Showing posts with label geno1. Show all posts
Showing posts with label geno1. Show all posts

Monday, November 12, 2018

High SVR12 rate for 16 week glecaprevir/pibrentasvir regimen in HCV GT1

Meeting Coverage > AASLD
Combo HCV Pill Effective in Certain Refractory Patients
High SVR12 rate for 16 week glecaprevir/pibrentasvir regimen in HCV GT1 patients
by Molly Walker, Staff Writer, MedPage Today November 11, 2018 
November 11, 2018 T

A 16-week treatment course had a SVR 12 of 95%, including 94% in non-cirrhotic patients and 97% in cirrhotic patients who had failed prior treatment containing NS5A inhibitors, with no virologic failure among those with HCV genotype 1b infection, reported Mark S. Sulkowski, MD, of Johns Hopkins Hospital in Baltimore.

He said that glecaprevir/pibrentasvir was approved by the FDA in 2017 for treatment of NS5A inhibitor-experienced patients with genotype 1 infection and no NS3/4A protease inhibitor therapy.

A 16-week course of treatment was approved based on a small group of 17 patients in a trial where 16 of 17 achieved SVR12, Sulkowski explained at a press conference at the annual Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD).

But that wasn't enough for the AASLD/Infectious Diseases Society of America (IDSA) guidelines panel, which labeled the therapy an "alternative regimen" and did not put it in the recommended category for treatment for this population, with "concerns based on the small number of human beings treated."
Read More: https://www.medpagetoday.com/meetingcoverage/aasld/76266
Website MedPage Today Twitter @medpagetoday

Coverage > Liver Meeting
Mavyret SVR high in patients with Sovaldi, NS5A inhibitor experience
November 11, 2018
SAN FRANCISCO — Mavyret was highly effective and well-tolerated in patients with chronic hepatitis C genotype 1 who had experience with a combination of Sovaldi, NS5A inhibitor and ribavirin, according to data presented at The Liver Meeting 2018.

“The context of this study was that the FDA granted approval in August 2017 for [Mavyret] for 16 weeks in persons who failed an NS5A-containing regimen that did not also contain a protease inhibitor,” Mark S. Sulkowski, MD, from Johns Hopkins Hospital in Maryland, said during a press conference presentation.
Website Healio - Twitter @HealioHep

Combined Glecaprevir/Pibrentasvir Highly Effective in HCV Patients Who Have Failed Other Therapies 
SAN FRANCISCO – Data from a new study presented this week at The Liver Meeting® – held by the American Association for the Study of Liver Diseases – found the combination of glecaprevir and pibrentasvir is highly effective and well tolerated in patients with chronic hepatitis C virus (commonly called HCV) genotype-1 infections who have prior treatment experience with sofosbuvir/NS5A inhibitor.

Meeting Updates 
View all updates on this blog, (LINK), coverage elsewhere, (LINK).

Abstract
American Association for the Study of Liver Diseases
Website AASLD Twitter @AASLDtweets

Wednesday, October 17, 2018

Shortened Therapy of Eight Weeks With Paritaprevir/ritonavir/Ombitasvir and Dasabuvir Is Highly Effective in People With Recent HCV Genotype 1 Infection

Is an 8-week therapy of paritaprevir/ritonavir/ombitasvir and dasabuvir + ribavirin as effective as the standard 12-week regimen in individuals with recent HCV infection?

October 17, 2018 
Articles Available on Medscape 
J Viral Hepat. 2018;25(10):1180-1188. 
and dasabuvir

Abstract 
Paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 12 weeks are approved for treatment of chronic HCV genotype 1 infection. This study assessed the efficacy of shortened duration paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 8 weeks among people with recent HCV infection. In this open-label single-arm trial conducted in Australia, England and New Zealand, adults with recent HCV (duration of infection <12 months) received paritaprevir/ritonavir/ombitasvir and dasabuvir (with weight-based ribavirin for genotypes 1a and 1, no subtype) for 8 weeks. The primary endpoint was sustained virological response at 12 weeks post-treatment (SVR12) in the intention-to-treat (ITT) population. Thirty people (median age 38 years, male 93%) commenced treatment (with ribavirin, 97%), of whom 77% (n = 23) were HIV-positive, 93% (n = 28) had genotype 1a infection and 53% (n = 16) had ever injected drugs. Median maximum ALT in the preceding 12 months was 433 IU/L (IQR 321, 1012). Acute clinical hepatitis with ALT > 10 x ULN was documented in 83% (n = 25); one participant (3%) had jaundice. At baseline, median estimated duration of infection was 30 weeks (range 11, 51), and median HCV RNA was 5.7 log10 IU/mL (range 2.7, 7.3). SVR12 was achieved in 97% (29/30; early discontinuation at week 2, n = 1; per protocol 100%, 29/29). No relapse or reinfection was observed. In conclusion, paritaprevir/ritonavir/ombitasvir and dasabuvir (with ribavirin) for eight weeks were highly effective among HIV-positive and HIV-negative individuals with recent HCV infection. These data support the use of this shortened duration direct-acting antiviral regimen in this population.

Read the full-text articlehttp://www.medscape.com/viewarticle/902923

Free registration may be required

Friday, August 24, 2018

Treatment in HCV genotype 1b patients with advanced fibrosis and cirrhosis

PLoS One. 2018 Aug 23;13(8):e0202777. doi: 10.1371/journal.pone.0202777. 

Hepatic decompensation during paritaprevir/ritonavir/ombitasvir/dasabuvir treatment for genotype 1b chronic hepatitis C patients with advanced fibrosis and compensated cirrhosis.
Hsieh YC1, Jeng WJ1,2,3, Huang CH1,2, Teng W1, Chen WT1, Chen YC1,2, Lin SM1,2,3, Tai DI1,2, Lin CY1,2, Sheen IS1,2.

Full Text

Abstract
BACKGROUND AND AIM: 
Hepatic decompensation is a severe on-treatment adverse event for chronic hepatitis C treated with paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD). Till now, few papers regarding on-treatment hepatic decompensation have been reported. The study aims to analyze the general feature and predictive factors of on-treatment hepatic decompensation in hepatitis C virus (HCV) genotype 1b-infected patients with advanced fibrosis and compensated cirrhosis who receive treatment with PrOD.

METHODS: A real-word cohort enrolled 189 HCV genotype 1b patients with advanced fibrosis and compensated cirrhosis treated with 12-week PrOD. Clinical and laboratory data were analyzed between patients with and without on-treatment hepatic decompensation.

