US-based drug firm Gilead Sciences on Monday announced it was expanding its existing voluntary hepatitis-C license agreement with eight Indian generic companies. The pact would include its investigational pan-genotypic medicine GS-5816 as part of a single tablet regimen along with sofosbuvir and ledipasvir.
As per the new anti-diversion deal of Gilead, eight Indian-based generic manufacturers now hold licenses to manufacture Gilead’s HCV medicines— Biocon Limited, Cadila Healthcare Limited, Cipla Limited, Hetero Labs Limited, Mylan Laboratories Limited, Ranbaxy Laboratories Limited, Sequent Scientific Limited and Strides Arcolab Limited.
Sofosbuvir recently received regulatory approval in India and regulatory submissions have been completed in additional countries—including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria.
These drugs are direct-acting antivirals used in the treatment of the hepatitis C virus (HCV).
GS-5816 is an important anti-hepatitis C compound that, in combination with sofosbuvir, will greatly simplify treatment for developing countries. The compound is pan-genotypic (covers all different genotypes of HCV) which will simplify treatment, reduce the cost of diagnosis and help harmonise treatment regimens. The drug may also help to shorten treatment from 12 weeks to eight weeks for some genotypes.
However, the Gilead’s effort does not seem genuine as far as making the drug access to needy. Gilead’s anti-diversion programme not only potentially jeopardises patient confidentiality and privacy, but could also exclude many patients that may lack the citizenship and identification papers that Gilead requires them to have in order to get access to treatment. Under the new system, the patients will have to follow a system and register themselves for getting the medicine that too with several terms and conditions.
Gilead’s programme introduces coercion and policing upon medical providers and may result in treatment interruptions for patients, leading to treatment resistance and failure. As far as is known to MSF, such a programme, motivated solely by commercial interests, is unprecedented, says Rohit Malpani, director of policy and analysis, MSF Access Campaign.
He says, access to low-cost versions of hepatitis C compounds, including GS-5816, is critical to expanding access to treatment in developing countries. Gilead’s voluntary license falls short of ensuring widespread access to these new drugs in middle-income countries, where over 70 percent of people with hepatitis C live today.