Efficacy and Safety of an 8-Week Antiviral Therapy for Chronic Hepatitis C with Ravidasvir and Sofosbuvir

Introduction. Hepatitis C virus (HCV) genotype 3 is associated with accelerated progression of liver disease; therefore, individuals infected with this genotype represent a clinically significant subgroup of patients. Despite the high efficacy of direct-acting antivirals, the optimal duration of therapy remains a subject of debate.

Aim. To evaluate, in a real-world clinical setting, the efficacy and safety of an 8-week treatment regimen consisting of ravidasvir (200 mg) and sofosbuvir (400 mg) once daily in treatment-naive patients with chronic hepatitis C virus genotype 3 (HCV-3) infection and F0–F2 liver fibrosis (according to the METAVIR score).

Materials and methods. This prospective, single-cohort, observational study (ClinicalTrials.gov, NCT07316842) enrolled 30 patients with HCV-3; the final per-protocol analysis included 29 patients who completed the full course of antiviral therapy and were available for the assessment of sustained virological response 12 weeks after treatment cessation (SVR12). The diagnosis of HCV-3 was verified in accordance with the Clinical Guidelines “Chronic Hepatitis C”, approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation. The mean age of the patients was 40.4 ± 7.1 years, and 65.5 % were men. The stage of liver fibrosis was determined by transient elastography using the FibroScan device (Echosens, France). The distribution of fibrosis stages was as follows: F0 — 44.8 %, F1 — 48.3 %, and F2 — 6.9 %. The primary endpoint was the achievement of SVR12, while the secondary endpoints included the achievement of aviremia 4 weeks after antiviral therapy completion (SVR4), viral load dynamics, changes in ALT and AST activity during treatment, as well as the safety and tolerability of the antiviral therapy.

Results. In patients with HCV-3 and F0–F2 liver fibrosis (according to the METAVIR score), SVR12 was registered in 28 out of 29 patients (96.6 %; 95% CI: 82.8–99.4). SVR4 was achieved in 24 out of 25 patients with available data (96.0 %; 95% CI: 80.5–99.3). The median viral load decreased from 8.3 × 10⁵ IU/mL at baseline to an undetectable level after 4 weeks of treatment and remained at this level at the time of SVR12 assessment. The median ALT activity decreased from 115.2 to 18.0 U/L, and AST activity decreased from 66.0 to 23.3 U/L (p < 0.001 for both parameters). No serious adverse events or treatment discontinuations due to adverse events were registered.

Conclusion. The shortened 8-week antiviral therapy regimen with a combination of ravidasvir (200 mg) and sofosbuvir (400 mg) once daily in patients with HCV-3 without advanced liver fibrosis demonstrates high efficacy and a favourable safety profile in this cohort.

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