10 year HCV treatment programme in people who inject drugs: No effect of recent or former injecting drug use on treatment adherence or SVR

Outcomes from a large 10 year hepatitis C treatment programme in people who inject drugs: No effect of recent or former injecting drug use on treatment adherence or therapeutic response
Omar Elsherif , Ciaran Bannan, Shay Keating, Susan McKiernan, Colm Bergin, Suzanne Norris

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Abstract
Background and aims

People who inject drugs (PWID) are historically viewed as having “difficult to treat” hepatitis C disease, with perceived inferior treatment adherence and outcomes, and concerns regarding reinfection risk. We evaluated for differences in treatment adherence and response to Peginterferon-alfa-2a/Ribavirin (Peg-IFNα/RBV) in a large urban cohort with and without a history of remote or recent injection drug use.

Methods

Patient data was retrospectively reviewed for 1000 consecutive patients—608 former (no injecting drug use for 6 months of therapy), 85 recent (injecting drug use within 6 months) PWID, and 307 non-drug users who were treated for chronic hepatitis C with Peg-IFNα/RBV. The groups were compared for baseline characteristics, treatment adherence, and outcome.

Results

There was no significant difference in treatment non-adherence between the groups (8.4% in PWID vs 6.8% in non-PWIDs; RR = 1.23, CI 0.76–1.99). The overall SVR rate in PWID (64.2%) was not different from non-PWIDs (60.9%) [RR = 1.05, 95% CI 0.95–1.17]. There was no significant difference in SVR rates between the groups controlling for genotype (48.4% vs 48.4% for genotype 1; 74.9 vs 73.3% for genotype 3). Former and recent PWID had similar adherence rates.

Conclusions

PWID have comparable treatment adherence and SVR rates when compared to non-drug users treated with Peg-IFNα/RBV. These data support a public health strategy of HCV treatment and eradication in PWID in the DAA era.

Published: June 21, 2017 https://doi.org/10.1371/journal.pone.0178398
PLOS ONE

Medscape New HCV Video Series - Hepatitis C Virus: Containing the Threat

Medscape - New Video Series
Hepatitis C Perspective

Hepatitis C Virus: Containing the Threat

About this Series
In the past few years, a new class of direct-acting antiviral agents has made the treatment of HCV easier and more effective than ever before, with cure rates nearing 100%, even among HIV-positive patients. But not all patients with HCV who are eligible for antiviral treatment are identified, and even fewer are being referred for care. Thus, HCV infection remains a significant risk for progression to cirrhosis, liver failure, and hepatocellular carcinoma. Liver specialists at two prestigious Chicago medical centers confront the key issues in the management of patients with chronic HCV infection.

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Safety of the 2D/3D direct acting antiviral regimen in HCV-induced Child-Pugh A cirrhosis - a pooled analysis

Journal of Hepatology - June 20, 2017
Articles in Press

DOI: http://dx.doi.org/10.1016/j.jhep.2017.06.011

Publication stage: In Press Accepted Manuscript

Published online: June 20, 2017

Safety of the 2D/3D direct acting antiviral regimen in HCV-induced Child-Pugh A cirrhosis - a pooled analysis
Fred Poordad Correspondence information about the author Fred Poordad Email the author Fred Poordad , David R. Nelson, Jordan J. Feld, Michael W. Fried, Heiner Wedemeyer, Lois Larsen, Daniel E. Cohen, Eric Cohen, Niloufar Mobashery, Fernando Tatsch, Graham R. Foster

Highlights

• •OBV/PTV/r ± DSV ± RBV was well-tolerated in patients with Child-Pugh A cirrhosis.
• •Low rates of serious adverse events and those leading to discontinuation of study drugs.
• •Events consistent with hepatic decompensation occurred in 1.2% of patients (13/1066)
• •Decompensation events occurred across the treatment period and post-treatment.
• •Rates of decompensation events were comparable in treated and untreated patients.

Abstract

Background & aims

Chronic hepatitis C virus (HCV)-infected patients with cirrhosis are a high-priority population for treatment. To help inform the benefit–risk profile of the all-oral direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir (OBV/PTV/r ± DSV) in patients with Child-Pugh A cirrhosis, we undertook a comprehensive review of AbbVie-sponsored clinical trials enrolling patients with Child-Pugh A cirrhosis.

