PROMISE Study findings released Monday support benefits of ongoing antiretroviral treatment for all pregnant women.
Dr. Anthony Fauci calls findings “another important step in our efforts to define the best approaches toward the goal of eliminating mother-to-child transmission globally”
When the multi-country PROMISE study to identify means of “Promoting Maternal-Infant Survival Everywhere” by preventing transmission of HIV from mother to child began in January 2010, it aimed to compare the standard of care at the time to more ambitious measures.
Officials of health ministries in some of the countries where the study was to take place expressed concern that they could not provide the more ambitious regimens being tested, particularly when the prevailing standard of care appeared effective enough, Carl Dieffenbach, director of the National Institute of Allergy and Infectious Disease Division of AIDS recalls now.
World Health Organization guidelines then recommended pregnant women living with HIV who were not considered eligible to start ongoing antiretroviral treatment to control the virus take one drug during pregnancy, another during labor, and two more after giving birth. Guidelines then also recommended that pregnant women living with HIV begin ongoing antiretroviral treatment to control the virus at the same point as everyone else — when an immune cell count indicated the need to. The magic number then was 200 CD4 cells per cubic milliliter of blood, or less, indicating patients’ immune systems could not ward off illnesses. Seven months later WHO, citing new evidence, upgraded the guidelines, recommending that all people with HIV begin treatment while healthier, with immune cell counts of 350 or less, and recommending earlier and longer continuing antiretroviral treatment for pregnant women, whether or not eligible to begin ongoing antiretroviral therapy. In three more years, WHO would upgrade its guidelines once again, setting the immune cell count at which all patients should start antiretroviral treatment at 500, and suggesting that when possible, all pregnant women living with HIV should begin antiretroviral treatment for life.
Findings from PROMISE, released Monday, support current WHO guidelines, showing that for HIV-infected women whose immune systems were healthy, a three-drug antiretroviral drug regimen during pregnancy prevented transmission of the virus more effectively than the administration of individual drugs administered across pregnancy, labor and after delivery.
The findings add numbers to calls for countries to adopt the approach to treatment for HIV-infected pregnant women known as Option B+, which has also been cited for its potential to lower rates of HIV transmission from infected women to uninfected partners, prevent mother to child HIV transmission during future pregnancies, and better protect the health of the women themselves.
Dieffenbach on Tuesday hoped the results “will now give ministries of health all the ammunition they need to agressively roll out Option B+.”
Getting there wasn’t easy, Dieffenbach said.
Each time WHO guidelines changed, he said, researchers returned to ministry of health officials and research institutional review boards to re-examine ethical approaches to a study around which standards of care were shifting. Each time, he said, health ministry officials said they would need objective proof for the more ambitious approaches to become standards of care in their countries.
In the time since, the benefits — including long term cost effectiveness, to Option B+ became more widely accepted, and in July, Dieffenbach said, researchers stopped enrolling pregnant women in the study. Women in the study who remain pregnant will now consult with researchers and their care providers to determine their options.
The study, sponsored by the National Institutes of Health and its Eunice Kennedy Shriver National Institute of Child Health and Human Development, will continue to follow women and their children to determine outcomes on health.