Showing posts with label Mavyret (glecaprevir/pibrentasvir). Show all posts
Showing posts with label Mavyret (glecaprevir/pibrentasvir). Show all posts

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

Thursday, January 11, 2018

Ira M. Jacobson MD: 8-week therapy for patients with HCV infection

Clinical Care Options 
How New Data From AASLD 2017 Inform the Use of 8-Week Regimens for HCV
Ira M. Jacobson MD - 1/9/2018
Several studies presented at the 2017 AASLD meeting in Washington, DC, assessed 8-week therapy for patients with HCV infection. In this commentary, I discuss how key data from these studies may have an impact on management of patients with HCV infection.

Studies discussed:
8-Week GZR/EBR for Treatment-Naive, Noncirrhotic Patients With Genotype 1b HCV Infection
GLE/PIB for Treatment-Naive Genotype 3 HCV
8-Week LDV/SOF for Acute Genotype 1 or 4 HCV and HIV Coinfection


New At Clinical Care Options 
New Insights on NAFLD/NASH From AASLD 2017
Philip Newsome PhD, FRCPE - 1/8/2018
Here’s my take on how new data from AASLD 2017 on noninvasive imaging modalities and emerging investigational agents may affect the NAFLD/NASH patient management landscape.

How Injection Drug Use Affects HCV Treatment
Norah Terrault MD, MPH - 1/3/2018
Here’s my take on why colocalization of HCV treatment with other medical and social services may be ideal for persons who inject drugs. 

Saturday, January 6, 2018

Mavyret (glecaprevir/pibrentasvir) for HCV genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial

In case you missed it

Glecaprevir/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial
Authors David Wyles, Fred Poordad, Stanley Wang, Laurent Alric, Franco Felizarta, Paul Y. Kwo, Benedict Maliakkal, Kosh Agarwal, Tarek Hassanein, Frank Weilert, Samuel S. Lee, Jens Kort, Sandra S. Lovell, Ran Liu, Chih-Wei Lin, Tami Pilot-Matias, Preethi Krishnan, Federico J. Mensa

First published: 4 January 2018
DOI: 10.1002/hep.29541

Full Text
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Abstract
This study assessed the efficacy and safety of ribavirin-free coformulated glecaprevir/pibrentasvir (G/P) in patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis, a patient population with limited treatment options. SURVEYOR-II, Part 3 was a partially randomized, open-label, multicenter, phase 3 study. Treatment-experienced (prior interferon or pegylated interferon ± ribavirin or sofosbuvir plus ribavirin ± pegylated interferon therapy) patients without cirrhosis were randomized 1:1 to receive 12 or 16 weeks of G/P (300 mg/120 mg) once daily. Treatment-naive or treatment-experienced patients with compensated cirrhosis were treated with G/P for 12 or 16 weeks, respectively. The primary efficacy endpoint was the percentage of patients with sustained virologic response at posttreatment week 12 (SVR12). Safety was evaluated throughout the study. There were 131 patients enrolled and treated. Among treatment-experienced patients without cirrhosis, SVR12 was achieved by 91% (20/22; 95% confidence interval [CI], 72-97) and 95% (21/22; 95% CI, 78-99) of patients treated with G/P for 12 or 16 weeks, respectively. Among those with cirrhosis, SVR12 was achieved by 98% (39/40; 95% CI, 87-99) of treatment-naive patients treated for 12 weeks and 96% (45/47; 95% CI, 86-99) of patients with prior treatment experience treated for 16 weeks. No adverse events led to discontinuation of study drug, and no serious adverse events were related to study drug. Conclusion: Patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis achieved high SVR12 rates following 12 or 16 weeks of treatment with G/P. The regimen was well tolerated.
(Hepatology 2017)

In summary, SURVEYOR-II Part 3 enrolled and treated some of the most difficult-to-cure HCV patients: those with GT3 infection and prior treatment experience and/or cirrhosis. Overall, the fixed-dose combination of once-daily RBV-free G/P was well tolerated and demonstrated high SVR12 rates (≥95%) in treatment-naive patients with cirrhosis treated for 12 weeks and treatment-experienced patients with or without cirrhosis treated for 16 weeks. Therefore, G/P provides an efficacious and well-tolerated once-daily RBV-free treatment option for patients with HCV genotype 3 and prior treatment experience and/or cirrhosis.

Wednesday, December 6, 2017

HCV Patients SVR with Mavyret After Previous DAA Failure

HCV Patients SVR with Mavyret After Previous DAA Failure
DECEMBER 05, 2017
Gail Connor Roche

“The few patients who fail a primary treatment attempt with direct acting antivirals have over a 90% chance of cure using a 16-week regimen of the newly approved glecaprevir and pibrentasvir,’’ author Fred Poordad, MD, Professor of Medicine at University of Texas Health, San Antonio, told MD Magazine. “This means we should be able to cure over 99% of all hepatitis C patients.’’

Saturday, December 2, 2017

Mavyret: A Pan-Genotypic Combination Therapy for the Treatment of Hepatitis C Infection

Published as part of the Biochemistry series “Biochemistry to Bedside”
Department of Biochemistry and Molecular Pharmacology, University of Massachusetts Medical School, Worcester, Massachusetts 01605, United States
DOI: 10.1021/acs.biochem.7b01160
Publication Date (Web): December 1, 2017
Copyright © 2017 American Chemical Society

Viewpoint
Mavyret: A Pan-Genotypic Combination Therapy for the Treatment of Hepatitis C Infection
Ashley N. Matthew, Nese Kurt Yilmaz, and Celia A. Schiffer

Hepatitis C virus (HCV), a virus that infects more than 180 million people worldwide, is the causative agent of chronic liver disease, which often progresses to fibrosis, liver cirrhosis, and hepatocellular carcinoma (HCC). According to the World Health Organization, almost half a million patients infected with HCV die each year from cirrhosis and HCC alone. In the last several years, treatment of HCV infections has been revolutionized by the development of small molecular inhibitors that target essential proteins encoded by the viral genome. These inhibitors, known as direct-acting antivirals (DAAs), have improved treatment option and outcomes and eliminated the need for interferon injections. However, the emergence of resistance-associated variants (RAVs) and high genetic variation among the six distinct genotypes of the virus have been presenting challenges, even leading to treatment failure.

