Patient-reported tolerability and acceptability of cabotegravir + rilpivirine long-acting injections for the treatment of HIV-1 infection: 96-week results from the randomized LATTE-2 study. Issue 4 (3rd September 2019)

• Record Type: Journal Article
• Authors: Murray, Miranda; Pulido, Federico; Mills, Anthony; Ramgopal, Moti; LeBlanc, Roger; Jaeger, Hans; Canon, Viviam; Dorey, David; Griffith, Sandy; Mrus, Joseph; Spreen, William; Margolis, David
• Is Part Of: HIV research & clinical practice. Volume 20:Issue 4/5(2019)
• Page Start: 111
• Page End: 122
• Publication Date: 2019-09-03
• Subjects: HIV -- antiretroviral agent -- injectable therapy -- long-acting -- patient-reported outcome -- treatment satisfaction; HIV Infections -- therapy; Acquired Immunodeficiency Syndrome -- therapy; Clinical Trials as Topic; Clinical Medicine; AIDS (Disease) -- Treatment -- Periodicals; AIDS (Disease) -- Treatment; Periodicals; Periodical; 616.9792
• DOI: 10.1080/25787489.2019.1661696
• Languages: English
• ISSNs: 2578-7489

Abstract

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/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.