A long-acting injectable ART regimen of cabotegravir and rilpivirine was highly acceptable and tolerable in patients with HIV-1 infection, according to patient-reported outcomes from the LATTE-2 study presented at the International AIDS Conference in Amsterdam.
“For a successful therapy over a lifetime, an individual with HIV needs to adhere closely to their medication,” Bill Spreen, PharmD, medicines development leader for ViiV Healthcare, told Infectious Disease News. “What we’re seeing with the LATTE-2 data are encouraging signs that a long-acting, infrequently administered regimen could be an alternative for many patients to overcome some of those challenges associated with daily, oral medication taken over a lifetime.”
Safety and efficacy outcomes of the injectable regimen were previously reported. It was found to be as effective as a three-drug oral regimen in maintaining HIV suppression through 96 weeks. Treatment-naive adults with HIV received 30 mg of oral cabotegravir plus 600/300 mg of abacavir/lamivudine once daily during a 20-week induction period. In the following maintenance period, participants were randomly assigned to continue the oral regimen, receive the injections of cabotegravir and rilpivirine once every 4 weeks (Q4W) or receive the injections once every 8 weeks (Q8W). At 96 weeks, virologic suppression, defined as HIV-1 RNA less than 50 copies/mL by the FDA snapshot algorithm, was maintained in 94% of patients in the Q8W group and 87% of patients in the Q4W group as compared to 84% of patients who continued the three-drug oral regimen.
The recent findings highlight patient satisfaction, tolerability and acceptability with the long-acting injectable therapy or the oral regimen determined through patient-reported outcomes.
“This demonstrates that cabotegravir and rilpivirine long-acting is an option for the right patient,” said Miranda Murray, PhD, study co-author and head of ViiV global health outcomes.
Murray and colleagues administered HIV Treatment Satisfaction Questionnaires, which included 10 standard items and an additional two adapted items assessing the level of ease or difficulty with treatment, to study participants. According to the presentation poster, study participants also completed a six-item HIV Medication Questionnaire, which assessed each injectable and oral tablet medication for acceptability, tolerability and participant-reported ease or difficulty with adherence.
When compared with patients randomly assigned to the three-drug oral regimen, patients in the Q8W and Q4W groups reported statistically significant difference in satisfaction with treatment at 96 weeks. Moreover, Murray and colleagues observed that patients who received long-acting cabotegravir and rilpivirine injectable therapy every 4 or 8 weeks were more likely to be satisfied with their treatment than those on the daily oral regimen. In the Q8W group, 89% of patients expressed being “very satisfied” to continue treatment and 88% in the Q4W group reported similar levels of satisfaction. However, only 43% of patients receiving oral medication were “very satisfied” to continue treatment.
“The levels of satisfaction were higher with the long-acting injectable therapy groups in the study than those individuals randomized to oral therapy,” Spreen said.
Furthermore, patients reported on the convenience and difficulty of adhering to their treatment method at 96 weeks, with 76% of Q8W and 68% of Q4W patients reporting that it was never inconvenient or difficult, as compared with the 39% of similar patient responses in the oral regimen group.
“Overall, both the 4-week and 8-week dosing regimens were highly acceptable, tolerable and patients were highly satisfied compared to the daily oral regimen,” Murray added. “That is a great option for the right patients moving forward.” – By Marley Ghizzone
Murray M, et al. Abstract THPEB042. Presented at: International AIDS Conference; July 23-27, 2018; Amsterdam.
Disclosures: Murray and Stern are employed by ViiV Healthcare.