KEEN: St. Balikuddembe Market vendors undergoing training by Afya Sokoni Initiative on HIV/AIDS awareness

Dr Sam Okuonzi

RECENT press reports, which resurrected old safety concerns about nevirapine are deceptive, insincere and meant to mislead. They could not have been in the best interest of children or HIV-positive mothers. Reports by the Associated Press (Las Vegas Sun, December 15, 2004) hyped on the death of one Joyce Ann Hafford, who reportedly died on August 1, 2003, of liver failure, after she enrolled for nevirapine in US National Institutes of Health (NIH) study, just before she was due to deliver her baby.

This study is an outgrowth of a previous Uganda study code-named HIVNET 012. Using Hafford as an entry point, the anti-generic ARV campaigners seek to resurrect long-concluded concerns associated with the Ugandan study to lend strength to their cause. According to the Las Vegas Sun, these concerns include failure to get consent from patients, and delays and under-reporting of life-threatening reactions. But it is known that while nevirapine can cause lethal liver damage, this can only happen occasionally during a long-term use. Other procedural shortfalls have been corrected in an updated clinical administration of the drug.
In the case of Hafford, according to an NIH review, she had had a liver disease prior to taking the drug as a single dose.

Furthermore, there was a delay in evaluating her liver functions, a move that would have led to first dealing with her liver disease.

Nevirapine was therefore possibly only contributory, if at all, not the primary cause of the failure of her liver. The bleak picture being painted by organisations that have suddenly got interested in AIDS, contrasts with that of organisations that are truly and continuously working for people living with AIDS, especially in poor countries.

According to the release of US National Institute of Allergy and Infectious Diseases of AIDS (NIAID), the agency is “confident”, in spite of these renewed campaigns against nevirapine, that previous studies indicating that the drug is safe and effective for use in HIV-positive pregnant women to reduce the risk of vertical HIV transmission “will be upheld”. The agency further states that the drug “has been used in developing countries to prevent HIV infection in thousands of infants; it represents a major public health advance and is one of the true success stories on HIV prevention”, adding that no new data exist to “suggest that current recommendations regarding the use of this regimen should be changed”.

Other responses by organisations genuinely working for a global control of HIV/AIDS have also dismissed the ‘new concerns’ about nevirapine as a false alarm.

The South African HIV/AIDS treatment Advocacy Group said in a release that “criticisms levelled at parties involved in the NIH news story … do not provide evidence questioning the safety or efficacy of short-course nevirapine (Daily HIV/AIDS Report, December 17, 2004). The “question raised about the Uganda clinical trial do not ultimately raise real concerns about the safety or effectiveness of single-dose nevirapine”, said a release by the South African Project Inform, December 12, 2004.

Global Strategies for HIV Prevention, another well known organisation working for people living with HIV/AIDS “will continue to support programmes in resource poor countries using single-done nevirapine alone or in combination with other ARVs to reduce the number of newly HIV-infected infants, which number 1,800 each day”.

The Elizabeth Glaser Pediatric AIDS Foundation “supports providing the safest, most effective regimen of drugs to prevent mother-to-child transmission (PMTCT) of HIV in all instances. In the developing world, due to poor infrastructure and high cost of other regimens, nevirapine, administered as one dose to the mother at the onset of labour and one dose to the child within 72 hours of birth is frequently the only option feasible and available. There is scientific data to prove that this is effective and should continue to be used.”

Current protocols of using nevirapine for PMTCT are not based on HIV Net 012 Uganda study alone. There are now 17 clinical trials throughout the world conducted by multiple investigators.

Seven of the 17 clinical trials show that single dose nevirapine reduces transmission from mother-to-child by over 90%. The other studies show a reduction by between 50% to 90%, which is scientifically a range of significant effectiveness.

No fatalities have been attributed to single dose nevirapine. But when used over a long period by men and non-pregnant women, the drug can cause skin rash, liver disease and occasional fatality. This is not how nevirapine is used in PMTCT.

These long-term complications of the drug have been well documented and known for over five years. Transient HIV resistance against nevirapine occurs to mothers, who have been given a single dose of the drug.

But no evidence has been shown to prevent the effectiveness of nevirapine in subsequent pregnancies. Besides, many low cost combinations of ARVs include nevirapine, which are all as likely to cause resistance as any other drug.

There are about 20 ARVs used in various combinations to treat HIV/AIDS and to circumvent resistance. But in poor countries, only a single dose nevirapine is safe, feasible and available for preventing the infection of millions of babies with HIV by their HIV-positive mothers.

The writer is the Secretary General for the National
Council of Children