ribavirin is not effective in HCV
News Type: Clinical News
While six weeks of sofosbuvir and ribavirin therapy was safe and well tolerated in HCV patients, its efficacy was sub-optimal, a study concluded. In this open-label study conducted in Australia and New Zealand, 19 adults with recent HCV (68% genotype 1; duration of infection median 37 weeks) received sofosbuvir 400mg daily and weight-based ribavirin for six weeks.
Four reported a symptomatic HCV seroconversion illness, including two with jaundice. At baseline, the median HCV RNA was 5.4 log10 IU/mL and at the end-of-treatment, it was non-quantifiable in 89%. SVR4 and SVR12 were 42% and 32%, respectively. Treatment failure was because of non-response in two, post-treatment relapse in nine, re-infection in one, and with one loss to follow up.
The regimen was well tolerated with minimal haematological toxicity. SVR12 was related to baseline HCV RNA (≤6 log10 IU/mL, p=0.018) and early on-treatment viral kinetics.
The researchers suggest that further research is needed to determine whether more potent interferon-free direct-acting antiviral regimens will allow treatment duration to be shortened in recent, predominantly asymptomatic, HCV infection.
Reference - Sofosbuvir and ribavirin for six weeks is not effective among people with recent HCV infection: The DARE-C II study.
Martinello M, Gane E, Hellard M et al. Hepatology. 2016 Sep 17 [Epub ahead of print]

​Podcast - Genotype 2 and 3
Management of HCV Genotype 2 and 3 Treatment - Naive and Treatment - Experienced Patients
This podcast will discuss the strategies for treating treatment-naive and treatment-experienced patients who have HCV genotype 2 and 3. Listen to the podcast here, and download or view slides to the presentation, here.
Presented by An Intensive Workshop on Evolving Strategies in Hepatitis C Management in Sept 2016.

Sept 23
Summary Presentation - EASL Recommendations on Treatment of Hepatitis C 2016
Watch the livestreamed EASL updated HCV recommendations with a follow-up Q&A session.

Pacific Hep C Network has published a few key topics on hepatitis C treatment presented at the Paris conference.
​Highlights included treatment approach for HCV genotype 2,3, and 4-6.
(Part I)
​(Part 2)

AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C
98 percent of previously untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected patients without cirrhosis achieved SVR12 in Phase 3b GARNET study1
- First study evaluating 8 weeks of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets)
- GARNET study results on 8-week treatment duration included in newly published 'EASL Recommendations on Treatment of Hepatitis C

Epclusa - NICE says yes to another hepatitis C drug
NICE has published new draft guidance which recommends sofosbuvir-velpatasvir – an anti-viral drug that offers patients with chronic hepatitis C a potential cure.

​Of Interest
Epidemiology and Outcomes of Hepatitis C Infection in Elderly US Veterans
Patients with hepatitis C infection are getting older in the United States, yet are underrepresented in clinical trials. How does age impact outcomes with and without antiviral treatment?​

​Sept 21
Hepatitis Australia - Pharmaceutical Benefits Advisory
​Hepatitis Australia will be gathering information from people living with hepatitis C who will benefit from the latest medicines to be considered by the Pharmaceutical Benefits Advisory Committee. In particular we would like input from people living with hepatitis C genotypes 2, 3, 4, 5 and 6. ​

Genotype 1b
Ultrashort treatments may benefit some patients with HCV
Cornberg M and Manns MP. Lancet Gastroenterol Hepatol. 2016:doi:1016/S2468-1253(16)30029-2.
Lau G, et al. Lancet Gastroenterol Hepatol. 2016:doi:10.1016/S2468-1253(16)30015-2.
“No one expected that even 4 weeks of treatment would be sufficient. All previous studies had failed,” Raymond F. Schinazi, PhD, DSc, the Frances Winship Walters Professor of Pediatrics at Emory University School of Medicine, Atlanta, Ga., told Healio.com/Hepatology.
Continue reading....