RESULTS: The sustained virologic response rate at 12 weeks after treatment was 97.3% in HCV subtype 1b patients with advanced fibrosis and cirrhosis. On-treatment hyperbilirubinemia (total bilirubin >2 mg/dL) occurred in 27 (14.3%) patients, and the incidence of the increase of total and direct form bilirubin was significantly different during treatment between patients with Child-Turcotte-Pugh score 5 and score 6. Five (18.5%) hyperbilirubinemia patients progressed to hepatic decompensation. Older age (adjusted OR: 1.2, 95% CI: 1.0-1.4) and albumin ≤3.6 g/dL (adjusted OR: 10.4, 95% CI: 1.3-81.2) may be two predictors for on-treatment hepatic decompensation by multivariate analysis.

CONCLUSIONS: PrOD is an effective direct-acting antiviral agent for antiviral therapy in HCV genotype 1b patients with advanced fibrosis and cirrhosis. Hyperbilirubinemia is possibly the early warning feature of on-treatment hepatic decompensation. This serious adverse event of on-treatment hepatic decompensation is not common. Older age and low baseline albumin level may be predictive factors.


PMID: 30138456 DOI: 10.1371/journal.pone.0202777

Tuesday, April 10, 2018

Sweden-Introduction of second-generation direct-acting antivirals in HCV:Register-based Study

Introduction of the second-generation direct-acting antivirals (DAAs) in chronic hepatitis C: a register-based study in Sweden
P. Frisk, K. Aggefors T. Cars N. Feltelius S. A. LoovB. Wettermark O. Weiland

First Online: 09 April 2018

The conditions for introducing the first six of the second-generation direct-acting antivirals for chronic hepatitis C infection in Sweden were outlined in a national introduction protocol. The overall cure rate was estimated to 96%, with some variation between genotypes. Despite regional variation in other cost containment strategies, the high level of adherence to recommendations among prescribers and similar introduction rates in the regions indicate that the protocol contributed considerably to a rapid uptake and equal distribution of DAAs in Sweden.

Full-Text

Abstract
Purpose Introduction of the direct-acting antivirals (DAAs) for treatment of chronic hepatitis C (CHC) infection has been challenging in all health systems. In Sweden, a national protocol for managed introduction was developed. It was optional, but all county councils agreed to implement and follow it. The purpose of this study was to study (a) cure rates among all patients initiated on treatment in 2014–2015, (b) prescribers’ adherence to the drug recommendations and treatment eligibility criteria in the protocol, and (c) introduction rate in the six Swedish healthcare regions.

Method
A cross-sectional study where national data from the Prescribed Drug Register and the quality register InfCare Hepatitis defined the study population, and clinical data from the Patient Register and InfCare Hepatitis were used to monitor outcomes. Descriptive statistics were used.

Results
A total of 3447 patients were initiated on treatment during 2014–2015. The overall cure rate, based on data from 85% of the cohort, was 96%, with variation between genotypes. Adherence to drug recommendations increased over time and varied between 43.2 and 94.2%. Adherence to the treatment eligibility criteria was initially 80% and increased to 87% when treatment restrictions were widened. The introduction rate differed initially between the regions and reached stable levels 15–18 months after the launch of the first DAA.

Conclusion
The estimated overall cure rate was 96%, with some variations between genotypes. A high level of adherence to the introduction protocol as well as similar introduction rates in the health care regions indicate that the introduction protocol, alongside with other measures taken, contributed considerably to a rapid uptake and equal distribution of DAAs in Sweden.

Continuer reading online: https://link.springer.com/article/10.1007%2Fs00228-018-2456-y

Wednesday, April 4, 2018

Elbasvir/grazoprevir in Asia‐Pacific/Russian participants with chronic hepatitis C genotype 1, 4, or 6 infection

Elbasvir/grazoprevir in Asia‐Pacific/Russian participants with chronic hepatitis C virus genotype 1, 4, or 6 infection
Jacob George Eduard Burnevich I‐Shyan Sheen Jeong Heo Kinh Van Nguyen Tawesak Tanwandee Pin‐Nan Cheng Do Young Kim Won Young Tak Svetlana Kizhlo Konstantin Zhdanov Vasily Isakov Liwen Liang Pauline Lindore Joy Ginanni Bach‐Yen Nguyen Janice Wahl Eliav Barr Michael Robertson Paul Ingravallo Rohit Talwani on behalf of the C‐CORAL Study Investigators

First published: 4 April 2018 https://doi.org/10.1002/hep4.1177

The prevalence of hepatitis C virus (HCV) infection in Asian countries is high. This study assessed the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in participants with HCV infection from Asia‐Pacific countries and Russia. In this phase 3, randomized, placebo‐controlled, double‐blind study, treatment‐naive participants with HCV genotype (GT) 1, 4, or 6 infection were randomized to EBR 50 mg/GZR 100 mg (immediate‐treatment group [ITG]) or placebo (deferred‐treatment group [DTG]) once daily for 12 weeks (Protocol PN‐5172‐067, NCT02251990). The primary efficacy variable was a nonrandomized comparison of sustained virologic response at 12 weeks after the end of therapy (SVR12) for the ITG with a historical control. The primary safety outcome was a randomized comparison between the ITG and DTG. Three hundred thirty‐seven participants were randomized to the ITG (n = 251) or DTG (n = 86); 199 (59.2%) participants were Asian, and 250 (74.4%) had HCV GT1b infection. Overall, 232/250 (92.8%) participants in the ITG achieved SVR12 (97.5% confidence interval, 89.1, 96.5). Of the 18 participants who failed to attain SVR12, 1 was lost to follow‐up and 17 had virologic failure, 13 of whom had HCV GT6 infection. The incidence of adverse events was similar between participants receiving EBR/GZR and placebo (50.8% versus 51.2%; difference, −0.3%; 95% confidence interval, −12.3, 11.9).

Conclusion: EBR/GZR for 12 weeks provides an effective and well‐tolerated regimen for chronic HCV GT1 infection in treatment‐naive people from Asia‐Pacific countries and Russia, particularly for the large population with GT1b infection. EBR/GZR is not recommended for the treatment of individuals with HCV GT6 infection. (Hepatology Communications 2018)


Friday, February 9, 2018

HCV infection and liver cirrhosis - Predictors of functional benefit of hepatitis C therapy in a ‘real-life’ cohort

World J Gastroenterol. Feb 21, 2018; 24(7): 852-861
Published online Feb 21, 2018. doi: 10.3748/wjg.v24.i7.852

Retrospective Study
Predictors of functional benefit of hepatitis C therapy in a ‘real-life’ cohort
Niels Steinebrunner, Kerstin Stein, Catharina Sandig, Thomas Bruckner, Wolfgang Stremmel, Anita Pathil

Therapeutic regimens for patients with chronic hepatitis C virus (HCV) infection have substantially improved over the last few years. However real-life data in patients with cirrhosis are still limited, and predictors of functional benefit of direct-acting antivirals are not well defined. We analysed data from patients with HCV infection and liver cirrhosis to evaluate predictors of functional benefit for identifying patients profiting most from antiviral therapy beyond HCV eradication.


