High SVR-Rates in Patients With HCV Genotype 1-Infection, Who Are Dually Infected With Either Genotype 2 or 3 and Treated With PEG-IFNα-2B and Ribavirin

BACKGROUND: In patients chronically infected with the hepatitis C virus (HCV), it is not established whether viral outcomes or health-related quality of life (HRQoL) differ between individuals treated at academic or community centres.METHODS: In the present observational study, adults with chronic HCV were treated with peginterferon alfa-2a 180 μg/week plus ribavirin at 45 Canadian centres (16 academic, 29 community). The primary efficacy end point was sustained virological response (SVR). Other outcome measures included HRQoL (assessed using the 36-item Short-Form Health Survey), heath resource use, and workplace productivity and absences within a 60-day interval.RESULTS: In treatment-naive patients infected with HCV genotype 1, significantly higher SVR rates were achieved in those treated at academic (n=54) compared with community (n=125) centres (52% versus 32% [P=0.01]), although rates of dosage reduction and treatment discontinuation were similar across settings. SVR rates among patients infected with genotype 2/3 were similar between academic (n=59) and community (n=100) centres (64% versus 67% [P=0.73]). Following antiviral therapy, patients with genotype 1 who achieved an SVR (n=67) had significantly higher mean scores on the physical (P=0.005) and mental components of the 36-item Short-Form Health Survey (P=0.043) compared with those without an SVR (n=111). In contrast, HRQoL scores were similar in HCV genotype 2/3 patients with and without an SVR. There were no differences in workplace productivity or absences between patients with and without an SVR. The most frequently used health care resources by all patients were visits and phone calls to hepatitis nurses, and general practice or walk-in clinics.CONCLUSION: Patients infected with HCV genotype 1 achieved higher SVR rates when treated at academic rather than community centres in Canada. The reasons for this difference require additional investigation.

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Prevalence of end of treatment RNA-positive/sustained viral response in HCV patients treated with sofosbuvir combination therapies

Therapeutic Advances in Gastroenterology ◽

10.1177/1756283x16672392 ◽

2016 ◽

Vol 10 (1) ◽

pp. 68-73 ◽

Cited By ~ 14

Author(s):

Miguel Malespin ◽

Tamara Benyashvili ◽

Susan L. Uprichard ◽

Alan S. Perelson ◽

Harel Dahari ◽

...

Keyword(s):

Antiviral Agents ◽

Sustained Viral Response ◽

Hcv Rna ◽

Genotype 1 ◽

Genotype 3 ◽

Hcv Genotype ◽

End Of Treatment ◽

Genotype 2 ◽

Study Population ◽

Hcv Genotype 1

Background: Some chronic hepatitis C virus (HCV), genotype 1 infected patients treated with direct antiviral agents (DAAs) remain viremic at end of treatment (EOT+), yet go on to achieve sustained virological response 12 weeks after completion of therapy (SVR12). The incidence of EOT+/SVR in patients with genotype 1 and other genotypes, as well as whether such patients achieve SVR24 remain in question. The aims of this study were to evaluate the frequency and durability of EOT+/SVR12&24 and other response categories in HCV genotype 1, 2, or 3 infected patients treated with DAA in clinical practice. Methods: Data from patients treated with all oral sofosbuvir-based regimens at a university hepatology practice by 1 July 2015 were reviewed retrospectively. Responses were categorized based on virus levels during and post DAA treatment. HCV RNA levels were measured by Abbott RealTime HCV (ART) or by Roche CobasTaqMan v2.0 (RCTM) assays. Results: The study population included 89 patients. Participants were 62% genotype 1, 19% genotype 2 and 19% genotype 3, 54% cirrhotic and 46% treatment-experienced. A total of 45 received sofosbuvir–simeprevir, 38 sofosbuvir–ribavirin and 6 sofosbuvir–ledipasvir. The SVR12 rate was 82%. A total of 5 patients (6%), all with genotype 1, had EOT+ by ART assay and each achieved SVR12&24. Conclusions: A total of 9% of genotype 1 patients (6% overall) treated with DAAs were EOT+ by ART and all EOT+ cases achieved SVR24. EOT+/SVR was not observed with genotype 2 or 3 or by the RCTM assay. In patients treated with DAAs, EOT+ by the ART assay does not indicate treatment failure.

