Monthly cabotegravir-rilpivirine favoured by PLHIV
Persons living with HIV (PLHIV) who received monthly long-acting (LA) intramuscular formulations of the INSTI* cabotegravir and the NNRTI** rilpivirine reported higher levels of treatment satisfaction and treatment acceptance, and greater willingness to continue therapy as opposed to a daily oral antiretroviral therapy (ART) regimen, according to patient-reported outcomes of the ATLAS*** and FLAIR# trials presented at IAS 2019.
In ATLAS, 616 individuals (median age 42 years, 33 percent female) who were virologically suppressed for >6 months on an oral regimen## were randomized 1:1 to either switch to monthly LA cabotegravir 400 mg plus rilpivirine 600 mg (C+R) after a lead-in phase with oral C+R once daily for 4 weeks, or to continue their current daily oral ART regimen. [IAS 2019, abstract MOAB0103]
After adjusting for baseline score, age, sex, race, and third agent class at week 44, participants in the C+R arm reported better treatment satisfaction than those in the ART arm (adjusted mean change, 5.68, 95 percent confidence interval [CI], 4.37–6.98; p<0.001).
Treatment acceptance rate was also better with C+R vs ART at week 48 (adjusted mean change, 10.7, 95 percent CI, 7.1–14.4; p<0.001), with majority of the C+R recipients rating their injection site reactions (ISRs) as ‘totally’ or ‘very’ acceptable (90 percent and 86 percent, respectively). Only 1 percent of those who had ISRs withdrew from treatment.
Overall, 94 percent and 66 percent of participants in the C+R and ART arms, respectively, noted that they were ‘satisfied to continue treatment’. Almost all participants (97 percent) in the overall cohort preferred LA treatment over daily ART, translating to a high level of treatment satisfaction, noted the researchers.
The maintenance phase of FLAIR included 566 participants (median age 34 years, 22 percent female) who achieved HIV-1 RNA <50 c/mL at week 16. Subjects were randomized 1:1 to either transition to an injectable LA C+R regimen as in ATLAS or continue oral induction therapy comprising dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). [IAS 2019, abstract MOPEB258]
At week 48, C+R recipients reported greater improvement in treatment satisfaction vs those who remained on DTG/ABC/3TC (adjusted mean change, 4.1, 95 percent CI, 2.8–5.5; p<0.001).
Week 48 also saw a reduction in the frequency of ISRs in the C+R arm from baseline (from 71 percent to 20 percent), with a greater fraction of participants rating the ISRs as ‘totally’ or ‘very’ acceptable (55 percent and 31 percent, respectively). Statistically significant improvements in mean PIN### ‘Acceptability of ISRs’ dimension scores were noted from week 5 to weeks 41 and 48 (from 2.08 to 1.71 [p<0.001] and 1.66 [p<0.001], respectively).
With 99 percent of the overall cohort preferring C+R over their prior oral regimen, the FLAIR findings likewise reflected a clear preference for monthly injectable formulations despite the necessary clinic visits, noted the researchers.
Taken together, the high level of overall acceptability observed in both ATLAS and FLAIR trials suggests that the LA C+R regimen met subjects’ expectations. Investigators of both trials concur that the findings support the therapeutic potential of monthly LA C+R for virologically suppressed PLHIV seeking an alternative to daily oral regimens, which could facilitate or even improve treatment adherence and enhance convenience while reducing dosing frequency.