April 29, 2014
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Rilpivirine-based regimen yielded fewer lipid changes than efavirenz

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In adults with HIV, daily treatment with rilpivirine appeared to yield fewer lipid changes and similar body fat changes after 96 weeks compared with efavirenz, according to recent findings.

The study was a subanalysis of the ECHO and THRIVE studies, which compared the safety and efficacy of rilpivirine (Edurant, Janssen) and efavirenz (Sustiva, Bristol-Myers Squibb) given with two nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs). The subanalysis focused on comparing the long-term effects of rilpivirine and efavirenz on blood lipids and distribution of body fat, and also assessed the N[t]RTI background regimen.

The researchers evaluated overnight lipids at screening visits, at baseline, at each visit up to 96 weeks, and 4 weeks after the end of the study. They also measured blood levels of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides, and they monitored adverse effects, such as dyslipidemia and lipodystrophy.

They found that total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides were minimally affected by rilpivirine. Compared with rilpivirine, efavirenz resulted in significantly elevated lipids (P<.001). Efavirenz and rilpivirine yielded comparable decreases in total cholesterol and HDL cholesterol.

The background regimen of N[t]RTIs appeared to have an intensifying effect on rilpivirine-induced lipid changes. With zidovudine/lamivudine and abacavir/lamivudine (Epzicom, ViiV Healthcare), all lipids were increased, except triglycerides, which were unchanged. Emtricitabine/tenofovir (Truvada, Gilead) resulted in increased HDL cholesterol, slightly changed total cholesterol and decreased triglycerides.

Efavirenz led to lipid increases in each N[t]RTI subgroup.

Fewer rilpivirine-treated patients than efavirenz-treated patients had total cholesterol, LDL and triglyceride levels above the cutoffs established by the National Cholesterol Education Program (NCEP). In addition, more rilpivirine than efavirenz patients had HDL cholesterol levels below the NCEP cutoffs (P=.0186). Rilpivirine-treated patients had a lower prevalence of dyslipidemia adverse events than those treated with efavirenz.

Loss of limb fat was comparable between rilpivirine vs. efavirenz patients, and both groups experienced a significant increase in limb fat (P<.0001). Patients receiving a zidovudine/lamivudine background regimen were found to have lost limb fat at week 96, whereas those on emtricitabine/tenofovir had an increase in limb fat.

“The 96-week pooled analyses of ECHO/THRIVE demonstrate that rilpivirine results in significantly lower increases in serum lipid parameters, and fewer treatment-emergent lipid abnormalities versus [efavirenz], while it was associated with similar changes in Framingham

[coronary heart disease] risk scores and body fat distribution changes,” the researchers wrote. “These analyses support the overall findings from ECHO/THRIVE indicating that [rilpivirine] has a more favorable safety profile than [efavirenz] at week 96.”

Disclosure: Please see the full study for a list of relevant disclosures.