Methods

Twelve phase II or III clinical trials of the 2-DAA regimen of OBV/PTV/r ± ribavirin (RBV) or the 3-DAA regimen of OBV/PTV/r + DSV ± RBV that included patients with Child-Pugh A cirrhosis were reviewed; patients who completed treatment by November 16, 2015 were included in a pooled, post hoc safety assessment. The number and percentage of patients with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs consistent with hepatic decompensation were reported.

Results

In 1066 patients with Child-Pugh A cirrhosis, rates of serious TEAEs and TEAEs leading to study drug discontinuation were 5.3% (95% CI: 4.1–6.8) and 2.2% (95% CI: 1.4–3.2), respectively. Thirteen patients (1.2%; 95% CI: 0.7–2.1) had a TEAE that was consistent with hepatic decompensation. The most frequent TEAEs consistent with hepatic decompensation were ascites (n=8), esophageal variceal hemorrhage (n=4), and hepatic encephalopathy (n=2).

Conclusions

This pooled analysis in 1066 HCV-infected patients with Child-Pugh A cirrhosis confirms the safety of OBV/PTV/r ± DSV ± RBV in this population. These results support the use of OBV/PTV/r ± DSV ± RBV in this high-priority population.

Lay summary

This pooled safety analysis in 1066 HCV-infected patients with compensated cirrhosis, receiving treatment with ombitasvir, paritaprevir, and ritonavir with or without dasabuvir, with or without ribavirin, shows that the rate of hepatic decompensation events was comparable to rates from historical reports for untreated patients.

Hepatitis C - CDC New Surveillance for Viral Hepatitis

Of Interest

Medscape - New Video Series

Hepatitis C Virus: Containing the Threat

About this Series

In the past few years, a new class of direct-acting antiviral agents has made the treatment of HCV easier and more effective than ever before, with cure rates nearing 100%, even among HIV-positive patients. But not all patients with HCV who are eligible for antiviral treatment are identified, and even fewer are being referred for care. Thus, HCV infection remains a significant risk for progression to cirrhosis, liver failure, and hepatocellular carcinoma. Liver specialists at two prestigious Chicago medical centers confront the key issues in the management of patients with chronic HCV infection.
View: Episode 1/ Strides and Obstacles

Surveillance for Viral Hepatitis – United States, 2015

The Centers for Disease Control and Prevention’s (CDC) National Notifiable Diseases Surveillance System (NNDSS) (1) receives viral hepatitis case reports electronically each week from state and territorial health departments in the United States (U.S.) via CDC’s National Electronic Telecommunications System for Surveillance (NETSS), a computerized public health surveillance system. The surveillance system accepts case reports of acute and chronic infections from all states and the District of Columbia, though not all jurisdictions report their data. In 2015, a total of 48 states submitted reports of acute hepatitis B virus (HBV) infection, 40 submitted reports of acute hepatitis C virus (HCV) infection, 40 submitted reports of chronic HBV infection, and 40 submitted reports of chronic HCV infection.

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CDC Surveillance for Viral Hepatitis – United States, 2015

Hepatitis C: 
Reported cases of acute HCV infection increased more than 2.9-fold from 2010 through 2015, rising annually throughout this period. Examining annual trends beginning in 2011, reported cases of acute HCV infection increased 44.3% from 2011 to 2012 (n=1,232 and 1,778 cases, respectively), increased 20.3% to 2,138 cases in 2013, increased 2.6% to 2,194 cases in 2014, and increased 11% to 2,436 cases in 2015. The increase in acute HCV case reports reflects new infections associated with rising rates of injection-drug use, and, to a much lesser extent, improved case detection (15). Several early investigations of newly acquired HCV infections reveal that most occur among young, white persons who live in non-urban areas (particularly in states within the Appalachian, Midwestern, and New England regions of the country) (16); trends in these states likely indicate an overall increase in HCV incidence throughout the country (15, 17). States with the highest rate of new HCV infections (e.g., West Virginia, Kentucky, and Tennessee) did not receive CDC support for case finding during these reporting years (2011-2015). After adjusting for under-ascertainment and under-reporting (2), an estimated 33,900 (95% CI=26,800–115,000) new HCV infections occurred in 2015.

