Improving HIV Outcomes in Africa with Long-acting Antiretrovirals
Long-acting (LA) injectable therapy for the treatment of Human Immunodeficiency Virus (HIV)-1 infection offers a reduced dosing frequency and an additional option to the currently available 2 or three-drug oral combinations. A parenteral LA formulation of rilpivirine (RPV) (Janssen) for intramuscular (IM) injection in combination with ViiV Healthcare’s parenteral LA formulation of the integrase inhibitor cabotegravir (CAB) for IM injection may offer improved adherence and treatment satisfaction in virologically suppressed patients.
The IMPALA study is a phase 3b randomised, multicentre, open-label study evaluating the effectiveness of switching to two-monthly long-acting injectable cabotegravir and rilpivirine from first-line oral antiretroviral therapy in HIV-1 positive virologically suppressed adults with a history of, or at risk of, sub-optimal HIV control in sub-Saharan Africa.
The primary objective of the study was to demonstrate the non-inferior efficacy of switching to every 2 months (Q2M) intramuscular (IM) injection of cabotegravir (CAB) long-acting (LA) plus Rilpivirine (RPV) LA compared with continuation of daily oral ART over 12 months in people living with HIV-1 (PLHIV1) with a history of, or at risk of, sub-optimal ART adherence or engagement in care.
RESULTS: The 2-monthly injectable cabotegravir + Rilpivirine (CAB/RPV) regimen was non-inferior to daily oral Dolutegravir-based therapy. At week 48, 91% of participants in the injectable arm maintained a viral load below 50 copies/mL, compared to 89% in the oral treatment arm.
Expected impact: The results, alongside similar data from the CARES study, supported WHO’s decision to include this regimen in the updated HIV treatment guidelines. This has emphasized the need to expand access to long-acting injectables for PLHIV in Africa.
Recruitment rate: 100%
Retention rate: 100%