Newer all-oral DAA combination regimens for HCV infection consist of inhibitors that target the NS3/4A, NS5A, and NS5B viral proteins. Of note, NS3/4A protease inhibitors have become a mainstay of treatment as most new therapies contain an inhibitor from this class. While highly effective against other genotypes, treatment of genotype 3 infections has been the most challenging, especially in patients who failed previous therapy or have cirrhosis. Recently, AbbVie received Food and Drug Administration (FDA) approval for one of the first pan-genotypic combination therapies, Mavyret, consisting of glecaprevir and pibrentasvir, an NS3/4A protease and an NS5A inhibitor, respectively (Figure 1). Given the excellent pan-genotypic response and safety profile in patients, Mavyret was approved for the treatment of genotypes 1–6 in patients without cirrhosis, or with compensated cirrhosis. In patients with non-cirrhotic chronic HCV who were treatment-naïve or had previously been treated with pegylated interferon or ribavirin, the sustained virological response (SVR) rate was 83–100% across all genotypes.(1) In treatment-naïve patients with compensated liver disease, 99% of patients achieved SVR with a 12-week course.(2) Mavyret was approved as an 8-week course for treatment-naïve patients without cirrhosis, shortening the previous standard of care by an additional 4 weeks.

One component of the Mavyret combination, pibrentasvir (ABT-530), has excellent potency across all HCV genotypes and retains potency against common RAVs. Pibrentasvir had EC50 values across genotypes ranging from 1.4 to 5 pM against the HCV replicon in antiviral assays.(3) Under the selective pressure of inhibitors, RAVs emerge at positions 28, 30, 31, and 93 in the NS5A protein. In fact, all current NS5A inhibitors are susceptible to mutations at Tyr93. In vitro studies indicate pibrentasvir also selects these mutations, including Y93H, that confer resistance to other NS5A inhibitors.(3) However, pibrentasvir maintained good potency against many single-site NS5A mutations, suggesting double or triple mutants need to emerge to confer high levels of resistance against this inhibitor.

The other component of Mavyret, glecaprevir (ABT-493), is a P2–P4 macrocyclic NS3/4A protease inhibitor with subnanomolar to low nanomolar activity against all genotypes, including genotype 3.(4) NS3/4A protease inhibitors are often susceptible to single-site mutations at residues Arg155, Ala156, and Asp168. Most if not all protease inhibitors are susceptible to mutations at Asp168, which are often present in patients who fail therapy with a protease inhibitor. Notably, this active site residue is not conserved in genotype 3 and is Gln168 instead, contributing to the natural resistance of genotype 3 to most treatments. While potent against 168 variations, including genotype 3, glecaprevir is highly susceptible to A156T and A156V mutations. We have shown that inhibitors containing P2–P4 macrocycles, as in glecaprevir, are susceptible to changes at Ala156, as substitutions with a larger side chain result in steric clash with the inhibitor’s macrocycle.(5) Luckily, mutations at Ala156 do not occur alone because of reduced replicative capacity; however, additional mutations could restore the enzymatic fitness, which can lead to clinically viable multi-mutant resistant variants.

Thus, both components of Mavyret have good resistance profiles against wild type genotypes and single-mutant variants of HCV. What needs to be considered is the emergence of double, triple, or other multi-mutant variants that may have high levels of resistance to one or both components of this combination. Such multi-mutant variants potentially pose a threat to the longevity and success of HCV treatment. There are already double- and triple-mutant variants that have been isolated from patients who failed therapy with previously FDA-approved combination therapies. Considering the similarity in the inhibitor scaffolds and modes of action, there is a danger that these variants may be cross-drug resistant and not respond to any current treatment option, including Mavyret. As new drugs and combinations are developed, it will be important to understand the mechanisms of resistance for these multi-mutant variants and incorporate those insights into drug design. Rather than concentrating all effort into inhibitors from the same class with highly similar scaffolds, diversifying the arsenal of DAAs and considering triple-combination therapy may be required to avoid cases of incurable HCV infection.

The approval of Mavyret dual-combination therapy marks another milestone in the treatment of HCV infections. There had been a major effort to develop an all-oral combination therapy with activity against all genotypes. With the approval of Mavyret, this goal has been met. The newer-generation inhibitors and various combinations provide treatment options for patients and improve SVR rates across all genotypes. For many cases, Mavyret has decreased the standard of care from 24 to 8 weeks. More importantly, treatment options for patients with compensated liver disease are now available. One major remaining concern is the possible emergence of drug resistance. The newer inhibitors have better activity against single-site RAVs, but highly resistant multi-mutant strains may become clinically relevant. Preventing the emergence and spread of cross-resistant variants and developing inhibitors with improved potency against such variants may be the next challenge.

Full Text

Saturday, November 18, 2017

Vosevi & Mavyret: The Impact of New Options for DAA-Experienced Patients With HCV

Updated
Latest ClinicalThought commentaries from Clinical Care Options (CCO).

Over at Clinical Care Options, using an easy to follow patient case scenario experts discuss treatment options with newly approved drugs: Mavyret (glecaprevir/pibrentasvir) GLE/PIB and Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) SOF/VEL/VOX.

