2017-HCV Genotypes/Treatment

News And Research

2017-HCV Genotypes/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. 


April 2017
Direct-acting antivirals: the endgame for hepatitis C?

March 2017
Genotype 1-6
February 2017
New and Updated HCV Treatment Fact Sheets Now Online
New fact sheets include:
HCV Genotypes, Epclusa and an updated fact sheet on Viekira XR and Technivie.

Liver Health
The Liver Loving Diet - A Must Read For People With HCV Or Liver Disease

International Liver Congress (ILC 2016)
April 19-23
Updates On This Blog

2017
Care of Patients Who Have Achieved a Sustained Virologic Response (SVR) Following Antiviral Therapy for Chronic Hepatitis C Infection

HCV Guidelines
The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America with the International Antiviral Society developed a living document with ever evolving guidelines to treat HCV.
Stay current with all guideline updates, click here.

2017
Recommended treatments for chronic hepatitis C genotypes 1-6
PDF - Treatment of HCV Genotype 1
PDF - Treatment of HCV Genotype 2
PDF - Treatment of HCV Genotype 3
PDF - Treatment of HCV Genotype 4
PDF - Treatment of HCV Geno 5 or 6.
Source - Hepatitis C Online

Helpful Links
Premier Hepatitis C Websites, Blogs and Support Forums

2016
Treating HCV according to genotype
News Archive

Summary for AASLD 2016
New HCV two and three drug regimens on their way: what do they promise?

2017 June
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 widely
prescribed DAA combination regimens used to treat HCV patients within the VHA using an
intent-to-treat analysis which included both initial and secondary treatment episodes.  We
control for the impact of various patient, disease, and treatment characteristics on treatment
effectiveness 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

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 12
weeks 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.
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.  

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

Newsletters
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
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
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
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
News Archive

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