EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE  , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , 

 ISSN 2394-3211

Impact Factor: 4.897

 ICV - 79.57

Abstract

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.


[Full Text Article]

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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process)