11/16/2017
The Impact of New Options for DAA-Experienced Patients With HCV
Jordan J. Feld MD, MPH - 11/16/2017
With the approvals of SOF/VEL/VOX and GLE/PIB, what is the new management approach for DAA-experienced patients with HCV infection?

In this viral hepatitis case series, we highlight common patient case scenarios and the critical decision making that informs selection of optimal patient management strategies. This commentary features a woman with cirrhosis who is seeking retreatment after failure of first-line direct-acting antiviral (DAA) therapy. The impact of the recent approvals of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) and glecaprevir (GLE)/pibrentasvir (PIB) on treatment for this class of patient is discussed.

Case Details
A 59-year-old white woman with compensated cirrhosis (elastography 24 kPa) and genotype 1a HCV infection was previously treated with SOF/ledipasvir (LDV) for 12 weeks, but she experienced a relapse at posttreatment Week 6. She reports strict adherence to her previous regimen and is seeking advice on retreatment options.
Continue reading @ CCO

11/15/2017
How Recent Drug Approvals Have Affected First-line HCV Treatment
Nancy Reau MD, FAASLD, AGAF - 11/15/2017
What parameters now qualify a patient infected with HCV for shortened first-line therapy?

In this viral hepatitis case series, we highlight common patient case scenarios and the critical decision making that informs selection of optimal patient management strategies. This commentary features a treatment-naive, noncirrhotic patient who is infected with HCV and ready to begin therapy. The candidacy of this patient for 8-week vs 12-week therapy is discussed, with a focus on the latest treatment options and guidelines.

Case Details
A 56-year-old white man newly diagnosed with genotype 1a HCV infection presents for initiation of treatment. His baseline HCV RNA is 8,500,000 IU/mL and he has F2 fibrosis. He expresses a desire to take as short a course of HCV treatment as possible.
Continue reading @ CCO

*Free registration is required

Monday, October 23, 2017

The Liver Meeting® 2017 - Mavyret (Glecaprevir/Pibrentasvir) for Treatment-Naive Patients With HCV Genotype 3

NAM Publications
An integrated analysis of clinical trial data showed that glecaprevir/pibrentasvir taken for 8 weeks cured 98% of people without cirrhosis with hard-to-treat genotype 3, while a 12-week course cured 100% of people with genotype 3 with cirrhosis. A related analysis showed that the combination taken for 12 or 16 weeks cured 96% of people with compensated cirrhosis across all genotypes.

Steven Flamm of Northwestern Feinberg School of Medicine in Chicago and colleagues performed an integrated analysis of efficacy and safety data from phase 2 and 3 clinical trials of glecaprevir/pibrentasvir for previously untreated people with HCV genotype 3, either without cirrhosis or with compensated cirrhosis.
Read the article @ aidsmap

aidsmap coverage
Conference news: The Liver Meeting

NATAP
WASHINGTON, DC -- October 23, 2017 -- Glecaprevir/pibrentasvir was well-tolerated and resulted in high virologic response rates in treatment-naive patients with hepatitis C virus (HCV) genotype 3 infection, according to a study presented here at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
Read the article @ FirstWord Pharma

Of Interest - HCV Genotype 3
Of Interest - FirstWord Pharma
By Andrew D. Bowser
The findings add new perspective to the ongoing discussion among researchers and clinicians as to whether adding ribavirin might prevent a relapse in patients with HCV genotype 3, particularly if they were previously treated.

Results of the current study represent “real world” experience with patients with HCV genotype 3 treated at 9 sites in Germany, according to Stefan Christensen, MD, Department of Infectious Diseases, Center for Interdisciplinary Medicine, Muenster, Germany.

“We could confirm the high SVR12 rates [sustained virologic response at 12 weeks] from the clinical phase 3 studies with sofosbuvir/velpatasvir, [but] in our cohort, it seems like the addition of ribavirin in cirrhotic patients did not have further benefit for those patients,” he said.
Read the article @ FirstWord Pharma

FirstWord Pharma

Tuesday, October 17, 2017

The changing HCV treatment cascade

Pharmacology Consult
The changing HCV treatment cascade
Infectious Disease News, October 2017
Jocelyn Mason, PharmD; Kimberly D. Boeser, PharmD, MPH, BCPS, AQ-ID
The rapid development of DAA combinations provides simplified regimens, shorter durations, improved efficacy and greater tolerability, unlike the previous interferon and ribavirin cornerstone regimens. Although the IDSA/AASLD guidelines provide the map to managing HCV, they do not identify the ideal interferon-free regimen to begin with, nor have they given a clear path to treating genotype 3 and those with decompensated cirrhosis. This ever-changing field will require collaboration among health care providers, including those specializing in infectious diseases, hepatology and gastroenterology, as well as pharmacists, to optimize treatment strategies. As the landscape of HCV continues to update with new literature and new medications, this subspecialty continues to be dynamic.
Continue to article - https://www.healio.com/infectious-disease/hepatitis-c/news/print/infectious-disease-news/%7B87b74536-f358-43d3-a804-f37a98402b0b%7D/the-changing-hcv-treatment-cascade

Thursday, October 12, 2017

Mavyret (Glecaprevir and Pibrentasvir) - Combo confirmed as safe and effective for HCV patients with chronic kidney disease


Sustained Response with HCV Combo Drug in CKD
Patients with both diseases had virologic response and no failure

by Molly Walker, Staff Writer, MedPage Today
October 11, 2017
A combination therapy for patients with chronic kidney disease (CKD) and hepatitis C (HCV) was confirmed as safe and effective, according to researchers in New Zealand.

Overall, 102 of 104 patients (98% virologic response rate, 95% CI 95-100) treated with the combination of NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir (Mavyret) for 12 weeks had a sustained virologic response rate, with no patients reporting virologic failure, reported Edward Gane, MD, of Auckland City Hospital, and colleagues.

