Cardiovascular Risk Assessment Using the Atherosclerotic Cardiovascular Disease Risk Score Model after Continuing or Switching to a Doravirine-Based HIV Treatment Regimen.

BACKGROUND

People living with HIV (PLWH) on antiretroviral therapy have an increased risk of atherosclerotic cardiovascular disease (ASCVD). Doravirine (DOR), a non-nucleoside reverse transcriptase inhibitor, has a favorable lipid profile, minimal effect on weight, and is not expected to impact ASCVD risk. We evaluated the impact of DOR on ASCVD risk in PLWH in 2 phase 3 trials.

SETTING

Post hoc analysis of DRIVE-FORWARD (NCT02275780) and DRIVE AHEAD (NCT02403674).

METHODS

Participants were randomized to DOR + 2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) or ritonavir-boosted darunavir + 2 NRTIs (DRIVE-FORWARD) or to DOR/lamivudine/tenofovir or efavirenz/emtricitabine/tenofovir (DRIVE-AHEAD) for 96 weeks. Participants could continue or switch to the DOR-based regimen in 96-week open-label extensions. The 10-year ASCVD risk was calculated at baseline and weeks 24, 48, 96, and 192.

RESULTS

The 369 participants included 60.4% White men, 19.0% Black/African American men, 11.7% Black/African American women, and 8.9% White women. Baseline characteristics were generally comparable across the subgroups and trials. A slight trend toward increased ASCVD risk scores for men was observed at week 192. This increase was not observed when the analysis used age at baseline as a fixed value instead of natural age at each study visit, suggesting that age rather than DOR might have caused the increase in ASCVD risk scores in the male population.

CONCLUSIONS

After ∼4 years, DOR-based regimens were not associated with changes in ASCVD risk scores in PLWH. Given the increased burden of HIV-associated ASCVD, DOR may represent a therapeutic option that does not increase ASCVD risk.