Genotype 4
Rapid Virological Response After Early Treatment with a Combined Therapy of Ledipasvir and Sofosbuvir in HCV Genotype 4 After Living Donor Liver Transplantation in a HCC Downstaged
Patient: Case Report and Review of the Literature
Aiman Obed, Abdalla Bashir, Anwar Jarrad Am J Case Rep 2016; 17:672-675 DOI: 10.12659/AJCR.898594
Published: 2016-09-20
BACKGROUND: Hepatitis C virus (HCV) genotype 4 (GT-4) is widespread in the Middle East, where it is responsible for the majority of HCV infections. It shows moderate treatment response rates when compared to other genotypes in the current era of interferon-based regimens. However, in the era of direct acting antiviral (DAA) drugs, its response is at least as good as observed for HCV genotypes 1-3.
CASE REPORT: We present a case of a 44-year-old patient with HCV cirrhosis. Since 2007, he has been treated for HCV infection with multiple ineffective regimens of interferon (INF) and ribavirin. A liver biopsy in 2010 revealed stage 5-6/6 indicating cirrhosis, which was later complicated by the occurrence of portal vein thrombosis and a large hepatocellular carcinoma (HCC) (maximum diameter 9 cm).
The patient was successfully treated with sorafenib, transcatheter arterial chemoembolization (TACE), and radiofrequency ablation. After four TACE procedures, the patient’s AFP (alpha-fetoprotein) decreased remarkably and almost normalized. The HCC disappeared radiologically as shown by triple phase CT, MRI with contrast, and PET-CT.
He successfully underwent a living donor liver transplantation. Four weeks post liver transplantation he started treatment with sorafenib, and switched from tacrolimus to Rapamune (sirolimus) as immunosuppressant therapy. Ten weeks after liver transplantation, HCV treatment was introduced along with ledipasvir and sofosbuvir due to his increasing liver enzyme levels. A rapid viral response was achieved after 14 days. In total, the patient received 12 weeks of this treatment.
CONCLUSIONS: This case study might be of significance in informing early management and personalized treatment of patients with recurrent HCV GT-4 infections after liver transplantation, even in complex clinical surroundings.
Download PDF

Sept 9
EASL/AASLD2016 - Achillion Reports 100% SVR In Phase2a Trial:Odalasvir, AL-335, and Simeprevir for Geno 1 Treatment-Naive
This phase 2a study was designed to determine the pharmacokinetics, efficacy and safety of ODV and AL-335 with or without SMV, in treatment naïve patients with GT1 or 3 HCV infection for treatment durations of eight weeks or less.

Sept 7
​Geno 1
Hepatitis C Drug Regimen Simplifies Treatment
Viekira XR is intended for people with chronic genotype 1 hepatitis C, however, unlike Viekira Pak, it is not intended for people with decompensated cirrhosis. This is the first co-formulated three direct-acting antiviral (DAA) treatment approved for this population.

​August 2016
Aug 31
​Geno 3
MD Magazine August/ RNA Assessment Predicts Hepatitis C Relapse Two Weeks into Treatment
Published in the Journal of Hepatology, the results showed that hepatitis C RNA levels in people with HCV genotype 3 who achieved sustained virologic response (SVR) were significantly lower during the first four weeks of SOF/RBV treatment than the levels observed in those who ended up relapsing.

Aug 26
Geno 1, 2, 3, or 4
Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of Patients With Hepatitis C in the Veterans Affairs National Health Care System
We investigated the real-world effectiveness of sofosbuvir, ledipasvir/sofosbuvir, and paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD) in treatment of different subgroups of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, or 4.

Aug 21
Link To: The Current treatment recommendations in HCV liver transplant recipients

Aug 18
Are Pan-Genotypics a Panacea for HCV?
"We should be giving the best regimen to whatever patients need it," he said. "It costs a lot of money to the healthcare systems to wait before one initiates therapy, as people will get sick from a multitude of things."
Meanwhile, the pan-genotypic HCV drug list is growing quickly.

Aug 5
​Geno 1-4
GS-9857 in Patients With Chronic Hepatitis C Virus Genotype 1–4 Infection