Preliminary results were first presented at the 2016 American Association for the Study of Liver Diseases (AASLD) annual meeting. Gane's group have now published the full peer-reviewed results of the phase III trial in the New England Journal of Medicine. The combination therapy received FDA approval in August 2017, and is indicated for the treatment of all major genotypes (GT1-6) of chronic HCV.

Wednesday, October 11, 2017

AbbVie Demonstrates Leadership in HCV with New MAVYRET™ Data to be Presented at The Liver Meeting® 2017

AbbVie Demonstrates Leadership in HCV with New MAVYRET™ (glecaprevir/pibrentasvir) Data to be Presented at The Liver Meeting® 2017

16 HCV abstracts to be presented including 12 data presentations on the safety and efficacy of MAVYRET
- MAVYRET is recommended in new AASLD guidelines as a first line treatment option for 8 weeks in treatment-naïve non-cirrhotic HCV patients across all genotypes (GT1-6)

NORTH CHICAGO, Ill., Oct. 11, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced that it will present new data evaluating MAVYRET™ (glecaprevir/pibrentasvir), its once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6), at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). Sixteen AbbVie scientific abstracts have been accepted, including two oral presentations studying the use of MAVYRET in patients across genotypes (GT1-6) with compensated cirrhosis and treatment-naïve patients with genotype 3 (GT3) HCV. These populations have historically had limited treatment options. A third oral presentation evaluates adherence to treatment with MAVYRET in the clinical development program. The Liver Meeting® 2017 will take place in Washington, D.C., from October 20 – 24, 2017.

"AbbVie's data presentations at this year's The Liver Meeting reinforce our commitment to people living with hepatitis C," said Janet Hammond, M.D., Ph.D., vice president, infectious diseases development, AbbVie. "These data add to a robust collection of clinical trial results to further enhance scientific knowledge of MAVYRET's safety and efficacy across a number of patient populations."

Researchers will also present data obtained from the MAVYRET clinical program evaluating patients with cardiovascular, metabolic and renal conditions as well as data on HCV patient preferences.

"On the heels of AASLD's newly released HCV treatment guidance, we are excited to see additional data on MAVYRET across a broad range of patients," said Fred Poordad, M.D., vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. "The updated recommendations on available treatments, including the use of MAVYRET in the majority of patients, serve as an additional source of information to help physicians make treatment decisions."

Select AbbVie clinical presentations include:
MAVYRET Abstracts
  • Adherence to Pangenotypic Glecaprevir/Pibrentasvir Treatment and SVR12 in HCV-Infected Patients: An Integrated Analysis of the Phase 2/3 Clinical Trial Program - Abstract 198; Oral Presentation; Monday, October 23, 2017; 4:15 p.m. ET
  • Efficacy and Safety of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Treatment-Naïve Patients with Chronic HCV Genotype 3: An Integrated Phase 2/3 Analysis - Abstract 62; Oral Presentation; Sunday, October 22, 2017; 1:15 p.m. ET
  • Efficacy, Safety, and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis - Abstract 74; Oral Presentation; Sunday, October 22, 2017; 3:15 p.m. ET
  • Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Infected with HCV GT1-3 by Renal Impairment Status: A Pooled Analysis of Two Phase 3 Japanese Trials - Abstract 1179; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1–6 and Recent Drug Use - Abstract 1182; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients Aged 65 Years or Older With Chronic Hepatitis C: A Pooled Analysis of Phase 2 and 3 Clinical Trials - Abstract 1188; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Impact of Hepatitis C Treatment With Glecaprevir + Pibrentasvir on Patient`s Health-Related Quality of Life: Results From Phase 3 CERTAIN Trials - Abstract 1187; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Exposure-Safety Response Relationship for Glecaprevir and Pibrentasvir in Hepatitis C Virus-Infected Subjects in Phase 2 and 3 Studies - Abstract 1189; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Exposure-Response Analyses of Virologic Response to Glecaprevir and Pibrentasvir in HCV Subjects from Phase 2 and 3 Studies - Abstract 1185; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Glecaprevir and Pibrentasvir Exposures in Hepatitis C Virus-Infected Subjects in Phase 2 and 3 Studies - Abstract 1190; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
HCV Health Outcomes Abstract
  • Assessing Patient Preferences for and Relative Importance of Features of New Direct Acting Antiviral (DAA) Treatments for Chronic Hepatitis C Virus (HCV) Infections - Abstract 741; Poster Session; Friday, October 20, 2017; 8:00 a.m.5:30 p.m. ET

The full AASLD 2017 scientific program can be found at www.aasld.org.
About MAVYRET™ (glecaprevir/pibrentasvir)
MAVYRET™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVYRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets, taken with food.

MAVYRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment, who comprise the majority of people living with HCV. MAVYRET is also approved as a treatment for patients with specific treatment challenges, including those (GT1) not cured by prior treatment experience to either a protease inhibitor or NS5A inhibitor (but not both), and in patients with limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.
Full prescribing information can be found here.

Source

Sunday, October 1, 2017

Weekend Reading - Sofosbuvir-Velpatasvir-Voxilaprevir for Chronic Hepatitis C – A Review

Weekend Reading
Greetings, hope you're enjoying this lovely Sunday, thanks for stopping by.

Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)
We begin with a recent review article about Gilead's Vosevi, titled; “Sofosbuvir-Velpatasvir-Voxilaprevir for Chronic Hepatitis C – A Review” published September 22, 2017, in Gastroenterology & Hepatology.

HCV Genotype 3
Over at NEJM Journal Watch, a small study for HCV genotype 3 patients is reviewed by Atif Zaman, MD, MPH, published last week in Hepatology. The study; Glecaprevir/pibrentasvir for HCV genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase III clinical trial, is available for download over at NATAP

New Online
Make sure to check out HCV Advocate's October Newsletter, published today!

