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.

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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.

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ViiV Healthcare receives FDA Breakthrough Therapy Designation for investigational, long-acting cabotegravir for HIV prevention. [press release]. London, England; November 18, 2020.