Geno 3
HCV Therapy of Genotype 3: Is It Still a Challenge?
Published on07/22/2016
By Ramakrishna Behara and Nancy Reau
Hepatitis C genotype 3 accounts for 30 percent of all infections secondary to hepatitis C and is the second most common genotype worldwide, behind genotype 1. Estimates report that in the U.S., it accounts for 8 to 13 percent of infections. Historically, genotype 3 has been uniquely challenging to manage in large part due to lower response to therapy combined with high rates of steatosis, fibrosis progression and a disproportionately high rate of hepatocellular carcinoma. With the launch of the first wave of interferon-free treatment, many of the direct-acting antivirals (DAA) had higher overall sustained virologic response (SVR) to genotype 3 but did not compare to the SVR rate for treatments approved for genotype 1. Thus, recent drug development has focused on pan-genotypic agents to equalize efficacy across all genotypes.For decades, genotype 3 had been associated with longer treatment and poorer results. Previously, genotype 2 and 3 had been grouped together in management as both responded to interferon-based therapy with higher SVR rates compared to genotype 1. However, several experts suggested separating the genotypes in light of different SVR rates as pegylated interferon (PEG-IFN) plus ribavirin was achieving SVR rates as high as 93 percent for genotype 2 compared to 65 to 80 percent for genotype 3. With the approval of the first DAAs — telaprevir and boceprevir — treatment efficacy significantly improved in HCV genotype 1 patients but had no impact on genotype 3.

Since then, several all-oral regimens have been approved for the treatment of HCV, many of which have efficacy against genotype 3 infection, including sofosbuvir (a nonstructural protein 5B inhibitor) plus ribavirin for 24 weeks as demonstrated in the FISSION, FUSION, POSITRON and VALENCE trials and more recently daclatasvir (nonstructural protein 5A inhibitor) plus sofosbuvir. Tolerability and efficacy improved dramatically, but SVR rates still failed to achieve rates similar to those with other genotypes, especially in challenging populations such as those with cirrhosis. Strategies to improve viral eradication included the addition of PEG-IFN, extension of therapy to 24 weeks and the addition of ribavirin, yet real-world data showed that SVR rates often fell below 90 percent and below 80 percent in those with more advanced disease. The recent push to develop pan-genotypic regimens with simple algorithms is erasing this gap.

On June 28, 2016, FDA approved the pan-genotypic, fixed-dose combination of sofosbuvir/velpatasvir for the treatment of HCV. Given once daily for 12 weeks despite genotype, this is again a major advance for individuals with hepatitis C, especially those with genotype 3.

The ELECTRON-2 trial investigated the use of the NS5A inhibitor velpatasvir, with sofosbuvir and demonstrated a 96 to 100 percent SVR12 rate in genotype 3 treatment-naïve patients without cirrhosis. This success was further supported in the Phase 3 ASTRAL-3 trial, which revealed a 95 percent SVR 12 using the combination of sofosbuvir and velpatasvir for 12 weeks in 277 treatment-naïve and experienced genotype 3 patients, including 30 percent with cirrhosis.

This regimen was superior to sofosbuvir and ribavirin for 24 weeks, which achieved SVR in only 80 percent of 275 subjects. Other promising pan-genotypic combinations include the nonstructural protein 5A inhibitor ABT-530 and the NS3/4A ABT 530, which recently demonstrated 100 percent SVR12 rates with eight weeks of therapy in treatment-naïve genotype 3 without cirrhosis and with 12 weeks of therapy for treatment-naïve patients with cirrhosis.

The transition of therapy from an interferon-and-ribavirin-based regimen to DAA treatments has resulted in a marked improvement in eradicating genotype 1 infection. As a result, genotype 3 has emerged not only as the most virulent but also as the most difficult genotype to treat. The success of sofosbuvir in combination with agents such as daclatasvir has provided more avenues for treatment in patients with genotype 3 infections

Though barriers in treatment still exist, including the high cost of therapy, the success of more recent trials holds promise that equal success to treating genotype 1 may be seen in the near future for genotype 3. In particular, the combination of pan-genotypic agents has a goal to shorten treatment courses while eliminating the need for ribavirin and providing high rates of SVR. Thus, while there is a pressing need to improve treatment options for genotype 3, new opportunities are on the horizon.

Treatment regimens for chronic hepatitis C virus genotype 1 infection in adults
All topics are updated as new evidence becomes available and our peer review process is complete.
Literature review current through: Jul 2016. | This topic last updated: Jul 29, 2016.

Sofosbuvir-ribavirin works against HCV genotype 2 in real-world
By Will Boggs MD
NEW YORK (Reuters Health) - The combination of sofosbuvir and ribavirin is effective for treating hepatitis C virus (HCV) genotype 2 in real-world, clinical practice, the HCV-TARGET study confirms.

