WHO’s objective is to enable 3 million people living with HIV to have access to antiretroviral treatments by 2005. The development of simple and inexpensive generic fixed-dose combined therapies appears the most suitable solution for making possible this access to treatments in developing countries with meagre resources.
The tritherapies that associate two different classes of antiretrovirals (two inverse transcriptase nucleoside inhibitors and a non-nucleosidic inhibitor of this same viral enzyme), used as a basic treatment, are effective and well tolerated. Their combined form in a single tablet, developed by a firm producing generic drugs, encourages better treatment compliance by the patient and simplifies management of orders and storage of the medicines. Their cost is much lower than that of tritherapies of patented medicines.
Consequently, these combined generic forms provide the possibility of treating more subjects infected with HIV. However, although prequalified by WHO and available in many developing countries, at present some international aid agencies involved in programmes of access to antiretrovirals do not recognize them. The main reason cited is the absence of full clinical studies that could allow assessment of their effectiveness, safety and quality.
Researchers from the IRD and their partners have just shown, by means of a clinical trial performed in Cameroon, that the generic fixed-dose antiretroviral tritherapy currently most commonly used in Africa satisfied these criteria. This treatment uses a combination of a dose of nevirapine, one of stavudine and one of lamivudine in a single tablet.
The trial was conducted by means of a pilot project of access to the antiretroviral medicines initiated in Yaoundé, the capital of Cameroon. For six months, 60 adults infected by HIV-1 were treated with one tablet twice a day, in two of the city’s hospitals. Clinical and biological monitoring of these infected subjects kept a close check on their health status with time and evaluated the effectiveness, the tolerance and treatment compliance. The appearance of resistance and the quality of the different batches of medicines administered as part of the trial were also investigated.