DURHAM, N.C. – Investigators from the HIV Prevention Trials Network (HPTN) today announced The Lancet has published key results from HPTN 074. At 52 weeks from enrollment, participants in the intervention arm nearly doubled their antiretroviral therapy usage, viral suppression and medication-assisted treatment usage compared to the standard of care arm. Mortality was also reduced by more than half with the intervention.
The HPTN 074 study assessed an integrated intervention combining psychosocial counseling and supported referrals for antiretroviral therapy at any CD4 cell count and substance use treatment for people living with HIV who inject drugs compared to the locally available standard of care. The primary objectives of the study included estimating incidence in the standard of care arm while assessing the uptake of an integrated HIV prevention intervention.
“Facilitating antiretroviral therapy and substance use treatment referrals through systems navigation, combined with flexible counseling, led to enhanced antiretroviral therapy and substance use treatment uptake, viral load suppression, and decreased mortality among people living with HIV who inject drugs,” said William C. Miller, MD, PhD, MPH, HPTN 074 protocol chair and professor and chair of the Department of Epidemiology at The Ohio State University College of Public Health in Columbus, Ohio. “Although this vanguard trial was not powered for comparing HIV incidence, the occurrence of no HIV infections among partners of the people who inject drugs in the intervention group offers the potential for prevention benefits.”
HPTN 074 was a randomized, controlled trial conducted among people who inject drugs in Ukraine, Indonesia and Vietnam. Overall, 502 people living with HIV and 806 people with whom they injected drugs entered the study over 15 months and were followed for 12 to 24 months after enrollment. The median age was 35 years. Eighty-five percent of participants enrolled were men; most of the women who participated in the study were enrolled in Ukraine. At week 26, intervention arm participants were twice as likely to report antiretroviral therapy use compared to the standard of care arm participants and twice as likely to achieve an undetectable viral load. The effects persisted at week 52. Among intervention arm participants at week 52, self-reported substance use treatment uptake was higher compared to the standard of care arm participants. Mortality was significantly lower among intervention arm participants and their partners compared to the standard of care arm participants and their partners. For partners of intervention arm participants, no new HIV infections were observed, while seven were observed among partners in the standard of care arm.
“Injection drug use is a major factor underlying the HIV epidemic in Eastern Europe and Central and Southeast Asia,” said Wafaa El-Sadr MD, MPH, MPA, HPTN co-principal investigator and professor of epidemiology and medicine at Columbia University in New York. “This persistently high incidence of HIV infection among people who inject drugs in many locations with concentrated epidemics necessitates aggressive efforts to prevent HIV transmission.”
HPTN 074 study sites have completed a one-year study extension, which ended July 6, 2018. Due to the strength of the preliminary study results, all sites began offering the integrated intervention to participants who had not initiated antiretroviral therapy and substance use therapy in the standard of care arm in late 2017.
“The HPTN 074 study assessed the feasibility of an integrated intervention for people living with HIV who inject drugs to reduce HIV transmission to their HIV-uninfected injection partners,” said Myron Cohen, MD, HPTN co-principal investigator and director of the University of North Carolina at Chapel Hill Institute for Global Health and Infectious Diseases in Chapel Hill, NC. “These study findings related to antiretroviral therapy use and HIV prevention are promising, and this and other interventions are needed to get people living with HIV who inject drugs into care for their own health and to stop transmission of the virus.”
HPTN 074 is funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), and the U.S. National Institute on Drug Abuse (NIDA), both part of the U. S. National Institutes of Health (NIH).
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection. The HPTN research agenda is focused primarily on the use of integrated strategies: use of antiretroviral drugs (antiretroviral therapy and pre-exposure prophylaxis); interventions for substance abuse, particularly injection drug use; behavioral risk reduction interventions and structural interventions. NIAID, NIDA and the NIH’s National Institute of Mental Health co-fund the HPTN. For more information, visit hptn.org.