Doctors and HIV/AIDS advocates in Africa are concerned that their governments will halt the use of the antiretroviral drug nevirapine to prevent mother-to-child HIV transmission because of recent reports that have raised questions about the drug's safety in pregnant women, the AP/USA Today
reports (Muleme, AP/USA Today
, 12/17). NIH
in 1997 began studying the use of nevirapine in single doses among HIV-positive pregnant women in Uganda to determine the drug's ability to prevent vertical HIV transmission. The initial results showed that the drug prevented HIV transmission to newborns in as many as half of the births. However, by early 2002, medical safety specialists and an auditor with NIH as well as the drug's manufacturer Boehringer Ingelheim
all cited "widespread" problems with the research in Uganda -- including a failure to receive participants' consent about changes in the study, administration of incorrect doses, and delays and underreporting of fatal and life-threatening reactions to the drug. Because of the reported problems, NIH suspended the research for 15 months from spring 2002 to summer 2003 to review the trial and take corrective steps (Kaiser Daily HIV/AIDS Report
, 12/16). Earlier this week, Dr. Edmund Tramont, director of the National Institute of Allergy and Infectious Diseases Division of AIDS
, admitted that he altered a safety report on the use of nevirapine in pregnant women to change its conclusions and remove negative information about the drug (Kaiser Daily HIV/AIDS Report
Ugandan Study 'Fallout'
According to Dr. Saul Onyango, a medical officer involved with the Ugandan study, officials are "worried about the fallout" over the research, the AP/USA Today reports. "It's an issue affecting people's lives. A lot of damage has already been done, and we need to do damage control," Onyango said. Dr. Sam Okware, a Ugandan health official in charge of community health services, said the use of nevirapine in pregnant women has become a "highly contentious" political issue in the country for more than two years (AP/USA Today, 12/17). Recent findings indicating that even a single dose of nevirapine administered during pregnancy can result in drug resistance also are "threatening" South Africa's national treatment program, which provides the drug to HIV-positive pregnant women to reduce the risk of vertical HIV transmission, the AP/Atlanta Journal-Constitution reports (Zavis, AP/Atlanta Journal-Constitution, 12/17). South Africa's Medicines Control Council during the XV International AIDS Conference in July said that the government would stop recommending the use of nevirapine as a monotherapy because of reports that it increases the risk of developing drug-resistant HIV strains by up to 50%. Although the regimen has become increasingly common in clinics throughout Africa, MCC recommended against administering a single dose of nevirapine to a pregnant woman before childbirth and also said that the drug is more effective when used in combination with other antiretrovirals. In August, the country's Ministry of Health said that further research was needed on MCC claims concerning nevirapine (Kaiser Daily HIV/AIDS Report, 8/13).
However, South African doctors have said that until other options become available, they will continue to provide the drug to HIV-positive pregnant women. "You can't apply a standard here in Africa that says, 'Until we can get the Rolls Royce of treatment, let's not do anything,'" Dr. Ashraf Coovadia, head of the pediatric HIV clinic at Coronation Mother and Child Hospital in Johannesburg, South Africa, said. He added, "If we just pull the plug on nevirapine ... many, many more babies would die" (AP/Atlanta Journal-Constitution, 12/17). Other doctors in South Africa's public health system have "privately expressed fears they will be pressured" to stop using nevirapine as a monotherapy before alternatives are available, according to the AP/USA Today. The South African HIV/AIDS treatment advocacy group Treatment Action Campaign has said that "reopening debate" over the study in Uganda could "frighten patients off their treatment" despite subsequent research confirming nevirapine's safety and efficacy, the AP/USA Today reports. "I don't see a problem with nevirapine at all. I use it twice daily," TAC head Zackie Achmat said (AP/USA Today, 12/17).
Jackson Calls for Congressional Investigation
Rev. Jesse Jackson, founder and president of the Rainbow/PUSH Coalition, on Thursday called for a congressional investigation into reports that U.S. government health officials withheld information concerning nevirapine from White House officials, the AP/Yahoo! News reports (Colias, AP/Yahoo! News, 12/17). Although NIH officials were warned that the Ugandan clinical trial was flawed months before President Bush announced an initiative to reduce mother-to-child HIV transmission in Africa and the Caribbean, they did not inform the White House of the risks associated with the drug's use in pregnant women. The initiative aimed to provide treatment to one million HIV-positive pregnant women annually to reduce vertical HIV transmission by 40% in target countries within five years or less (Kaiser Daily HIV/AIDS Report, 12/14). "This was not a thoughtful and reasonable decision but a crime against humanity," Jackson said, adding, "Research standards and drug quality that are unacceptable in the U.S. and other Western countries must never be pushed onto Africa." He also said that the United States should halt distribution of the drug in Africa (AP/Yahoo! News, 12/17). Officials from the World Health Organization have said that concerns about drug resistance to nevirapine "must be balanced against the practicality of delivering" single doses of the drug, and the group has recommended that nevirapine remain an option in Africa, according to the AP/Journal-Constitution (AP/Atlanta Journal-Constitution, 12/17).
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