Treatment adherence and virological response rates in hepatitis C virus infected persons treated with sofosbuvir‐based regimens: results from <scp>ERCHIVES</scp>

Butt, Adeel A.; Yan, Peng; Shaikh, Obaid S.; Chung, Raymond T.; Sherman, Kenneth E.

doi:10.1111/liv.13103

Cited by 25 publications

(19 citation statements)

References 26 publications

(37 reference statements)

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“…These results show how we have successfully simplified HCV management in a high-burden setting, and confirm under operational conditions the high efficacy of DAAs that has previously been reported in the controlled environment of clinical trials. [16–19]…”

Section: Discussionmentioning

confidence: 99%

“…The new all-oral treatment regimen, with the exception of GT1 (which requires pegylated IFN on top of the SOF-RBV combination), is highly tolerable with documented limited adverse events in clinical trials. [16–19] The VALENCE study, a multicenter Phase 3 trial in Europe showed that the SOF-RBV regimen for 24 weeks in GT3 patients had an SVR12 of 85%. [18] Conventional management relying on an IFN-based treatment regimen over a prolonged time period [10] resulted in general SVR rates of 42–93% for all genotypes, showing only moderate efficacy for the combination of pegylated IFN with Ribavirin in multiple randomized control trials.…”

Section: Discussionmentioning

confidence: 99%

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Management of chronic Hepatitis C at a primary health clinic in the high-burden context of Karachi, Pakistan

et al. 2017

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BackgroundThe burden of hepatitis C (HCV) infection in Pakistan is among the highest in the world, with a reported national HCV prevalence of 6.7% in 2014. In specific populations, such as in urban communities in Karachi, the prevalence is suspected to be higher. Interferon-free treatment for chronic HCV infection (CHC) could allow scale up, simplification and decentralization of treatment to such communities. We present an interim analysis over the course of February-December 2015 of an interferon-free, decentralised CHC programme in the community clinic in Machar Colony, Karachi, Pakistan.DesignA retrospective analysis of a treatment cohort.ResultsThere were 1,089 patients included in this analysis. Aspartate to platelet ratio index score was used to prioritize patients in terms of treatment initiation, with 242 patients placed in high priority for treatment and 202 starting treatment as scheduled. 169 patients started HCV treatment with Sofosbuvir-Ribavirin regimen according to HCV genotype over the course of 2015: of these, 35% had Hemoglobin reductions below 11.0 g/dl during the treatment course. Among the 153 patients (85%) with genotype 3 HCV infection, 84% of patients achieved sustained virologic response at 12 weeks following treatment completion (SVR 12).ConclusionOutcomes of HCV treatment with all oral combination in an integrated, decentralized model of care for CHC in a primary care setting, using simplified diagnostic and treatment algorithms, are comparable to the outcomes achieved in clinical trial settings for Sofosbuvir-based regimens. Our results suggest the feasibility and the pertinence if including interferon-free treatment regimens in the national programme, at both provincial and national levels.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Management of chronic Hepatitis C at a primary health clinic in the high-burden context of Karachi, Pakistan

et al. 2017

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“…We conducted a retrospective cohort study among HCV‐infected persons in the Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES) database. ERCHIVES is a large, well‐established national cohort of HCV‐infected and uninfected Veterans and has been described . All HCV‐infected Veterans at any of the nation‐wide Department of Veterans Affairs (VA) medical facilities with a positive HCV antibody test between 2002 and 2016 were identified.…”

Section: Methodsmentioning

confidence: 99%

The short‐term incidence of hepatocellular carcinoma is not increased after hepatitis C treatment with direct‐acting antivirals: An ERCHIVES study

et al. 2018

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DAA treatment is not associated with a higher risk of HCC in persons with cirrhosis with chronic HCV infection in the short term. Previously reported higher rates of HCC associated with DAA treatment may be explained by both the presence of relatively fewer baseline HCC risk factors in persons treated with IFN as well as selection bias, given that DAA regimens were used to treat persons at higher risk for developing HCC. (Hepatology 2018;67:2244-2253).

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“…Treating HCV has recently been revolutionized by the introduction of effective direct acting antivirals (DAA) which have made possible interferon-free treatment with a very high success rate (5,6). In fact, there is now a prospect for HCV elimination (7).…”

Section: Introductionmentioning

confidence: 99%

The Efficacy of 12 Weeks of Sofosbuvir, Daclatasvir, and Ribavirin in Treating Hepatitis C Patients with Cirrhosis, Genotypes 1 and 3

et al. 2016

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Background: The combination of sofosbuvir and daclatasvir can be used to treat all genotypes of hepatitis C. Current guidelines for treating hepatitis C cirrhosis do not clarify weather 12 weeks or 24 weeks of treatment is appropriate. Objectives: In the present study, we aimed at evaluating the efficacy of sofosbuvir, daclatasvir, and ribavirin given for 12 weeks in treating cirrhotic patients with hepatitis C genotypes 1 and 3 infections. Methods: One hundred patients with hepatitis C and cirrhosis infected with Genotypes 1 and 3 were included in the present study. They were treated with 1 tablet of a combination pill of 400 mg sofosbuvir and 60 mg daclatasvir daily and weight-based ribavirin for 12 weeks. Response to treatment was assessed 12 weeks after the end of the treatment with a sensitive assay (SVR12). This study was registered with ClinicalTrials.gov, ID: NCT02596880. Results: One patient developed increased creatinine level following severe diarrhea and gastroenteritis and was excluded, 1 patient died due to unrelated reasons and 4 others were lost to follow-up. Among the 94 patients who finished the study, 92 achieved SVR12 (98%, per-protocol, 92% intention-to-treat). None of the patients reported any side effects. Of the 100 original patients, 56 were Genotype 1 and 44 were Genotype 3. One of the two patients not achieving SVR12 was Genotype 1, and the other two were Genotype 3. Conclusions:The fixed-dose combination drug of sofosbuvir and daclatasvir given together with weight-base ribavirin for 12 weeks is extremely effective and safe in treating HCV patients with Genotypes 1 and 3 and cirrhosis.

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Treatment adherence and virological response rates in hepatitis C virus infected persons treated with sofosbuvir‐based regimens: results from ERCHIVES

Abstract: Sofosbuvir-based treatment regimens are highly effective in achieving SVR12. This efficacy is not significantly affected when treated persons receive less than a full prescribed course of treatment.

Cited by 25 publications

References 26 publications

Management of chronic Hepatitis C at a primary health clinic in the high-burden context of Karachi, Pakistan

Management of chronic Hepatitis C at a primary health clinic in the high-burden context of Karachi, Pakistan

The short‐term incidence of hepatocellular carcinoma is not increased after hepatitis C treatment with direct‐acting antivirals: An ERCHIVES study

The Efficacy of 12 Weeks of Sofosbuvir, Daclatasvir, and Ribavirin in Treating Hepatitis C Patients with Cirrhosis, Genotypes 1 and 3

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