The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to long-acting cabotegravir injection (ViiV Healthcare) for HIV pre-exposure prophylaxis (PrEP).
The designation was based on data from the phase 2b/3 HPTN 083 trial that compared the investigational long-acting injectable to oral emtricitabine/tenofovir disoproxil fumarate 200mg/300mg (FTC/TDF) for HIV prevention among men who have sex with men and transgender women who have sex with men (N=4566). Patients received either cabotegravir intramuscularly every 8 weeks or daily FTC/TDF for up to a maximum of 3 years.
Results from the final analysis showed that cabotegravir was 66% (95% CI, 38-82) more effective than FTC/TDF in preventing HIV acquisition among the study population (incidence rate: 0.41% [95% CI, 0.22-0.69] in the cabotegravir group vs 1.22% [95% CI, 0.87-1.67]). As for safety, injection site reactions, pyrexia, and hypertension were observed to be more common in the cabotegravir arm, while nausea was more common in the FTC/TDF group. Overall, both therapies were found to be well tolerated.
Data from the HPTN 083 study as well as the HPTN 084 trial, an HIV prevention study in sub-Saharan African women, will form the basis of the Company’s future regulatory submission. The Breakthrough Therapy designation allows for expedited review of the application by the FDA.
For more information visit viivhealthcare.com.
ViiV Healthcare receives FDA Breakthrough Therapy Designation for investigational, long-acting cabotegravir for HIV prevention. [press release]. London, England; November 18, 2020.