Lack of scientific evidence about the clinical effectiveness of such generic fixed-dose combinations has until now caused some international AIDS donors to refuse to fund their use.
But a team from the French national agency for AIDS research and Swiss charity Medecins sans Frontieres said Cipla’s Triomune performed as well as brand drugs in the first open clinical study in a developing country.
They found that 80% of HIV-infected patients given the tablet twice a day had undetectable levels of virus in their blood after six months of treatment.
Results of the study involving 60 patients in Cameroon, 92% of whom had full-blown AIDS, were published in The Lancet medical journal on Friday.
“It is now no longer possible to raise scientific uncertainty as an objection to the widespread utilisation of FDCs in the developing countries”
“This generic fixed-dose combination (FDC) gives results comparable to those seen in the developed world using triple-drug therapy comprising brand-name drugs,” said study coordinator Eric Delaporte.
“It is now no longer possible to raise scientific uncertainty as an objection to the widespread utilisation of FDCs in the developing countries.”
In addition to being cheaper, drugs like Triomune – which contains GlaxoSmithKline’s lamivudine, Bristol-Myers Squibb’s stavudine and Boehringer Ingelheim’s nevirapine – are simpler to use since patients need to take only two pills a day.
As such, they have a major role to play in meeting the World Health Organisation’s goal of getting antiretrovirals to three million people in the developing world by the end of 2005, N Kumarasamy of the YRG Centre for AIDS Research and Education in Chennai wrote in a commentary accompanying the research.