Stavudine generic makers from India hit a roadblock as WHO strikes out drug from HIV therapy list

Stavudine leads to irreversible side-effects; zidovudine (AZT) or tenofovir (TDF) are other options

Stavudine or d4T, a widely used anti-retroviral drug to HIV infection, will go out of the therapy list soon as WHO recommended a phase out of the drug due to severe side-effects.

Stavudine causes “long-term, irreversible” side-effects in HIV patients including wasting and a nerve disorder, the World Health Organisation said asking the member countries to strike out the most widespread antiretroviral.

Stavudine is marketed as Zerit by U.S. drugmaker Bristol-Myers Squibb Co.

Generic versions of stavudine are made Indian drug makers including Cipla Ltd, Aurobindo Pharma Ltd and Strides Arcolab Ltd.

Stavudine, also known as d4T, is widely available as a first-line therapy to treat HIV infection.

Compared to other HIV drugs stavudine is relatively cheap and easy to use, according to the United Nations agency.

However, stavudine could lead to a nerve disorder causing numbness and burning pain in the hands and feet, and loss of body fat known as lipoatrophy or wasting. These conditions are often “disabling and disfiguring”, WHO said.

Therefore countries should 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), WHO recommended.

Currently 2 million of the total 4 million HIV infected people around the world are on a regimen containing stavudine.

Stavudine was used by more than 80% of the HIV infected people till 2006 when the WHO first said countries should envisage moving away from it because of its long-term effects.

Indian companies are considered to be the largest suppliers of antiretroviral HIV generic drugs all over the world especially to developing countries

Zidovudine, which was originally developed by GlaxoSmithKline Plc, is also currently being produced by Indian generic firms like Aurobindo and Ranbaxy Laboratories following its patent expiry in 2005.

Viread is the brand name of tenofovir, which is marketed by Gilead Sciences.

Zidovudine or tenofovir are “equally effective alternatives.”

WHO has also recommended that people with HIV, including pregnant women, should start taking antiretroviral drugs earlier to live a longer and healthier life, in its new HIV guidelines.

In 2006, WHO recommended that all patients start ART when their CD4 count (a measure of immune system strength) falls to 200 cells/mm3 or lower, at which point they typically show symptoms of HIV disease. Since then, studies and trials have clearly demonstrated that starting ART earlier reduces rates of death and disease.

WHO is now recommending that ART be initiated at a higher CD4 threshold of 350 cells/mm3 for all HIV-positive patients, including pregnant women, regardless of symptoms.

An earlier start to antiretroviral treatment boosts the immune system and reduces the risks of HIV-related death and disease. It also lowers the risk of HIV and TB transmission.

The new prevention of mother to child transmission (PMTCT) recommendations have the potential to reduce mother-to-child HIV transmission risk to 5% or lower. Combined with improved infant feeding practices, the recommendations can help to improve child survival.

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