Pitavastatin 4 mg Provides Superior LDL-C Reduction vs. Pravastatin 40 mg Over 12 weeks in HIV-Infected Adults with Dyslipidemia, the INTREPID Trial

Drug Interactions and Antiretroviral Drug Monitoring

“…56 Recently the INTREPID study (NCT01301066) was conducted to assess the effects of pitavastatin versus pravastatin in lowering cholesterol in HIV-infected adults receiving cART. 57 In this multicenter, 12-week, randomized, trial followed by a 40-week safety extension study, patients were randomized to receive either pitavastatin or pravastatin. Participants randomized to pitavastain had greater reductions of LDL-c levels and had similar adverse event rates compared to those randomized to pravastatin (9.8% difference, p < 0.01).…”

Use of HMG-CoA Reductase Inhibitors in the HIV Population: Implications for Individualized Treatment Selection

“…The primary outcome measure was the percent change in fasting serum LDL-C from baseline to week 12. 35 TC was lowered by 20.4% in the pitavastatin group, compared with 13.8% in the pravastatin group (P < 0.001). LDL-C was lowered by 35.1% in the pitavastatin group, compared with 20.9% in the pravastatin group (P < 0.001).…”

“…Adverse events in the pravastatin arm included arthralgia (n = 4), myalgia (n = 3), back pain (n = 2), and pain in an extremity (n = 3). 35 A randomized, multicenter, open-label trial was conducted to compare the efficacy of rosuvastatin 10 mg and pravastatin 40 mg, after 45 days treatment, on plasma lipid levels in 88 HIV-1-infected patients taking a combined ART regimen containing at least 1 PI boosted with ritonavir. The primary outcome measure was the change in LDL-C. 36 Median change in TC was -14% in the pravastatin group compared with -28% in the rosuvastatin group (P < 0.001).…”

“…The overall adverse event profiles of pitavastatin 4 mg and pravastatin 40 mg appeared similar. 35 PIs, NNRTIs (except rilpivirine), and cobicistat are known to inhibit and/or induce CYP450 iso-enzymes.…”

“…53,54 In contrast, simvastatin and lovastatin are contraindicated for individuals on HIV PIs or cobicistat because of the potential for significant elevation in statin blood concentrations and increased risk for toxicity. 35,49 Co-administration of the NNRTI efavirenz with simvastatin, atorvastatin, or pravastatin can result in significant induction of statin metabolism. 55 The reduced inhibition of HMG-CoA reductase activity during co-administration of efavirenz may result in diminished antilipid efficacy at usual doses, and statin dosages may need to be cautiously increased.…”