Shared on Twitter, by @HenryEChang, is one must read article: Chronic hepatitis C virus infection: Everyone should be treated, published in the multimedia journal Clinical Liver Disease. Here are a few other updates over at CLD as well.

Reviews - Controversies in HCV Management
Chronic hepatitis C virus infection: Everyone should be treated
Authors Steven Flamm
First Published: 29 September 2017
Abstract
Full Text (HTML)
PDF (91.3KB)
PDF (91.3KB)
References
Watch a video presentation of this article
Watch the interview with the author

Reviews - Controversies in HCV Management
Authors Philippe J. Zamor, Mark W. Russo
First Published: 29 September 2017

Reviews - From Operation to the First 30 Days
Innovative care models after liver transplant
Authors C. Burcin Taner, Andrew P. Keaveny
First Published: 29 September 2017
Abstract
Full Text (HTML)
PDF (217.7KB)
PDF (217.7KB)
References
Watch a video presentation of this article
Watch the interview with the author

Begin here...

Enjoy the rest of your weekend!
Tina

Friday, September 29, 2017

TGIF HCV Review - Merck Discontinues MK-3682B and MK-3682C Development Programs

Happy Friday! Here are a few updates on viral hepatitis you may have missed this week.

Quick Links
Weekly news recap at HepCBC.

In The News
Merck Discontinues MK-3682B and MK-3682C Development Programs
Sep 29, 2017
Company to Focus on Maximizing the Potential of ZEPATIER ® (Elbasvir and Grazoprevir)
Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced its strategic decision to discontinue the development of the investigational combination regimens MK-3682B (grazoprevir/ruzasvir/ uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection. This decision was made based on a review of available Phase 2 efficacy data and in consideration of the evolving marketplace and the growing number of treatment options available for patients with chronic HCV infection, including ZEPATIER® (elbasvir and grazoprevir).

8 top stories on injection drug users, HIV/HCV coinfection
Sep 29, 2017
At the recent International Symposium on Hepatitis Care in Substance Users, researchers presented new data on injection drug users and their unique risk factors for hepatitis C infection and transmission, including younger age, and the critical need for HCV education among addiction clinic workers.

Flu Updates
Sept 29, 2017



Read all past and current Seasonal Flu Vaccine articles posted on this blog.

Sep 28,2017
by Liz Highleyman
The FDA recently approved two new combination regimens for hepatitis C, raising the question of whether further drug development is warranted in this area.
Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir) and AbbVie's Mavyret (glecaprevir/pibrentasvir) work against all hepatitis C virus (HCV) genotypes, with cure rates exceeding 95%. And Mavyret, which many patients will be able to take for just 8 weeks, brings a lower cost option to the market.
* Free registration required

CDC
Weekly / September 29, 2017 / 66(38);1031
QuickStats: Death Rates* for Chronic Liver Disease and Cirrhosis, by Sex and Age Group — National Vital Statistics System, United States, 2000 and 2015
From 2000 to 2015, death rates for chronic liver disease and cirrhosis in the United States increased 31% (from 20.1 per 100,000 to 26.4) among persons aged 45–64 years. Rates in that age group increased 21% for men (from 29.8 to 36.2) and 57% for women (from 10.8 to 17.0). Among persons aged 25–44 years, the death rate for men decreased 10% (from 6.1 to 5.5), and the rate for women increased 18% (from 2.8 to 3.3). Overall, among persons aged ≥65 years, rates increased 3% (from 29.4 to 30.2). Death rates for both men and women increased with age.

CDC - Mandating HCV Screening Increased Newly Diagnosed and Access to Care
Sept 28, 2017
Implementation of the New York law mandating health care providers to offer HCV testing to persons born during 1945–1965 was associated with an increase in HCV testing, and an increase in the percentage of persons with newly diagnosed HCV infections who were linked to care. Marked increases in the number of HCV tests performed and rates of testing were observed immediately after enactment of the law and remained steady over a 12-month period. Smaller increases were noted in the number of persons who accessed care after receiving a positive HCV screening test result....

Related: Does Mandating HCV Screening Among Baby Boomers Improve Outcomes?

Does Sustained Virologic Response Improve Glycemic Control in HCV?
Sept 29, 2017
Eradicating hepatitis C virus (HCV) infection with direct-acting antiviral (DAA) agents in patients with diabetes reduced the amount of diabetic medication needed and significantly reduced the need for insulin, according to a study in Diabetes Care.

Hepatitis C Formulary Choices for 2018: Will CVS Risk Looking Bad?
Sep 28, 2017
AbbVie’s aggressive list pricing for its new Hepatitis C Virus (HCV) drug Mavyret is disruptive to the current PBM business model.  It essentially asks PBMs to align with client interests by adding a cost-effective drug to their national formularies despite little to no possibility for retained rebates.
On September 15, 2017 Express Scripts (ESRX) chose to align with client interests by opening up the HCV therapeutic class to include Mavyret as well as other HCV drugs previously excluded.   If CVS chooses not to add Mavyret, it will be a sign that CVS is so desperate for rebate income that it is willing incur a very public case of misaligned interests.

FDA improves access to reports of adverse drug reactions
Sep 28, 2017
The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

Japan - AbbVie Announces Approval of MAVIRET™ (glecaprevir/pibrentasvir) of Chronic Hepatitis C in All Major Genotypes (GT1-6)
Sept. 27, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved MAVIRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes
Sep 26,2017
Most patients with hepatitis C genotype 2, 4, 5 or 6 who received Mavyret for 8 weeks achieved sustained virologic response with a high safety profile, according to results from three phase 3 studies. The rate of virologic failure was less than 1%.

