Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study
Graham H R Smith, W Keith Henry, Daniel Podzamczer, Maria Del Mar Masiá, Christopher J Bettacchi, Keikawus Arasteh, Hans Jaeger, Marie-Aude Khuong-Josses, Maria Luisa Montes-Ramírez, Hans-Jürgen Stellbrink, Yazdan Yazdanpanah, Gary J Richmond, Kenneth C Sutton, Feifan Zhang, Cynthia C McCoig, Marty H St Clair, Kati Vandermeulen, Rodica Van Solingen-Ristea, Kimberly Y Smith, David A Margolis, William R Spreen, Graham H R Smith, W Keith Henry, Daniel Podzamczer, Maria Del Mar Masiá, Christopher J Bettacchi, Keikawus Arasteh, Hans Jaeger, Marie-Aude Khuong-Josses, Maria Luisa Montes-Ramírez, Hans-Jürgen Stellbrink, Yazdan Yazdanpanah, Gary J Richmond, Kenneth C Sutton, Feifan Zhang, Cynthia C McCoig, Marty H St Clair, Kati Vandermeulen, Rodica Van Solingen-Ristea, Kimberly Y Smith, David A Margolis, William R Spreen
Abstract
Background: In the Long-Acting Antiretroviral Treatment Enabling Trial 2 (LATTE-2) phase 2b study, long-acting (LA) injectable cabotegravir + rilpivirine dosed every 8 weeks (Q8W) or every 4 weeks (Q4W) demonstrated comparable efficacy with daily oral antiretroviral therapy (ART) through 96 weeks in ART-naive adults with human immunodeficiency virus type 1 (HIV-1). Here we report efficacy, tolerability, and safety of cabotegravir + rilpivirine LA over approximately 5 years.
Methods: After 20 weeks of oral cabotegravir + abacavir/lamivudine, participants were randomized to cabotegravir + rilpivirine LA Q8W or Q4W or continue oral ART through the 96-week maintenance period. In the extension period through week 256, participants continued their current LA regimen (randomized Q8W/Q4W groups) or switched from oral ART to Q8W or Q4W LA therapy (extension-switch groups). Endpoints assessed included proportion of participants with HIV-1 RNA <50 copies/mL (Snapshot algorithm) and adverse events (AEs).
Results: At week 256, 186 of 230 (81%) participants in randomized Q8W/Q4W groups and 41 of 44 (93%) participants in extension-switch groups had HIV-1 RNA <50 copies/mL. No protocol-defined virologic failures occurred after week 48. Injection wsite reactions infrequently resulted in discontinuation (4 [2%] and 1 [2%] participants in randomized Q8W/Q4W and extension-switch groups, respectively). Three participants in randomized Q8W/Q4W groups experienced drug-related serious AEs, including 1 fatal serious AE (Q4W group); none occurred in extension-switch groups. Of 25 participants with AEs leading to withdrawal, 20 were in the randomized Q4W group; no AE leading to withdrawal occurred in >1 participant.
Conclusions: Cabotegravir + rilpivirine LA exhibited long-term efficacy and tolerability, demonstrating its durability as maintenance therapy for HIV-1 infection.Clinical Trials Registration. NCT02120352.
Keywords: cabotegravir; integrase strand transfer inhibitor; long-acting; nonnucleoside reverse transcriptase inhibitor; rilpivirine.
© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
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Source: PubMed