Presentations and discussions about the latest HIV research continued at the 23rd International AIDS Conference (AIDS 2020: Virtual) yesterday. HIV.gov shared an interview with Carl Dieffenbach, Ph.D., director of the Division of AIDS at NIH’s National Institute of Allergy and Infectious Diseases (NIAID), about some of this week’s scientific highlights. He focused on:
- Additional data from the Tsepamo study on the prevalence of neural tube defects among infants born to women taking the HIV drug dolutegravir at the time of conception
- 96-week findings from the South African ADVANCE trial comparing three first-line HIV treatment regimens
- Evidence of weight gain caused by different HIV drugs
View our conversation below:
Here is additional information on the study findings that Dr. Dieffenbach highlighted:
- Encouraging update from the Tsepamo study shows lower prevalence of neural tube defects in babies exposed to dolutegravir than initially reported at AIDS 2018. The ongoing NIH-supported Tsepamo study surveys birth outcomes at hospitals in Botswana by maternal HIV status and ART regimen. In 2018, the study reported preliminary findings that suggested a substantially greater risk of neural tube defects (serious birth defects of the brain and spine) among newborns of women who started taking the anti-HIV drug dolutegravir before conception compared to newborns of women who started other anti-HIV drugs before conception and of women without HIV. This was cause for concern worldwide because HIV treatment guidelines recommended antiretroviral treatment regimens containing dolutegravir, which is more effective, easier to take, and has fewer side effects than other HIV drugs. In light of the preliminary findings, some countries paused their plans to make dolutegravir-based regimens their preferred first-line HIV therapy, while others either declined to offer dolutegravir to women of childbearing potential or offered the drug to that population only if women demonstrated they were using effective contraception. However, at last summer’s IAS Conference on HIV Science, study investigators presented findings from their analysis of additional data indicating that the risk of neural tube defects among infants born to women taking dolutegravir at the time of conception was less than the initial 2018 findings had suggested and not significantly higher than among women taking efavirenz or other antiretroviral drugs. Subsequently, the World Health Organization (WHO) in July 2019 issued updated HIV treatment guidelines reconfirming the recommendation to use dolutegravir-containing regimens as the preferred option for first-line and second-line antiretroviral treatment for all populations, including pregnant women and those of childbearing potential. New Tsepamo study data presented at AIDS 2020 by Dr. Rebecca Zash of Harvard Medical School and the Botswana Harvard AIDS Institute Partnership covered 39,200 additional births surveyed from March 2019 to April 2020. Dr. Zash reported that newborns of mothers who were on dolutegravir at the time of conception were not significantly more likely to have neural tube defects compared with newborns of mothers taking non-dolutegravir antiretrovirals. Dr. Zash observed that these data further support WHO’s 2019 decision to continue to recommend dolutegravir for all adults, including women of childbearing potential.
- Comparison of three first-line HIV treatment combinations yields positive results. Dr. Simiso Sokhela of the University of the Witwatersrand in South Africa reported 96-week findings from the ADVANCE trial, which was supported by USAID. South African researchers launched the trial in 2017 after several studies had demonstrated the safety, efficacy, and possible benefits of dolutegravir (DTG) and recommendations were emerging for its use in first-line antiretroviral therapy (ART) regimens. Because those studies were conducted primarily among middle-aged white men from high-income countries in the North America and Europe, researchers wanted to assess how dolutegravir-based ART regimens would perform in a population with very different demographics. (In South Africa, the country with the largest number of individuals on ART in the world, the HIV epidemic affects mainly black individuals and over half of those living with HIV are women, many under age 40.) In the ADVANCE trial, 1,053 people with HIV were randomly assigned to receive one of the following regimens: South Africa’s standard of care regimen of efavirenz, tenofovir disoproxil fumarate, and emtricitabine (EFV/TDF/FTC); dolutegravir, tenofovir disoproxil fumarate, and emtricitabine (DTG/TDF/FTC); or dolutegravir, tenofovir alafenamide, and emtricitabine (DTG/TAF/FTC). The results after 96 weeks of follow-up reported at AIDS 2020 showed that DTG/TAF/FTC and DTG/TDF/FTC were just as effective as EFV/TDF/FTC. Dr. Sokhela reported that study participants receiving either DTG regimen achieved viral suppression faster, but the proportion of participants with viral suppression by week 24 was similar across all three regimens and was maintained up to week 96. Dr. Sokhela noted that the study findings provide further evidence supporting WHO’s decision to recommend DTG/TDF/FTC-based regimens for first-line therapy worldwide.
- More evidence of weight gain resulting from some ART regimens. The ADVANCE trial also found that weight gain was more common among study participants on the DTG-based regimens compared to the EFV-based regimen. Weight gain may place people with HIV at higher risk of cardiovascular disease, diabetes, and high blood pressure. Dr. Sokhela reported that men receiving either DTG-based regimen gained more weight than those receiving the EFV-based regimen, with the highest weight gain among those receiving DTG/TAF/TDF. Similarly, women receiving DTG/TAF/FTC gained significantly more weight—8.2 kg (18.1 lbs.) on average over 96 weeks—than women receiving either of the other two combinations. Incomplete 144-week data suggest that this weight gain persists. Further, Dr. Sokhela noted that the body composition changes are concerning, particularly because they are largely fat and not lean mass. Investigators from another study presented at AIDS 2020: Virtual also reported an association between the use of a DTG-based regimen and increased incidence of weight gain as well as hyperglycemia. Dr. Julie Ake of the U.S. Military HIV Research Program at Walter Reed Army Institute of Research reported the findings from the African Cohort Study (AFRICOS) that enrolled 3,514 participants at 12 twelve PEPFAR-supported clinics in Uganda, Kenya, Tanzania and Nigeria. The study compared people who began treatment with tenofovir, lamivudine and dolutegravir with people who had not started ART or who received a non-dolutegravir antiretroviral regimen.
AIDS 2020: Virtual
The first-ever virtual edition of the world’s largest conference on HIV is taking place from July 6-10. Organized by the International AIDS Society, the conference convenes every other year and brings together scientists, policy makers, healthcare professionals, people living with HIV, funders, media, and community.
For more information about what’s happening at the conference, visit: