Originally published on Advocate.com July 07 2004 12:00 AM ET
A cheap three-in-one generic anti-HIV pill from India is just as good as more expensive branded medicines and should be widely used in developing countries, researchers said on Friday. 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 the Swiss charity Doctors Without Borders said Cipla's Triomune performed as well as brand-name drugs in the first open clinical study in a developing country. They found 80% of HIV patients given the tablet twice a day had undetectable levels of virus in their blood after six months. Results of the study, involving 60 patients in Cameroon, 92% of whom had progressed to an AIDS diagnosis, were published in last week's issue of The Lancet.
"This generic fixed-dose combination gives results comparable to those seen in the developed world [that use] 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 utilization of [fixed-dose combinations] in the developing countries."
In addition to being cheaper, drugs such as Triomune--which contains generic versions of 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. The World Health Organization has judged Triomune and another Indian combination called Triviro, from Ranbaxy Laboratories, to be safe and effective under a scheme that "prequalifies" them for use. But both products, which use compounds still covered by patents, remain controversial. Washington has barred groups receiving U.S. government funds from buying them, insisting that only drugs approved by the Food and Drug Administration be used. U.S. officials and Western pharmaceutical executives also argue that health providers are taking a risk by using medicines that have not passed the rigorous standards of the U.S. drug watchdog. (Reuters)