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

Journal Article · Sun Oct 16 00:00:00 EDT 2016 · Therapeutic Advances in Gastroenterology

DOI:https://doi.org/10.1177/1756283x16672392· OSTI ID:1626246

Malespin, Miguel ^[1]; Benyashvili, Tamara ^[2]; Uprichard, Susan L. ^[2]; Perelson, Alan S. ^[3]; Dahari, Harel ^[2]; Cotler, Scott J. ^[2]

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1. Univ. of Florida Health, Jacksonville, FL (United States)
2. Loyola Univ. Medical Center, Maywood, IL (United States)
3. Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

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+/SVR_12&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 SVR_12&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.

• Research Organization: Los Alamos National Laboratory (LANL), Los Alamos, NM (United States)
• Sponsoring Organization: USDOE; National Institutes of Health (NIH)
• Grant/Contract Number: AC52-06NA25396; R01-AI078881; R01-OD011095; P20-GM10 3452
• OSTI ID: 1626246
• Journal Information: Therapeutic Advances in Gastroenterology, Vol. 10, Issue 1; ISSN 1756-283X
• Publisher: SAGE
• Country of Publication: United States
• Language: English

Related Subjects

60 APPLIED LIFE SCIENCES
Gastroenterology & Hepatology
HCV
SVR
direct antiviral agents
end of treatment response