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.

Autor: Smith GHR; Maple Leaf Research, Toronto, Ontario, Canada., Henry WK; Department of Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA., Podzamczer D; HIV Unit, Department of Infectious Diseases, Hospital Universitari de Bellvitge, L'Hospitalet, Barcelona, Spain., Masiá MDM; Infectious Diseases Unit, Hospital General Universitario de Elche, Elche, Spain., Bettacchi CJ; North Texas Infectious Disease Consultants, Dallas, Texas, USA., Arasteh K; Epimed GmbH, Berlin, Germany., Jaeger H; MVZ Karlsplatz, HIV Research and Clinical Care Centre, Munich, Germany., Khuong-Josses MA; Service Maladies Infectieuses, CHG-Hôpital Delafontaine, Saint Denis, France., Montes-Ramírez ML; HIV Unit, Service of Internal Medicine, Hospital La Paz Institute for Health Research, Madrid, Spain., Stellbrink HJ; ICH Study Center, Hamburg, Germany., Yazdanpanah Y; Infectious Disease Department, Hôpital Bichat Claude Bernard, Paris, France., Richmond GJ; Gary J. Richmond, Fort Lauderdale, Florida, USA., Sutton KC; Clinical Development, ViiV Healthcare, Research Triangle Park, North Carolina, USA., Zhang F; Dev Biostatistics, GlaxoSmithKline, Collegeville, Pennsylvania, USA., McCoig CC; Clinical Development, ViiV Healthcare, Tres Cantos, Spain., St Clair MH; Department of Translational Medical Research, ViiV Healthcare, Research Triangle Park, North Carolina, USA., Vandermeulen K; Medical Department of Infectious Diseases Therapeutic Area, Janssen Research and Development, Beerse, Belgium., Van Solingen-Ristea R; Medical Department of Infectious Diseases Therapeutic Area, Janssen Research and Development, Beerse, Belgium., Smith KY; Global Research and Medical Strategy, ViiV Healthcare, Research Triangle Park, North Carolina, USA., Margolis DA; Clinical Development, ViiV Healthcare, Research Triangle Park, North Carolina, USA., Spreen WR; Medicines Development, ViiV Healthcare, Research Triangle Park, North Carolina, USA.
Jazyk: angličtina
Zdroj: Open forum infectious diseases [Open Forum Infect Dis] 2021 Aug 25; Vol. 8 (9), pp. ofab439. Date of Electronic Publication: 2021 Aug 25 (Print Publication: 2021).
DOI: 10.1093/ofid/ofab439
Abstrakt: 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.
(© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze: MEDLINE
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