Registry to Understand Patient Characteristics, Treatment Patterns, and Therapy Outcomes in Adults with Chronic Hepatitis C Virus Infection in Asia, Africa, and Eastern Europe

Abstract

Background: Several patient, government, payer, and provider-level barriers to Hepatitis C virus (HCV) treatment have been identified in regions like Asia, Africa, and the Commonwealth of Independent States (CIS). A patient registry was created in these regions to understand the patterns of clinical care and outcomes in real-world settings. Methods: This prospective study was conducted between 2018 to 2021 across 14 centers. Adult patients considered eligible for treatment with directly acting antivirals (DAAs) were included in the study. The primary endpoint was to understand the prevalence of HCV genotypes (GTs) and DAA treatment strategies The secondary endpoint was to evaluate efficacy and safety of various DAA regimens. Results: A total of 476 patients were enrolled of which 386 (81.1%) completed the study and remaining 90 were lost to follow-up. The most prevalent GT were GT 3 (30.5%) and GT 1 (19%). Patients with GT1 and GT 6 have demonstrated high SVR 12 cure rates(100%; n=55, n=24) followed by GT3 (95.9%, n=94). The most commonly prescribed DAAs were Daclatasvir (60mg)/ Sofosbuvir (SOF/DCV; 43.7%, n=208), Sofosbuvir/Ledipasvir (SOF/LDV; 16.2%, n=77), and Sofosbuvir/Velpatasvir (SOF/VEL; 14.3%, n=68). The SVR12 rates were as follows: SOF/LED, 98.2%, n= 54/55; SOF/VEL, 97.6%, n=35/36; and SOF/DCV, 90.8%, n=128/141. Adverse events were reported in 13 patients, with one death that was not considered treatment-related. Conclusion: Overall, sofosbuvir-based regimens were found to be safe and efficacious. GT 3 and 1 were the most prevalent HCV genotypes.