Comparison of sustained virologic responses to ledipasvir/sofosbuvir plus ribavirin therapy between previously treated and naïve patients with chronic hepatitis c in yemen: a retrospective comparative cohort study

Abstract

Hepatitis C virus (HCV) infection remains a major global health burden, with high prevalence in the Eastern Mediterranean region, including Yemen. Direct-acting antivirals (DAAs) such as ledipasvir/sofosbuvir (LDV/SOF) combined with ribavirin have demonstrated high sustained virologic response (SVR) rates in clinical trials. However, data on their efficacy and safety in Yemeni patients are limited. We conducted a retrospective comparative cohort study at the Hepatobiliary Gastroenterology Specialized Research Center in Sana’a, Yemen, between April 2019 and March 2021. A total of 100 chronic HCV patients were enrolled: 50 treatment-naïve and 50 previously treated with pegylated interferon plus ribavirin. Patients received LDV/SOF plus ribavirin for 12 weeks. HCV RNA was measured at baseline and 12 weeks post-treatment (SVR12) using COBAS ® TaqMan ® real-time PCR. Clinical and laboratory parameters, including ALT, AST, AFP, and hematological indices, were assessed. Adverse events and adherence were recorded. Among naïve patients, 48/50 (96%) achieved SVR12, while 47/50 (94%) of previously treated patients responded. No statistically significant differences were observed between groups ( p  = 0.6). Age, sex, and diabetes mellitus were not associated with SVR12 outcomes. Anemia was the most frequent laboratory abnormality, attributed to ribavirin use. Other adverse events were mild to moderate, including fatigue, headache, nausea, and pruritus. No treatment discontinuations occurred. LDV/SOF plus ribavirin therapy is safe, well tolerated, and highly effective in achieving SVR12 among Yemeni patients with chronic HCV infection, regardless of prior treatment status. These findings support the use of DAAs as a standard of care in resource-limited settings.