A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men
*** 7 July 2020 ***
HPTN 083 Study Demonstrates Superiority of Cabotegravir for the Prevention of HIV
What is HPTN 083?
HPTN 083 is the first study to compare the efficacy of CAB LA to daily oral TDF/FTC for HIV PrEP. HPTN 083 enrolled 4,570 cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men at 43 sites in Argentina, Brazil, Peru, United States, South Africa, Thailand and Vietnam.
Why is HPTN 083 important?
For many people, taking a daily pill can be challenging. The development of safe and effective long acting alternative agents for HIV PrEP would increase HIV prevention choices and help those who find taking a daily pill challenging. Some people also may find periodic injections to be a more discreet form of HIV PrEP than daily pills and may prefer CAB LA for that reason.
What happened during the study?
Participants were assigned randomly (by chance) to either the CAB or oral TDF/FTC group. Neither the participants nor the study team knows who was in which group. Participants in each group received both injections and oral tablets – each participant received one active drug and one placebo (no active drug) in order to maintain the blinded nature of the study. Participants were randomized to one of two study arms and included three steps: Step 1 consisted of 5 weeks of daily oral CAB and a TDF/FTC placebo or 5 weeks of daily oral TDF/FTC and an oral CAB placebo; Step 2 consisted of 148 weeks of intramuscular CAB LA 600 mg every 8 weeks plus daily oral TDF/FTC placebo or 148 weeks of daily oral TDF/FTC plus an intramuscular CAB LA placebo every 8 weeks ; and Step 3 consisted of an open-label daily oral TDF/FTC for 48 weeks after participants completed Step 2.
What were the results of the study?
On May 14, 2020 a Data and Safety Monitoring Board (DSMB) reviewed HPTN 083 study data and recommended that the blinded part of the study be stopped early for successfully meeting its specified objectives. The study results showed that CAB LA, administered every eight weeks, provided high efficacy compared to TDF/FTC. A total of 50 incident HIV infections occurred in HPTN 083, with 38 incident HIV infections in the TDF/FTC arm (incidence rate 1.21%) and 12 incident HIV infections in the CAB arm (incidence rate 0.38%): in other words, approximately three times the number of incident HIV infections were in the TDF/FTC arm than in the CAB arm. The study sponsor, the U.S. National Institute of Allergy and Infectious Diseases (NIAID), approved the decision to stop the blinded part of the study.
After a more extensive analysis of the interim study data, the regimen containing CAB LA was found to be statistically superior to daily oral TDF/FTC for PrEP among the cisgender men and transgender women who have sex with men enrolled in HPTN 083. A total of 52 incident HIV infections occurred, with 13 incident infections in the CAB arm (incidence rate 0.41%) and 39 incident infections in the TDF/FTC arm (incidence rate 1.22%). The hazard ratio for the CAB versus TDF/FTC arms is 0.34 (95% CI 0.18-0.62), corresponding to a 66% reduction in incident HIV infections in study participants given CAB compared to TDF/FTC. These results were presented at AIDS 2020.
HPTN 083 Version 3.0
- HPTN 083 Protocol V3 – 31 October 2019
- HPTN 083 Summary of Changes from V2 to V3 – 31 October 2019
- HPTN 083 V3.0 LoA # 1 - 19 May 2020
- HPTN 083 V3.0 LoA # 2 - 1 July 2020
- HPTN 083 V3.0 LoA #3 - 23 July 2020
- HPTN 083 V3.0 CM #3 - 4 May 2020
- HPTN 083 V3.0 CM #2 - 2 April 2020
- HPTN 083 V3.0 CM #1 - 10 Feb 2020
HPTN 083 Version 2.0
HPTN 083 Version 1.0
- HPTN 083 Protocol V1.0 - 2 Feb 2016
- HPTN 083 V1.0 LoA #4 - 14 Dec 2017
- HPTN 083 V1.0 LoA #3 - 10 Nov 2016
- HPTN 083 V1.0 LoA #2 - 26 July 2016
- HPTN 083 V1.0 LoA #1 - 24 May 2016
- HPTN 083 V1.0 CM #1 - 13 October 2017
- HPTN 083 V1.0 CM #2 - 19 October 2017
- December 2016: HIV Prevention Trials Network Launches HPTN 083
- May 2020: Long-acting injectable cabotegravir is highly effective for the prevention of HIV infection in cisgender men and transgender women who have sex with men
- Community Educators Training
- Study Specific Training Community Educator Breakout: Retention Strategies
- Study Specific Training Community Educator Breakout: Tracking
- AIDS 2020: HPTN 083 Final Results
Community Presentations for HPTN 083 Results (May 2020)
- English Speakers
- Portuguese Speakers
- Spanish Speakers
- Thai Speakers
- Vietnamese Speakers