Gatell JM, et al. - This study was performed to compare the efficacy, safety, and impact on lipid fractions of switching from a ritonavir-boosted protease inhibitor (PI/r) to a dolutegravir (DTG) regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk. Findings revealed that switching to a DTG regimen was noninferior, and significantly improved lipid profiles in these patients.

Methods

• Eligible patients were HIV type 1-infected adults more than 50 years or with a Framingham score more than 10%, if plasma HIV RNA less than 50 copies per ml for at least 24 weeks while on a PI/r regimen.
• Researchers randomized patients to switch to DTG or to remain on PI/r.
• For this study, primary endpoints were: proportion maintaining HIV RNA less than 50 copies per ml and percentage change from baseline of total cholesterol at week 48.

Results

• Researchers randomized 415 patients (32 sites in six European countries): 205 to DTG and 210 to continue PI/r.
• In this study, about 89% were men, 87% more than 50 years, 74% had a Framingham score more than 10%, with a median CD4+ cell count of 617 cells per μl and suppressed viremia for a median of 5 years.
• The intent-to-treat analysis indicated treatment success rate of 93.1% in DTG group and 95.2% in PI/r group (difference -2.1%, 95% confidence interval -6.6 to 2.4, noninferiority demonstrated) at week 48.
• With DTG, four virological failures and with PI/r, one virological failure were observed; no emergent resistance mutations appeared.
• Observations revealed no significant difference in severe adverse events or grade 3 or 4 adverse events or treatment modifying adverse events.
• In the DTG group, marked improvement in total cholesterol and other lipid fractions (except high-density lipoprotein cholesterol) was observed (P < 0.001) regardless of PI/r at baseline.