Indian Experience With Use Of Sofusbuvir For Treatment Of Hepatitis C Virus Infection: Preliminary Data From Southern India

Background: Hepatitis C virus (HCV) infection is a major health problem worldwide. India has a burden of over 10 million HCV chronic carriers. The previous standard of care for HCV was pegylated IFN (Peg IFN) and ribavirin (RBV). The new direct acting antivirals that are now available promise sustained virological response, tolerability and higher cure rates. This study aims to look at the response to sofosbuvir (SOF) (an NS5B nucleotide analog) in combination with RBV with/ without Peg IFN among Indian patients. Methods & Materials: Plasma from 44 patients (including 5 post transplant) was obtained from those who were treated with SOF and RBV ± PegIFN. RNA extraction and amplification was done using real time PCR. HCV genotypes were ascertained using the NS5B region based sequencing. Samples were tested for RNA negativity, one month after treatment initiation (RVR), and 3 to 6 months later. Results: Thirty eight of 44 patients were genotyped. Genotype distribution was 7(18.4%) for type 1, 28(73.7%)for type3, 3(9%) for type 4 respectively. Patients with 1, 3 & 4 genotypes on additional Peg IFN was 4(10.5%), 5(14.7%) & 1(2.94%) and without Peg IFN was 3(7.9%), 23(60.5%) & 2(5.9%). RVR for all patients was 100% and at ≥3 month follow up, there was 100% response to SOF based therapy. RVR for the 5 post transplant patients was 100%. Conclusion: This preliminary study in this tertiary care centre shows a 100% rapid virus response to SOF based therapy irrespective of genotype and transplant status among Indian patients. Long term prospective studies are warranted to estimate sustained virological response to Sofosbuvir in Indian patients