| A pharmacist in Mumbai checks a vial of the drug. (AFP)
London, July 2 (Reuters): A cheap three-in-one generic AIDS pill from India is just as good as more expensive branded medicines and should be widely used in developing countries, researchers said today.
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 per cent 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 per cent of whom had full-blown AIDS, were published in The Lancet medical journal.
“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 co-ordinator 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 as 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 anti-retrovirals to three million people in the developing world by the end of 2005, . Kumarasamy of the YRG Centre for AIDS Research and Education in Chennai wrote in a commentary accompanying the research.
Industry analysts at ABN AMRO said the news was slightly negative for makers of patented drugs but the profitability of AIDS drugs was already weak, limiting the commercial impact on firms in the West.
Shares in Cipla rose 3 per cent in late trade in Mumbai while GSK and Roche held steady in a firmer European drugs sector.
The WHO has judged Triomune and another Indian combination, 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 US government funds from buying them, insisting only drugs approved by the Food and Drug Administration be used. US officials and western pharmaceutical executives argue that health providers are taking a risk by using medicines that have not passed the rigorous standards of the US drugs watchdog.
Worries about the quality of Indian medicines were fuelled last month when the WHO removed two Cipla products — though not Triomune — from its prequalification list because they had not been proven equivalent to the original products. Cipla says it is collecting data from new studies that should lead to the drugs being re-instated.
In Cameroon, where drugs are subsidised by the government, the cost of one month’s Triomune is $20, compared to $35 for the equivalent brand name therapy, even after heavy discounting by big pharmaceutical companies.
Elsewhere, cost differences can vary by as much as 100 per cent, according to Medecins sans Frontieres.