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Sofosbuvir/Velpatasvir

Annals of Pharmacotherapy ◽

10.1177/1060028016668897 ◽

2016 ◽

Vol 51 (1) ◽

pp. 44-53 ◽

Cited By ~ 12

Author(s):

Elias B. Chahine ◽

Allana J. Sucher ◽

Brian A. Hemstreet

Keyword(s):

Literature Search ◽

Data Extraction ◽

Decompensated Cirrhosis ◽

Genotype 1 ◽

Additional Material ◽

Hcv Genotype ◽

Compensated Cirrhosis ◽

Genotype 2 ◽

Hcv Genotype 1 ◽

Chronic Hcv

Objectives: To review the pharmacology, efficacy, and safety of sofosbuvir/velpatasvir in the treatment of patients with hepatitis C virus (HCV) infection. Data Sources: A literature search through PubMed was conducted (June 2008 to August 2016) using the terms GS-5816, velpatasvir, and sofosbuvir. References from retrieved articles and the prescribing information were reviewed for any additional material. Study Selection/Data Extraction: The literature search was limited to human studies published in English. Phase I, II, and III studies of sofosbuvir/velpatasvir for HCV were identified. Data Synthesis: Sofosbuvir/velpatasvir is indicated for adult patients with chronic HCV genotype 1 through 6. It is given without ribavirin in patients with or without compensated cirrhosis and with ribavirin in patients who have decompensated cirrhosis. The ASTRAL-1 study demonstrated that sofosbuvir 400 mg plus velpatasvir 100 mg for 12 weeks was effective at achieving high sustained virological response (SVR12) rates in patients with HCV genotype 1, 2, 4, 5, or 6. The ASTRAL-2 and ASTRAL-3 studies demonstrated that the same regimen was effective at achieving high SVR12 rates in patients with HCV genotype 2 or 3. The ASTRAL-4 study demonstrated that the same regimen plus ribavirin was effective at achieving high SVR12 rate in patients with decompensated cirrhosis. The most common adverse reactions (≥10% of patients) associated with sofosbuvir/velpatasvir were headache and fatigue. Conclusions: Sofosbuvir/velpatasvir is safe and effective to treat HCV genotypes 1, 2, 3, 4, 5, and 6 in patients with or without compensated cirrhosis. The addition of ribavirin is recommended in patients with decompensated cirrhosis.

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Optimizing Hepatitis C Therapy in HIV/hepatitis C Virus (HCV) Coinfected Patients: Analysis of HCV Viral Kinetics on Treatment

Canadian Journal of Infectious Diseases and Medical Microbiology ◽

10.1155/2012/384630 ◽

2012 ◽

Vol 23 (1) ◽

pp. 31-35 ◽

Cited By ~ 5

Author(s):

Paul Damien James ◽

David KH Wong

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Pegylated Interferon ◽

Hcv Rna ◽

Genotype 1 ◽

Viral Kinetics ◽

Hcv Genotype ◽

Hiv Coinfection ◽

Genotype 2 ◽

Hcv Genotype 1

INTRODUCTION: Hepatitis C virus (HCV) infection is potentially curable, but the sustained virological response (SVR) has been shown to be lower in patients coinfected HIV. A single-centre experience treating individuals with HCV and HIV coinfection is reported.METHODS: Twenty-one patients who received standard doses of pegylated interferon with weight-based dosing of ribavirin (mean 14.3 mg/kg) were retrospectively reviewed. Qualitative HCV polymerase chain reaction (PCR) was performed prospectively every four weeks if the patient remained HCV PCR positive. All patients with HCV genotype 1 were treated for 48 weeks. Patients with genotype 2 or 3 were treated for 24 weeks and 32 weeks to 36 weeks if their HCV RNA level was undetectable after four weeks (RVR4) or eight weeks (RVR8) of therapy, respectively. If RVR8 was not achieved, the treatment was continued for 48 weeks.RESULTS: There were no dropouts or dose reductions within the first 12 weeks of treatment. SVR status was available for 20 patients and adequate serum for viral kinetics analyses was available for 17 patients. Eighty per cent of the patients achieved SVR (50% genotype 1; 100% genotypes 2 and 3). The week 8 viral load remained elevated for all genotype 1 nonresponders.DISCUSSION: High effectiveness rates were seen, particularly in patients with HCV genotype 2 and 3 who were treated for shorter durations. HCV viral loads after eight weeks of therapy helped distinguish patients with HCV genotype 1 who would respond to therapy.

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