The HIV drug manufacturers Gilead Sciences, Bristol-Myers Squibb (BMS) and Merck have announced a joint venture to develop a single-pill, once-a-day HIV treatment.
The companies plan to seek approval in the US and Europe to market a new combination of two existing Gilead drugs — FTC (emtricitabine, Emtriva) and tenofovir (Viread) — with efavirenz (marketed in the US by BMS and in the UK and Australia by Merck). If the plan succeeds, the new pill could be the first one-pill-a-day treatment for HIV, and the first branded HIV treatment to include drugs from two different manufacturers.
The development of so-called fixed-dose antivirals has been a major focus in the developing world, where simplified therapies are widely seen as a key component of the push to roll out generic medicines in resource-poor countries.
In countries where patent laws allow the production of generic HIV medicines, such as Thailand and India, fixed-dose combinations are becoming commonplace, typically based on nevirapine. In developed countries, however, no such products exist because none of the major drug companies has a marketable combination of drugs with which to produce such a pill.
The alliance between Gilead, BMS and Merck is designed to overcome this obstacle, and is an extension of the current trend towards co-formulated HIV treatments. Gilead already has a combined FTC/tenofovir pill, sold under the brand name Truvada (but not yet approved in Australia).
In a joint press statement issued in December, Gilead and BMS say the work necessary to ‘co-formulate’ the drugs has been ongoing throughout 2004 and is continuing. The companies say they will share responsibility for taking the combined product through the US and EU approvals and marketing processes, likely to take at least another year. If approved, an Australian marketing application would likely follow sometime thereafter.
The companies have also discussed possible ‘co-blistering’ of their products — an approach that would put FTC and tenofovir in the same package (but not the same pill) as efavirenz. As well as being simpler to manufacture, a co-blistered product would be simpler to obtain marketing approval for.
In a related move, GlaxoSmithKline and Boehringer Ingelheim are also believed to have discussed co-blistering their products, in this case Boehringer’s Viramune (nevirapine) and Glaxo’s Combivir (AZT plus 3TC).
If these joint ventures are successful in bringing combined products to market, they would likely be popular with doctors and people living with HIV/AIDS. The simplicity of taking a single pill, or a number of identical pills, make this an attractive choice, especially for people who have adherence difficulties with more complex combination treatments.
Clinical evidence supports the combination of efavirenz, FTC and tenofovir, which is one of several combinations recommended by the US department of health for first-line therapy.
Treatments advocates have welcomed the announcement, saying that the development of simpler HIV therapies is likely to increase adherence and improve treatments outcomes for positive people.
