Shorn off moral concerns of encouraging “reckless” behaviour, health workers are raising public health concerns over AIDS drug Truvada’s “new use” as a preventive.
Truvada is a fixed-dose, once-daily pill from drug-maker Gilead, that recently received approval from the US regulator as a pill to prevent HIV infection among adults.
A combination drug (emtricitabine / tenofovir disoproxil fumarate) it is now approved in the US to prevent the sexual transmission of HIV for people who do not have HIV, but who are at high risk of being exposed to the virus. There are concerns on whether the approval will encourage reckless behaviour. But representatives of the scientific community are debating whether rampant use of the drug will create resistance to the drug in the community.
About 13 local companies – including Hetero, Strides, JB Chemicals and Ranbaxy - are in a licensing pact with Gilead for making and selling a clutch of medicines including Truvada, in certain markets and at a 5 per cent royalty payment. Though Cipla is not part of the pact, it makes and sells the drug.
However, healthworkers are urging the Indian drug regulator to exercise caution in giving Truvada’s new preventive application a green signal. A company needs to get a fresh marketing approval on an existing drug, if it plans to promote it for a new use – as is the case here for Truvada.
It is a significant medicine used to treat people with HIV/AIDS. But as a preventive among adults, it could be taken indiscriminately. This could result in the AIDS-virus mutating to adapt to the medicine -- leading to resistance, where the body does not react to the medicine, explains a health-advocacy worker.
Opportunity?
The drug cannot be sold over the counter, so as a preventive – will it be sold to patients only on a doctor’s prescription, asks a representative with a generic pharma company. Or will it be distributed only in high-risk groups and through restricted channels like non-government organisations, he points out.
The opportunity for local drug companies would depend on whether individual countries mirror the US regulator’s latest approval or take a more conservative stance.
Globally, the drug costs about $14,000 a year, but it is down to $100 in developing markets. In India, the private market sells the drug at about Rs 2,000 for a month’s supply. The estimated global government-procured market is estimated at about $800 million. There is also the private market, say industry representatives, unable to quantify the existing opportunity or what it would grow to – if Truvada becomes popular as a preventive.