May 18, 2020
Dear MTN Friends and Family,
Today we celebrate a significant advance in the fight against HIV, and we have our HPTN colleagues to thank for making this one of the brightest days in recent memory.
If you haven’t already heard, the Data and Safety and Monitoring Board (DSMB) for HPTN 083 – a Phase 2b/3 randomized, double-blind clinical trial comparing the safety and efficacy of two pre-exposure prophylaxis (PrEP) approaches: injectable cabotegravir every eight weeks versus daily tenofovir disoproxil fumarate/emtricitabine (Truvada) pills – has recommended the study discontinue its double-blind phase. HPTN 083 was designed to determine whether cabotegravir was as at least as safe and effective for preventing HIV as Truvada in HIV-uninfected cisgender men and transgender women who have sex with men. The DSMB’s review of the data found the study had more than met the threshold for that comparison. In other words, both were highly effective for HIV prevention. You can read more about the findings and next steps in the announcement from HPTN here: https://www.hptn.org/news-and-events/press-releases/long-acting-injectable-cabotegravir-highly-effective-prevention-hiv
This is indeed a significant milestone for the field. We need different options for preventing HIV so that people can choose the one that works best for them. Truvada, the first medication to prove effective as PrEP, and the similar medication tenofovir alafenamide/emtricitabine (Descovy), are both highly efficacious but only if taken used as directed, and a daily regimen can be difficult for some people. The monthly dapivirine vaginal ring, currently under regulatory review, was the first long-acting product to show clinical efficacy for reducing the risk of HIV. We are hopeful that long-acting injectable cabotegravir will be yet another option.
A second trial, HPTN 084, is still ongoing, evaluating safety and efficacy of long-acting cabotegravir and Truvada as daily PrEP for preventing HIV in cisgender women. We look forward to those results with great anticipation. It is absolutely essential that robust evidence be accumulated for women for this potential new modality and we send our best thoughts to the HPTN 084 team who are continuing to operate that trial during this COVID-19 pandemic. Additional studies of long-acting cabotegravir in women during pregnancy and lactation and in adolescent populations are planned and are absolutely essential – no prevention methods can have great impact without being able to protect individuals across the life-cycle.
As for HPTN 083, we would like to congratulate Raphael Landovitz (Protocol Chair) and Beatriz Grinsztejn (Protocol co-Chair) and the entire HPTN 083 study team for achieving such an important milestone.
All our best,
Sharon Hillier and Jared Baeten