AIDS Advocates: Stop Single-Dose Treatment for Pregnant Mothers, Infants

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In a Letter Sent Today to General Director Dr. Margaret Chan, Signed by AHF-Led Coalition of Hundreds, Urges Immediate Update of WHO Recommendations to End Sub-Standard AIDS Treatment Practice Widely-Known to Cause Drug-Resistance and Endanger Lives.

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 regimens 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 acknowledges 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.”

The full text of the letter sent to Dr. Chan today is below.

November 25, 2008

Dr. Margaret Chan, Director General
World Health Organization
Avenue Appia 20

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CH - 1211 Geneva 27

Re: WHO Guidelines for the Use of HAART in HIV Infected Pregnant and Breastfeeding Women

Dear Director Chan,

We the undersigned HIV/AIDS medical care providers and advocates are concerned about the use and recommendation of short-course therapy (such as single-dose Nevirapine and/or Zidovudine) for expecting and breastfeeding mothers considered ineligible for full-course Highly Active Antiretroviral Therapy (HAART) by WHO's current guidelines. Short-course treatment has been proven to be less effective at preventing HIV transmission and less safe for both mother and child than a full HAART regimen. Therefore, we call for World Health Organization (WHO) treatment guidelines to be changed to recommend full-course antiretroviral treatment for all expecting and breastfeeding mothers worldwide.

It is universally acknowledged that the reduction – and eventual elimination – of HIV among children represents not only a moral obligation but also an important front in preventing new HIV infections. Currently, over 2 million children are infected with HIV and there are several hundred thousand children born HIV positive each year (an estimated 330,000 to 410,000 in 2007). Over 90% of these infections are a result of transmission from HIV positive mothers to their infants [2008 AIDS epidemic update. Geneva, UNAIDS/WHO, 2008]. While these troubling numbers actually represent some progress compared to previous years, it is clear that more effective and sustainable interventions are needed to meet our commitment to reduce HIV among children and deaths among mothers.

Despite this, WHO guidelines on the prevention of mother to child transmission (PMTCT) still recommend short-course therapy even though it is clinically less effective at preventing MTC transmission and more harmful than full-course antiretroviral treatment. In contrast, the use of full-course ARV therapy essentially eliminates MTC transmission, lowering the overall risk to as little as 1.2%. The largest study of MTCT rates to date found that when appropriate full-course treatment is administered, 99% of babies were born uninfected with HIV. Moreover, these findings are consistent with several other studies that found that the primary effect of HAART, a reduction in the amount of HIV virus in the body, also essentially eliminates the risk of acquiring HIV via sexual transmission.

However, changes to the clinical practices of countries using short-course therapy cannot take place without the WHO’s leadership. Most developing countries rely on WHO guidance before they change or implement any clinical policy; therefore it is imperative for the WHO to revise its treatment guidelines on this matter to help facilitate the transition from short-course therapy to full-course HAART.

Widespread implementation of this standard will dramatically reduce the number of children born with HIV, reduce the number of women at risk for developing resistance to standard first-line treatments and will have a tremendous economic impact in lower income countries as the number of people requiring higher-priced second-line treatments will also be reduced. Implemented worldwide, the health outcomes of thousands of women would be vastly improved and the lives of thousands of children could be saved.

We look forward to the WHO’s leadership and action on this matter.

Sincerely,

Michael Weinstein, President
AIDS Healthcare Foundation
Homayoon Khanlou, M.D., Chief of Medicine
AIDS Healthcare Foundation
Robert R. Redfield, M.D., Chief of Infectious Diseases
University of Maryland School of Medicine
Jane Aronson, M.D., CEO/Founder
Worldwide Orphans Foundation
Sophia Mengistu, M.D., Country Director/Ethiopia
Worldwide Orphans Foundation
Rodney L. Wright, M.D., M.S., Director of HIV Programs
Albert Einstein College of Medicine
Martina C. Fuchs, M.D., PhD, CEO
Real Medicine Foundation
Julio Montaner, M.D.

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