India has an estimated 12 million people living with hepatitis C virus (HCV), most of whom do not know their status. The widespread availability of better diagnostic tests for the virus, combined with affordable, highly effective treatment, would be a game-changer.
As part of a framework collaboration agreement signed by FIND and Cipla, potential areas of focus for the new partnership include: supporting work to improve the sensitivity of new HCV diagnostic tests; building diagnostic capacity and an enabling environment for HCV treatment scale-up; and collaborating on the development and evaluation of demonstration programmes that combine HCV testing and treatment for high-risk populations, including those with HIV co-infection. Deaths from viral hepatitis have now surpassed those associated with HIV in many parts of the world. Unlike HIV, however, HCV is curable.
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“The new direct-acting antiviral therapy is effective, with few side effects and more affordable. Partnering with leading doctors in the field of liver disease, Cipla has been able to provide treatment to thousands of patients over the past year. As prices keep decreasing, several states have started to finance the treatment of hepatitis C, which will make it available to low-income patients,” said Denis Broun, head of Government Affairs, Cipla.
The new HCV therapies, which are relatively non-toxic compared to earlier interferon-based treatments, have a greater than 95 percent cure rate over just 12-24 weeks of treatment. Older treatments took a year or more, and were much less effective.
“The challenge is to increase access to the new treatments in countries that do not have simple, low-cost screening and confirmatory tests for HCV. Public screening and diagnosis programmes paired with treatment are needed if we are to maximise the impact of new HCV drugs in low- and middle-income countries,” said Dr Catharina Boehme, CEO of FIND.
ALSO READ: Cipla launches hepatitis C drug Hepcvir-L
Currently, HCV diagnosis requires two or more steps, including a rapid HCV screening test followed by a molecular test of HCV core antigen or HCV RNA. None of these tests are available in rapid formats at affordable prices. A single confirmed case of active HCV infection currently costs more than $ 100 to diagnose. Even with streamlined testing, the cost of screening will exceed $ 30 without interventions to address the issue.
Affordable screening tests adapted for resource-limited settings, the political will to implement comprehensive HCV programmes, and innovative public-private partnerships are all needed to improve HCV care in most countries. Partnerships will necessarily involve a wide range of institutions across academia, industry, the public sector and civil society. Gilead has established an access program for HCV treatment in low- and middle-income countries through non-exclusive licenses to other pharmaceutical companies, including Cipla, at greatly reduced prices.
In fact, Cipla had launched generic drug sofosbuvir for treating chronic hepatitis C under the brand name Hepcvir in March last year, following the non-exclusive licensing agreement signed by Cipla with Gilead Sciences in September 2014.
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