CLINICAL RESPONSE OF SOFOSBUVIR (GENERIC, SEARLE) BASED TREATMENT OF CHRONIC HEPATITIS C INFECTION: A PAKISTANI REAL LIFE STUDY HOME (HEPATITIS OBSERVATIONAL MANAGEMENT ENVISION) STUDY SPONSOR: THE SEARLE COMPANY LIMITED (TSCL), PAKISTAN

Tayyab Ghayas Un Nabi, Akhtar Shakil2, Malik Sadiq Hussain, Ather Mumtaz, Hassan Nazeer Ul, Mehmood Tariq, Pasha Burhan, Ikram Yousif, Latif Amir, Sherazi Irfan, Sarfraz Muhammad, Ahmed Shahab, Latif Muhammad2, Toor Ul Haq Israr, Nasir Bilal, Mehmood Asif, Baig Mirza Ilyas, Nisar Sajid, Saleem Inamullah, Ahmed Mukhtar, Hafeez Muhammad Shahzad, Mirza Shakeel, Tarmizi Ikram, Naeem Abdul, Salamat Amjad, Adnan Mohammad, Mohammad Riaz, Iltaf Mohammad, Dr. Ali Yasir*

ABSTRACT

Background: Globally, Interferon-free direct-acting antiviral therapy has revolutionized treatment for Chronic Hepatitis C (HCV). However, due to the slow regulatory process of DAAs registration in Pakistan and differ the current AASLD/IDSA Hepatitis C guidance, the Sofosbuvir/Ribavirin combination is the registered treatment therapy. Objective: This Post-Marketing Observational Studies (PMOS) conducted across 30 sites at 10 major cities of Pakistan, evaluating the safety and efficacy of Sofosbuvir (Searle, Pakistan) plus Ribavirin (generic, Searle, Pakistan) therapy among treatment-naïve Pakistani patients with chronic genotype 3 HCV infection. Methods: In the HOME (Hepatitis Observational Management Envision) study as per study inclusion/exclusion criteria, 244 GT-3 HCV infected naïve Pakistani patients, non-cirrhotic received SOF (generic) 400mg with Ribavirin (generic, Searle) daily for 24 weeks. The study assess the overall safety, virological response at week 4 and Sustained Virological Response at week 12 (SVR). Results: Out of 244 patients, 121 (49.59%) females while 123 (50.40%) were males with Mean age of 43.16±11.21 (S.D). The HCV RNA become negative in 231 (94.6%) patients at week 4 of treatment. Headaches and fatigue were the most common reported adverse events with no serious adverse event reported. Conclusion: The week 4 study interim analysis response indicates the probability of achieving SVR12 in the heterogeneous group (demographics distribution) across Pakistan with Sofosbuvir Ribavirin (Generic, Searle) regimen therapy in HCV genotype 3-infected individuals without cirrhosis. With the promising week 4 results, the better outcomes are expected in the final SVR results of the study. Overall, the regimen of SOF/RIB (Generic, Searle) for 4 weeks therapy also observed to be safe and well tolerated.

Keywords: Chronic Hepatitis C, Sofosbuvir, Ribavirin, Effectiveness, Pakistani population.