Abstract
AIM
To define predictors of functional benefit of direct-acting antivirals (DAAs) in patients with chronic hepatitis C virus (HCV) infection and liver cirrhosis.

METHODS
We analysed a cohort of 199 patients with chronic HCV genotype 1, 2, 3 and 4 infection involving previously treated and untreated patients with compensated (76%) and decompensated (24%) liver cirrhosis at two tertiary centres in Germany. Patients were included with treatment initiation between February 2014 and August 2016. All patients received a combination regimen of one or more DAAs for either 12 or 24 wk. Predictors of functional benefit were assessed in a univariable as well as multivariable model by binary logistic regression analysis.

RESULTS
Viral clearance was achieved in 88% (175/199) of patients. Sustained virological response (SVR) 12 rates were as follows: among 156 patients with genotype 1 infection the SVR 12 rate was 90% (n = 141); among 7 patients with genotype 2 infection the SVR 12 rate was 57% (n = 4); among 30 patients with genotype 3 infection the SVR 12 rate was 87% (n = 26); and among 6 patients with genotype 4 infection the SVR 12 rate was 67% (n = 4). Follow-up MELD scores were available for 179 patients. A MELD score improvement was observed in 37% (65/179) of patients, no change of MELD score in 41% (74/179) of patients, and an aggravation was observed in 22% (40/179) of patients. We analysed predictors of functional benefit from antiviral therapy in our patients beyond viral eradication. We identified the Child-Pugh score, the MELD score, the number of platelets and the levels of albumin and bilirubin as significant factors for functional benefit.

CONCLUSION
Our data may contribute to the discussion of potential risks and benefits of antiviral therapy with individual patients infected with HCV and with advanced liver disease.

Full Text

Sunday, January 28, 2018

Efficacy of direct-acting antiviral treatment for chronic hepatitis C: A single hospital experience

World J Hepatol. Jan 27, 2018; 10(1): 88-94
Published online Jan 27, 2018. doi: 10.4254/wjh.v10.i1.88

Efficacy of direct-acting antiviral treatment for chronic hepatitis C: A single hospital experience

Rena Kaneko, Natsuko Nakazaki, Risa Omori, Yuichiro Yano, Masazumi Ogawa, Yuzuru Sato

Abstract
AIM
To evaluate the efficacy of direct-acting antivirals (DAAs) in Kanto Rosai Hospital.

METHODS
All patients with hepatitis C virus (HCV) who underwent DAA prescription were enrolled in this study. The present study was a single center retrospective analysis using patients infected with HCV genotype 1 or 2. Resistance analysis was performed by using direct sequencing and cycleave PCR in genotype 1 patients treated with interferon (IFN)-free DAA. The primary endpoint was sustained virologic response at 12 wk after therapy (SVR12).

RESULTS
A total of 117 patients participated in the study, including 135 with genotype 1 and 42 with genotype 2. Of the 135 patients with genotype 1, 16 received protease inhibitor + IFN + ribavirin and all achieved SVR. Of the 119 patients who received IFN-free DAA (in different combinations), 102 achieved SVR and 9 failed (7/9 were on daclatasvir/asunaprevir and 2/9 on ledipasvir/sofosbuvir). Efficacy analysis was done only for 43 patients who received daclatasvir/asunaprevir. From this analysis, Y93 resistance-associated substitutions were significantly correlated with SVR.

CONCLUSION
The SVR rate was 98% for genotype 1 and 100% for genotype 2. However, caution is needed for HCV NS5A resistance-associated substitutions that are selected by HCV NS5A inhibitors because cerebrovascular adverse events are induced by some DAA drugs.

Key Words: Resistance-associated substitutions, Direct-acting antivirals, Sustained viral response, Hepatitis C

Core tip:
Direct-acting antivirals have been approved for the treatment of hepatitis C virus (HCV) genotype 1 and 2 infections in Japan since 2011. In the new era of DAA therapy, predictors who fail to respond to DAA might be compromised by resistance-associated substitutions. There have been few reports of daclatasvir/asunaprevir failure because daclatasvir/asunaprevir is limited in Japan. Therefore, it might be important to report these cases for future research and treatment of HCV.

Thursday, January 25, 2018

Glecaprevir–Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection

Glecaprevir–Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection
Stefan Zeuzem, M.D., Graham R. Foster, Ph.D., Stanley Wang, M.D., Armen Asatryan, M.D., Edward Gane, M.D., Jordan J. Feld, M.D., M.P.H., Tarik Asselah, M.D., Ph.D., Marc Bourlière, M.D., Peter J. Ruane, M.D., Heiner Wedemeyer, M.D., Stanislas Pol, Ph.D., Robert Flisiak, M.D., Ph.D., Fred Poordad, M.D., Wan-Long Chuang, M.D., Ph.D., Catherine A. Stedman, M.B., Ch.B., Ph.D., Steven Flamm, M.D., Paul Kwo, M.D., Gregory J. Dore, Ph.D., M.P.H., Gladys Sepulveda-Arzola, M.D., Stuart K. Roberts, M.D., Ruth Soto-Malave, M.D., Kelly Kaita, M.D., Massimo Puoti, M.D., John Vierling, M.D., Edward Tam, M.D., Hugo E. Vargas, M.D., Rafi Bruck, M.D., Francisco Fuster, M.D., Seung-Woon Paik, M.D., Franco Felizarta, M.D., Jens Kort, M.D., Ph.D., Bo Fu, Ph.D., Ran Liu, Ph.D., Teresa I. Ng, Ph.D., Tami Pilot-Matias, Ph.D., Chih-Wei Lin, Ph.D., Roger Trinh, M.D., M.P.H, and Federico J. Mensa, M.D.et al.

Full Text Article
https://jumpshare.com/v/9GtWUYi3hENIx8GnabyH

Article shared and downloaded via Twitter by Henry E. Chang 

Abstract
Background
Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity and a high barrier to resistance. We evaluated the efficacy and safety of 8-week and 12-week courses of treatment with 300 mg of glecaprevir plus 120 mg of pibrentasvir in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection.

