Cipla Limited, a global pharmaceutical company, announces the launch of generic drug sofosbuvir in India under the brand name ‘Hepcvir’.
Following the non-exclusive licensing agreement signed with Gilead Sciences in September last year, to manufacture and market chronic hepatitis C medicines, Cipla is now all set to make the drug sofosbuvir available to Indian patients in a week’s time.
Sofosbuvir is the first-in-class NS5B polymerase inhibitor to be launched in India for hepatitis C treatment and represents a paradigm shift in the existing hepatitis C management. The high potency, high barrier to resistance, pangenotypic activity, once-daily dosage, good safety profile and the limited drug-drug interactions of sofosbuvir makes it a breakthrough drug in hepatitis C treatment.
This drug in combination therapy has shown to have high cure rates of around 90 per cent. Globally, it is estimated that 170-185 million people (about 3 per cent of the world’s population) are chronically infected with hepatitis C virus (HCV). Untreated chronic hepatitis C increases the risk of cirrhosis of liver, liver failure and hepatocellular carcinoma. In India alone, it is estimated that 12-18 million patients are infected with hepatitis C which is several fold greater than those with HIV/AIDS. Globally, HCV is implicated in 28 per cent of cases of liver cirrhosis and 26 per cent of cases of hepatocellular carcinoma, which accounts for almost 500,000 deaths per year.
Subhanu Saxena, managing director and global chief executive officer, Cipla Limited said, “Cipla has always brought accessible and affordable medicines to fight against diseases like AIDS and hepatitis B and is a leader in India with anti-virals; hence, Cipla has made it a priority to bring Hepcvir to patients in India as well as the other developing nations.”
Dr Jaideep Gogtay, chief medical officer, Cipla said: “The benefits of Hepcvir will be felt by patients who will have much lower discomfort while on the treatment and therefore much higher levels of adherence. Sofusbuvir marks a new era of medicines in oral treatment of hepatitis C which reduce the need for injectibles. It is hoped that in the future these drugs will eventually mean a totally oral regimen.”
The availability of product in other markets is subject to approvals from the regulatory authorities in respective countries.