Outcomes and Predictors of Non-Responsiveness in Treatment of Naïve and Non-Cirrhotic Patients with HCV Genotype 3 Infection – A Third World Perspective

Abstract

Objective: To assess the clinical outcome in treatment naïve and non-cirrhotic patients with HCV genotype 3 infection after treatment with Sofosbuvir with declastasvir and valpatasvir (in case of non-responsiveness). Methods: Study included 263 participants. The inclusion criteria were HCV genotype 3 infection confirmed through PCR, age above 18 years, treatment naïve and non-cirrhotic. HCV PCR below the threshold of quantification at 12th week of treatment was defined as SVR12 (sustained virological response). The patients were started on a fixed dose generic combination of declastasvir 60 mg and Sofosbuvir 400 mg and PCR was performed at 12, 24 and 48 weeks. PCR positive patients at 24 weeks were given valpatasvir with Sofosbuvir. Results: There were 162 males and 101 females. PCR performed at 12 weeks showed that 251 patients (95.4%) became PCR negative and 12 (4.56%) remained positive. Repeat PCR of these 12 patients started on valpatasvir and Sofosbuvir at 48 weekswas negative. The treatment was well tolerated by all.Probability of positive HCV PCR at 12 weeks decreases by 0.73 with one unit increase in the hemoglobin, whereas one unit increase in TLC reduces the probability of HCV PCR at 12 weeks, positive by 0.001. Conclusion: The combination of Sofosbuvir and declastasvir is a cheap and effective treatment strategy for treatment naïve and non-cirrhotic HCV genotype 3 infections. Those not responding will achieve PCR negativity with a 6 month therapy of Sofosbuvir and valpatasvir combination. A high hemoglobin level and high total leucocyte count are predictors of good treatment response.