Effects of Steady-State Lopinavir/Ritonavir on the Pharmacokinetics of Pitavastatin in Healthy Adult Volunteers

Morgan, Roger; Campbell, Stuart; Suehira, Kazuhito; Sponseller, Craig A.; Yu, Christine; Medlock, Matthew M.

doi:10.1097/qai.0b013e318251addb

Cited by 26 publications

(10 citation statements)

References 16 publications

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“…Pitavastatin AUC was reduced by ~20%, and C max was unaffected with concurrent use of pitavastatin 4 mg once daily and lopinavir/r 400/100 mg twice a day. 7 When combined with ritonavir-boosted atazanavir, a 31% increase in the pitavastatin AUC was observed. 23 …”

Section: Discussionmentioning

confidence: 98%

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Lack of Pharmacokinetic Interactions Between Pitavastatin and Efavirenz or Darunavir/Ritonavir

Malvestutto

Morse

et al. 2014

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Background The drug–drug interactions between pitavastatin and darunavir/ritonavir (DRV/r) as well as pitavastatin and efavirenz (EFV) were examined in an open-label, parallel-arm, pharmacokinetic (PK) study in HIV-uninfected healthy volunteers. Methods Subjects received a pitavastatin dose of 2 mg for 4 days, followed by either EFV 600 mg (n = 14) or DRV/r 800/100 mg (n = 14) daily for 10 days, and pitavastatin 2 mg coadministered with EFV 600 mg or DRV/r 800/100 mg for 4 days. Full PK profiles were determined for pitavastatin and its lactone metabolite on days 4 and 18 and for EFV or DRV on days 14 and 18. Results In the EFV arm, the geometric mean area under the concentration time curve (AUC0-τ) and Cmax of pitavastatin were 85.3 ng·h·mL−1 and 15.6 ng/mL, respectively, when given alone, versus 76 ng·h·mL−1 and 18.8 ng/mL when coadministered with EFV. The geometric mean ratio for pitavastatin with EFV versus alone was 0.89 [90% confidence interval (CI): 0.73 to 1.09] for AUC0-τ and 1.20 (90% CI: 0.79 to 1.83) for Cmax. In the DRV/r arm, AUC0-τ and Cmax were 62.8 ng·h·mL−1 and 24.0 ng/mL, respectively, when pitavastatin was administered alone, versus 56.9 ng·h·mL−1 and 23.2 ng/mL when coadministered with DRV/r. The geometric mean ratio for pitavastatin with DRV/r versus alone was 0.91 (90% CI: 0.78 to 1.06) for AUC0-τ and 0.93 (90% CI: 0.72 to 1.19) for Cmax. Conclusions There were no significant PK interactions between pitavastatin and EFV or DRV/r. No significant safety issues or lipid changes were noted.

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Section: Discussionmentioning

confidence: 98%

“…6 A PK study assessing the potential DDIs of lopinavir/ritonavir in combination with pitavastatin showed that concomitant administration of both drugs was safe and well tolerated. 7 …”

Section: Introductionmentioning

confidence: 99%

Lack of Pharmacokinetic Interactions Between Pitavastatin and Efavirenz or Darunavir/Ritonavir

Malvestutto

Morse

et al. 2014

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…55 Among 23 healthy subjects, the combination of pitavastatin and twice daily LPV/r did not demonstrate significant differences in serum concentrations of all three drugs when given concurrently versus individually. 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.…”

Section: Drug-drug Interactions For the Treatment Of Chronic Co-morbimentioning

confidence: 99%

Drug Interactions and Antiretroviral Drug Monitoring

et al. 2014

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Due to the improved longevity afforded by combination antiretroviral therapy (cART), HIV-infected individuals are developing several non-AIDS related comorbid conditions. Consequently, medical management of the HIV-infected population is increasingly complex, with a growing list of potential drug-drug interactions (DDIs). This article reviews some of the most relevant and emerging potential interactions between antiretroviral medications and other agents. The most common DDIs are those involving protease inhibitors or non-nucleoside reverse transcriptase inhibitors which alter the cytochrome P450 enzyme system and/or drug transporters such as p-glycoprotein. Of note are the new agents for the treatment of chronic hepatitis C virus infection. These new classes of drugs and others drugs which are increasingly used in this patient population represent a significant challenge with regard to achieving the goals of effective HIV suppression and minimization of drug-related toxicities. Awareness of DDIs and a multidisciplinary approach are imperative in reaching these goals.

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“…Solo existen datos clínicos de interacciones con lopinavir/r, no siendo estas clínicamente significativas 38 .…”

Section: Estatinasunclassified

Documento de consenso sobre alteraciones metabólicas y riesgo cardiovascular en pacientes con infección por el virus de la inmunodeficiencia humana

Metabólicas¹,

Rodríguez²,

Puerto³

et al. 2015

Enfermedades Infecciosas y Microbiología Clínica

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Effects of Steady-State Lopinavir/Ritonavir on the Pharmacokinetics of Pitavastatin in Healthy Adult Volunteers

Abstract: The effect on exposures when pitavastatin and lopinavir/ritonavir are coadministered was minimal. Concomitant use of pitavastatin and lopinavir/ritonavir was safe and well tolerated in healthy adult volunteers.

Cited by 26 publications

References 16 publications

Lack of Pharmacokinetic Interactions Between Pitavastatin and Efavirenz or Darunavir/Ritonavir

Lack of Pharmacokinetic Interactions Between Pitavastatin and Efavirenz or Darunavir/Ritonavir

Drug Interactions and Antiretroviral Drug Monitoring

Documento de consenso sobre alteraciones metabólicas y riesgo cardiovascular en pacientes con infección por el virus de la inmunodeficiencia humana

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