​Full Text Original article
Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study

​HCV Advocate Newsletter
HCV Advocate newsletter
Epclusa ​- High cure rates for genotype 3 - The clinical trials of people without cirrhosis or compensated cirrhosis achieved cure rates of 95%. In people with decompensated cirrhosis the addition of ribavirin to Epclusa produced 85% cure rates. Previous therapies produced suboptimal cure rates and treatment duration was 24 weeks especially for people with cirrhosis

Updated fact sheets –Acute HCV and HCV Genotype, Quasi-Species and Subtype

European Commission approves Zepatier for HCV genotypes 1, 4
August 1, 2016
Merck announced the European Commission granted marketing authorization for Zepatier to treat adult patients with chronic hepatitis C virus genotype 1 and 4 infection, with or without ribavirin, according to a company news release.

July 2016
July 31
​Geno 1,2,3,4, or 6
Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 Genotype 1, 2,3,4 or 6 / Phase 2 Trial
Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients with HCV Genotype 2, 3, 4, or 6 Infections in an Open-label, Phase 2 Trial

Studies are needed to determine the optimal regimen for patients with chronic hepatitis C virus (HCV) genotype 2, 3, 4, or 6 infections who have failed by a prior course of antiviral therapy, and the feasibility of further shortening treatment duration. We performed a phase 2 study to determine the efficacy and safety of the combination of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857 in these patients.

Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients with Genotype 1 Hepatitis C Virus Infection in an Open-label, Phase 2 Trial

The best regimen to retreat patients who do not respond to direct-acting antivirals (DAAs) and the feasibility of further shortening regimens is unclear. We assessed the efficacy and safety of the combination of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857 in patients with hepatitis C virus (HCV) genotype 1 infection.
Begin here...

Geno 1
Full Text
Adding ribavirin to newer DAA regimens does not affect SVR rates in HCV genotype 1 infected persons: results from ERCHIVES
​To determine the SVR rates with paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimen ± ribavirin and compare this with sofosbuvir/simeprevir and sofosbuvir/ledipasvir regimens.

July 26
Geno 1

​July 25
Geno 1​
FDA approves Viekira XR for HCV genotype 1
The FDA has approved a new drug application for Viekira XR — an extended-release, co-formulation of the active ingredients in Viekira Pak — for the treatment of chronic hepatitis C virus infection genotype 1, according to a press release from the manufacturer.​​

FDA approves a New Drug Application (NDA) for VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir)
​VIEKIRA XR is a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). VIEKIRA XR is not for people with decompensated cirrhosis.

**Currently, VIEKIRA PAK is taken twice daily as three tablets in the morning and one tablet in the evening, taken with a meal. VIEKIRA XR fixed-dose formulation is given once-daily as three oral tablets and must be taken with a meal.

Please see VIEKIRA XR full Prescribing Information, including the Medication Guide.

VIEKIRA PAK full Prescribing Information, including the Medication Guide. ​
Press release

Geno 4
CHMP Grants Positive Opinion for 12 weeks of Viekirax for Geno 4 with compensated cirrhosis

July 14
Reference Guide To FDA Approved HCV Medications
HCV Advocate HCV Medications Blog
Great new blog listed by genotype with information about SVR rates, treatment duration and side effects.

Twelve-week ribavirin-free direct-acting antivirals for treatment-experienced Chinese with HCV genotype 1b infection including cirrhotic patients

July 13
Hepatitis C Cures: New Drugs and Treatment Discussed
Hepatitis C can now be cured. There are new FDA approved medicines to treat hepatitis C with over a 95% cure rate. Dr. Joseph Galati with Liver Specialists of Texas discusses the new drugs including Epclusa, Zepatier, Harvoni, Sovaldi, Viekira Pak, and Olysio.

July 7
Geno 2 and 3
Velpatasvir/Sofosbuvir Makes HCV Treatment Simpler, Especially For Genotypes 2 and 3
Dr. Paul Sax tells us why the newly approved velpatasvir/sofosbuvir combination makes treatment of hepatitis C infection easier, especially for genotypes 2 and 3.

HCV Guidelines Update: Reflect Recent Approval of Epclusa (Sofosbuvir/Velpatasvir)

Sof/Velpatasvir in India
Gilead, in 2014, licensed its newly-approved HCV regimens to 11 of India's pharmaceutical companies, including the prospective Epclusa, which had not yet been cleared by the US FDA​

Robust HCV Genotype 3a Infectious Cell Culture System Permits Identification of Escape Variants With Resistance to Sofosbuvir

July 2
Genotype 1
Grazoprevir plus ribavirin linked to rapid, sustained suppression of HCV RNA
The combination of grazoprevir plus ribavirin for 12 or 24 weeks demonstrated fast and sustained suppression of hepatitis C virus RNA in treatment-naive patients with hepatitis C virus genotype 1 infection, according to study results.

