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Nevirapine - lifesaver or harmful drug?
Sunday 23 January 2005
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AFRICA: Nevirapine - lifesaver or harmful drug?

[This report does not necessarily reflect the views of the United Nations]


Tough words have been exchanged between President Thabo Mbeki and TAC

JOHANNESBURG, 12 January (PLUSNEWS) - The antiretroviral drug, Nevirapine, commonly used in Africa to prevent transmission of HIV from mother to child, is at the centre of a bitter controversy.

The debate surrounding the medication erupted in December 2004, after a series of articles by news agency Associated Press claimed that American health authorities had covered up information about the drug's potentially negative effects and alleged flaws in the Ugandan study that assessed its safety and efficacy.

Drug manufacturer Boehringer-Ingelheim and Ugandan scientists involved in the clinical trial, conducted in Kampala's Mulago Hospital, said the flaws were procedural and unconnected to the drug's safety.

Concerns about the flawed research are not new, and first emerged in 2002 after problems in the Ugandan trials led to Boehringer-Ingelheim withdrawing an application to have the medication approved in the United States.

After conducting its own investigations, South Africa's Medicines Control Council (MCC) last year decided to reject the study on similar grounds. At the International AIDS conference in Bangkok last July, South Africa's Health Minister Manto Tshabalala-Msimang, announced that her ministry was reviewing the use of single-dose Nevirapine.

This time around, however, the issue has become even more emotional, and political and AIDS activists fear that the negative publicity could stop countries, and many mothers in them, from using the drug.

South Africa's ruling party, the African National Congress (ANC), has weighed into the debate by accusing American health officials and local AIDS activists of "a conspiracy with a pharmaceutical company to tell lies to promote the sales of Nevirapine" and of using Africans as guinea pigs.

Controversy aside, it has been generally accepted that a single dose of Nevirapine, given to an HIV-positive pregnant woman just before labour, and a few drops administered to the newborn in the first 72 hours, halves the risk of HIV transmission.

A study on the demographic impact of AIDS in South Africa last year estimated that 37,000 babies were born with HIV and 26,000 were infected through breast-feeding. UNAIDS estimates that in Africa 800,000 babies are born HIV-positive every year.

The drug, which Boehringer gives free of charge to many governments in Sub-Saharan Africa, is recommended by the World Health Organisation (WHO) and is also used in triple therapy HIV/AIDS treatment.

But the danger in using Nevirapine is that some mothers can become resistant to it, limiting their future treatment options. Recent evidence has indicated that although there was high resistance six weeks after a woman had taken a single dose, this dropped to 14 percent after six months.

"The hypothetical risk of creating resistance does not outweigh the risk of giving birth to an HIV-positive baby, in a context where so few people access treatment anyway," said Marta Darder of the relief agency Medecins Sans Frontieres in South Africa.

Nevirapine began to be used specifically for the prevention of mother-to-child transmission (PMTCT) in 1997, when large-scale antiretroviral treatment for Africans was unimaginable. Even as treatment slowly expands today, less than four percent of Africans who need it get it.

WHO has acknowledged that a better alternative would be to start the mother on a short course of combination therapy at least six weeks before giving birth or, at the latest, two weeks before, and to continue this after the birth.

At US $40 for combination therapy, compared to $4 for a single dose of Nevirapine, this is not only more complex but also more expensive. Mother and baby would also need weeks of daily medication, good nutrition and continuous health monitoring, which are unavailable to most African mothers.

"Moving from one tablet to two or even three tablets might seem like a fairly easy task if you are sitting in a first world clinic. But implementing this in South Africa would be difficult," the ANC's national health secretary, Dr Saadiq Kariem, admitted.

Although it made sense to continue using the cheaper and more practical single-dose Nevirapine, the country hoped to explore more effective options. "We have to keep pushing for progress. Ultimately, [providing] combination therapy for HIV-positive mothers is where we want to be going," he told PlusNews.

Nevertheless, even single-dose Nevirapine fails to reach the vast majority of African women who need it. On average, 40 percent of rural women never visit a health clinic and give birth at home, often without a midwife.

In Uganda, where the national response to the pandemic has been widely praised as a success, just four percent of pregnant women living with the virus access Nevirapine. The health system reaches a fraction of mothers, with only two out of 10 giving birth at a health facility.

"Nevirapine is not the silver bullet we had hoped for," Dorothy Ochola-Odongo, a PMTCT officer with UNICEF in Kampala, told PlusNews.

South Africa was also still grappling with the provision of the drug in their PMTCT programme, Kariem noted. "Some clinics are struggling with the infrastructure to handle drug supply and distribution. There still haven't been nearly enough training courses for doctors and nurses to reach all the sites."

But, as UNAIDS, UNICEF and the Elizabeth Glaser Paediatric AIDS Foundation said in a statement, "where the infrastructure does not allow for long-term and more complex treatment, the recommended public health approach is single-dose Nevirapine."

After years of a bitter standoff between South African AIDS activists and the department of health over its refusal to implement a treatment policy, the activists are concerned about the effects of the negative press surrounding Nevirapine.

"Unfortunately this issue has become entangled with politics and this is also evident on the ground. There is a lot of anger among ordinary people who feel that they have been used and abused by major pharmaceutical companies," Kariem noted.

The South African lobby group, Treatment Action Campaign (TAC), was harshly attacked in an ANC article for "marketing antiretroviral drugs at all costs". The relationship between President Thabo Mbeki and TAC has been fraught with controversy.

In 2002 TAC won a Constitutional Court case that compelled the government to provide treatment for prevention of mother-to-child transmission in the public health services. The court did not prescribe which drug should be used, but TAC has consistently said that short-course combined therapy was better, while single-dose Nevirapine was easier and cheaper.

TAC is now considering legal action against the department of health's "unscientific, irresponsible and inaccurate statements", and its continued alleged misinformation campaign on Nevirapine.

"I am ashamed that the power of the president's office, the resources of government and the prestige, power and strength of the ANC is used to sow confusion among people who are sick and dying," said Treatment Action Campaign leader Zackie Achmat.


Recent AFRICA Reports
IRIN PlusNews Weekly Issue 217, 21 January 2005,  21/Jan/05
Glaring lack of child ARVs and slow rollout,  19/Jan/05
Closing the treatment gap,  18/Jan/05
Volunteer caregivers being exploited, says study,  14/Jan/05
IRIN PlusNews Weekly Issue 216, 14 January 2005,  14/Jan/05
Le portail d'informations générales de la Côte d’Ivoire
The Global Fund to fight AIDS, Tuberculosis & Malaria
Mothers and HIV/AIDS

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