The Efficacy and Adverse Effects of Combining Sofosbuvir and Velpatasvir in Viral Hepatitis C Hemodialysis in Pakistani Population.

Abstract

Purpose: The study objectives were to evaluate the efficacy and safety of SOF and VLP combination in HCV-infected patients on Hemodialysis (HD) in the local community as usual Pakistani practice.

Methodology: In this study, 252 patients were given treatment who participated. Patients who maintain their hemodialysis are often given a combination of SOF and VLP. Before beginning the drug, the patient had testing that included an upper GI endoscopy, genotyping, measurement of the viral load, and a liver brow scan. Patients were administered SOF and VLP at dosages of 400 mg/day and 100 mg/day, respectively, for the duration of the study. Between March 2019 and March 2021, this study was conducted at the Department of Kidney Diseases at LRH Hospital in Peshawar, Pakistan, which was an observational, prospective, single-center study. 27 HCV-HD patients were on a SOF/VLP regimen during the experiment. The ICH-GCP criteria were surveyed in an intended manner. During the data analysis, a p-value of 0.05 or below was considered statistically significant.

Results:  Forty percent ofthe patients were male, and sixtypercent were female between the ages of 27 and ninety. According to the findings of 252 participants (n = female 14, 43.5 percent and n = male 18, 45.5 percent), 21 subjects were naïve, and six issues were in the treatment-experienced group (with SOF/RBV), with a mean age of 35.5 years and a standard deviation of 9.6 years. At the post-treatment follow-up visit after 12 weeks of therapy with SOF/VLP, the sustained virological response (SVR) rate was 100 percent (252 of 252), indicating that all of the patients had successfully recovered from their infection. During the study, not a single patient had a virological setback or was lost to follow-up. The most common adverse effects (AEs) recorded were nausea, headache, and tiredness; however, there were no reports of significant AEs. In addition, there were no cases of therapy being stopped prematurely owing to adverse effects.

Conclusion: Patients in regular care in Pakistan who have HCV and are receiving HD are offered an extraordinarily efficient, risk-free, and well-tolerated treatment consisting of the total dosage of SOF-VLP given for 12 weeks.