The drug called Epclusa, which is developed to treat all genotypes of the Hepatitis C virus by Gilead Sciences in its latest breakthrough treatment, was last week approved by the United States Food and Drug Administration (FDA).
The deadly Hepatitis C virus afflicts as many as 150 million people worldwide and possibly 12 million in India. This pan-genotypic treatment does not require gene-type testing, eliminating the need for costly gene-type diagnostics, allowing doctors and specialists the ability to prescribe the medicine to anyone who tests positive for Hepatitis C, by taking one pill a day for eight-12 weeks before a cure is achieved.
“The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate HCV as it provides a safe, simple and effective cure for the majority of HCV-infected patients, regardless of genotype,” said Ira Jacobson, MD, Chairman of the Department of Medicine at Mount Sinai Beth Israel, New York, and a principal investigator in the Epclusa clinical trials.
“Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens,” he said.
As part of its effort to make it an affordable treatment, Gilead Sciences, together with its 11 partners in India, are pioneering a Voluntary Licensing model that transfers technology and Intellectual Property for latest treatments and cures for viral Hepatitis and HIV.
Gilead, in 2014, licensed its newly-approved HCV regimens to 11 of India’s pharma companies, including the prospective Epclusa, which had not yet been cleared by the US Food and Drug Administration.
“This forward thinking strategy opened for these Indian firms the market across all of India for generic versions of these drugs, plus the market for 100 other countries,” said an industry source.