November 30, 2009 / 12:15 AM / 10 years ago

New WHO guidelines urge phase-out of major HIV drug

GENEVA (Reuters) - Countries should phase out the use of stavudine, the most common AIDS drug, because of “long-term, irreversible” side effects in HIV patients including wasting and a nerve disorder, the World Health Organization said on Monday.

HIV infected boy Gao Jun, 8, holds in his hands antiretroviral drugs used in the treatment of HIV, in an orphanage run by the Fuyang AIDS Orphan Salvation Association in Fuyang, Anhui province November 27, 2009. REUTERS/Aly Song

In sweeping changes to its guidelines, the WHO also recommended that people with HIV, including pregnant women, should start taking AIDS 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 U.N. 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.

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.

About 20 HIV drugs are on the market, many made in combinations so patients can take a cocktail in one tablet.


Doctors once delayed giving them because of fears about toxic side-effects, and because the human immunodeficiency virus that causes AIDS can easily evolve resistance to drugs. Several recent studies have shown that early treatment can keep patients healthier.

Of more than 4 million people globally who take HIV drugs, known as 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.

“It is the most widely used. There is a trend moving away from it. We think it will take some time,” she said.

An earlier start to treatment of HIV-infected adults and adolescents reduces their viral load — the amount of virus in the blood — much sooner and therefore may also lower the risk of them spreading the virus, according to the WHO.

“The new recommendations are based on a solid body of evidence indicating that rates of death, morbidity and HIV and tuberculosis transmissions are all reduced by starting treatment earlier. This prolongs and improves quality of life,” it said.

An estimated 33.4 million people worldwide, two thirds of them in sub-Saharan Africa, are infected with the AIDS virus, an annual United Nations report said last week.

A separate report issued in New York on Monday by the WHO and three other U.N. agencies said there had been progress against mother-to-child transmission of HIV. Globally, 45 percent of HIV-positive pregnant women now receive treatment to prevent transmission, a rise of nearly 200 percent since 2005.

Treatment for HIV-positive children, though still trailing adult treatment, had increased to cover 38 percent of those in need, a rise of nearly 40 percent in a year, the report said.

However, most countries would still not meet goals set out at the start of a campaign launched by the United Nations four years ago to combat the effect of AIDS on children, it said.

Additional reporting by Patrick Worsnip; Editing by Robin Pomeroy

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