Paula Donovan Answers Infrequently Asked Questions: As We Rush Toward a Goal, Will the UN Give Us an Honest Baseline?
By Paula Donovan
Note: Although things have evolved since this blog entry was first written, many of the concerns raised about the Global Plan's approach are still valid, particularly in light of the gains being touted by UNAIDS and partners about the reduction of new HIV infections in children.
On April 8th, I dialed in to the first of two scheduled meetings (this one by phone, and the next in person a month from now) among a hastily organized “Global Task Team on Elimination of New HIV Infections Among Children by 2015 and Keeping their Mothers Alive.” UNAIDS Executive Director Michel Sidibe and PEPFAR’s Dr. Eric Goosby co-chaired the teleconference among some 50 – 60 participants, who included African Ministers of Health, the heads of WHO, UNICEF and UNFPA and the executive directors of NGOs and foundations such as Gates, CARE, the Elizabeth Glazer Pediatric AIDS Foundation and the ONE Campaign. One after another, Task Team members endorsed the goal and vowed to continue working toward it.
The premise is this: in 2009, for the first time, over half of all pregnant women with HIV received antiretrovirals to prevent transmission to their babies.
The goal: "virtual elimination" of vertical transmission to infants, and "keeping their mothers alive."
But the problem is this: that "over 50 percent" figure is a false baseline. At least a third of the "over 50 percent" received just single-dose nevirapine: far from eliminating new infections among children, it can prevent HIV transmission in less than half of all cases. And when it works, the uninfected newborns remain at risk of HIV through the breastmilk of their mothers, who haven’t been given any ARVs to reduce the HIV in their systems; 17 percent of uninfected infants will contract HIV through "mixed feeding" by mothers who haven’t been informed or supported to breastfeed safely — that is, exclusively, without any other liquid or solid for 6 months. Nevirapine is in a class of ARVs called NNRTIs; it’s an important drug when used correctly, and can be deadly when prescribed incorrectly — in single doses during childbirth. Even when that dosage works to prevent transmission, it will also cause about 30 percent of the HIV-positive women and half of the infected babies to develop resistance to nevirapine and all other NNRTIs. This means that when those mothers and babies are eventually placed on antiretroviral therapy, the most commonly used "triple combination therapies" won’t take effect, since the single dose of nevirapine they received during childbirth will have tipped off the virus, which morphed into an HIV strain that is impervious to one essential component: NNRTIs.
Yet another giant subset of the "over 50 percent of pregnant women" we’re led to believe were prevention success stories were actually “lost to follow-up”: no one has tracked them, and so we have no idea whether their babies are positive or negative. And finally, there’s the misleading tag end of the Global Task Team’s name, “and Keeping Their Mothers Alive.” The truth, buried deep in UN reports, is that most of the “over 50 percent” of HIV-positive women who were given some form of prophylaxis during 2009 to reduce the risk of transmission to their babies received no assistance at all to keep themselves alive. In fact, the vast majority were never even assessed by a medical professional to determine what kind of help they needed for their own HIV.
So, subtract from the “over 50 percent” starting point all the women and babies who received single-dose nevirapine instead of a WHO-recommended regimen and didn’t avoid transmission. Subtract all the babies who survived childbirth without infection, and then contracted HIV through mixed feeding. Subtract all the mothers who developed ARV resistance from a dangerous single dose of nevirapine; subtract all the women who weren’t given any medical attention at all for their own health, and then subtract the droves lost to follow-up. I don’t know the mathematical formula, but even without one, it’s easy to see that “over 50 percent” is not the baseline against which to measure progress toward “eliminating new HIV infections among children by 2015 and keeping their mothers alive.”
After the teleconference, I sent an email to Michel Sidibe, copied to several of his colleagues at UNAIDS who’d been present on the call. He replied today. Here’s the correspondence:
April 8, 2011
Thank you for inviting AIDS-Free World's Co-Directors to join the Global Task Team on Elimination of New HIV Infections Among Children by 2015 and Keeping their Mothers Alive. On this morning's teleconference — the first of the task team's two meetings — I asked a question about the joint WHO/UNAIDS/UNICEF yearly report, "Towards Universal Access." You indicated that questions would be answered toward the end of the teleconference, but it appears that there wasn't enough time for that. Would you be so kind as to answer the question now?
Now that single-dose nevirapine is no longer recommended by WHO, and now that WHO has acknowledged that single-dose nevirapine places women and children at risk of developing resistance to NNRTIs, will the next Towards Universal Access report provide a global percentage of progress against vertical transmission that excludes those women who received just single-dose nevirapine (sdNVP)?
Towards Universal Access: Progress report 2010 stated that "an estimated 53% of pregnant women living with HIV received antiretrovirals to reduce the risk of transmitting HIV to their infants." In the published report (but not in UN press releases or statements made to the media) that overall percentage was followed by this qualifier: "A large proportion continued to receive the less efficacious single-dose nevirapine regimen." This was two months after WHO had released its final revised recommendations on Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants and its new infant feeding guidelines, and had withdrawn its support for the use of sdNVP.
As recently as March 28, 2011, when the Secretary-General released his global progress report on HIV and AIDS, the UN was still stating that over half of all women living with HIV had received prophylaxis to prevent vertical transmission — again reporting a percentage that includes women who had received only the suboptimal, dangerous sdNVP. And as you know, countries such as Namibia are listed as having achieved the UNGASS goal of preventing vertical transmission — despite the fact that nearly half of the women reached in Namibia were given sdNVP. To count women given sdNVP among the "virtual elimination and keeping mothers alive" success stories seems especially illegitimate now, following WHO's new guidelines that advise against the use of sdNVP (and its statements yesterday, on World Health Day, about the shared responsibility at all levels, including international partners, to make every effort to prevent drug resistance.)
I would hope that when you and Eric Goosby report progress toward "Elimination of New HIV Infections Among Children by 2015 and Keeping their Mothers Alive," you will provide all those involved with an overall percentage that is a true reflection of where things stand, so that we will have an accurate baseline against which to measure progress.
But at the moment, I would very much appreciate just a quick answer to the primary question: will future UN progress reports, such as the next Towards Universal Access report, include an overall total that excludes women given sdNVP?
With thanks and best regards,
April 12, 2011
Thank you for participation in Friday’s call — it was great to have you contribute to the important kick-off for this important and time-sensitive initiative.
You are raising a critical question on the measurement of the percentage of pregnant women who received antiretrovirals to reduce the risk of transmitting HIV to their infants. This kind of comment should inform the discussion in the e-forum for the GTT. I am sharing your question with our team that will set-up this forum this week.
I am also sending your comment to Margaret Chan and the HIV team at WHO for clarification on this issue.
I look forward to your continued engagement in the GTT.