Communication of the Alcohol Guidelines ‘needs to be improved’
A study published today concludes that more needs to be done to communicate the drinking guidelines to the public. The study, published in the Journal …

Fibrosis
September 28, 2017
There is a considerable burden of hepatitis C in Europe related to the lack of prompt diagnosis. We aimed to estimate the prevalence and related risk factors of HCV infections by the stages of liver fibrosis, using non-invasive methods, to understand testing needs in Poland.

Accepted manuscript online:
Article provided by @HenryEChang via Twitter

Cirrhosis
September 26, 2017
In a recent study, researchers examined whether muscle volume loss or portal hypertension were predictive of mortality among patients with liver cirrhosis.

Gut Health - Deaths from liver disease are soaring and people in deprived areas are at far higher risk. Now doctors are calling for more action to cut the death toll.

In case you missed it
Study of prevalence and pattern of peripheral neuropathy in patients with liver cirrhosis
Mahim Mittal, Pavan Kumar Singh, Sonu Kurian
Peripheral neuropathy is present in more than half of cirrhosis patients and is unrelated to etiology and nutritional status but related to the severity of cirrhosis.
LINK: Download Full Text - PDF

Liver Transplant
September 28, 2017
A recently published analysis of veterans with hepatocellular carcinoma showed that receipt of liver transplantation, Barcelona Clinic Liver Cancer stage and…

September 26, 2017
Patel and Su are among more than 16,000 Americans waiting for a liver transplant because of conditions such as hepatitis, cancer or cirrhosis. But only about 7,000 livers are donated each year. So they know their odds aren't great.

Rising Rates of Hepatocellular Carcinoma Leading to Liver Transplantation in Baby Boomer Generation with Chronic Hepatitis C
25 September 2017
We aim to study the impact of the baby boomer (BB) generation, a birth-specific cohort (born 1945–1965) on hepatocellular carcinoma (HCC)-related liver transplantation (LT) in patients with chronic hepatitis C virus (HCV), alcoholic liver disease (ALD), and non-alcoholic steatohepatitis (NASH).

Liver Cancer
Quantitative imaging predicts microvascular invasion in hepatocellular carcinoma
Last Updated: 2017-09-28
By Will Boggs MD
NEW YORK (Reuters Health) - Quantitative image analysis of preoperative CT scans can be used to predict microvascular invasion in patients with hepatocellular carcinoma (HCC), researchers report...

Reduce Liver Cancer Risk and Join a Liver Cancer Awareness Twitter Chat Oct. 12
October is Liver Cancer Awareness Month and it’s time to “chat” about reducing liver cancer, particularly in people living with hepatitis B and C. On Thursday, Oct. 12, representatives from Hepatitis B Foundation, CDC’s Division of Viral Hepatitis, and NASTAD (the National Alliance of State and Territorial Aids Directors) will co-host a twitter chat at 2 p.m. EST using the hashtag #liverchat.

Estrogen receptor expression in chronic hepatitis C and hepatocellular carcinoma pathogenesis
World J Gastroenterol. Oct 7, 2017
AIM - To investigate gender-specific liver estrogen receptor (ER) expression in normal subjects and patients with hepatitis C virus (HCV)-related cirrhosis and hepatocellular carcinoma (HCC). Various epidemiological studies around the globe have recognized the role of gender bias in the progression of HCV infection to chronic liver disease and cirrhosis due to poor therapeutic responses or further development of HCV-related HCC in these patients...

Environmental Contributions to Gastrointestinal and Liver Cancer in the Asia-Pacific Region
September 28, 2017
Liver cancer is the second most common digestive cancer in Asia. The high incidence of liver cancer in East Asia and South-East Asia is concordant with the high prevalence of hepatitis B virus and hepatitis C virus infection. Other important risk factors include alcohol use, smoking, and diabetes.

New At Clinical Care Options
* Free registration required
Downloadable Slides: Latest Developments in the Treatment of HCC in Veterans
9/19/2017          
Download this slideset to review the latest data on best practices for the care of patients with HCC across the disease spectrum and to address specific issues unique to treating veterans.   

Quick Reference Guide: HCV Screening and Testing
9/26/2017          
Download this practical guide to help you appropriately screen your patients for hepatitis C virus infection
                                    
9/26/2017
Download this practical reference sheet on all the FDA-approved regimens for treating hepatitis C virus 
Start here.....

Updated
HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C
September 21, 2017
New Genotype 1 & 3 Treatment-Naïve & Treatment-Experienced
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.

Blog Updates From Around The Web
September 27, 2017
By Kimberly Morgan Bossley
Liver Disease can cause severe muscle loss and weakness..

September 27, 2017
By Connie M. Welch
Hepatitis C patients have many obstacles to fight and deal with, one of the first and biggest is stigma, the danger of labels...

September 25, 2017
By Lucinda K. Porter, RN
Before the Affordable Health Care Act (Obamacare), I was uninsurable. Hepatitis C marked me as having a preexisting condition.  This meant that insurance companies could deny me insurance...

By Kare Hoyt - September 28, 2017
It’s nearly impossible to get medical care without feeling judgment about Hepatitis C. You get used to it, but when you don’t feel good and need help, you expect professionals to show...

By Debra Walters - September 27, 2017
My first dance with Hepatitis C treatment was in 2008-2009. The only option was Ribavirin and peginterferon, so I signed up for a study at Baylor College of Medicine. I was randomized...

Living with PTSD and Hepatitis C (Part 3) 
By Karen Hoyt - September 25, 2017
Check out Part 1 and Part 2 of Karen’s series on PTSD. Post-Traumatic Stress Disorder or PTSD can come from a lot of little traumas and hepatitis C is one of them....

Off The Cuff
The British Liver Trust highlights the common causes of hepatitis A
Published in July, download it, here

In obese adults and children, the microbiome plays key role in one of the most common and serious liver diseases
September 29, 2017
BUFFALO, N.Y. — New clues to non-alcoholic fatty liver disease (NAFLD), which affects nearly all obese adults and a rising percentage of obese children, have been reported in a paper published earlier this month in the journal Gut.

