AIDS advocates tell WHO: Stop harmful single-dose treatment for expectant mothers and infants

Nov 25 2008

As World AIDS Day 2008 approaches, a coalition of hundreds of HIV/AIDS medical care providers and advocates, representing dozens of organizations, today sent a letter to Dr. Margaret Chan, Director General of the World Health Organization (WHO), urging an end to harmful single-dose HIV/AIDS treatment as a recommended treatment for expectant mothers and infants worldwide.

The letter expresses concern over the use and recommendation of short-course therapy (such as single-dose Nevirapine and/or Zidovudine) for expectant and breastfeeding mothers as short-course treatment-standard practice in many resource-constrained settings has been proven to be less effective at preventing mother-to-child HIV transmission as well as less safe for both mother and child than full-course Highly Active Antiretroviral Therapy (HAART).

Calling for an immediate revision of WHO's treatment guidelines to reflect current knowledge regarding the dangers of single-dose treatment is a broad coalition led by AIDS Healthcare Foundation (AHF). Supporters include Dr. Homayoon Khanlou , AHF's Chief of Medicine, USA; Dr. Julio Montaner ; Dr. Robert R. Redfield Jr. , Director of the HIV Program at the University of Maryland, School of Medicine; Dr. Jane Aronson , CEO/Founder of Worldwide Orphans Foundation; Dr. Sophia Mengistu , Country Director/Ethiopia, Worldwide Orphans Foundation; Dr. Rodney L. Wright , Director of HIV Programs, Albert Einstein College of Medicine; and, Dr. Martina C. Fuchs , Founder/CEO, Real Medicine Foundation.

"AHF, together with hundreds of AIDS medical providers and advocates, urges Dr. Chan and WHO to put an end to the harmful use of sub-standard single-dose HIV treatment for expectant mothers and their newborns," said Michael Weinstein, President of AIDS Healthcare Foundation, which spearheaded the effort. "Study after study has linked the use of single-dose treatments to viral resistance, jeopardizing the effectiveness of future treatment and lowering the chances of a patient's survival. Accepting the status quo and treating expectant mothers and infants in low-income countries with low-quality therapy - especially as the number of people accessing treatment increases - has dire consequences and is a practice that must end."

At issue with changing the standard of care are clinical efficacy and fairness. Numerous studies have shown that a short-course, single-dose regimen can raise the risk of viral resistance and jeopardize the effectiveness of future treatment for the mother as well as the child if transmission prevention fails and treatment is needed. Just one example: a recent study comparing anti-HIV treatment regimens - " DSMB Finds Ritonavir-boosted Lopinavir Superior to Nevirapine in HIV-positive Women Who Previously Took Single-dose Nevirapine," published on October 28, 2008 as a bulletin in the National Institute of Allergy and Infectious Diseases - demonstrates the ineffectiveness of Nevirapine to treat HIV-infected women who previously took single-dose Nevirapine to avoid transmitting HIV to their newborns.

The rate of mother-to-child HIV transmission has been reduced drastically in high-income countries. The largest study of mother-to-child transmission rates to date, published in 2008 in the journal AIDS , found that if appropriate full-course treatment is administered, 99% of babies were born uninfected with HIV. Yet several hundred thousand babies are born with HIV annually because their mothers do not have access to this same standard of care. An estimated 90% of these infections occur in sub-Saharan Africa.

"It is simply unacceptable to continue a practice that endangers the lives of mothers and infants while low-cost full-course treatment is available," said Terri Ford , Director of Global Advocacy for AIDS Healthcare Foundation. "While the current WHO guidelines acknowledge the risk of viral resistance, single-dose therapy remains a recommended method. Since most developing countries rely on the guidelines to help shape health policy, WHO must lead the way toward widespread implementation of full-course therapy for all expectant mothers and infants. The health outcomes of thousands of women would be vastly improved and the lives of thousands of children could be saved. It is wrong to save babies only to make them orphans."

http://www.aidshealth.org/