At a session at the 19th International AIDS Conference (AIDS 2012) in Washington DC, UNICEF official Chewe Luo called for transforming “PMTCT programmes into ART programmes” in order to meet global HIV targets.
Luo expressed emphatic support for an emerging model for prevention of mother-to-child transmission of HIV (PMTCT): initiating lifelong antiretroviral therapy in HIV-positive pregnant women, regardless of their CD4 count.
Since 2010, many countries have based their national PMTCT policies on one of two interventions identified in 2010 guidelines issued by the World Health Organization (WHO). Under both Option A and Option B, HIV-positive pregnant women who have CD4 cell counts of 350 or less are advised to start lifelong antiretroviral therapy using a triple-combination regimen.
However, women with higher CD4 cell counts are not considered medically eligible for lifelong antiretroviral therapy, and are advised to take antiretrovirals only as prophylaxis against mother-to-child transmission of HIV.
Options A and B differ in their choice of antiretroviral regimens for mothers and infants. Option A has a more complicated treatment protocol, with different maternal regimens administered before birth, during delivery and during the postpartum period. Option B simply calls for a triple antiretroviral regimen to be administered from the fourteenth week of pregnancy until one week after breastfeeding has ended (or until after childbirth if the woman is not breastfeeding). Under both options, infants receive antiretroviral prophylaxis as well.
In April 2012, WHO released a 'programmatic update' to its 2010 guidelines. The update reported that Option B has a number of benefits over option A. It went on to explain the advantages of offering all HIV-positive pregnant women the same triple-combination regimen – an approach dubbed “Option B+”. The new option eliminates the use of a CD4 threshold to determine who is eligible for lifelong treatment and who should only take antiretrovirals until the infant is no longer at risk of HIV exposure.
On the basis of the WHO update, UNICEF is now strongly encouraging countries to consider switching to Option B+. In her remarks, Luo called attention to the experience of Malawi, which adopted Option B+ in 2010. Malawi has since seen major increases in the proportion of HIV-positive pregnant women initiating antiretroviral therapy for the prevention of mother-to-child transmission of HIV and for their own health.
Luo said that, for the Malawian government, a major consideration in deciding to offer antiretrovirals to all HIV-positive pregnant women was the impracticality of providing universal CD4 screening to determine which women were eligible for PMTCT regimens. Another factor was the growing evidence regarding the potential for antiretroviral treatment to reduce HIV transmission to HIV-negative sexual partners.
The Malawian PMTCT programme uses the same triple-combination antiretroviral regimen that serves as as the standard first-line antiretroviral regimen nationally. From a programmatic standpoint, this makes drug procurement, distribution and prescribing more straightforward.
The Malawian government’s decision to invest in Option B+ is notable in light of its limited resources for responding to a national adult HIV prevalence rate of 11%.
Cost has been a factor encouraging many countries hard-hit by HIV to choose Option A over Option B, since Option A costs less to implement. However, the operational challenges associated with Option A may make it less cost-effective than Option B in the long run, if Option A leads to a higher number of infants needing treatment for HIV infection.
Option B+, not surprisingly, is the most expensive option – but in a newly published Business Case for Options B and B+, the Business Leadership Council for a Generation Born HIV-Free and UNICEF propose that there may again be a net savings resulting from the higher outlay. An important benefit of Option B+ is that it can be expected to lower HIV transmission to male partners of HIV-positive women, since being on antiretroviral therapy will make women less infectious. UNICEF also points out that ongoing antiretroviral therapy should also reduce the risk of mother-to-child transmission of HIV in subsequent pregnancies.
Ultimately, cost-benefit analyses are not the only consideration for governments and the international community. Shortly before the opening of the AIDS 2012 conference, UNICEF Executive Director Anthony Lake called attention to a “moral argument” for Option B+ while speaking at a PMTCT leadership forum co-sponsored by UNICEF and WHO.
“Option B+ treats women as more than vessels for having babies,” he said. “Of course every woman wants her baby to live, but every woman wants to live, and who should deny that right?”
UNICEF’s decision to emphasise the benefits of Option B+ comes in the context of evidence showing that progress must be accelerated in order for the global community to achieve ambitious PMTCT-related targets.
At the 2011 United Nations High Level Meeting on AIDS, world leaders presented the UNAIDS-crafted Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping Their Mothers Alive. The plan calls for a 90% reduction in the number of new HIV infections among children and a 50% reduction in the number of AIDS-related maternal deaths by 2015. The number of new HIV infections among children has dropped in recent years, but modeling indicates that the rate of decline is not steep enough to achieve the 2015 target.
PMTCT expert Prof. James McIntyre, speaking at the 4th International Workshop on HIV Pediatrics shortly before the conference opened, expressed concern about the speed of travel and the direction UNICEF is taking regarding PMTCT options.
“It’s important in this wave of optimism to stay grounded in science," he said, noting the lack of long-term data on the outcomes of Option B+ implementation. Finally, he noted, “Amidst all the hype, what happened to treating all women with CD4 cell counts under 350? This seems to have been lost in the process.”
R.J. Simonds, Vice President of Innovation and Policy at the Elizabeth Glaser Pediatric AIDS Foundation, endorsed efforts to roll out Option B+, while at the same time recognising that the implications of this strategy are not yet well understood. “There is huge potential for an Option B+ approach, but we want to make sure that we are doing this in a rational way,” he said in an interview.
“This is a substantive change,” Simonds added. “We need to be moving quickly to generate evidence so that we can fine-tune things.” He cited the need to learn more about adherence in women with higher CD4 counts, and about retention in care.