Women account for a disproportionate percentage of new human immunodeficiency virus (HIV) infections in sub-Saharan Africa, comprising 59% of 18 million new adult HIV infections in 2017.¹Nachman S et al. Lancet HIV. 2019;6(8):e552-e558. Current treatment for HIV patients consists of daily oral antiretroviral therapy (ART), but inadequate or incomplete adherence leads to treatment failure and drug resistance.¹Nachman S et al. Lancet HIV. 2019;6(8):e552-e558. One option to improve adherence is long-acting ART, which would be given on a monthly or bimonthly basis.¹Nachman S et al. Lancet HIV. 2019;6(8):e552-e558.

Cabotegravir (CAB) is a potent integrase strand transfer inhibitor (INSTI) with unique pharmacokinetic properties that allow for delivery as a long-acting nanosuspension for monthly to quarterly intramuscular (IM) injections.²Trezza C et al. Curr Opin HIV AIDS. 2015;10(4):239-245. It is currently under investigation in combination with rilpivirine (RPV) for the treatment of HIV.²Trezza C et al. Curr Opin HIV AIDS. 2015;10(4):239-245. At the HIV Glasgow 2020 conference, the results for the subgroup of women in the ATLAS-2M trial were presented.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020.

The open-label phase 3 non-inferiority ATLAS-2M trial investigated CAB+RPV maintenance therapy administered every 8 weeks (Q8W; CAB 600mg + RPV 900mg) or Q4W (CAB 400mg + RPV 600mg) in treatment-experienced, HIV-infected adults.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020. A subgroup analysis by sex at birth was planned, and the trial had a target recruitment for women of 25%.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020. The primary endpoint was the proportion of patients with plasma HIV-1 RNA ≥50 copies/mL at week 48.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020. The secondary endpoint was proportion of patients with plasma HIV-1 RNA <50 copies/mL.[mfn referencenumber=3]Benn P et al. Abstract P017. Presented at HIV Glasgow 2020.[/mfn]

In total, 280 women were randomised and treated with CAB+RPV Q8W (n=137) and Q4W (n=143).³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020. Of these women, 56% were white, with a median age of 44 years, and 53% were CAB+RPV-naïve.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020. In the Q8W and Q4W groups, 3.6% and 0% of women respectively, had HIV-1 RNA ≥50 copies/mL.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020. In both arms 91% of women had HIV-1 RNA <50 copies/mL.[mfn referencenumber=3]Benn P et al. Abstract P017. Presented at HIV Glasgow 2020.[/mfn] Five women developed confirmed virologic failure, with none occurring after week 24, and four out of these five had archived NNRTI resistance associated mutations.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020.

Amongst women with prior CAB+RPV exposure in the Q8W arm, 88% preferred the Q8W dose, compared with 8% and 2% of the Q4W and oral doses, respectively.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020. The safety profile was similar in both treatment arms, with mild to moderate injection site reactions that lasted a median duration of three to four days.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020. Fewer than 4% of the study population discontinued due to adverse events.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020. Women without prior CAB+RPV experience reported increased treatment satisfaction.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020.

The results of this subgroup analysis indicate that the long-acting combination of CAB+RPV is effective in women, well tolerated, and with high satisfaction rates.³Benn P et al. Abstract P017. Presented at HIV Glasgow 2020.