Based on the data from national health surveys conducted in the 2003-2010 time period, approximately 3.5 million persons are currently infected with HCV (18). Mortality among HCV-infected persons—primarily adults aged 55–64 years—increased during 2006-2010 (19, 20). In 2013, HCV associated deaths exceeded the combined number of deaths with 60 other infectious diseases as underlying causes (21). CDC data indicate the number of HCV-associated deaths increased 10.9% from 2011 through 2014 and decreased 0.2% to 19,629 in 2015. Approximately one-half of all deaths in 2015 occurred among persons aged 55-64 years. However, deaths associated with HCV are largely underestimated; the only large U.S. study of deaths among persons with confirmed HCV infection indicated that only 19% had HCV listed anywhere on the death certificate despite 75% having evidence of substantial liver disease (20). To increase the proportion of persons with HCV who are tested and linked to recommended care including curative treatment for HCV (12, 13), CDC and USPSTF recommend one-time testing for HCV infection among all adults born during 1945–1965 and among others at increased risk for HCV infection (22).

Continue reading report @ https://www.cdc.gov/hepatitis/statistics/2015surveillance/commentary.htm

Funding the war on hepatitis – deploying innovative finance mechanisms to eliminate hepatitis C in Europe

Funding the war on hepatitis – deploying innovative finance mechanisms to eliminate hepatitis C in Europe

"In this blog, co-authors Rob Walton (Cello Health Public Affairs), Jeffrey V Lazarus (CHIP, WHO Collaborating Centre on HIV and Viral Hepatitis at Rigshospitalet, the University of Copenhagen and Editor-in-Chief of Hepatology, Medicine and Policy), Homie A. Razavi (Center for Disease Analysis), Jagpreet Chhatwal (Harvard Medical School), Charles Gore (Hepatitis C Trust), Pierre Van Damme (Vaccine & Infectious Disease Institute – VAXINFECTIO, University of Antwerp), Luís Mendão (GAT –Treatment Activist Group), and Angelos Hatzakis (Athens University Medical School and Hepatitis B & C Public Policy Association), discuss an innovative financing mechanism to eliminate Hepatitis C in Europe."

Rob Walton

20 Jun 2017

It is no coincidence that the emerging international consensus to tackle HCV has come at the same time as the arrival of new and highly effective range of direct-acting antiviral (DAA) treatments for hepatitis C virus (HCV). These new drugs offer, for the first time, a realistic opportunity for the elimination of the disease across Europe by 2030. While effective, the high price of these treatments could pose a significant financial challenge to healthcare systems. But the costs of failing to take action could potentially be even higher. If HCV is left untreated, in many cases it can lead to liver failure and liver cancer which means that a liver transplant is the only viable course of treatment available.

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"Speak Up" on World Hepatitis Day - The Hepatitis C Trust Patient Conference programme announced

The Hepatitis C Trust Patient Conference programme announced
Wed, 06/21/2017 - 14:06
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"Speak Up" on World Hepatitis Day, The Hepatitis C Trust Patient Conference

The Hepatitis C Trust is delighted to confirm the programme for this year's Patient Conference, which is being held in London on 28th July to coincide with World Hepatitis Day. Speakers will include Professor Graham Foster (Professor of Hepatology, Queen Mary University), Sam May (Head of Support Services, The Hepatitis C Trust), and Dr Magdalena Harris (Lecturer, London School of Hygiene and Tropical Medicine), and there will also be an opportunity to share personal stories about the impact of hepatitis C.

The event is free to attend for all patients and professionals and you can secure your place here.

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Investigational Hepatitis C Drugs Show Promising Results

Investigational Hepatitis C Drugs Show Promising Results

By Barbara Jungwirth

From TheBodyPRO.com

June 20, 2017

Newer hepatitis C (HCV) drugs have shown very good sustained viral response (SVR) rates and little risk of resistance-associated substitutions, David L. Wyles, M.D., of Denver Health Medical Center reported in an International Antiviral Society-USA (IAS-USA) webinar.

