MEXICO CITY — Dolutegravir (Tivicay, Dovato) is strongly recommended as both first- and second-line therapy for HIV, including for pregnant women and those who may become pregnant, according to updated guidelines released by the World Health Organization (WHO).
In light of new evidence showing the safety signal for dolutegravir-based therapy in pregnancy was lower than previously reported, the WHO updated their guidelines to a strong recommendation for dolutegravir for the treatment of HIV.
“Dolutegravir safety during pregnancy has been one of the most urgent questions in global health for the last year,” said Anton Pozniak, MD, PhD, president of the International AIDS Society (IAS), and IAS Conference on HIV Science international scientific chair, who moderated a press conference here.
It has been over a year since a study that found safety signals about increased risk of neural tube defects led to a series of warnings about the drug for use in women of reproductive age, and led the WHO to issue interim guidance that steered this population towards efavirenz-based regimens.
But with this new data, the WHO reversed course. Meg Doherty, MD, WHO Coordinator of Treatment and Care, Department of HIV/Hepatitis and STIs, said these new recommendations took into account both data on the safety and efficacy of dolutegravir, as well as “population-level benefits and harms,” including preferences of women and the cost of implementation.
“Since the interim recommendations, we’ve been able to work with a number of scientists, community members, and modelers to follow the rapidly developing evidence on the safety and efficacy of dolutegravir,” she said. “The goal of this rapid update is to provide better information, to help countries grappling with a year of uncertainty.”
Doherty said that the WHO found a weighted global estimate of prevalence of neural tube defects of 0.36%, which includes seven total cases, the majority of which are in countries that are not folate-fortified. She added that the organization has also reaffirmed its standing recommendation for food folate supplementation, folate fortification, and folate supplements during pregnancy.
‘We Lost 15 Months’
“We appreciate the new guidelines. They are extraordinary and important,” said Ambassador-at-Large Deborah Birx, MD, U.S. Global AIDS Coordinator and U.S Special Representative for Global Health Diplomacy. “But to reverse the misperception about the level of risk will take another year. We lost 2 years in access to a drug that will save women’s lives.”
Birx praised the NIH for supporting the research that expanded the study, and eventually found out that the safety signal was not as dire as initially predicted, especially because dolutegravir was looked at as a “game-changer” for people age <30 to be virally suppressed. So much so that in a former plan, 90% of adults would be on this particular drug today, had this not happened, Birx said.
“This decision was put out with a very low signal in 400 women and it grinded [sic] everything to a halt,” Birx said. “When we have these early signals, we [need to] bring everyone to the table for decision-making.”
Birx also shared examples of the number of women who had to “prove they would not get pregnant” in order to be put on dolutegravir therapy.
“Nine million women had zero access to this drug for the last 15 months. We made decisions for women, we made decisions that limited their choice,” Birx said.
Echoing that sentiment was Jacque Wambui, a member of HIV treatment advocates network AfroCAB, from Kenya. She began her remarks by relaxing back into her chair and letting out a long breath.
“I can finally exhale,” she said.
Wambui emphasized the most important lesson to come out of what happened was that women need the information about both risks and benefits to decide on their HIV treatment for themselves.
“It is my body. My pregnancy. I am the one to decide,” she said. “Whatever happened should never happen again. Access to treatment is a fundamental right.”
Birx discussed the importance of “treatment literacy,” saying that a decision like this should be a dialogue between the community, scientists, and ministries of health. She encouraged science, community, and the government to speak with one voice in the future.
“Let’s learn from this, ensuring that community voices are brought together, even when we have early signals and alerts,” she said.