Plans for human trials of an anti-AIDS drug that would have involved Cambodian sex workers have been halted by the country’s government. Expressing concerns about “the effect on the Cambodian people and on the human values and rights,” the health minister announced that tests on tenofovir (Viread) will not be allowed to go forward.
Made by the California-based biotech company Gilead Sciences, Inc., tenofovir is already used to treat people infected with HIV. The new trial, which would have involved 1,000 sex workers, was designed to determine if the drug can prevent infection in those who do not have the disease.
Cambodia’s current HIV infection rate, the highest in Southeast Asia, is blamed largely on its active sex trade, and the tenofovir trial was aimed at those workers. But local representatives of sex workers as well as activists led by Act Up objected to certain aspects of the proposed human trial, most significantly the lack of insurance against potential side effects. Although the Cambodian government had approved the project in 2003, in September the prime minister shut down the trial and called for the drug to be tested on animals. The study had been funded in part by the Bill and Melinda Gates Foundation and was to have been conducted by researchers from the University of California at San Francisco. (Associated Press, 9/28/04)
The World Health Organization (WHO) has removed three generic ARV drugs produced by the Indian drug manufacturer Ranbaxy from its list of approved HIV/AIDS treatments because of failures at the lab that tested the medications. The drugs—a combination of lamivudine, stavudine, and nevirapine in two strengths, as well as a lamivudine, zidovudine combination pill—are relied upon widely in East Africa, and their removal from the approved list has generated consternation among international organizations.
According to WHO, the contract research organization that tested Ranbaxy’s generic AIDS drugs to see if they were bioequivalent to the patented versions failed to meet international standards of clinical and laboratory practices. The company has begun new tests and plans to submit the results in the hope of having the drugs reinstated on the WHO list. In June, WHO had removed two generic ARV drugs produced by another Indian drug manufacturer, Cipla, but a later inspection of the lab that performed those bioequivalence studies found that it was in compliance and the drugs have now been placed back on the approved treatment list. (Economic Times, 8/11/04)
Generic drug manufacturer Cipla has cut prices on ARV drugs by 25 to 30 percent in the Indian domestic market. The move, announced in August, affects such medicines as Triomune (which combines lamivudine, stavudine, and nevirapine) and Duovir (lamivudine and zidovudine). (AIDS-INDIA eFORUM, 8/16/04)
Hoping to curb the spread of HIV among migrant workers entering Thailand from neighboring Myanmar, Thailand has delivered one million condoms and a supply of ARV drugs to Myanmar. As part of a three-year commitment to help the less prosperous Myanmar, in September Thai officials provided US$242,000 in aid, including generic ARVs for 200 patients.
While Thailand has had significant success reducing its own HIV prevalence in recent years, the country’s health officials are concerned that the disease is being reintroduced by approximately one million migrant workers who cross into Thailand from Myanmar seeking employment. (Associated Press, 9/22/04)
Over the last two years the number of HIV-positive Burmese between the ages of 15 and 49 has doubled and the disease affects between 20 and 30 percent of commercial sex workers as well as almost 75 percent of intravenous drug users. According to UNAIDS officials at the XV International AIDS Conference held in Bangkok in July, Myanmar’s public health system does not have the resources to handle the epidemic without assistance. (Agence France-Presse, 9/22/04)