http://orcid.org/0000-0002-4417-8076
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Abstract
Background: In both Russia and Sweden, the dominant hepatitis C virus (HCV) is genotype 1, but around one-third of patients have genotype 3 infection. For such countries, HCV genotype testing is recommended prior to therapy. An effective pangenotypic therapy may potentially eliminate the need for genotyping. In this study, we evaluated the efficacy and safety of sofosbuvir/velpatasvir for 12 weeks in patients from Russia and Sweden.
Methods: In an open-label, single-arm phase-3 study, patients could have HCV genotype 1–6 infection and were treatment-naïve or interferon treatment-experienced. All patients received sofosbuvir/velpatasvir, once daily for 12 weeks. The primary endpoint was sustained virologic response 12 weeks post-treatment (SVR12).
Results: Of 122 patients screened, 119 were enrolled and treated. Overall, half (50%) were male, 18% had cirrhosis, and 24% had failed prior interferon-based therapy. In total, 66% of patients were infected with HCV genotype 1 (59% 1b and 7% 1a), 6% with genotype 2, and 29% with genotype 3. The overall SVR12 rate was 99% (118/119, 95% confidence interval 95–100%). One treatment-experienced patient infected with HCV genotype 3 experienced virologic relapse after completing treatment. The most common adverse events were headache (16%) and fatigue (7%). Serious adverse events were observed in four patients, but none were related to treatment. No patients discontinued treatment due to adverse events.
Conclusion: Sofosbuvir/velpatasvir as a pangenotypic treatment for 12 weeks was highly effective in patients from Russia and Sweden infected with HCV genotypes 1, 2, or 3. Sofosbuvir/velpatasvir was safe and well-tolerated.
Trial registration: ClinicalTrials.gov identifier: NCT02722837.
Acknowledgements
We thank all patients and investigators involved in the study. Medical writing support (including manuscript drafts in consultation with the authors, assembling tables and figures, fact checking and referencing) was provided by Joanna Chapman, PhD at Aspire Scientific (Bollington, UK), and funded by Gilead Sciences Inc., Foster City, CA, USA.
Disclosure statement
VI has received research grants from MSD, AbbVie and R-Pharm, and has been a consultant for MSD, Bristol-Myers Squibb, AbbVie, and Echosens. VC has received research grants from Bristol- Myers Squibb, Gilead, and Janssen, has participated in advisory boards for BMS, Gilead, MSD, Roche, Janssen, and Novartis, and has served as a speaker for BMS, Gilead, MSD, AbbVie, Roche, and Janssen. DZ has served as a speaker for Gilead, MSD, and AbbVie. EB has received research grants from Gilead, AbbVie, R-Pharm, and Takeda, and has participated in advisory boards for R-Pharm. GK has participated in advisory boards for BMS, and has served as a speaker for BMS, Gilead, and Novartis. RHH, SL, ESS, JM, and DMB are employees of and hold stock in Gilead. VI has served as a speaker for Gilead, Janssen, Astra-Zeneca, PRO.MED. CS, and Krka, and has participated in advisory boards for PROM.MED.CS and Krka. VM has received research grants from BMS, Gilead, Janssen, and Shionogi, and has served as a speaker for BMS and AbbVie. IB has participated in advisory boards for AbbVie, BMS, Gilead, GlaxoSmithKline, Janssen MSD, Roche, and R-Pharm, and has served as a speaker for AbbVie, BMS, Gilead, GlaxoSmithKline, Janssen, MSD, Roche, and R-Pharm. KZ has served as an investigator in trials by Gilead, AbbVie, BMS, Biocad, Janssen, MSD, Novartis, Roche, and R-Pharm, has served as a speaker for Gilead, AbbVie, Abbott, Biocad, Janssen, MSD, Novartis, Roche, and R-Pharm, and has served as an advisor for Gilead, AbbVie, Abbott, Biocad, Janssen, MSD, Novartis, Roche, and R-Pharm. OW discloses work with Gilead, AbbVie, BMS, and MSD. EN, NG, SZ, SR, ML declare no conflicts of interest.