Methods
We conducted two phase 3, randomized, open-label, multicenter trials. Patients with genotype 1 infection were randomly assigned in a 1:1 ratio to receive once-daily glecaprevir–pibrentasvir for either 8 or 12 weeks. Patients with genotype 3 infection were randomly assigned in a 2:1 ratio to receive 12 weeks of treatment with either glecaprevir–pibrentasvir or sofosbuvir–daclatasvir. Additional patients with genotype 3 infection were subsequently enrolled and nonrandomly assigned to receive 8 weeks of treatment with glecaprevir–pibrentasvir. The primary end point was the rate of sustained virologic response 12 weeks after the end of treatment.

Results
In total, 1208 patients were treated. The rate of sustained virologic response at 12 weeks among genotype 1–infected patients was 99.1% (95% confidence interval [CI], 98 to 100) in the 8-week group and 99.7% (95% CI, 99 to 100) in the 12-week group. Genotype 3–infected patients who were treated for 12 weeks had a rate of sustained virologic response at 12 weeks of 95% (95% CI, 93 to 98; 222 of 233 patients) with glecaprevir–pibrentasvir and 97% (95% CI, 93 to 99.9; 111 of 115) with sofosbuvir–daclatasvir; 8 weeks of treatment with glecaprevir–pibrentasvir yielded a rate of 95% (95% CI, 91 to 98; 149 of 157 patients). Adverse events led to discontinuation of treatment in no more than 1% of patients in any treatment group.

Conclusions
Once-daily treatment with glecaprevir–pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis. (Funded by AbbVie; ENDURANCE-1 and ENDURANCE-3 ClinicalTrials.gov numbers, NCT02604017 and NCT02640157.)

View full text article: https://jumpshare.com/v/9GtWUYi3hENIx8GnabyH

Wednesday, January 10, 2018

Effect of ombitasvir/paritaprevir/ritonavir + dasabuvir regimen on health-related quality of life for patients with hepatitis C

Accepted Article

Effect of ombitasvir/paritaprevir/ritonavir + dasabuvir regimen on health-related quality of life for patients with hepatitis C
Sammy Saab, Darshan Mehta, Stacie Hudgens, Nathan Grunow, Yanjun Bao, Brett Pinsky
Accepted manuscript online: 5 January 2018
DOI: 10.1111/liv.13690

Full-text article
Downloaded & shared by @HenryEChang via Twitter.
View Article: https://jumpshare.com/v/HJEqCzaQ8N23yhY1Bwoq

Abstract 
Background and Aims 
This study analyzes health related quality of life (HRQoL) data from 8 randomized clinical trials using ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) ± ribavirin [RBV] to investigate: [1] the impact of the treatment vs. placebo during treatment on HRQoL; [2] the sustainability of such treatment effect after 12-week treatment period; and [3] if results from [1] and [2] differ in subgenotypes 1a vs. 1b.

Methods
Six registration trials and 2 post-approval trials were pooled and analyzed using longitudinal mixed models (MM) to estimate the effect of 3D + RBV on HRQoL outcomes adjusting for baseline scores, as well as patient demographics and clinical characteristics.

Results
Patients treated with RBV free 3D regimen reported statistically significant increase in HRQoL outcomes as compared to placebo patients. While 3D+RBV treatment saw statistically significant decline in HRQoL outcomes during treatment vs. baseline and vs. placebo, effect on HRQoL outcomes associated with RBV did not persist in the post treatment period for 3D patients followed for up to 52 weeks. The analysis also found GT1b patients reported greater improvements in HRQoL as compared to GT1a patients.

Conclusions
During active treatment period, small but statistically significant decrements in HRQoL outcomes were observed potentially driven by RBV, which were not sustained during the post treatment follow up period. Differences were observed by patient subgenotype, where HRQoL improvements were consistently higher for GT1b patients as compared to GT1a patients.

Tuesday, December 12, 2017

Retreatment of patients with treatment failure of direct-acting antivirals: Focus on hepatitis C virus genotype 1b

World J Gastroenterol. Dec 14, 2017; 23(46): 8120-8127
Published online Dec 14, 2017. doi: 10.3748/wjg.v23.i46.8120

Retreatment of patients with treatment failure of direct-acting antivirals: Focus on hepatitis C virus genotype 1b
Tatsuo Kanda, Kazushige Nirei, Naoki Matsumoto, Teruhisa Higuchi, Hitomi Nakamura, Hiroaki Yamagami, Shunichi Matsuoka, Mitsuhiko Moriyama

Abstract
The recent development of direct-acting antiviral agents (DAAs) against hepatitis C virus (HCV) infection could lead to higher sustained virological response (SVR) rates, with shorter treatment durations and fewer adverse events compared with regimens that include interferon. However, a relatively small proportion of patients cannot achieve SVR in the first treatment, including DAAs with or without peginterferon and/or ribavirin. Although retreatment with a combination of DAAs should be conducted for these patients, it is more difficult to achieve SVR when retreating these patients because of resistance-associated substitutions (RASs) or treatment-emergent substitutions. In Japan, HCV genotype 1b (GT1b) is founded in 70% of HCV-infected individuals. In this minireview, we summarize the retreatment regimens and their SVR rates for HCV GT1b. It is important to avoid drugs that target the regions targeted by initial drugs, but next-generation combinations of DAAs, such as sofosbuvir/velpatasvir/voxilaprevir for 12 wk or glecaprevir/pibrentasvir for 12 wk, are proposed to be potential solution for the HCV GT1b-infected patients with treatment failure, mainly on a basis of targeting distinctive regions. Clinicians should follow the new information and resources for DAAs and select the proper combination of DAAs for the retreatment of HCV GT1b-infected patients with treatment failure.

Core tip: In this minireview, we focused on the retreatment of patients with treatment failure of direct-acting antiviral agents against hepatitis C virus genotype 1b (HCV GT1b) infection. We summarized the retreatment regimens for patients with failure of peginterferon and ribavirin plus HCV NS3/4A inhibitors and for those with failure of HCV NS5A inhibitors. We also demonstrated the resistance-associated substitutions of HCV NS5B nucleos(t)ide inhibitors. Attention should be paid when selecting both the initial treatment and retreat regimens to completely eradicate HCV infection.

Full Text Article
View Online
Download PDF

Retreatment regimens for patients with hepatitis C virus infection for whom the initial combination of direct-acting antivirals has failed.

DAAs: Direct-acting antivirals; HCV GTs: Hepatitis C virus genotypes; RAS: Resistance-associated variants; N/A: Not available.

Monday, October 9, 2017

Seeking Shorter, Simpler Treatments for HCV Genotype 1

Seeking Shorter, Simpler Treatments for HCV Genotype 1
Kenneth Bender

Three interferon-free direct-acting antiviral (DAA) regimens approved for genotype 1 hepatitis C virus (HCV) require treating for 12 to 24 weeks, but recent trials suggest 8 weeks could be sufficient for certain patients.

