Long-Acting HIV Therapy in African Adults with Adherence Challenges.
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Cresswell Fiona V, Kitonsa Jonathan, Norcross Claire, Tumusiime Victoria, Ombajo Loice Achieng, Garrett Nigel, Kassim Sheetal, Owarwo Noela C, Laker Odongpiny Eva A, Yawe Ibrahim, Mahomed Sharana, Mugerwa Henry, Kafeero Paddy L, Nkuranga Joseph, Bahemuka Ubaldo, Nabbuto Jane, Ankunda Violet, Nabaggala Phiona, Ogwang Charles, Kimbugwe Geofrey, Kakande Ayoub, Singh Upasna, van der Vendt Dorothie, Onyango Arnold, Koile Eve, Lawrence David S, Idahosa Awhonukeh, van Eygen Veerle, Addo Boateng Fafa, Eshun-Wilsonova Ingrid, Grint Daniel J, Ruzagira Eugene, IMPALA Study Group
Аннотация
METHODS: We conducted a phase 3b, open-label, randomized trial to compare long-acting injectable cabotegravir plus rilpivirine with oral dolutegravir-based therapy among adults with virally suppressed HIV type 1 (viral load, <200 copies per milliliter) and suboptimal adherence or care engagement. The participants were assigned in a 1:1 ratio to receive intramuscular injections of cabotegravir (600 mg) plus rilpivirine (900 mg) every 8 weeks, with the first two injection visits occurring 4 weeks apart, or to continue daily oral dolutegravir-based therapy; baseline drug-resistance testing was not performed. The primary end point was a viral load of less than 50 copies per milliliter at week 48; noninferiority was assessed with a margin of -10 percentage points. Confirmed virologic failure (two consecutive viral loads of ≥200 copies per milliliter) was a key secondary end point.
RESULTS: A total of 540 participants were enrolled across seven sites in Kenya, South Africa, and Uganda; 537 were included in the primary analysis. At 48 weeks, 244 of 268 participants (91.0%) in the long-acting-therapy group had a viral load of less than 50 copies per milliliter, as compared with 240 of 269 participants (89.2%) in the oral-therapy group (risk difference, 1.9 percentage points; 95% confidence interval [CI], -3.1 to 6.9), which met the criterion for noninferiority. The results of a per-protocol analysis were consistent with those of the primary analysis. Confirmed virologic failure occurred in 5 participants (1.9%) in the long-acting-therapy group and in no participants in the oral-therapy group (risk difference, 1.9 percentage points; 95% CI, 0.3 to 3.5). Serious adverse events were reported in 11 of 271 participants (4.1%) who received long-acting therapy and in 8 of 269 participants (3.0%) who received oral therapy (risk difference, 1.1 percentage points; 95% CI, -1.1 to 4.2).
CONCLUSIONS: Among persons with HIV in Africa who have adherence challenges, long-acting cabotegravir plus rilpivirine was noninferior to oral dolutegravir-based therapy for maintaining a viral load of less than 50 copies per milliliter. (Funded by Johnson & Johnson; IMPALA ClinicalTrials.gov number, NCT05546242; Pan African Clinical Trials Registry number, PACT202301600757432TMC278LAHTX3005.).