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Year : 2017  |  Volume : 31  |  Issue : 2  |  Page : 77-85

Sofosbuvir: Arrival of a paradigm shift in the management of hepatitis C in India


1 Department of Pharmacology and Therapeutics, Seth G.S. Medical College and K.E.M. Hospital, Mumbai, Maharashtra, India
2 Department of Gastroenterology, Seth G.S. Medical College and K.E.M. Hospital, Mumbai, Maharashtra, India

Correspondence Address:
KNM Singh
Pharmacology and Therapeutics, Seth G.S. Medical College and K.E.M. Hospital, 1st Floor, Acharya Donde Marg, Parel, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jms.jms_68_16

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More than 185 million people in the world are affected by hepatitis C, with India having a huge patient load of about 18 million cases. The association of various complications and hepatocellular carcinoma risk with hepatitis C makes it a dangerous health issue. In the early 90s, due to lack of choice for hepatitis C treatment, pegylated interferon (peg-IFN) and ribavirin (RBV) were the widely used agents, but they have low efficacy and multiple side effects. Last decade saw the development of direct-acting antiviral (DAA) agents, including the hepatitis C-specific drug sofosbuvir (SOF). Multiple clinical trials were carried out testing SOF which showed it has excellent efficacy and low side effects. This ultimately led to the approval of SOF in the USA for hepatitis C treatment, in combination with RBV and/or peg-IFN as well as with other newer DAAs. India considered the excellent efficacy and tolerability profile of SOF in the international trials and gave it a marketing approval in early 2015, with a waiver of the national clinical trial data. This has come as a major boost to the millions of hepatitis C patients in the country. However, the exorbitant cost remains a deterrent for its universal use, especially in developing countries like India. The literature search was performed across various databases such as PubMed, EMBASE, and Google Scholar for articles.


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