Omar El-Sherif, MB, BCh (pictured), from the Hepatology Centre at St. James Hospital, Dublin, Ireland and colleagues at Beth Israel Deaconess Medical Center, Boston, MA reviewed clinical trials with dual- and triple-therapy regimens that can be effective in 8 weeks for HCV genotype 1, as well as several smaller trials that suggest circumstances in which shorter treatment periods may suffice.

Continue reading article.....

The review, "No one size fits all—Shortening duration of therapy with direct-acting antivirals for hepatitis C genotype 1 infection," was published online in the Journal of Viral Hepatitis this month.

MD Magazine - Back to all news

Of Interest
Shortening the duration of therapy for chronic HCV
Lancet Published online August 9, 2017 

Friday, September 22, 2017

HCV Guidance Updates - Recommendations Reflecting Vosevi and Mavyret


HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C
The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) with the International Antiviral Society developed a living document with ever evolving guidelines to treat HCV.

The guidelines have a complex algorithm for practitioners around the country to follow and see what's the right treatment, for the right patients, for the right about of time. The document is beneficial for patients as well living with or treating HCV. When new HCV drugs are approved, and new real world data is established, the guidelines are updated.

What’s New, Updates, and Changes to the Guidance
Thursday, September 21, 2017
This version of the guidance has been updated to reflect several important developments, including the recent approvals of glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir. Updated recommendations reflecting these approvals are provided throughout the guidance.

Updated references have been provided throughout the guidance.

In addition to updates to all the sections, the following new sections have been added to the guidance:
Genotype 1 & 3
New Treatment-Naïve & Treatment-Experienced
The following pages include guidance for management of treatment-naive patients.
The following pages include guidance for management of treatment-experienced patients.
Stay current with all guideline updates, "click here."

Complete Guidance
Download the PDF
Version: September 21, 2017

Friday, September 8, 2017

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

Correspondence
The American Journal of Gastroenterology -

Case series of 5 patients with quantifiable viral loads at the end of treatment who subsequently achieved sustained virologic response (SVR)

Owing to the limitations of this small case series of 5 patients, definitive conclusions regarding the clinical usefulness of end-of-treatment viral loads cannot be made. Although further studies are needed to determine the significance of quantifiable viremia at the end of treatment, the results of this case series demonstrate that this phenomenon does not always imply therapeutic failure.

Download PDF
View Online

Detectable Viremia at the End of Treatment With Direct-Acting Antivirals Can Be Associated With Subsequent Clinical Cure in Patients With Chronic Hepatitis C: A Case Series
Lindsey M. Childs-Kean University of Florida College of Pharmacy, Department of Infectious Diseases, Gainesville, Florida Joseph Hong Antimicrobial Stewardship Program, Bay Pines VA Healthcare System, Bay Pines, Florida

DOI: http://dx.doi.org/10.1053/j.gastro.2017.06.062

We report a case series of 5 patients with quantifiable viral loads at the end of treatment who subsequently achieved sustained virologic response (SVR) with recommended hepatitis C virus (HCV) direct-acting antiviral (DAA) regimens.

All 5 patients had HCV genotype 1a, were male, and none were coinfected with human immunodeficiency virus.

Their ages ranged from 56 to 67 years. All patients had a baseline viral load between 2,000,000 and 7,000,000 IU/mL (Table 1).

Three of the patients received 8 weeks of ledipasvir/sofosbuvir (LDV/SOF), one received 12 weeks of LDV/SOF, and one received 12 weeks of paritaprevir/ritonavir/ombitasvir/dasabuvir with ribavirin (PrOD+RBV). One patient who received 8 weeks of LDV/SOF and the patient who received PrOD+RBV were African American. One of the patients who received LDV/SOF had possible cirrhosis based on his elevated Fibrosis-4 scores; none of the other patients who received LDV/SOF seemed to have cirrhosis. The patient who received PrOD+RBV had compensated cirrhosis. All of the patients who received LDV/SOF were treatment naïve; the patient who received PrOD+RBV had previously received pegylated interferon monotherapy. Two patients receiving LDV/SOF received concomitant omeprazole therapy and were advised to take it at the same time as LDV/SOF. All patients reported complete adherence to the DAA regimen and tolerated treatment well. Viral loads were measured using the Abbott M2000 RealTime System (Abbott Laboratories, Lake Bluff, IL), which has a lower limit of quantification of 12 IU/mL, lower than that in published phase III trials.1, 2, 3


Table 1 Virologic Trends During and After HCV Treatment
       
Patients Units Baseline Week 2 Week 4 Week 6 Week 8 Week 10 Week 12 SVR4 SVR12
1IU/mL2,200,2243501817023ND
Log_HCV6.342.542.261.851.36ND
2IU/mL2,557,795496321<12ND
Log_HCV6.411.691.801.33<1.08ND
3IU/mL3,852,0201005113NDND
Log_HCV6.5921.711.12NDND
4IU/mL5,799,6601564486286107<12ND
Log_HCV6.763.192.692.462.03<1.08ND
5IU/mL6467,86930087804412485625<12ND
Log_HCV6.813.482.892.642.391.751.40<1.08ND

Tuesday, August 29, 2017

Treatment Of HCV Infection with New Drugs: Real World Experience in Southern Brazil

2017 Sep-Oct;16(5):727-733. doi: 10.5604/01.3001.0010.2717.

Treatment of Chronic HCV Infection with the New Direct Acting Antivirals (DAA): First Report of a Real World Experience in Southern Brazil.
Cheinquer H1, Sette-Jr H2, Wolff FH1, de Araujo A1, Coelho-Borges S1, Soares SRP2, Barros MFA2.

Full Text 

Abstract
INTRODUCTION AND AIM:
There is almost no data regarding the efficacy of direct acting antivirals (DAAs) therapy in Brazil. The aim of this historical cohort study is to describe the sustained virologic response (SVR) rate among real-world compensated chronic hepatitis C patients in three hepatology centers from Southern Brazil.

MATERIALS AND METHODS:
Patients were included if they had at least 12 weeks follow-up after the end of therapy. Patients that were lost to follow-up or had treatment prematurely interrupted for any reason were considered treatment failure in this intention to treat analysis.