The cost of drugs confounds this gastroenterologist
Michael Kirsch, MD | Meds | September 25, 2017
Most of us do not know the basics of economics, although we should. It impacts every one of us every day that we are alive. Yet, for most of us, once we get beyond the law of supply and demand, our knowledge of the subject starts to vaporize. I can't explain fiscal or monetary policy. While I regard economics as a science, it seems that experts routinely interpret data differently, ...

Sep 2017
By Mollie Durkin
Internists can diagnose chronic abdominal wall pain with a simple physical exam and some savvy history taking, experts said, and reassure patients that their condition is not serious and may respond to treatment.... 

Posted September 28, 2017 
Monique Tello, MD, MPH, Contributing Editor Plenty of research supports the common-sense notion that a healthy lifestyle can prevent or treat many diseases. A diet high in fruits, veggies, whole grains, and plant protein and low in processed carbs, added sugars, saturated fats; regular physical activity; and emotional well-being are the potent treatments that can prevent the need for or even…

Enjoy the rest of your day!
Tina

Tuesday, September 26, 2017

Most patients with HCV genotypes 2, 4, 5, 6 achieve SVR with Mavyret

Most patients with HCV genotypes 2, 4, 5, 6 achieve SVR with Mavyret
Asselah T, et al. Clin Gastroenterol Hepatol. 2017;doi:10.1016/j.cgh.2017.09.027.
September 26, 2017
Most patients with hepatitis C genotype 2, 4, 5 or 6 who received Mavyret for 8 weeks achieved sustained virologic response with a high safety profile, according to results from three phase 3 studies. The rate of virologic failure was less than 1%.

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 15, 2017

HCV TGIF: Patient Voice Lacking in HCV Cost-effectiveness Research, Baby Boomers, and Liver Cancer

TGIF! Here's your HCV news with blog updates from around the web.

HCV Review
Sept 15
If you are interested in a weekly news recap start with HepCBC.

In The News
Viral hepatitis accounts for 1.34m deaths globally
Sep 16
Viral hepatitis with 1.34 million deaths globally has surpassed all chronic infectious diseases including HIV/AIDS, malaria and tuberculosis, according to a study by Global Burden of Disease.

'Exciting' discovery on path to develop new type of vaccine to treat global viruses
Sept 15
Scientists at the University of Southampton have made a significant discovery in efforts to develop a vaccine against Zika, dengue and Hepatitis C viruses that affect millions of people around the world.

Update on the Cost Burden of HCV Treatments
Sept 15
With the recent availability of the interferon-free combinations of direct-acting antivirals (DAAs) for hepatitis C viral infection (HCV), patients now have a highly effective treatment without the dismal side effects that interferon-based therapies offered in years past.

Of Interest
Will Express Scripts and CVS Health open their Hep C Virus therapeutic class and add Marvyet alongside Harvoni?
AbbVie’s Mavyret Drug Pricing: A Challenge to the Pharmacy Benefit Manager Business Model
Sept 15
AbbVie’s pricing for its new Hepatitis C Virus drug Mavyret is disruptive to the current PBM business model because it forces the Big 3 PBMs to consider a drug for inclusion in their national formularies that is aligned with their clients interests — more cost-effective that Harvoni — but not aligned with their own interests — needing to squeeze out all the rebates they can from specialty drug therapeutic classes. At the very least, will Express Scripts and CVS Health open their Hep C Virus therapeutic class and add Marvyet alongside Harvoni? Or, will they expose themselves to claims of misalignment by excluding Mavyret?

Newly approved hepatitis drugs mark a milestone in treatment and access
Briefly Sep+Oct 2017
The Gilead Sciences HCV medication Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) was approved on July 18 for the re-treatment of HCV in treatment-experienced people. Just two weeks later on August 3, the FDA approved the Abbvie medication Mavyret (glecaprevir 300 mg/pibrentasvir 120 mg) for the treatment of both treatment-naïve and treatment-experienced patients, including people living with HIV/HCV co-infection.

All too often, patients and advocates are told the medications are too expensive to cover and will wipe out Medicaid budgets, denying people treatment and/or making them wait until their liver health worsens so as to be eligible. This price significantly weakens this argument.
Again, there is nobody we can’t treat, and now we can afford to do it.

New At Behind The Headlines
Mice exposed to third-hand smoke developed brain and liver damage
Sept 15
"Third-hand smoke exposure can cripple your brain and liver, affecting your mannerisms, increasing your risk of neurodegenerative diseases, and ruining your metabolism," the Mail Online reports. But the study it reports on involved mice not people.

New At MD Magazine
A review of more than 1,000 studies found the vast majority of economic analyses of HCV therapies don’t incorporate patient input.

Worldwide HCV prevalence in 2017 dropped 2% from 2015 levels to 69.6 million viremic infections, thanks to increased treatment and prevention.

The fixed-dose combination of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) (Technivie, AbbVie), which is approved to treat HCV genotype 4, was combined with the pangenotypic DAA, sofosbuvir (SOF) (Sovaldi, Gilead), in addition to ribavirin for 12 weeks in patients having genotype 3 with cirrhosis, and with or without ribavirin in type 3 patients without cirrhosis. In addition, the regimen with ribavirin was administered for either 6 or 8 weeks to genotype 2 patients without cirrhosis.

New at Healio
Mavyret (glecaprevir/pibrentasvir), Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) and Liver cancer:
HCV NEXT September/October Issue - Two Approvals Offer Even More Options for HCV Treatment

Of Interest
CATIE's HepCInfo Update 8.18 for August 19 to September 1, 2017. Read on to learn more about new and updated scientific findings in hepatitis C prevention, care, treatment and support.

