New WHO Guidelines Urge Phase-out of Major HIV Drug

GENEVA (Reuters) - Countries should phase out the use of Stavudine, the most widespread antiretroviral, because of "long-term, irreversible" side-effects in HIV patients including wasting and a nerve disorder, the World Health Organization said on Monday.

In sweeping changes to its guidelines, the WHO also recommended that people with HIV, including pregnant women, should start taking antiretroviral drugs earlier to live a longer and healthier life.

For the first time it advised HIV-positive women and their babies to take the drugs while breastfeeding to prevent mother-to-child transmission of the virus that causes AIDS.

Stavudine, also known as d4T, is marketed as Zerit by U.S. drugmaker Bristol-Myers Squibb Co. Generic versions are made by Cipla Ltd, Aurobindo Pharma Ltd and Strides Arcolab Ltd, all of India.

Stavudine, widely available in developing countries as a first-line therapy, is relatively cheap and easy to use, according to the United Nations agency.

But it causes a nerve disorder leading to numbness and burning pain in the hands and feet, and loss of body fat known as lipoatrophy or wasting, it said, conditions that are "disabling and disfiguring."

LESS TOXIC ALTERNATIVES

The WHO recommended "that countries progressively phase out the use of Stavudine as a preferred first-line therapy option and move to less toxic alternatives such as Zidovudine (AZT) or Tenofovir (TDF)." These are "equally effective alternatives."

Zidovudine was first manufactured by GlaxoSmithKline Plc whose patent expired in 2005. Aurobindo and Ranbaxy Laboratories, also of India, are among makers of the generic version. Tenofovir is marketed by Gilead Sciences under the name of Viread.

Of over 4 million people globally who take antiretrovirals, about half are on a regimen containing stavudine, down from 80 percent in 2006 when the WHO first said countries should envisage moving away from it because of its long-term effects, according to Dr. Siobhan Crowley of WHO's HIV/AIDS Department.