> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ViiV Rolling NDA for HIV Prevention Drug
- URL: https://www.fdaweb.com/viiv-rolling-nda-for-hiv-prevention-drug/
- Published: 2021-05-04T12:00:00.000Z
- Updated: 2026-09-14T16:57:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149242

ViiV Healthcare has begun a rolling NDA submission for cabotegravir, a long-acting, injectable drug for preventing human immunodeficiency virus (HIV). The submission will be based on data from two Phase 2b/3 studies, HPTN 083 and HPTN 084\. HPTN 083 evaluated the safety and efficacy of long-acting cabotegravir for HIV prevention in men who have sex with men and transgender women, and HPTN 084 evaluated cabotegravir for HIV prevention in women who are at increased risk of HIV. A data safety monitoring board stopped the blinded, randomized portion of both studies early after cabotegravir was shown to be superior to daily emtricitabine/tenofovir disoproxil fumarate, the company says.