This posting will make some PMTCT fans upset.
The posting on the paper below gives a despairing prognosis for eliminating perinatal infection. If ninety per cent success in every stage is necessary for classical Prong 3 PMTCT to work, then it is time to scrap the whole idea. We will never reach 90% no matter how much money is thrown at the problem. The [him] moderator thinks we should spend the money increasing access to counselling, testing, and antiretroviral therapy for women to achieve a better impact.
The other three Prongs are never implemented anyway.
Stephen Lewis appears to oartly agree with me in the second article.
[him] moderator
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Efficiency of health system, not just better regimens, critical to reducing mother-to-child HIV cases
Prevention of mother-to-child transmission
Carole Leach-Lemens
Published: 13 December 2010
Reducing the number of children infected with HIV and ensuring that mothers have access to life-saving treatment will only happen when systems perform with greater than 90% efficiency at each step of the prevention of mother-to-child transmission (PMTCT) process, from counselling and testing to delivery of antiretrovirals, according to Pierre M Barker and colleagues in a modelling study published in the advance online edition of the Journal of Acquired Immune Deficiency Syndromes.
More effective antiretroviral combinations or starting antiretrovirals at higher CD4 cell counts will have a very limited effect on the rates of mother-to-child transmission and gains in maternal survival unless the performance of the health system is addressed, the authors add.
The elimination of mother-to-child transmission and gains in maternal survival from HIV infection are possible with effective antiretroviral treatment.
However, PMTCT involves a number of sequential steps. Failure at any step in the process will result in considerable cumulative loss of pregnant women (to follow-up) resulting in increased risk of transmission, note the authors.
These steps include: counselling, HIV testing, CD4 testing, antiretroviral distribution at antenatal care clinics and labour wards, and testing of infants at six weeks.
The authors cite the example of infants attending immunisation clinics in South Africa where in spite of single-dose nevirapine (sdNVP) offered at antenatal clinics, 21% of HIV-exposed infants were HIV-infected when tested six weeks after birth.
The authors explain if PMTCT is limited to three core steps even minimal losses at each step will have a significant effect on outcomes.
The three core steps include: 1) attending an antenatal care clinic 2) counselled and tested for HIV and 3) getting antiretrovirals before and during birth.
If each step happens with 95% reliability, a 5% loss compounded at each following step will result in 86% of women receiving antiretrovirals; 80% reliability (20% loss at each step) results in 51% of women getting antiretrovirals and at 60% reliability this translates into only 22% of women getting treatment.
The authors note this helps explain why in 2009 in low- and middle-income countries approximately 53% of HIV-infected women received antiretrovirals to prevent the transmission of the virus to their infants.
The authors developed a model that estimated the effect of antiretroviral interventions for PMTCT on transmission rates in infants. The model compared the differences in performance of the many steps of different PMTCT protocols using hypothetical and reported data from a PMTCT programme in a large province in South Africa.
The model was limited to antenatal and peripartum interventions, with the primary outcome defined as the HIV status of infants born to HIV-infected mothers at six weeks of age. Transmission after birth, because of breastfeeding, primary infection of a pregnant women or when a pregnant women might not test positive, for example with a newly-acquired HIV-infection was not included.
The authors looked at six scenarios reflecting actual PMTCT practices in different settings. These scenarios were then tested in a model (from South Africa) that used reported performance data for each of the three core steps described above.
1.
No intervention to HIV-infected women or HIV-exposed infants.
2.
HIV-infected women receive single-dose nevirapine (sdNVP)in labour. HIV-exposed infants receive sdNVP after delivery.
3.
HIV-infected women receive zidovudine (AZT) any time from 28 weeks of gestation and sdNVP in labour. HIV-exposed infants receive sdNVP and AZT one week after delivery.
4.
A 2-tier system in which HIV-infected women who do not fulfil criteria for lifelong ART and their infants receive sdNVP as in setting number 2, whereas HIV-infected women who do fulfil criteria are initiated on ART by 34 weeks of gestation. Eligibility for ART was set at CD4 counts <200 cells/mm³.
5.
A 2-tier system in which HIV-infected women who do not fulfil criteria for lifelong ART and their infants receive AZT and sdNVP as in setting number 3, whereas HIV-infected women who do fulfil criteria (CD4 count <200 cells/mm³. are initiated on lifelong ART by 34 weeks of gestation.
6.
A 2-tier system in which HIV-infected women who do not fulfil criteria for lifelong ART received triple antiretroviral prophylaxis (for example, AZT/3TC/Kaletra) for the duration of pregnancy, whereas HIV-infected women who do not fulfil criteria (CD4 count <200 cells/mm³.) are initiated on lifelong ART by 34 weeks of gestation.