NATAP
"Eradication of HCV has been shown to reduce the risk of hepatocellular carcinoma, to improve liver fibrosis, and to decrease the risk of other complications of chronic liver disease (39). However, the effects of HCV eradication on the extrahepatic manifestations of HCV have not been well studied in the new era of DAAs. Our study supports the idea that HCV eradication leads to a reduction in HbA1c in patients with diabetes."

Liver Cancer
"Most HCV-infected patients in the United States will undergo DAA-based antiviral treatment in the next few years and the vast majority of them will achieve SVR. Our results suggest that DAA-induced SVR is associated with a 71% reduction in HCC risk (AHR 0.29, 95% CI 0.23-0.37) compared to treatment failure. The reduction in HCC risk associated with SVR was similar irrespective of whether SVR was achieved by DAA-ONLY, DAA+IFN or IFN-ONLY regimens. This suggests that eradication of HCV reduces HCC risk independently of how it is achieved. In contrast to prior reports that suggested an increased HCC risk in patients treated with DAAs[[3], [7]], we found that receipt of DAA-ONLY antiviral treatment was not associated with increased risk of HCC when compared to receipt of IFN-ONLY antiviral treatment.....We found no evidence that treatment with DAAs was associated with increased risk of HCC compared to treatment with IFN.

More Than Okay to Reduce Sorafenib Dose for Liver Cancer
In the treatment of hepatocellular carcinoma (HCC), it's "safe and reasonable" to start sorafenib (Nexavar, Bayer) at reduced dosages, conclude authors of a new retrospective analysis of nearly 5000 patients. Reduced dosing was not associated with inferior overall survival compared with standard dosing, report the study authors, led by Kim Reiss Binder, MD, a medical oncologist at the University of Pennsylvania in Philadelphia.

Review Article
Viral hepatitis and liver cancer - hepatitis B and C virus
Published:19 October 2017; volume 372, issue 1732

Medscape Medical News
Sofosbuvir Safe, Effective for HCV in Those With CKD
Sofosbuvir-based antiviral therapy cured hepatitis C virus infection in more than 80% of patients with chronic kidney disease, a retrospective cohort study found.

Lower GI Reading Room
Integrated care in prison systems key to reducing rates, transmission risk post-release

Medscape Gastroenterology
Updated Advice on Managing Liver Disease During Pregnancy
Dr Rowen Zetterman reviews the new American College of Gastroenterology guidelines on caring for pregnant patients with diseases ranging from liver masses to viral infections.

New at aidsmap
High prices of DAAs mean there's been little progress towards achieving WHO target of eliminating HCV by 2030
Sept 15
Only a handful of countries are on course to achieve the World Health Organization (WHO) target of eliminating hepatitis C virus (HCV) as a major public health concern by 2030, according to a study published in the Journal of Virus Eradication. Investigators estimated progress towards elimination by examining 2016 data on rates of cure after therapy with direct-acting antivirals (DAAs), HCV-related deaths and new HCV infections. An overall reduction in prevalence of 0.71% was observed in the 91 countries included in the study, and global prevalence fell by just 0.4%.

New at The Body PRO
This Week in HIV Research: 'Massive Loss of Life'
Sept 15
This week, a study finds that reducing U.S. foreign aid for HIV-fighting efforts is a really bad idea no matter which way you cut it. We also examine meta-analysis data regarding pregnancy and the "old" tenofovir; newly published findings regarding cancer risk among people with HIV; and data regarding the potential viability of a neighborhood-specific approach to reduce HIV disparities in the U.S. To beat HIV, you have to follow the science!

On Twitter
Tweets By - Henry E. Chang
In Case You Missed It  - DAA therapy for chronic HCV infection results in liver stiffness regression over 12 months post-treatment

Full Text Articles
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.

Baby Boomers - New At HepatitisC.net 
Out of 3.5 million Americans chronically infected with HCV, 80% are “baby boomers” (born between 1945 and 1965). If you were born between 1945 and 1952, you're now eligible for a senior citizen discount. Turning 65 does have its perks, especially grandchildren, right? If you're a grandparent living with the hepatitis C virus, Karen Hoyt, has a few tips for you; What to Tell Your Grandchild About Hepatitis C. Jump over to HepatitisC.net and view all blog updates, here.

HCV Stigma - New at HEP
HCV Stigma is in the spotlight over at Hep, Rick Nash, always positive, writes about stigma from a fresh prospective; Stigma: It’s not me, it’s you. In addition, "Science over Stigma explores the discriminatory, biased, and unnecessary practice of requiring a period of sobriety prior to receiving HCV curative treatment." Read the article, here.

Triaging Hepatitis C Treatment: Why the Fibrosis Score Is Not Valid, is a look at the bottom line results, what they mean for patients seeking treatment, written by devoted HCV advocate Greg Jefferys. Read additional blog articles at Hep, here.

October issue of Attitude
Gay men with hepatitis C are suffering stigma not seen since the HIV/Aids crisis, read the article published in the latest issue of Attitude.

New At Hepatitis B Foundation 
Over at Hepatitis B Foundation is a three part series with easy to read information about the hepatitis B virus, last week part three was published: Part I is about how the virus is transmitted, and may have helped you determine how you were infected with HBV. In Part II we will discuss the people closest to you who may be susceptible to your infection. Part III is about preventing future transmission to others. View all blog updates, here.

The Doctor Weighs In
Sept 15
Examining the Federal Response to the Opioid Crisis
The disease of addiction has claimed so many young lives and shows no signs of relenting. Today, overdoses are the leading cause of death in Americans under the age of 50. An addiction specialist on the front lines of battling the opioid epidemic in Ohio provides her perspective on Drug Addiction Commission's interim report.

In Case You Missed It
Tina