A Ugandan doctor has accused those raising concerns about the safety of nevirapine, an anti-retroviral drug also being used in the prevention of mother-to-child transmission of HIV, of being “deceptive” and “insincere”.
Dr Sam Okuonzi of the Ugandan National Council for Children said in an article in the New Vision those who were raising these concerns did not have the interests of children and HIV-positive mothers at heart.
“No fatalities have been attributed to single dose nevirapine. But when used over a long period by men and non-pregnant mothers, the drug can cause skin rash, liver disease and occasional fatality,” he said. “This is not how nevirapine is used in PMTCT (prevention of mother-to-child transmission).”
Okuonzi was responding to a series of articles that have been published by Associated Press which said that the head of the AIDS Programme at the National Institutes of Health (NIH) in the United States had doctored reports about the safety of nevirapine following clinical trials in Uganda.
Nevirapine, also known as viramune, is manufactured by a German company, Boehringer Ingelheim, and is used as a triple combination for the treatment of AIDS while it is used as a single dose for PMTCT.
The drug is currently being given free to a number of governments in sub-Saharan Africa and is recommended by the World Health Organisation.
Dr Jonathan Fishbein, an expert hired by the NIH to review the results of the Ugandan clinical trials, argues that investigators in Uganda focused only on showing that nevirapine worked and overlooked its dangerous side-effects.
“African life, it would appear, is not to be regarded as highly as American life,” he was quoted by Reuters news agency as saying.
Other experts, however, argue that though it has several disadvantages, its advantages far outweigh these disadvantages.
“Nevirapine is not the optimal solution, but it is working and there is no better help in very poor countries to prevent HIV-positive mothers passing the virus on to their children,” a spokesman for the drug manufacturer was quoted as saying.
The same sentiments were echoed by the United States Food and Drug Administration (FDA), which approves the use of drugs in that country.
In a public health advisory statement on nevirapine on January 23, the FDA said in spite of the potential serious and life-threatening liver toxicity and skin rashes with nevirapine, there were multiple reasons why nevirapine remained an important part of an HIV treatment regimen.
It said triple antiretroviral regimens had been shown to have a huge impact on the reduction of AIDS morbidity and mortality.
The FDA has just approved the use of a generic drug manufactured by a South African company. It has nevirapine as one of the combinations.
The FDA said symptomatic liver toxicity, which normally occurs only a few weeks after treatment and may cause liver failure, has not been reported with the use of single doses of nevirapine to the mother and to the child for prevention of perinatal HIV infection.
Another advantage is that nevirapine is available in liquid form, which can be given to children, while many antiretrovirals are not.
About 800 000 babies in Africa are born HIV-positive each year.
Though the FDA warns health care providers to weigh the benefits and risks associated with nevirapine before prescribing it to patients, it says the underlying disease must be considered as part of the risk benefit analysis when treating HIV-infected patients.
“HIV infection will progress to AIDS and death if untreated. Treatment with combination antiretroviral drugs, including nevirapine, can slow clinical progression and may delay the development of AIDS or death for years.”
The FDA, however, says nevirapine should not be used on women with CD4+ cell counts greater than 250 cells per cubic millimetre of blood unless the benefits outweigh the risks.
CD4 cells, or helper cells, boost the person’s immune system and are the ones attacked by HIV. The normal count is anywhere between 500 and 1500 cells per cubic millimetre of blood.