• Saudi Med J · Dec 2023

    Effectiveness of generic sofosbuvir in the treatment of chronic hepatitis C virus infection in Saudi patients.

    • Hamdan S AlGhamdi, Ali A AlHabobi, Rakan S AlQahtani, Firas A Ghomraoui, Khalefa M AlThiab, Abdulrahman A AlOun, Abduljaleel M AlAlwan, Mutaz B Abdelmahmoud, Ibrahim H AlTraif, and Abdulrahman A Aljumah.
    • From the Hepatobiliary Sciences & Organs Transplant Department (AlGhamdi, AlAlwan, Alqahtani, Aloun, Abdelmahmoud, ATtraif), Hepatology Section and From the Department of Internal Medicine (AlHabobi), King Abdulaziz Medical City of National Guard; from King Saud Bin Abdulaziz University for health sciences (AlGhamdi, AlAlwan, AlThiab); from King Abdullah International Research Centre (AlGhamdi, AlAlwan, AlThiab), Ministry of National Guard Health Affairs; From the Department of Pharmaceutical Care Services (AlThiab), King Abdulaziz Medical City of National Guard; Form the College of Medicine (AlJumah), Dar Al-Uloom University, Riyadh, Kingdom of Saudi Arabia; and From the Department of Internal Medicine (Ghomraoui), Sisters of Charity Hospital, Buffalo, New York, United States of America.
    • Saudi Med J. 2023 Dec 1; 44 (12): 124012471240-1247.

    ObjectivesTo assess the effectiveness of generic sofosbuvir (SOF) and branded daclatasvir (DCV) for the treatment of chronic hepatitis C virus (HCV)infected patients.MethodsThis retrospective study, performed in a single center in Saudi Arabia between August 2017 and July 2022, we enrolled 140 consecutive patients with HCV who received generic SOF and branded DCV. The primary outcome was sustained virologic response at week 12 (SVR12).ResultsThe majority of the patients were female (62.1%), infected with genotype 4 (57.9%), and treatment-naïve in 120 (85.7%) patients with baseline cirrhosis in 55 (39.3%). The mean patient age was 61±13.6 years. In the intention-to-treat analysis, 131 (93.6%) patients achieved SVR12. Moreover, 85.7%, 100%, 100%, 88.9%, and 96.3% of genotypes 1a, 1b, 2, 3, and 4, respectively, achieved SVR12. In the per-protocol analysis, 131 (96.3%) patients achieved an SVR of 12. Additionally, 92.3%, 100%, 100%, 88.9%, and 98.7% of the patients with genotypes 1a, 1b, 2, 3, and 4, respectively, achieved SVR12. No HCV virologic breakthroughs occurred. In the subgroup analysis, SVR12 rates were comparable regardless of baseline characteristics, such as treatment history, cirrhosis, and hepatocellular carcinoma. Patients achieving SVR12 showed a significant improvement in post-treatment serum liver enzyme and total bilirubin levels.ConclusionThe findings of our study confirm the effectiveness of generic sofosbuvir as a treatment option for HCV infection.Copyright: © Saudi Medical Journal.

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