He summarized studies on various direct-acting antiviral agents (DAAs) from the recent International Liver Congress (EASL) in Amsterdam.
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Letter: the influence of direct acting agents for hepatitis C, on hepatitis B reactivation

Volume 46, Issue 2
July 2017  Page 208

Alimentary Pharmacology & Therapeutics

LETTERS TO THE EDITORS

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Letter: the influence of direct acting agents for hepatitis C, on hepatitis B reactivation
C.-C. Wang, J.-H. Kao
First published: 15 June 2017
Full publication history DOI: 10.1111/apt.14116  

SIRS,
We read with great interest the article by Londono et al.[1] In this study, baseline HBsAg positivity or isolated anti-HBc positivity were 2.8% and 18% in 352 chronic hepatitis C (CHC) patients receiving direct-acting antivirals (DAAs), respectively. They found that 50% of HBsAg-positive and 1.6% of anti-HBc-positive patients had hepatitis B virus (HBV) viral reactivation (> 1 log increase in HBV-DNA level). In addition, the increase in HBV-DNA was modest and early during the course of DAAs treatment. There were no serious clinical events in such patients. They thus suggested that HBV viral reactivation is frequent and early during DAAs treatment; however, the reactivation is modest and without clinical impact. Although these data provide more evidence about the risk of HBV reactivation during DAAs for CHC, several issues are worthy of discussion and further investigations.

First, this study found HBV reactivation is frequent in HBsAg-positive patients receiving DAAs against HCV. However, only 10 HBV/HCV co-infected patients were included, and they had a higher risk of HBV viral reactivation than those positive for anti-HBc antibody. Among these HBsAg-positive patients, six were inactive carriers and four received anti-HBV agents. Therefore, the frequency and severity of HBV viral reactivation may be underestimated as is observed in clinical practice. It is recommended that HBV status, either chronic active infection, inactive carrier or resolved infection, must be confirmed before starting DAAs, especially in HBV endemic area by measuring serum HBsAg, HBV-DNA, anti-HBc, and anti-HBs antibody. On-treatment HBV-DNA monitoring at Week 4 of DAAs treatment is required for early detection of HBV viral reactivation to prompt anti-HBV treatment and prevent the occurrence of hepatitis flare as well as subsequent fulminant hepatic failure.[2, 3] Second, 24.8% of HBV/HCV co-infected patients had HBeAg-negative chronic hepatitis in our previous study.[4] Our data showed that combination of pegylated interferon plus ribavirin is equally effective for patients with HCV mono-infection and those with dual HBV/HCV infection. In addition, post-treatment HBsAg seroclearance was observed in 11.2% of 161 HBV/HCV co-infected patients. Interferon-based regimen is known active against both HBV and HCV; however, DAAs are only effective for HCV. Whether combination of DAAs and anti-HBV agents is cost-effective for HBV/HCV co-infected patients with high HBV-DNA levels (> 2000 IU/mL) deserves additional studies. Third, a recent study showed a high rate of hepatocellular carcinoma (HCC) recurrence in HCV-related HCC patients receiving DAAs after curative treatment.[5] The possible explanation is the disruption of host immune surveillance after HCV clearance. Since host immune responses play an important role in the interaction between HBV and HCV in HBV/HCV co-infected patients, the dynamic change in immune markers during DAAs therapy for CHC deserves further investigations.

REFERENCES

Londono MC, Lens S, Marino Z, et al. Hepatitis B reactivation in patients with chronic hepatitis C undergoing anti-viral therapy with interferon-free regimens. Aliment Pharmacol Ther. 2017;45:1156-1161.

2De Monte A, Courjon J, Anty R, et al. Direct-acting antiviral treatment in adults infected with hepatitis C virus: reactivation of hepatitisB virus coinfection as a further challenge. J Clin Virol. 2016;78:27-30.

3Ende AR, Kim NH, Yeh MM, et al. Fulminant hepatitis B reactivation leading to liver transplantation in a patient with chronic hepatitis C treated with simeprevir and sofosbuvir: a case report. J Med Case Rep. 2015;9:164.

4Liu CJ, Chen PJ, Chen DS, Tseng TC, Kao JH. Perspectives on dual hepatitis B and C infection in Taiwan. J Formos Med Assoc. 2016;115:298-305.

5Reig M, Marino Z, Perello C, et al. Unexpected early tumor recurrence in patients with hepatitis C virus –related hepatocellular carcinoma undergoing interferon-free therapy: a note of caution. J Hepatol. 2016;65:719-726.