RESULTS:
219 patients were analyzed. Mean age was 57.4 ± 10.9 years and 142/219 (64.8%) were male. Genotype 1 was present in 166 patients (75.8%; 1a 29.2%, 1b 46.6%); Genotypes 2, 3 and 4 in 8 (3.7%), 43 (19.6%) and 2 (0.9%), respectively. 96 (43.8%) were cirrhotic. 134 (59.5%) were treatment experienced. DAA therapies were: sofosbuvir (SOF) + ribavirin (RBV) in 10 patients; SOF + simeprevir (SMV) ± RBV in 73; SOF + pegylated interferon (PEG-IFN) + RBV in 6; SOF + daclatasvir (DCV) ± RBV in 51, SOF + ledipasvir (LDV) ± RBV in 61, and paritaprevir/ ritonavir + ombitasvir + dasabuvir (PTVr/OBV/DSV) ± RBV in 18 patients. SVR-12 was achieved in 208/219 (95%). Ten patients had virologic failure: 6 cirrhotic, 7 treatment experienced, and 6 either genotype 3 or 1a. No adverse event was attributed to the DAA therapy.

CONCLUSIONS:
Real world experience with DAA therapy in Southern Brazil showed a high rate of SVR and excellent tolerability. Failure to achieve SVR was mainly observed among patients with at least one negative predictor of response: cirrhosis and/or genotypes 1a or 3.

Full text

Thursday, August 24, 2017

Harvoni in adolescents 12-17 years old with HCV genotype 1

In Case You Missed It

In the Journals
Balistreri WF, et al. Hepatol. 2017;doi:10.1002/hep.28995
All adolescent patients available for follow-up after treatment with Harvoni for chronic hepatitis C genotype 1 achieved sustained virologic response at 12 weeks with no serious adverse events, further supporting its approval in this population.
“Treatment of pediatric patients has been controversial as the current standard of care, pegylated interferon and weight-based ribavirin, is associated with significant side effects, including growth impairment, and poor tolerability,” William F. Balistreri, MD, from the Cincinnati Children’s Hospital Medical Center, and colleagues wrote. “Similar to what has been observed in adults, treatment with ledipasvir-sofosbuvir was well tolerated in adolescents.”
Continue reading @ Healio

Full Text 
Research Article
No all-oral, direct-acting antiviral regimens have been approved for children with chronic hepatitis C virus (HCV) infection. We conducted a Phase 2, multi-center, open-label study to evaluate the efficacy and safety of ledipasvir–sofosbuvir in adolescents with chronic HCV genotype 1 infection.

Abstract
The safety and effectiveness of ledipasvir−sofosbuvir in adolescents 12-17 years old with hepatitis C virus genotype 1 infection

Recommended Reading

HCV Advocate
Hepatitis C in Children
In this article, I will discuss the various aspects of hepatitis C (HCV) in children including what we know and what we don’t know!  The topics I will cover are mother-to-child transmission, hepatitis C transmission among children, HCV disease progression in children, which tests to monitor children with hepatitis C, and the newly approved medications to treat children.  The outlook for children with hepatitis C is looking better now that we have direct-acting antiviral medications to treat children with hepatitis C but we first have to identify, manage and treat them.
Read more...

Sunday, August 20, 2017

(grazoprevir-ruzasvir-uprifosbuvir) Shorter anti-HCV regimen effective in patients with or without cirrhosis

In Case You Missed It

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


Shorter anti-HCV regimen effective in patients with or without cirrhosis
Last Updated: 2017-08-18
By Will Boggs MD
NEW YORK (Reuters Health) - An eight-week regimen containing grazoprevir-ruzasvir-uprifosbuvir appears to be effective for treating hepatitis C virus (HCV) infection in patients with or without cirrhosis, according to findings from a pair of randomized phase 2 open-label trials.

Dr. Edward J. Gane from Auckland Clinical Studies, in Auckland, New Zealand, and colleagues - in part A of the C-CREST-1 and C-CREST-2 trials - randomly assigned 240 patients with HCV genotype 1, 2 or 3 and without cirrhosis to receive an eight-week course of a daily three-drug combination:

- grazoprevir 100 mg, plus

- either elbasvir 50 mg or ruzasvir 60 mg, plus

- either 300 mg or 450 mg of uprifosbuvir.

The studies were funded by Merck and Co.

Sustained virologic response rates 12 weeks after the end of therapy (SVR12) were 92% with both doses of the grazoprevir-ruzasvir-uprifosbuvir regimen and ranged from 85% to 88% (depending on uprifosbuvir dose) with grazoprevir-elbasvir-uprifosbuvir, according to one of the reports, both online August 9 in The Lancet Gastroenterology and Hepatology.

All four regimens were well-tolerated.

"These results support the selection of grazoprevir plus ruzasvir plus uprifosbuvir 450 mg as the regimen for further clinical investigation in broader populations," the researchers conclude.

Dr. Eric Lawitz from Texas Liver Institute at the University of Texas Health San Antonio and colleagues extended these findings in part B of C-CREST-1 and C-CREST-2. In this trial, 675 patients with HCV-1, -2, -3, -4 or -6, with or without cirrhosis, received eight, 12, or 16 weeks of grazoprevir-ruzasvir-uprifosbuvir 450 mg, with or without ribavirin.

SVR12 rates with eight weeks of therapy were 93% in individuals with genotype 1a, 98% with genotype 1b, 86% with genotype 2 (without cirrhosis; patients with HCV-2 and cirrhosis received a longer course), 95% with genotype 3 (treatment naive, without cirrhosis) and 100% with genotypes 4 and 6.

"We were surprised by the relatively lower efficacy of an 8-week duration of this regimen among those with genotype 2 infection," Dr. Lawitz told Reuters Health by email. "However, extending therapy to 12 weeks overcame this effect."

SVR12 rates were generally higher among participants with or without cirrhosis who received 12 or 16 weeks of therapy.

There were no documented virologic failures after week 12 of follow-up, although 10 participants who achieved SVR12 were lost to follow-up.

As in part A of the study, treatment with this fixed-dose combination with or without ribavirin was generally well tolerated.

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

"We await data from phase 3 to know how this regimen might impact the current treatment landscape," Dr. Lawitz said. "We hope that this regimen will be able to give providers more options with regard to pan-genotypic regimens for the treatment of HCV."

Dr. Eleanor M. Wilson from the University of Maryland School of Medicine, Baltimore, who coauthored an accompanying comment in the journal, told Reuters Health by email, "The safety and efficacy data seem promising, but it's still investigational, so not sure about its impact on the field of hepatitis C treatment yet."

"With the recent approvals of Vosevi and Mavyret, in addition to the previously available options, I think the overall take-away is that it's fantastic that there are more hepatitis C treatment options for patients and providers," she said. "It's tremendous that previously so-called 'difficult-to-treat patients' including those with previous treatment experience, comorbid conditions like HIV or renal disease, and those with advanced fibrosis and cirrhosis now have a variety of safe and highly effective options to treat their hepatitis C."

"My area of expertise is in novel treatment approaches, including strategies to reduce the treatment duration in order to increase access and decrease treatment cost, as well as options for patients who haven't successfully cleared HCV with first-line therapy (due to problems of adherence or viral resistance), and from that standpoint, it's an exciting time to be a hepatitis C provider," Dr. Wilson said.

