MEXICO CITY – Responding to expanded data gathered in Botswana and Brazil, and to input from communities of women living with HIV, the World Health Organization announced updated guidelines for the use of dolutegravir, restoring the agency’s recommendation that the antiretroviral medicine with fewer side effects, lower resistance, and quicker viral suppression than alternatives is a preferred drug for all people with HIV. WHO categorizes that recommendation as “strong,” an upgrade from the earlier “conditional” recommendation.
For 15 months preceding the update, however, following findings in Botswana of four babies born with defects to the brain, spine or spinal cord, among 426 women taking dolutegravir at conception – a rate of 0.9% — WHO guidelines cautioning against the use of dolutegravir among pregnant women led to policies withholding the preferred drug from women who might become pregnant. During that time the drug was difficult, and, more often, impossible for women perceived to be of child-bearing age to access, whether they intended to become pregnant or not. The barriers highlighted exclusions of affected populations, particularly women from consultations and ensuing policies affecting their health, leading to extensive protests and demonstrations including at AIDS 2018.
Highlighting the importance of dolutegravir today, U.S. President’s Emergency Plan for AIDS Relief leader Ambassador Dr. Deborah Birx noted that side effects from the alternative medicine, efavirenz, had led to half a million people falling off treatment rolls per year. PEPFAR’s response, she said was to try to ensure 100 percent access to dolutegravir.
“We lost 15 months,” she said. Reversing the impact of the interim WHO guidelines and subsequent policies, she added, would take “another full year.”
The expanded data, also released today, showed five babies with neural tube defects born to 1683 women taking the drug at conception, a rate of 0.3 % still marginally higher than the rate of 0.2% among women on all types of antiretroviral treatments, and also only slightly higher than that among babies born to women without HIV in Botswana. The rate was lower still in Brazil, where tracking of all antiretroviral use is computerized, and where women routinely access the folate supplementation – a form of vitamin B — recommended by WHO to prevent birth defects. The WHO updated dolutegravir recommendations also emphasize the importance of folate supplementation for pregnant women.
“I can finally exhale,” Jacque Wabui of AfroCAB, an African HIV treatment advocates network, welcoming the guidelines today. But, she added, the women who had been prevented from accessing the medicine for the 15 months just passed continued to concern her.
“What happened should never happen again,” she said. “Access to treatment is a fundamental human right.”
The policies during that time she noted, perpetuated perceptions that a woman’s worth “is just to bear babies,” she said. “Let the woman know what the risks are of all the drugs available, what the benefits are, and let her decide for herself.”