HIV Suppression Maintained After Switch to Dolutegravir Regimen

Dolutegravir-based treatment non-inferior to boosted protease inhibitor regimen in virally suppressed HIV-positive patients.

Switching from a boosted protease inhibitor regimen to a dolutegravir (Tivicay)-based regimen maintained viral suppression and decreased blood lipids in HIV-positive patients at high risk of cardiovascular disease (CVD), according to a study presented at the annual International AIDS Society conference in Paris.

Dolutegravir is an HIV integrase strand inhibitor (INSTI) approved in combination with other antiretroviral agents to treat adults with HIV-1 and pediatric patients who weigh at least 30 kg.

The open-label, randomized, non-inferiority NEAT 022 trial included adults with HIV, 50 years or older, with a Framingham CVD risk score of greater than 10% over the next 10 years.

A total of 415 patients from 6 European countries were randomized to switch from a boosted protease inhibitor to dolutegravir or remain on a boosted protease inhibitor for 48 weeks.

The primary endpoints were the proportion of patients with HIV RNA <50 copies/mL at week 48, a non-inferiority margin of -10%, and percentage change of total plasma cholesterol. The secondary endpoints included changes in other plasma lipid fractions and adverse events (AEs).

The results of the study showed that switching to a dolutegravir-based regimen in virologically suppressed HIV-positive patients with a high CVD risk was non-inferior compared with continuing a boosted protease inhibitor-based regimen. No emergent resistance mutations were observed in any of the groups.

Significant improvements were observed in total cholesterol and other lipid fractions—–excluding high-density lipoprotein cholesterol––among patients in the dolutegravir arm.

No significant differences were found in severe, grade 3 or 4, or treatment-modifying AEs.

“Simply having HIV is a risk factor for premature CVD, so it is important for people with HIV and other CVD risk factors to have effective treatment options that avoid adding to that risk,” Michael Aboud, vice president and global medical lead for dolutegravir, said in the release. “We are pleased to collaborate with the NEAT-ID group on this study that showed switching to a dolutegravir-based regimen not only maintained viral suppression in a population with HIV and high risk for CVD, but also improved their overall lipid profile.”

Cardiovascular disease is the leading cause of morbidity and mortality worldwide.

“This is the first switching study targeting a population with high cardiovascular risk,” Jose M Gatell, chief study investigator, senior consultant at Hospital Clinic/IDIBAPS, and professor of medicine at the University of Barcelona, said in the release. “To minimize this risk the interventions should be in this order: maintain the virological suppression, switching to antiretroviral agents with a neutral lipid profile and, if still necessary, adding lipid-lowering agents. In the NEAT 022 study, we have demonstrated that switching from a ritonavir-boosted PI [protease inhibitor] regimen to dolutegravir was able to maintain virological suppression and significantly improved the plasma lipid profile.”