​June 28
​Genotype 1-6
FDA Approved Gilead's Epclusa® (Sofosbuvir/Velpatasvir) to treat Genotype 1-6
Silver Spring, Maryland–(ENEWSPF)–June 28, 2016. The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.

Genotype 3 - Of interest
​New at ViralEd - Case 9 - Genotype 3
In June "ViralEd" released "HCV Virtual Patient" an easy to follow video CME with a look at different case scenarios. This activity is a helpful starting point for people who failed treatment, have cirrhosis or want to learn more about current treatment options for various HCV genotypes/ see Case 9 - Genotype 3. After each video module participants can either answer the questions, or click on Curbside Consult -
Begin here....

June 27
Geno 3
Hepatitis C virus genotype 3: Meta-analysis on sustained virologic response rates with currently available treatment options
The advent of direct acting antivirals has not solved all questions of successfully and effectively treating all hepatitis C virus (HCV) genotypes. Genotype 3, a common genotype globally, remains the last challenge.

Geno 3
Effectiveness and Safety of Sofosbuvir-Based Regimens for Chronic HCV Genotype 3 Infection: Results of the HCV-TARGET Study

​Geno 3
Fibrosis in HCV genotype 3 progresses with age
Evidence of fibrosis was common in older patients with hepatitis C virus genotype 3 infection, indicating fibrosis progresses with age and this patient population should be treated as often and with the same medications as other severe HCV patient populations, according to data presented at the British Society of Gastroenterology Annual Meeting.

June 14
Geno 1
Comparative effectiveness of ledipasvir/sofosbuvir ± ribavirin vs. ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin HCV genotype 1 patients 

June 11-12
Learn about regimens for treating genotype 2, 3, 4, 5, or 6 HCV infection and more...
Weekend Reading - Treating HCV genotype 4 and Treating HCV patients with diabetes & obesity
In this issue of "Weekend Reading" I suggest two new learning activities, as well as some great articles written by a small group of dedicated bloggers who share their personal stories about living with and treating HCV. ​

HCV Advocate Monthly Pipeline Update
A brief overview of how this pipeline is laid out:
Date: ​The Pipeline will be updated on a monthly basis and will be included with the HCV Advocate Newsletter Genotype (s): This lists the drugs or combination of drugs and the particular gentoype or genotypes that the drug is active against . Comments: This section will list the study results . Within this section, I will list the genotype(s) being studied and the phase of the study with a brief recap of the study . ​

May 2016
May 27
EU regulators recommend approving Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for All HCV Genotypes
--Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection-- ​

May 25
Investigative Combo ABT-493 plus ABT-530 - Succeeds Against Multiple HCV Genotypes
An investigative combination of two drugs helped patients infected with hepatitis C virus (HCV) across genotypes 1, 2, 3.4, 5 and 6 achieve sustained virologic responses, researchers reported here.

No cases of virologic failure were observed in the 8-week courses of ABT-493 plus ABT-530 in non-cirrhotic patients infected with genotypes 1, 2 and 3, and no virologic failures were observed among patients with genotypes 4, 5 and 6 who were treated in a 12-week course, according to Tarek Hassanein, MD, of the Southern California GI and Liver Centers/UC San Diego Health System, David Wyles, MD, of the University of California San Diego, and colleagues....​

Geno 4
AGATE-I: Technivie plus ribavirin yields high response in genotype 4 HCV

Combination Treatment with Ombitasvir, Paritaprevir/Ritonavir, Dasabuvir, and Sofosbuvir in Patients with Genotype 1 HCV Infection

May 25, 2016 | DDW 2016 | Katherine Hasal
Researchers report promising results from the QUARTZ-I study that assessed the efficacy of the 3D regimen combined with sofosbuvir in treatment-experienced patients with HCV genotype 1 infection.

Shorter Course of Ledipasvir-Sofosbuvir Therapy Effective in Patients with Genotype 1 Hepatitis C
May 25, 2016 | DDW 2016 | Katherine Hasal
Results from the ION-3 trial showed that the rapidity and durability of viral suppression achieved with ledipasvir-sofosbuvir therapy allows a shorter treatment course of 8 weeks in genotype 1, treatment-naïve, non-cirrhotic patients.

