With little fanfare, the World Health Organization (WHO) recently published a “Programmatic Update” on the use of antiretrovirals (ARVs) to treat pregnant women and prevent mother-to-child transmission of HIV (PMTCT) that identifies Option B and Option B plus as preferable to Option A. Both Option B and Option B+ call for the administration of triple combination antiretroviral therapy (ART) to all pregnant HIV-infected women. Under Option B, antiretroviral therapy would be stopped after the breast feeding period for women with CD4 counts above 350 while Option B + would continue ART in these women for life.
“Option B and specifically B+ seem to offer important programmatic and operational advantages and thus could accelerate progress towards eliminating new pediatric infections,” according to the update. “If option B+ can be supported, funded, scaled up at the primary care level and sustained, it will also likely provide the best protection for the mother’s health, and it offers a promising new approach to preventing sexual transmission and new HIV infections in the general population.”
The guidance also calls for standardization of the ART regimens utilized to allow for better integration with ART clinics post-partum. Limited access to CD4 testing, and consequently, the inability to identify women in need of treatment for their own health is one reason identified for the preferential view of Option B and Option B+.
The WHO summary lists advantages to the Option B+ approach, such as protection against mother-to-child transmission of HIV in future pregnancies and avoiding stopping and starting of ARVs. Other rationale for the update include the results of the HIV Prevention Trials Network (HPTN) 052 trial demonstrating that antiretroviral therapy reduces a person’s risk of transmitting HIV to an uninfected sexual partner by 96 percent; reassuring data on the safety of efavirenz during pregnancy; and the decreasing cost of ARV drugs. A number of countries have already adopted this approach, according to the WHO.
The WHO treatment guidelines were last updated in 2010 and prioritized starting all women with CD4 counts at or below 350 or with WHO-defined Stage 3 or 4 of disease on ART for life. Those with CD4 above 350 were recommended to receive ART early on in pregnancy and, in breastfeeding settings, to either the mother or child during the postpartum risk period.
“The move toward getting all HIV-positive pregnant women on HIV treatment for life makes sense on every level–it’s better for the mothers, better for their babies and much easier to put into practice in places where we work, where women often have multiple pregnancies and are hard to reach with care to begin with,” said Nathan Ford, medical director of the Medicines Sans Frontieres Access Campaign. “But the frustrating side is that countries wanting to provide this better care face an uphill battle because of the serious cash crunch at the Global Fund and bilateral donors pulling back treatment support. Donors need to provide the support to ensure that more child infections can be prevented, and that transmission of the virus in general can be stopped through treatment itself.” MSF is already providing option B+ to pregnant women in Malawi and is planning to pilot the option in Uganda, South Africa and Swaziland.
According to the executive summary, the WHO has started a comprehensive revision of all ARV guidelines, to include ARVs for pregnant women, which it plans to release in early 2013.
Another area of the overall treatment guidance that might need some tweaks is treatment for HIV-infected children. In the April 1 issue of Clinical Infectious Diseases, “Ruel et al present a case-control study that demonstrates neuro-cognitive and motor dysfunction in ‘asymptomatic’ HIV-infected children six to 12 years of age who do not qualify for ART,” according to Drs. Thor A. Wagner and Lisa M. Frenkel who penned an editorial commentary on the study in the same journal. “Their findings suggest that the WHO guidelines do not capture early neurologic disease and provide a rationale to explore whether earlier ART would benefit these children.”