Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection in 2015

Abstract

Overall prevalence of HCV infection in India has been estimated to be approximately 1.3% in the general population. Recent introduction of sofosbuvir in India at a relatively affordable price has led to great optimism about prospects of cure for these patients. This drug is likely to form the backbone of current and future treatment regimes for HCV infection, displacing pegylated interferon. Availability of directly acting antiviral drugs (DAAs) has necessitated revision of INASL guidelines for the treatment of HCV published in 2014, as has happened across the world. Current considerations for the treatment of HCV in India include the poorer response of genotype 3, nonavailability of many of the DAAs recommended by other guidelines and the cost of therapy. Since only one DAA, sofosbuvir, is available in India, only two sofosbuvir-based regimes are possible: either dual drug therapy in combination with ribavirin alone for 6 months or triple drug therapy in combination with ribavirin and pegylated interferon for 3 months. The utility of these regimes in various situations has been discussed. Availability of a few other newer DAAs, expected in 2016, is expected to lead to more widespread use of these agents. Current guidance will be updated once newer DAAs, newer evidence with DAAs and 'real-life experience' with use of DAAs accumulate in India.

Keywords: ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; CH-C, chronic hepatitis C; CTP, Child-Turcotte Pugh; DAA, directly acting antiviral agents; EIA, enzyme immunoassay; ESRD, end stage renal disease; EVR, early virological response; HCV; HCV, hepatitis C virus; HIV, human immunodeficiency virus; IFN-α, interferon alfa; INASL, Indian National Association for Study of the Liver; PCR, polymerase chain reaction; Peg-IFNα, pegylated interferon alfa; RBV, ribavirin; RVR, rapid virological response; SOC, standard of care; SVR, sustained virological response; Sof, sofosbuvir; ULN, upper limit of normal; anti-HCV, antibody to HCV; antiviral therapy; chronic hepatitis; hepatitis C virus.