The Future of Hep C Treatment
DDW TV covered this exciting and informative State-of-the-Art Lecture which presented the very latest information on hepatitis C.​

May 15
Geno 3
A Continued Role for Ribavirin in HCV Genotype 3 Infection with Advanced Liver Disease 

May 14
New Hep C Recs Target Unique Populations
Updated guidelines from the AASLD and IDSA for the treatment of HCV have identified ...The guidelines for decompensated cirrhosis recommend direct-acting antiviral agents for patients with HCV genotypes 1, 2, 3 and 4...

April 2016
Geno 4
Suboptimal response in HCV genotype 4 in Egypt driven by noncompliance
Suboptimal treatment response in chronic HCV genotype 4 in Egypt was driven primarily by...

Safety, Efficacy, and Tolerability of Sofosbuvir and Ribavirin in Management of Recurrent Hepatitis C Virus Genotype 4 After Living Donor Liver Transplant in Egypt: What Have We Learned so far?
April ‎29
Objectives: The aim of this study was to evaluate the efficacy, safety, and tolerability of sofosbuvir and ribavirin in LDLT recipients with recurrent HCV genotype 4.,Patients and Methods: Thirty-nine Egyptian LDLT recipients were treated for recurrent HCV after LDLT with nucleos(t)ide analog NS5B polymerase inhibitor, sofosbuvir, and ribavirin without pegylated interferon for 6 months (November 2014 to June 2015) in this intention-to-treat analysis.,Results: One recipient died 1 week after starting the treatment, but the remaining 38 patients completed 24 weeks of treatment and were then followed for 12 weeks after end of treatment (EOT). The sustained virological response (SVR) at week 12 after EOT was achieved in 76% (29/38) of recipients. SVR was significantly higher in treatment-naïve patients and in recipients with a low stage of fibrosis. Only 2 (5%) recipients developed severe pancytopenia and acute kidney injury.,Conclusions: We recommend initiating treatment as soon as possible after liver transplantation with newer combinations, such as ledipasvir/sofosbuvir or sofosbuvir/simeprevir, rather than sofosbuvir with Ribavirin, to achieve higher rates of SVR.,Background: Recurrence of HCV after living donor liver transplant (LDLT) is nearly universal, with almost one third of recipients developing cirrhosis and graft failure within 5 years after LDLT. Different studies have been published on the effect of sofosbuvir after liver transplantation on recurrent HCV with different genotypes.

April 25
AbbVie Receives NDA for Viekira Pak/HCV genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis
U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A). The application was previously granted priority review by the FDA, a designation given to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness

The International Liver Congress
April 21
Geno 4
Gilead Sciences' sofosbuvir (Sovaldi) and ravidasvir (formerly PPI-668), being developed by Pharco Pharmaceuticals

April 16
Geno 1-6
AbbVie ABT-493 and ABT-530 For Genotypes 1-6: New Phase 2 Data Presented At The International Liver Congress
- 97-98 percent SVR12 achieved with eight weeks of ABT-493 and ABT-530 in genotypes 1-3 hepatitis C virus patients without cirrhosis in SURVEYOR-1 and 2 studies(1,2)

- 100 percent SVR12 achieved with 12 weeks of treatment in difficult-to-treat genotype 3 patients with compensated cirrhosis (Child-Pugh A) new to therapy (3)

- 100 percent SVR12 achieved with 12 weeks of treatment in genotypes 4-6 patients without cirrhosis; eight-week duration investigated in this ongoing study (4)

Geno 3
ABT-493 and ABT-530 gets 1 step closer to offering HCV genotype 3 patients an effective therapeutic option
A Hepatitis C (HCV) drug currently under investigation, ABT-493 and ABT-530, which is an all-oral once-daily antiviral treatment, helped HCV genotype 3 patients with heavily scarred livers and no previous treatment history to achieve a 100% sustained virologic response after receiving the treatment for 12 weeks (SVR12).

ABT-493 and ABT-530 - Reported By Healio *Video
ABT-493, ABT-530 produce high SVR4 rates in HCV genotype 3
BARCELONA — In this exclusive video interview at International Liver Congress, Paul Y. Kwo, MD, professor of medicine and director of liver transplantation at Indiana University, and HCV Next Editorial Board member, discusses results from the two SURVEYOR studies investigating the safety and efficacy of pangenotypic agents ABT-493 and ABT-530 in patients with hepatitis C virus genotype 3 infection with and without cirrhosis.“We are clearly in need of different strategies for these individuals so the genotype 3 population can get the same benefits as the other [genotype patients],” Kwo told HCV Next.