Dr. Mark Sulkowski, who directs the viral hepatitis center at Johns Hopkins University in Baltimore, told Reuters Health by email, "We currently have multiple outstanding HCV regimens for the treatment of all genotypes of hepatitis C, which typically include combinations of direct-acting antiviral inhibitors of HCV protein targets NS3 (protease), NS5A and NS5B (polymerase). While we have seen the regulatory approval of multiple inhibitors of the NS3 and NS5A proteins, to date, only one (nucleotide) inhibitor of the NS5B polymerase active site has been approved, sofosbuvir."

"The C-CREST-1 and -2 studies provide a phase 2 evaluation of another (nucleotide) analogue inhibitor of NS5B, uprifosbuvir," said Dr. Sulkowski, who was not involved in the research. "Based on the results of these studies, uprifosbuvir appears to be poised to move to phase 3 studies, and if successful in phase 3 trials, this agent could become a valuable addition to the available drugs to treat hepatitis C."

Dr. Gane did not respond to a request for comment.
Merck funded the trials and employed most of the authors.

SOURCE: Lancet Gastroenterol Hepatol 2017.
Abstract 
Abstract 
Abstract 

Friday, August 18, 2017

Hepatitis C - Newly Approved Mavyret Has High Response Rates

The Lancet
Download Full Text Article - PDF provided by Henry E. Chang‏ via Twitter:

Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial
Xavier Forns, Samuel S Lee, Joaquin Valdes, Sabela Lens, Reem Ghalib, Humberto Aguilar, Franco Felizarta, Tarek Hassanein, Holger Hinrichsen, Diego Rincon, Rosa Morillas, Stefan Zeuzem, Yves Horsmans, David R Nelson, Yao Yu, Preethi Krishnan, Chih-Wei Lin, Jens J Kort, Federico J Mensa

Summary Background
The once-daily, ribavirin-free, pangenotypic, direct-acting antiviral regimen, glecaprevir coformulated with pibrentasvir, has shown high rates of sustained virological response in phase 2 and 3 studies. We aimed to assess the efficacy and safety of 12 weeks of coformulated glecaprevir and pibrentasvir in patients with hepatitis C virus (HCV) infection and compensated cirrhosis......
Continue reading....

The Lancet
Download Full Text Article - PDF provided by Henry E. Chang‏ via Twitter:

Comment 
New anti-HCV drug combinations: who will benefit?
Publication stage: In Press Corrected Proof
DOI: http://dx.doi.org/10.1016/S1473-3099(17)30486-3
In The Lancet Infectious Diseases1 Xavier Forns and colleagues present the results of a phase 3 trial assessing the efficacy and safety of 12 weeks of treatment with glecaprevir (300 mg) coformulated with pibrentasvir (120 mg) in patients with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5, or 6 infection and compensated cirrhosis. Of 146 enrolled patients, 145 (99%, 95% CI 98–100) achieved a sustained virological response. The study did not include patients with decompensated cirrhosis; the same is true for studies of sofosbuvir, velpatasvir, and voxilaprevir.2....
Continue reading......

Newly Approved Hepatitis C Drug Has High Response Rates
By Amy Orciari Herman
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Nearly all patients with chronic hepatitis C virus (HCV) infection treated with glecaprevir-pibrentasvir achieved sustained virologic response after 12 weeks of therapy, according to results of an industry-funded, phase 3 trial in the Lancet Infectious Diseases. The once-daily combination drug (brand name, Mavyret) was approved by the FDA earlier this month to treat all HCV genotypes.

The trial enrolled 146 adults with HCV genotype 1a, 1b, 2, 4, 5, or 6 and compensated cirrhosis who either had not been previously treated, or had not responded to interferon-based treatment or to treatment with sofosbuvir plus ribavirin (with or without pegylated interferon). At 12 weeks after treatment ended, all but one patient had sustained virologic response. A patient with HCV genotype 1a and a history of treatment with pegylated interferon plus ribavirin relapsed at week 8.

Nearly 70% of patients had adverse events, most of which were mild (e.g., fatigue). No serious events were related to the study drug.

Link(s):
The Lancet
Lancet Infectious Diseases article (Free abstract)
Lancet Infectious Diseases comment (Subscription required)
Background: Physician's First Watch coverage of glecaprevir-pibrentasvir (Free)
Source-

Saturday, July 22, 2017

Hepatitis C Treatment Regimens Are Cost-Effective: But Compared With What?

Hepatitis C Treatment Regimens Are Cost-Effective: But Compared With What?T. Joseph Mattingly II, PharmD, MBA1, Julia F. Slejko, PhD1, and C. Daniel Mullins, PhD1

DOI: 10.1177/1060028017722007 | First Published July 17, 2017

Full Text Article
Download PDF
Link provided by via @HenryEChang onTwitter

On Twitter
I highly suggest you follow Henry E. Chang if you are interested in reading full text articles about the treatment and management of hepatitis C.

Abstract
Background: Numerous economic models have been published evaluating treatment of chronic hepatitis C virus (HCV) infection, but none provide a comprehensive comparison among new antiviral agents.

Objective: Evaluate the cost-effectiveness of all recommended therapies for treatment of genotypes 1 and 4 chronic HCV.

Methods: Using data from clinical trials, observational analyses, and drug pricing databases, Markov decision models were developed for HCV genotypes 1 and 4 to compare all recommended drugs from the perspective of the third-party payer over a 5-, 10-, and 50-year time horizon. A probabilistic sensitivity analysis (PSA) was conducted by assigning distributions for clinical cure, age entering the model, costs for each health state, and quality-adjusted life years (QALYs) for each health state in a Monte Carlo simulation of 10 000 repetitions of the model.

Results: In the lifetime model for genotype 1, effects ranged from 18.08 to 18.40 QALYs and total costs ranged from $88 107 to $184 636. The lifetime model of genotype 4 treatments had a range of effects from 18.23 to 18.43 QALYs and total costs ranging from $87 063 to $127 637. Grazoprevir/elbasvir was the optimal strategy followed by velpatasvir/sofosbuvir as the second-best strategy in most simulations for both genotypes 1 and 4, with drug costs and efficacy of grazoprevir/elbasvir as the primary model drivers.

Conclusions: Grazoprevir/elbasvir was cost-effective compared with all strategies for genotypes 1 and 4. Effects for all strategies were similar with cost of drug in the initial year driving the results.

