Four-Week Direct-Acting Antiviral Regimens in Noncirrhotic Patients With Hepatitis C Virus Genotype 1 Infection

Kohli, Anita; Kattakuzhy, Sarah; Sidharthan, Sreetha; Nelson, Amy; McLaughlin, Mary; Seamon, Cassie; Wilson, Eleanor; Meissner, Eric G.; Sims, Zayani; Silk, Rachel; Gross, Chloe; Akoth, Elizabeth; Tang, Lydia; Price, Angie; Jolley, Tim A.; Emmanuel, Benjamin; Proschan, Michael A.; Teferi, Gebeyehu; Chávez, José; Abbott, Stephen; Osinusi, A.; Mo, Hongmei; Polis, Michael A.; Masur, Henry; Kottilil, Shyam

doi:10.7326/m15-0642

Cited by 52 publications

(54 citation statements)

References 12 publications

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“…10 These results suggest that 8 weeks is the threshold of treatment duration with combination DAAs for the easier-to-treat patient population, not 4 or 6 weeks as suggested by recent viral kinetic models. 11,12 This discrepancy may be explained by the stability of the HCV replication complex.…”

Section: Safety and Tolerabilitymentioning

confidence: 76%

Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections

et al. 2016

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Section: Safety and Tolerabilitymentioning

confidence: 76%

Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections

et al. 2016

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“…A sixth participant who had detectable, but not quantifiable HCV RNA and negative HCVcAg 12 weeks after an end of treatment response, did not have sustained post-treatment viraemia, thus providing further evidence that the lower sensitivity afforded by HCVcAg may be more clinically useful to monitor viral recurrence than highly sensitive RNA assays, as a strategy to avoid ambiguous and potentially irrelevant HCV RNA positive results due to the detection of low, or replication incompetent, HCV RNA. While limited to an interferon-ribavirin regimen, the results are likely transferable to relapse from DAA for which HCV RNA has been shown to rebound rapidly and to high levels [31,34,35].…”

Section: Journal Of Clinical Virology 92 (2017) 32-38mentioning

confidence: 99%

Hepatitis C Virus Core Antigen: A Simplified Treatment Monitoring Tool, including for Post-Treatment Relapse

Lamoury¹,

Soker²,

Martinez³

et al. 2016

Journal of Hepatology

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Background: Simple, affordable diagnostic tools are essential to facilitate global hepatitis C virus (HCV) elimination efforts. Objectives: This study evaluated the clinical performance of core antigen (HCVcAg) assay from plasma samples to monitor HCV treatment efficacy and HCV viral recurrence. Study design: Plasma samples from a study of response-guided pegylated-interferon/ribavirin therapy for people who inject drugs with chronic HCV genotype 2/3 infection were assessed for HCV RNA (AmpliPrep/COBAS Taqman assay, Roche) and HCVcAg (ARCHITECT HCV Ag, Abbott Diagnostics) during and after therapy. The sensitivity and specificity of the HCVcAg assay was compared to the HCV RNA assay (gold standard). Results: A total of 335 samples from 92 enrolled participants were assessed (mean 4 time-points per participant). At baseline, end of treatment response (ETR) and sustained virological response (SVR) visits, the sensitivity of the HCVcAg assay with quantifiable HCV RNA threshold was 94% (95% CI: 88%, 98%), 56% (21%, 86%) and 100%, respectively. The specificity was between 98 to 100% for all time-points assessed. HCVcAg accurately detected all six participants with viral recurrence, demonstrating 100% sensitivity and specificity. One participant with detectable (non-quantifiable) HCV RNA and non-reactive HCVcAg at SVR12 subsequently cleared HCV RNA at SVR24. Conclusions: HCVcAg demonstrated high sensitivity and specificity for detection of pre-treatment and posttreatment viraemia. This study indicates that confirmation of active HCV infection, including recurrent viraemia, by HCVcAg is possible. Reduced on-treatment sensitivity of HCVcAg may be a clinical advantage given the moves toward simplification of monitoring schedules.

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“…Shortening the duration of treatment is a potential method to decrease the cost of therapy. Future studies may also seek to establish a shorter or more potent therapy with different DAA combinations as was investigated for therapy with SOF/LDV, [39,40] ultimately seeking a short, effective treatment with a low pill-burden. But for now, with a recommended treatment duration of 12 weeks, single tablet FDC SOF/ VEL is an excellent option for patients with HCV GT1-6, requiring RBV only in patients with decompensated cirrhosis.…”

Section: Future Directionsmentioning

confidence: 98%

Sofosbuvir/velpatasvir: a pangenotypic drug to simplify HCV therapy

2016

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Treatment for chronic hepatitis C virus (HCV) has evolved rapidly from an interferon based regimen of modest efficacy with significant adverse events to a well-tolerated, highly effective all-oral directly acting antiviral (DAA) therapy. Although significant improvement in sustained virologic responses (SVR) has been reported with new DAAs for genotypes 1 and 4, effective treatments for genotype 3 have been lacking, and a single pill that can yield high SVR rates against HCV genotypes 1-6 has not been available until now. Sofosbuvir (a pangenotypic NS5B inhibitor) and velpatasvir (a pangenotypic NS5A inhibitor) were recently approved in a fixed-dose combination pill. The availability of this pangenotypic pill holds promise for providing highly effective treatment with minimal laboratory testing for chronic HCV worldwide.

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Four-Week Direct-Acting Antiviral Regimens in Noncirrhotic Patients With Hepatitis C Virus Genotype 1 Infection

Abstract: National Institute of Allergy and Infectious Diseases, National Cancer Institute, and Clinical Center Intramural Program; supported in part by a cooperative research and development agreement between the National Institutes of Health and Gilead Sciences.

Cited by 52 publications

References 12 publications

Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections

Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections

Hepatitis C Virus Core Antigen: A Simplified Treatment Monitoring Tool, including for Post-Treatment Relapse

Sofosbuvir/velpatasvir: a pangenotypic drug to simplify HCV therapy

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