EVALUATION OF EFFECTIVENESS AND SAFETY OF SOFOSBUVIR AND RIBAVIRIN COMBINATION IN ACHIEVING EARLY VIROLOGICAL RESPONSE IN CHRONIC HCV GENOTYPE 3 TREATMENT NAÏVE PATIENTS: A PROSPECTIVE COHORT STUDY

Abstract

Abstract:

Background: Chronic HCV infections pose a greater public health challenge globally, especially effecting resource-limited countries like Pakistan due to its association with rapid progression to fibrosis and hepatocellular carcinoma and spreading at a higher rate. Managing chronic HCV GT3 in low/Middle income regions remains a significant hurdle and thus requires further research. The goal of this study was to evaluate effectiveness and safety of the 4-week Sofosbuvir and Ribavirin combined treatment plan in subjects infected with HCV genotype 3 and no prior treatment between June 2021 and June 2022 at Peshawar Institute of Medical sciences Hayatabad Peshawar.

Materials & Methods: In our study adult patients (14–75 years) with PCR-confirmed HCV genotype 3, no ultrasound evidence of cirrhosis (Child-Pugh Class A) and no prior antiviral therapy were selected. Demographic, clinical and laboratory data was collected. HCV RNA quantification along with genotyping was conducted before starting the therapy. Patients received Sofosbuvir (400 mg once daily) and Ribavirin (1000 mg/day if <75 kg, 1200 mg/day if ≥75 kg) for 4 weeks. We defined Rapid Virological Response (RVR) as undetectable Hepatitis C Virus RNA (<15 IU/mL) at 4 weeks post treatment. We also recorded some mild and self-limiting adverse effects. Data analysis was done using SPSS v25. We also used Chi-square tests for associations (p<0.05= significant).

Results: Out of all the 230 patients enrolled, 228 completed the study (mean age 40.02 ± 13.09 years; 52.6% male, 47.4% female).2 were lost to follow-up. The mean HCV RNA load was 1.95 × 10⁶ ± 1.2 × 10⁶ IU/mL. Rapid Virological Response (RVR) was achieved in 222 subjects (97.4%) with not much difference by gender (p = 0.150) or age group (p = 0.312). Mild adverse events included headache (15.3%), fatigue (13.6%), myalgia (10.1%), and weakness (8.7%) and no treatment discontinuations occurred.

Conclusion: The Sofosbuvir–Ribavirin regimen achieved a high RVR rate and excellent tolerability in individuals with HCV-GT3 and treatment naïve thus making it a cost effective and practical option for resource-limited settings.