Geno 1
ABT-493 and ABT-530 - AbbVie's Press Release
AbbVie's Investigational Regimen ABT-493 and ABT-530 Shows High SVR In HCV Genotype 1 Patients Who Failed Previous Therapy
- 95 percent of patients achieved SVR12 with 12 weeks of ABT-493 and ABT-530 with and without RBV in GT1 chronic HCV infected patients without cirrhosis who failed previous therapy with DAAs in a modified intent-to-treat analysis

- 91 percent achieved SVR12 with RBV in the primary intent-to-treat analysis; 86 percent achieved SVR12 without RBV

BARCELONA, April 15, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that 91 percent (n=20/22) of genotype 1 (GT1) chronic hepatitis C virus (HCV) infected patients who failed previous therapy with direct-acting antivirals (DAAs) achieved SVR12 with 12 weeks of ABT-493 and ABT-530 with ribavirin (RBV) in the primary intent-to-treat analysis. Additionally, 86 percent (n=19/22) of GT1 patients who received ABT-493 and ABT-530 without RBV, achieved SVR12.1 SVR12 was achieved in 95 percent of patients with and without RBV (n=20/21, n=19/20; respectively) in a modified intent-to-treat analysis, excluding patients who did not achieve SVR for reasons other than virologic failure.

April 14
Sofosbuvir/velpatasvir and experimental compound GS-9857 shows promise in Hepatitis C infected patients whose previous treatment has failed
High sustained virologic response achieved with sofosbuvir/velpatasvir and GS-9857, even in patients unsuccessfuly treated with direct-acting antivirals

The study showed that 99% of patients with HCV genotype 1, 2, 3, 4 and 6 who had previously received treatment, achieved SVR 12 weeks after treatment using this triple combination.

Head-to-head study: once daily oral combination of elbasvir and grazoprevir versus sofosbuvir and pegylated interferon alpha 2b + ribavirin
The combination of elbasvir and grazoprevir resulted in an SVR12 of 99.2% (128/129) compared to 90.5% (114/126) in the sofosbuvir/pegylated interferon/ribavirin group.

Merck's Press Release
Merck’s ZEPATIER™ (Elbasvir and Grazoprevir) Showed Superiority on Efficacy and Safety Endpoints Compared to Sofosbuvir Plus Peginterferon and Ribavirin Treatment Regimen in Phase 3 Trial
Results From C-EDGE Head-to-Head Study in Patients with Chronic Hepatitis C Genotypes 1 or 4 Infection Presented at The International Liver Congress™ 2016

April 12
Simeprevir and Sofosbuvir to Treat Chronic HCV Genotype 1
The American Journal of Gastroenterology, April 12, 2016

Easy C Treatment Guides – Genotype 3 and 4

April 13
Video - Does sustained virologic response represent a cure for hepatitis C virus infection?
BARCELONA — In this video perspective from the International Liver Congress 2016, Ronald Koretz, MD, Emeritus professor of medicine at University of California Los Angeles School of Medicine, discusses results of a systematic review that asks: Does sustained virologic response represent a cure for hepatitis C virus infection?

March 2016
Mar 18
Recent advances in managing chronic HCV infection: focus on therapy in patients with severe liver disease
There are extensive data from phase III or IV studies on the efficacy of IFN-free regimens, but patients with compensated and decompensated cirrhosis were often underrepresented. Currently, more data are emerging from real-world studies on the efficacy of these regimens, which included patients with the most severe cirrhosis. Table 1–Table 4 show the data from phase III or IV studies available on the efficacy of IFN-free antiviral therapy. Here we will discuss the treatment regimens in a more conceptual way for the treatment of patients with compensated cirrhosis.

Mar 15
Pan-genotypic Drugs for Hepatitis C
By Jenelle Marie Davis - March 15, 2016
What does pan-genotypic mean? Before we can get into the definition of pan-genotypic, let’s back up and talk about genotypes overall. Currently, there are seven known hepatitis C genotypes (called “genotype 1,”...

Mar 1
FDA Update - OLYSIO (simeprevir) label revised to include pharmacokinetic, safety and efficacy data in treatment-naïve adult patients of East Asian ancestry with chronic hepatitis C virus genotype 1 infection.

