PMID- 34557563 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220426 IS - 2328-8957 (Print) IS - 2328-8957 (Electronic) IS - 2328-8957 (Linking) VI - 8 IP - 9 DP - 2021 Sep TI - 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. PG - ofab439 LID - 10.1093/ofid/ofab439 [doi] LID - ofab439 AB - 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. CI - (c) The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America. FAU - Smith, Graham H R AU - Smith GHR AD - Maple Leaf Research, Toronto, Ontario, Canada. FAU - Henry, W Keith AU - Henry WK AD - Department of Medicine, Hennepin County Medical Center, Minneapolis, Minnesota, USA. FAU - Podzamczer, Daniel AU - Podzamczer D AD - HIV Unit, Department of Infectious Diseases, Hospital Universitari de Bellvitge, L'Hospitalet, Barcelona, Spain. FAU - Masia, Maria Del Mar AU - Masia MDM AD - Infectious Diseases Unit, Hospital General Universitario de Elche, Elche, Spain. FAU - Bettacchi, Christopher J AU - Bettacchi CJ AD - North Texas Infectious Disease Consultants, Dallas, Texas, USA. FAU - Arasteh, Keikawus AU - Arasteh K AD - Epimed GmbH, Berlin, Germany. FAU - Jaeger, Hans AU - Jaeger H AD - MVZ Karlsplatz, HIV Research and Clinical Care Centre, Munich, Germany. FAU - Khuong-Josses, Marie-Aude AU - Khuong-Josses MA AD - Service Maladies Infectieuses, CHG-Hopital Delafontaine, Saint Denis, France. FAU - Montes-Ramirez, Maria Luisa AU - Montes-Ramirez ML AD - HIV Unit, Service of Internal Medicine, Hospital La Paz Institute for Health Research, Madrid, Spain. FAU - Stellbrink, Hans-Jurgen AU - Stellbrink HJ AD - ICH Study Center, Hamburg, Germany. FAU - Yazdanpanah, Yazdan AU - Yazdanpanah Y AD - Infectious Disease Department, Hopital Bichat Claude Bernard, Paris, France. FAU - Richmond, Gary J AU - Richmond GJ AD - Gary J. Richmond, Fort Lauderdale, Florida, USA. FAU - Sutton, Kenneth C AU - Sutton KC AD - Clinical Development, ViiV Healthcare, Research Triangle Park, North Carolina, USA. FAU - Zhang, Feifan AU - Zhang F AD - Dev Biostatistics, GlaxoSmithKline, Collegeville, Pennsylvania, USA. FAU - McCoig, Cynthia C AU - McCoig CC AD - Clinical Development, ViiV Healthcare, Tres Cantos, Spain. FAU - St Clair, Marty H AU - St Clair MH AD - Department of Translational Medical Research, ViiV Healthcare, Research Triangle Park, North Carolina, USA. FAU - Vandermeulen, Kati AU - Vandermeulen K AD - Medical Department of Infectious Diseases Therapeutic Area, Janssen Research and Development, Beerse, Belgium. FAU - Van Solingen-Ristea, Rodica AU - Van Solingen-Ristea R AD - Medical Department of Infectious Diseases Therapeutic Area, Janssen Research and Development, Beerse, Belgium. FAU - Smith, Kimberly Y AU - Smith KY AD - Global Research and Medical Strategy, ViiV Healthcare, Research Triangle Park, North Carolina, USA. FAU - Margolis, David A AU - Margolis DA AD - Clinical Development, ViiV Healthcare, Research Triangle Park, North Carolina, USA. FAU - Spreen, William R AU - Spreen WR AD - Medicines Development, ViiV Healthcare, Research Triangle Park, North Carolina, USA. LA - eng SI - ClinicalTrials.gov/NCT02120352 PT - Journal Article DEP - 20210825 PL - United States TA - Open Forum Infect Dis JT - Open forum infectious diseases JID - 101637045 PMC - PMC8454521 OTO - NOTNLM OT - cabotegravir OT - integrase strand transfer inhibitor OT - long-acting OT - nonnucleoside reverse transcriptase inhibitor OT - rilpivirine EDAT- 2021/09/25 06:00 MHDA- 2021/09/25 06:01 PMCR- 2021/08/25 CRDT- 2021/09/24 07:11 PHST- 2021/05/04 00:00 [received] PHST- 2021/08/23 00:00 [accepted] PHST- 2021/09/24 07:11 [entrez] PHST- 2021/09/25 06:00 [pubmed] PHST- 2021/09/25 06:01 [medline] PHST- 2021/08/25 00:00 [pmc-release] AID - ofab439 [pii] AID - 10.1093/ofid/ofab439 [doi] PST - epublish SO - Open Forum Infect Dis. 2021 Aug 25;8(9):ofab439. doi: 10.1093/ofid/ofab439. eCollection 2021 Sep.