The authors found that in scenario 4 in a health system functioning at the reported South Africa performance levels for each of the three steps, only one third of the mothers and their infants would get sdNVP or ART, with the expected reduction of vertical transmission rate to be approximately 8%. The remaining two-thirds of women would be lost during the process and have an anticipated 25% transmission rate. So the overall transmission rate would be 19.5%.
Introducing AZT as part of the protocol as in scenario 5 would make a minimal difference in the overall transmission rate bringing it down to 17%.
However, improved reliability to 95% efficiency in both scenarios 4 and 5 would have a significant impact on transmission rates reducing them to 9.4% and 4.1%, respectively.
The authors also found with at current South African performance levels raising the eligibility criteria in two-tier models from CD4 <200 cells/mm³ to CD4 <350 cells/mm³, while certainly improving the mother’s health, had little effect on the transmission rate (18.2% compared to 15.3%).
The authors underscore that without being able to deliver each step in the PMTCT process at greater than 90% efficiency and address health system performance, effective antiretroviral treatments and other interventions will not make any real difference in transmission rates.
The authors, while recognising human and financial constraints, suggest that initiatives to improve both the quality and reliability of services within the health system be matched with initiatives to increase the demand for services. Adding that “the simplification of protocols and methods to monitor and improve local performance will help.”
The authors suggest that quality improvement methods and other strategies including task-shifting can provide benefits i
n a relatively short time.
They add, “However, unless strategies to improve PMTCT delivery are energetically and resolutely pursued, then ARVs will remain in cupboards. Such interventions would not just improve PMTCT services but could strengthen essential maternal and child health services and related health information services.”
The authors conclude “Investments in and support for the mechanisms of delivering and sustaining PMTCT interventions at scale are required if gains in maternal and child survival are to be realised in countries highly affected by HIV.”
Reference
Barker PM et al. Antiretroviral drugs in the cupboard are not enough: the impact of health systems’ performance on mother-to-child transmission. Advance on line edition J Acquir immune Defic Syndr, November 16, 2010. Link to abstract.
http://www.aidsmap.com/print/Efficiency-of-health-system-not-just-better-regimens-critical-to-reducing-mother-to-child-HIV-cases/page/1577850/
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AIDS-Free World
PRESS RELEASE
The UN’s Pursuit of an AIDS Goal Puts Women and Children at Risk
3 December 2010
A set of reports issued by UN agencies in time for World AIDS Day 2010 announced advances in programmes aimed at “preventing mother-to-child transmission of HIV (PMTCT)”. But the assertions of progress for women set out in the UNAIDS Report on the Global AIDS Epidemic 2010 and UNICEF’s Children and AIDS: 5th Stocktaking Report do not hold up under scrutiny. And claiming that full success can be achieved by 2015 is as misleading as the programme’s very name, which points a finger of blame at infected mothers. One simple step toward respect for mothers’ rights would be a change of names, to “prevention of vertical transmission”. Other steps are far more urgently required.
The UN announced this week that “53 per cent of women in need received antiretrovirals for PMTCT”. Relying on partial data that make true comparisons across years nearly impossible, the reports compared the 2010 percentage with a 15 percent marker reached in 2005. Media packets did not mention that this year’s total included women who were prescribed only single-dose nevirapine. That quick fix is no longer recommended by the World Health Organization because it falls so short of acceptable standards of care, but worse, because it puts mothers and babies at risk.
About a third of women who are given a single dose of nevirapine during childbirth will develop resistance to that class of drugs. Later, when their HIV disease progresses and they need treatment to stay alive, the antiretroviral regimens (ARVs) used in most developing countries may not work. Over 50 percent of the babies exposed to single-dose nevirapine will also develop drug-resistant HIV.
Even the pharmaceutical company that patented nevirapine has since discouraged its use in single doses to prevent vertical transmission. But it was still prescribed to many programme beneficiaries, and that was still described by the UN as a 2010 success story. Of the four countries in sub-Saharan Africa applauded for achieving the UN’s 80 percent coverage goal, three – Namibia, South Africa and Swaziland -- reached the target in part by prescribing single-dose nevirapine; in Namibia, 48 percent of women enrolled in the programme received it. In Ethiopia and India, single-dose nevirapine was prescribed to all the women treated, and yet both countries earned a tick on the UN ledger that marks progress toward “virtual elimination of mother-to-child transmission”.
