Initial results of efficacy and safety of Sofosbuviramong Pakistani Population: A real life trial Hepatitis Eradication Accuracy Trial of Sofosbuvir (HEATS)

Abstract

Objective:The uridine nucleotide analogue sofosbuvir is a selective inhibitor of hepatitis C virus (HCV) NS5B polymerase approved for the treatment of chronic HCV infection with genotypes 1 – 4. The objective of the study was to evaluate the interim results of efficacy and safety of regimens containing Sofosbuvir (Zoval) among Pakistani population with the rapid virologic response (RVR2/4 weeks) with HCV infections.Methods:This is a multicenter open label prospective observational study. Patients suffering from chronic Hepatitis C infection received Sofosbuvir (Zoval) 400 mg plus ribavirin (with or without peg interferon) for 12/24 weeks. The interim results of this study were rapid virological response on week 4. Data was analyzed using SPSS version 21 for descriptive statistics.Results:A total of 573 patients with HCV infection were included in the study. The mean age of patients was 46.07 ± 11.41 years. Out of 573 patients 535 (93.3%) were treatment naive, 26 (4.5%) were relapser, 7 (1.2%) were non-responders and 5 (1.0%) were partial responders. A rapid virologic response was reported in 563(98.2%) of patients with HCV infection after four weeks of treatment. The treatment was generally well tolerated.Conclusion:Sofosbuvir (Zoval) is effective and well tolerated in combination with ribavirin in HCV infected patients.

Efficacy of generic oral directly acting agents in patients with hepatitis C virus infection

“…We previously reported an SVR (24 weeks) rate of 64% in patients treated with peginterferon and ribavirin in combination . In this present study, overall SVR12 was 95.9% (470/490), which is similar to those reported previously from other studies performed in the Indian subcontinent . Prior multicenter studies evaluating the efficacy of branded DAA have reported similar high SVR12 rates .…”

“…15 In this present study, overall SVR12 was 95.9% (470/490), which is similar to those reported previously from other studies performed in the Indian subcontinent. [16][17][18] Prior multicenter studies evaluating the efficacy of branded DAA have reported similar high SVR12 rates. [5][6][7]19 Our study supports the fact that generic DAAs are associated with high efficacy.…”

Rapid and Early Virological Response of Patients Treated With Sofosbuvir in Chronic Hepatitis C.

“…Another large multicenter study HEATS has found 98.2% patients achieving RVR in HCV infected patients with well tolerability. 28 The results of our study have found sofosbuvir to achieve 100% results of RVR and ETR in patients whose results have been collected and also SVR of patients chased also found 100% in both patients treated with dual and triple therapy.…”

HCV Treatment with Sofosbuvir in Pakistan; Current Scenario and Future Perspective

“…Keeping in mind this important aspect of therapy success and future prediction, the current study was designed to analyse the available data regarding the HCV treatment with sofosbuvir from Pakistan. Literature survey showed that there are only 07 studies reporting the antiviral response of sofosbuvir in Pakistan [12][13][14][15][16][17][18] . The available limited data showed that overall sustained virological response (SVR)/rapid virological response (RVR) is very good.…”

“…Capileno et al (2017) study from Karachi included 153 patients and reported that 84% patients showed RVR [13] . The detailed analysis of available data suggested a very good response for this DAA antiviral regimen in different cities with overall 80-100% SVR/RVR [13][14][15][16][17][18] . There is also a study which included 37 renal transplant HCV patients from Karachi and sofosbuvir treatment showed 89.2% RVR for these individuals [19] .…”