EFFICACY OF SOFOSBUVIR AND DACLATASVIR IN COMPENSATED CHRONIC HEPATITIS C INFECTION: A SINGLE CENTER, OPEN-LABEL AND PROOF OF CONCEPT STUDY

Abstract

AIMS AND OBJECTIVES: The advent of directly acting agents for the treatment of Hepatitis C infection has forever transformed our understanding and management of viral infections. With over 95 % patients achieving a sustained viral response at 12 weeks with some of these newly inducted agents, the prospect of eradicating the Hepatitis C virus seems like an achievable target, which makes this one of the most important discoveries in modern medicine. We studied the combination of Sofosbuvir and Daclatasvir in patients with chronic hepatitis C infection (Genotype 3) to assess the rates of sustained virological response at 12 weeks. We studied 67 treatment naive METHODS: patients with compensated chronic hepatitis C infection (genotype 3). They were all started on Tab Sofosbuvir 400 mg daily and Tab Daclatasvir 60 mg once daily for 12 weeks and followed up for a total of 24 weeks, which includes a treatment duration and observation period of 12 weeks each. The patients were monitored with HCV RNA levels at one, three and six months, with as many evaluations of liver function and routine hemogram. Our results show that 70.5% (p<0.05) achieved a rapid vi RESULTS: rological response, 88.5% (p<0.05) achieved an end of treatment response and, similarly, an impressive 88.05% (p<0.05) showed a sustained virological response at the end of 12 weeks. One patient who developed a psoriasiform rash discontinued the medication and was excluded from the analysis, as duration of treatment had not been completed. No major dose related adverse events were reported. Sofosbuvir and Daclatasvir is an acceptable, well tolerated regimen for treatment naive, CONCLUSIONS: compensated patients with genotype 3 infection. Based on our observations and data, we recommend this as the rst line DAA for patient with compensated genotype 3 infection until medications with higher SVR 12 are available in the Indian market.