AIDS-Free World’s own stocktaking leads us to conclusions starkly at odds with the UN’s assessment. The truth can be found by pouring over this week’s and other recent UN reports, and cobbling together pieces of fact scattered across hundreds of inside pages. They tell a different story than the one presented this week, about a programme with five characteristics that the public, the media and HIV-positive women should know:
First, in the UN reports, progress toward ending mother-to-child transmission is not measured by counting the babies protected from HIV. It is estimated by counting the women given drugs to prevent transmission, and then calculating the likelihood that the drugs succeeded. So far, no real data exists that establishes how many infant lives have actually been saved. The claim that an “HIV-free generation” is within reach is based on guesswork, not evidence.
Second, the figures said to represent beneficiaries of “PMTCT” services include not only pregnant positive women who received appropriate ARVs and infant feeding counseling and support, but also women who were given nothing more than single-dose nevirapine. Since that drug application is known to endanger the lives of women and children, it should be discontinued, not counted as an achievement.
Third, the vast majority of women offered single-dose nevirapine are deprived of their rights to informed consent. They are told that taking the drug will give their babies half a chance, but they are not informed that drug resistance may jeopardize their own chance of survival. Women have the right to decide for themselves whether that life-threatening risk is worth taking.
Fourth, the UN knows that interventions available in wealthy countries and many other places worldwide can be 99 percent effective. Prescribing effective anti-retroviral drugs (ARVs), providing correct infant feeding information and addressing the health needs of pregnant women with HIV protects infants from contracting the virus and keeps their mothers alive. Achievement of those goals is neither too complex nor too expensive to consider, if the intent is health equity, not efficiency. But the UN has not pressed hard to ensure that a 99 percent success rate is made available to all. Instead it settles for cheap and easy approaches, which yield low success rates and ignore both babies’ and mothers’ rights to the highest attainable standards of health.
Fifth, UNICEF, the World Health Organization (WHO) and UNAIDS appear to have abandoned efforts to support safe breastfeeding. For poor women with limited access to clinics, newly designed Mother-Baby Packs contain take-home ARVs for mothers and babies that extend only about six weeks past childbirth. The drug regimens provided do not last through the 12-month recommended breastfeeding period – and the packs contain no information about exclusive breastfeeding. This runs counter to guidelines revised by WHO in 2010. The health agency now concurs with research showing that HIV-positive women can breastfeed exclusively for six months without risk of transmitting HIV, provided they are given the right information, or ARVs, or ideally, both. Deprived of that guidance and support, mothers face a 15 percent risk that their babies will contract the virus through breastfeeding before reaching age one. The new Mother-Baby Packs do nothing to help mothers avert the risk of HIV transmission during the WHO and UNICEF recommended breastfeeding period.
World AIDS Day announcements strongly implied that success is evident in the number of babies saved from HIV infection. Of all the countries lauded, not one measured its progress by determining whether the babies born to mothers given prophylactic ARVs are now free of the virus, HIV-positive, dead or alive.
Using pass/fail grading systems, countries are said to have achieved the ultimate UN goal for prevention of “mother-to-child transmission” by administering some form of ARV to 80 percent of HIV-positive pregnant women. Equal weight is given to countries that provide the most effective drug regimens and services for both mothers and babies, and to countries that continue to use single-dose nevirapine; that take no steps to prevent nevirapine resistance; that do not provide the continued ARV regimens that protect babies born HIV-negative from contracting the virus later through bre
astfeeding; that offer no infant feeding information; and that discharge new mothers without first assessing whether they need ARVs for their own health.
Ironically, ensuring that babies remain free of HIV and keeping infected mothers alive and healthy through and well beyond childbirth is easier than any other HIV prevention. Children most likely to contract HIV can be singled out with absolute certainty: their mothers test HIV-positive while pregnant. It is possible to calculate within a few percentage points the best ways to reduce that risk. Needless to say, preventing HIV in a child is only half a success – unless the woman, too, is clinically assessed and treated, a child protected from HIV is placed on a path toward orphanhood.
The UN has focused its attention this year squarely on vertical transmission, since a prevention triumph is more likely there than anywhere else. After decades of inadequate achievement on AIDS, the agencies are desperate to achieve one goal. But if they stay on the current course, the UN will be unfurling its “mission accomplished” banner over the graves of women and children.
For information, please contact:
Paula Donovan, Co-Director
+1 (781) 734-0330 (direct)
+1 (781) 266-7187 (mobile)
+1 (212) 729-5084 (main)
media@aidsfreeworld.org
www.aidsfreeworld.org
