Miranda Murray1, Federico Pulido2, Anthony Mills3, Moti Ramgopal4, Roger LeBlanc5, Hans Jaeger6, Viviam Canon7, David Dorey8, Sandy Griffith9, Joseph Mrus9, William Spreen9, David Margolis9. 1. ViiV Healthcare, London, UK. 2. Hospital Universitario 12 de Octubre, UCM, (imas12), Madrid, Spain. 3. Southern California Men's Medical Group, West Hollywood, CA, USA. 4. Midway Immunology and Research Center, Fort Pierce, FL, USA. 5. Immunodeficiency Service Division of Hematology, Royal Victoria Hospital, McGill University Health Centre, Montreal, Quebec, Canada. 6. HIV Research and Clinical Care Centre, MUC Research GmbH and MVZ Karlsplatz, Munich, Germany. 7. Division of Janssen Pharmaceutica NV, Janssen Research & Development, Beerse, Belgium. 8. GlaxoSmithKline, Mississauga, Ontario, Canada. 9. ViiV Healthcare, Research Triangle Park, NC, USA.
Abstract
Background: Long-acting (LA) injectable antiretroviral therapy (ART) is a novel modality currently under development as an alternative to daily oral ART.Objective: The LATTE-2 study (ClinicalTrials.gov identifier NCT02120352) showed that cabotegravir LA + rilpivirine LA maintained virologic suppression through 96 weeks and included further exploration of patient-reported treatment outcomes with an LA injectable form of treatment. Methods: Two-hundred and eighty-six virologically suppressed participants on oral cabotegravir + abacavir/lamivudineonce-daily tablets (induction period) were randomized to cabotegravir LA + rilpivirine LA once every 4 weeks (n = 115), once every 8 weeks (n = 115), or the continuation of the oral tablet regimen (n = 56) during the maintenance period. Patient-reported outcome measures included the HIV Medications Questionnaire (HIVMQ) and the HIV Treatment Satisfaction Questionnaire status (HIVTSQ[s]) and change (HIVTSQ[c]) versions at prespecified study visits through Week 96 of the randomized maintenance period. Results: Most participants in the LA injectable groups reported injection-site-related adverse events; however, participants in the 4-week (median HIVTSQ[s] total score, 63.5; post hoc P = 0.02) and 8-week (65.0; post hoc P < 0.001) LA injectable groups were significantly more satisfied with treatment than participants in the oral maintenance group (60.0) at Week 96. This was consistent with results from the HIVTSQ[c] at Week 32, which revealed that participants in both LA groups were significantly more satisfied with therapy compared with patients receiving oral ART (both post hoc P < 0.001). Conclusion: Participants who received LA injectable therapy had high levels of treatment satisfaction and favorably viewed convenience and lifestyle-related aspects of the therapy.
RCT Entities:
Background: Long-acting (LA) injectable antiretroviral therapy (ART) is a novel modality currently under development as an alternative to daily oral ART.Objective: The LATTE-2 study (ClinicalTrials.gov identifier NCT02120352) showed that cabotegravir LA + rilpivirine LA maintained virologic suppression through 96 weeks and included further exploration of patient-reported treatment outcomes with an LA injectable form of treatment. Methods: Two-hundred and eighty-six virologically suppressed participants on oral cabotegravir + abacavir/lamivudine once-daily tablets (induction period) were randomized to cabotegravir LA + rilpivirine LA once every 4 weeks (n = 115), once every 8 weeks (n = 115), or the continuation of the oral tablet regimen (n = 56) during the maintenance period. Patient-reported outcome measures included the HIV Medications Questionnaire (HIVMQ) and the HIV Treatment Satisfaction Questionnaire status (HIVTSQ[s]) and change (HIVTSQ[c]) versions at prespecified study visits through Week 96 of the randomized maintenance period. Results: Most participants in the LA injectable groups reported injection-site-related adverse events; however, participants in the 4-week (median HIVTSQ[s] total score, 63.5; post hoc P = 0.02) and 8-week (65.0; post hoc P < 0.001) LA injectable groups were significantly more satisfied with treatment than participants in the oral maintenance group (60.0) at Week 96. This was consistent with results from the HIVTSQ[c] at Week 32, which revealed that participants in both LA groups were significantly more satisfied with therapy compared with patients receiving oral ART (both post hoc P < 0.001). Conclusion:Participants who received LA injectable therapy had high levels of treatment satisfaction and favorably viewed convenience and lifestyle-related aspects of the therapy.
Authors: Morgan M Philbin; Carrigan L Parish; Elizabeth N Kinnard; Sarah E Reed; Deanna Kerrigan; Maria L Alcaide; Mardge H Cohen; Oluwakemi Sosanya; Anandi N Sheth; Adaora A Adimora; Jennifer Cocohoba; Lakshmi Goparaju; Elizabeth T Golub; Margaret Fischl; Lisa R Metsch Journal: J Acquir Immune Defic Syndr Date: 2020-07-01 Impact factor: 3.771