​February 2016
​Feb 25
ABBVIE RECEIVES CHMP POSITIVE OPINION FOR VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets)
...today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).​

Treatment of Hepatitis C Virus Genotype 1-infected Patients
Liver International, February 25, 2016

Elbasvir/Grazoprevir - HCV Guidance Website Updated to Reflect Latest Drug Developments 

​Feb 16
Sovaldi plus ribavirin safe for Korean patients with HCV genotype 2
February 15, 2016
In a phase 3b study, treatment with Sovaldi plus ribavirin, an interferon-free regimen, was safe and effective for Korean patients with chronic hepatitis C virus…

Feb 12
FDA Update -Important changes to Harvoni affecting several categories of HCV patients
On February 12, 2016, the FDA approved changes to the Harvoni (ledipasvir and sofosbuvir) fixed-dose combination label to expand the patient population to include those with chronic hepatitis C virus genotype 1, infection who are liver transplant recipients, genotype 4 infection who are liver transplant recipients without cirrhosis, or with compensated cirrhosis, and genotype 1 infection with decompensated cirrhosis. ​​

​Feb 10
Feb 2016 Update: Upcoming and Recruiting Hepatitis C Clinical Trials

Faldaprevir yields high SVR in relapsers with HCV geno 1
Treatment with faldaprevir plus pegylated interferon alfa-2b and ribavirin was efficacious among patients with hepatitis C virus genotype 1 infection who relapsed on a prior treatment regimen with PEG-IFN a-2b and ribavirin, according to published findings.

​Feb 5
Bristol-Myers Gets Expanded Use for Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3

February 05, 2016
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza™(daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus (HCV) patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without (+/-) ribavirin for 12 weeks.

January 2016
Jan 28
Merck Receives FDA Approval of ZEPATIER™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review
ZEPATIER Achieves High Cure Rates (SVR12) in Broad Range of Patients with Chronic Hepatitis C Infection, Including Those with Compensated Cirrhosis, Renal Impairment of Any Degree and HIV-1/HCV Co-infection​

Bristol-Myers Announces Receipt of EC Approval for Daklinza in HCV Genotypes 1, 3 and 4
Updated label provides additional treatment options for multiple HCV patient populations, including difficult-to-treat patients with decompensated cirrhosis
HIV/HCV coinfected patients experience more rapid fibrosis progression than mono-infected HCV patients

Jan 22
Simeprevir + Sofosbuvir/OPTIMIST-1 Study Results Show Favorable HCV GT1 Combo Therapy

Jan 16
HCV NEXT January Issue - 2015: The Good The Bad The Ugly
Responsive to Treatment Elusive to Detection: HCV Genotypes 5 and 6
2015: An Exciting Year for Drug Approvals; More on the Horizon
HCV increases chronic kidney disease risk

Jan 13
New Hepatitis C Fact Sheets: (Sovaldi, Olysio, Viekira Pak and Technivie, Harvoni, Daklinza, and ribavirin)
Treatment Action Group has recently published hepatitis C fact sheets in both English and Spanish.

Jan 11


Jan 8
The Hepatitis C Revolution Part 2
Recent findings Patients with genotype 3 infection have consistently lower rates of virological clearance following DAA therapy when compared with other genotypes. However, in combination with sofosbuvir, the novel nonstructural protein 5A inhibitor daclatasvir has demonstrated high efficacy in the treatment of noncirrhotic genotype 3 infection.

Jan 7
U.S. FDA Grants Priority Review to AbbVie for Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Virus Patients with Compensated Cirrhosis
The current dosing recommendation for patients with GT1b and compensated cirrhosis is to administer RBV with VIEKIRA PAK for 12 weeks.

Jan 4
Gilead/FDA Grants Priority Review for Sofosbuvir/Velpatasvir - To Treat HCV Genotype 1-6
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 4, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company's New Drug Application (NDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. Gilead filed the NDA for SOF/VEL on October 28, 2015, and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016. - See more at: http://hepatitiscnewdrugresearch.com/index.html#sthash.tdhnFkKT.dpuf

3. Better Options for Treating HCV Genotype 3 and Advanced Liver Disease
Details Category: HCV Treatment
Published on Wednesday, 30 December 2015
Written by Liz Highleyman
This year saw the emergence of new and better treatment options for people with hepatitis C virus (HCV) genotypes other than 1 and for those with advanced liver disease...

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