Keywords hepatitis C, cost-effectiveness, cost-utility, genotype 1, genotype 4

Download PDF - Full Text Article

Friday, June 30, 2017

Harvoni - Effectiveness and safety of ledipasvir/sofosbuvir ± ribavirin in the treatment of HCV infection: The real-world HARVEST study

Advances in Medical Sciences
Volume 62, Issue 2, September 2017, Pages 387–392

Original research article
Effectiveness and safety of ledipasvir/sofosbuvir ± ribavirin in the treatment of HCV infection: The real-world HARVEST study
Robert Flisiaka, , , Mariusz Łucejkoa, Włodzimierz Mazurb, Ewa Janczewskac, Hanna Berakd, Krzysztof Tomasiewicze, Iwona Mozer-Lisewskaf, Dorota Kozielewiczg, Andrzej Gietkah, Katarzyna Sikorskai, Marta Wawrzynowicz-Syczewskaj, Krzysztof Nowakk, Dorota Zarębska-Michalukl, Joanna Musialikm, Krzysztof Simonn, Aleksander Garlickio, Robert Pleśniakp, Barbara Baka-Ćwierzq, Iwona Olszokr, Krystyna Augustyniaks, Wojciech Stolarzt, Jolanta Białkowskau, Anna Badurekv, Anna Piekarskaw

Download Full Text Article

Abstract
Background
To evaluate the effectiveness and safety of ledipasvir/sofosbuvir (LDV/SOF) ± ribavirin (RBV) regimen in a real-world setting.

Methods
Patients received a fixed-dose combination tablet containing LDV and SOF with or without RBV, for 8, 12 or 24 weeks. Patients were assessed at baseline, end of treatment, and 12 weeks after the end of treatment. The primary effectiveness endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12).

Results
Of the 86 patients, aged 20–80 years, 82.6% were HCV genotype 1b-infected and 50.0% were cirrhotic. More than half (52.3%) had previously followed pegylated interferon-containing (PEG-IFN) treatment regimens, and 38.5% were null-responders. SVR12 was achieved by 94.2% of patients. All non-responders were cirrhotic: two demonstrated virologic breakthrough and the remaining three relapsed. All patients treated with an 8-week regimen achieved SVR12 despite having high viral load at baseline (HCV RNA of >1 million IU/mL in 8/10 patients, including one with a viral load of >6 million IU/mL). Adverse events were generally mild and transient. Most frequently, fatigue (22.1%), headache (15.1%), and arthralgia (7.0%) were observed. Laboratory abnormalities included anemia and hyperbilirubinemia.

Conclusions
Treatment with LDV/SOF ± RBV is an effective and safe option for patients with HCV, including those with advanced liver disease or a history of non-response to PEG-IFN-based therapy.
Continue reading...

Full Text Article
Article link provided by Henry E. Chang via Twitter.
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C.

Original Article The clinical roles of rheumatoid factor in the treatment of chronic hepatitis C infection

Int J Clin Exp Med 2017;10(6):9456-9462 www.ijcem.com /ISSN:1940-5901/IJCEM0049611

Original Article The clinical roles of rheumatoid factor in the treatment of chronic hepatitis C infection
Wei-Ming Chen1,2,3*, Kao-Chi Chang1*, Ko-Ming Lin2,3,4, Kuo-Liang Wei1,3, Pey-Jium Chang2, Te-Sheng Chang1,2,3, Chein-Heng Shen1, Shui-Yi Tung1,3

Received January 24, 2017; Accepted April 28, 2017; Epub June 15, 2017; Published June 30, 2017

Download Full Text Article

Abstract: Objective:
The hepatitis C virus infection is associated with arthritis. However, the clinical roles of the rheumatoid factor in patients who received anti-viral treatment are not as clear.

Methods: To identify the association between the rheumatoid factor and the treatment response in hepatitis C virus infected patients, we enrolled patients who received anti-viral treatment with peg-interferon plus weight-based ribavirin according to response guided therapy. Patients who had a mix type hepatitis C infection, any autoimmune diseases, hepatitis B co-infection or intolerance to the side effects of therapy were excluded. Patients were divided into a rheumatoid factor (RF) positive (>20 IU/ml) group and a rheumatoid negative group. The patient’s characteristics, treatment response, dynamic changing of the rheumatoid factor and factors influenced the sustained virus response (SVR) of therapy, which were analyzed.

Results: A total of 271 patients completed the anti-viral treatment and analysis. The positive rate of the rheumatoid factor is 47.23% (128/271). In the RF positive group, the SVR rate was 82.8%, 71.0%, 96.6% for overall, genotype 1 infected, and non-genotype 1 infected patients, respectively. In the RF negative group, the SVR rate was 77.6%, 66.7%, 91.9% for overall, genotype 1 infected, and non-genotype 1 infected patients, respectively. There is a trend toward a higher SVR rate in RF positive patients, but no statistical difference was noted. In RF positive patients who achieved SVR, the RF values reduced significantly (56.4±78.0 vs. 39.4±39.6, P<0.001) after treatment but not in the non-SVR group (43.8±25.9 vs. 31.7±13.5, P=0.074). In the RF negative group, 37.8% and 34.4% of the patients’ RF became positive after treatment in the SVR group and in the non-SVR group. A lower virus load (<800,000 copies/ml), non-genotype 1 infection, alanine aminotransferase (ALT) rapid normalization, rapid viral response (RVR) and complete early viral response (cEVR) are significant predictive factors associated with SVR. The present or dynamic change of the rheumatoid factor cannot predict the effect of the treatment response.

Conclusions: The rheumatoid factor was positive in 47% of the chronic hepatitis C virus infected patients. In the RF positive group, the treatment response was better but not statistically significant. After treatment, the RF value was significantly reduced in cured patients.
Continue reading....

Recommended Reading
An Overview of Extrahepatic Manifestations of Hepatitis
A patient friendly fact sheet explaining conditions associated with HCV including symptoms.
The hepatitis C virus mainly affects the liver, but there are many other conditions that are associated with hepatitis C.  Extrahepatic manifestation means diseases or conditions that affect organs other than the liver.  Extrahepatic manifestations of hepatitis C can be found in the skin, eyes, joints, immune system, nervous system and kidneys.  Some of these conditions – cryoglobulinemia, for example – are somewhat more common and well documented, while others are infrequent or their association with hepatitis C has not yet been proven.

Recently published in Journal of Advanced Research is a nice collection of review articles on the extrahepatic manifestations of HCV.
Volume 8, Issue 2, March 2017, Pages 85–87

In The News
Lower Risk of Hep C Extrahepatic Manifestations With Sustained Virological Response
Patients who achieved a sustained virological response (SVR) to interferon-based antiviral therapy for hepatitis C virus (HCV) had a reduced risk of extrahepatic manifestations, according to a retrospective cohort study.