HIV Drugs

India’s largest manufacturers of antiretroviral drugs used to treat HIV/AIDS say they will adapt to new World Health Organization guidelines that call for the phaseout of stavudine, one of the cheapest drugs for treating AIDS.

On World AIDS Day on Dec. 1, WHO recommended that stavudine be progressively replaced by less toxic drugs not as likely to cause irreversible side effects. About 4 million AIDS sufferers in developing countries were treated with antiretrovirals in 2008, according to WHO. Roughly three-quarters of them live in Africa.

Indian producers of generic drugs, including Cipla, Aurobindo Pharma, and Ranbaxy Laboratories, are the largest suppliers of antiretroviral drugs in Africa. The drugs are mostly sold through tenders from national governments or international organizations.

Cipla Chairman Yusuf K. Hamied tells C&EN that the cost of treating a patient with antiretrovirals has been coming down steadily and now stands at about $60 per year. Because of their low cost, stavudine-containing treatments are the dominant drug “cocktails,” Hamied notes.

There is no valid reason for WHO to recommend the phaseout of stavudine, he argues. Resistance and side-effect rates are the “same as for any antiretroviral drug,” Hamied says. But Cipla is fully capable of supplying alternative treatments, he promises. The company already produces five antiretroviral regimens, and stavudine is a component in only one of them.

Aurobindo expects to boost its output of zidovudine and tenofovir-based AIDS drug combinations as a result of WHO’s new recommendation, a spokesman says. The company is evaluating how it will readjust its supply chain in the expectation of reduced demand for stavudine.