Patient Types

Overview

Patients ≥65 years

Patients with type 2 diabetes

Patients taking multiple medications

Patients taking CCBs

Patients taking warfarin

Patients with ≥2 risk factors for CHD

Patients of Asian descent

Patients with HIV

LIVALO effectively lowers LDL-C with no contraindications or dose limitations when prescribed in combination with HIV protease inhibitors*1,2

  • Co-administration of LIVALO with atazanavir, lopinavir/ritonavir, or darunavir/ritonavir did not result in clinically significant changes in the AUC or Cmax of LIVALO1
  • Based on its metabolism predominantly via glucuronidation, LIVALO may have reduced potential for clinically significant drug interactions mediated by the CYP450 system1,3,4

Statin therapy is further supported by established ACC/AHA risk enhancers for ASCVD that include chronic inflammatory diseases, including HIV infection5

  • LIVALO at the maximum daily dose has demonstrated similar safety in patients with chronic HIV infection to non-infected adults with high cholesterol1

The FDA issued contraindications and dose limitations for most statins when used with HIV protease inhibitors†2

FDA Statin-Prescribing Recommendations for Concomitant HIV Protease Inhibitor Therapy ‡2 Statin Interacting protease inhibitor(s) Prescribing recommendation Atorvastatin Tipranavir + ritonavir Avoid atorvastatin Lopinavir + ritonavir Use with caution and use with the lowest atorvastatin dose necessary Darunavir + ritonavir Fosamprenavir Fosamprenavir + ritonavir Saquinavir + ritonavir Do not exceed 20 mg atorvastatin daily Nelfinavir Do not exceed 40 mg atorvastatin daily Fluvastatin No data available Lovastatin HIV protease inhibitors Contraindicated Pitavastatin § Atazanavir ‡ ritonavir Darunavir ‡ ritonavir Lopinavir ‡ ritonavir No dose limitations Pravastatin Darunavir + ritonavir Lopinavir + ritonavir No dose limitations Rosuvastatin Atazanavir ‡ ritonavir Lopinavir ‡ ritonavir Limit rosuvastatin dose to 10 mg once daily Simvastatin HIV protease inhibitors Contraindicated FDA Statin-Prescribing Recommendations for Concomitant HIV Protease Inhibitor Therapy ‡2 Tipranavir + ritonavir Darunavir + ritonavir Fosamprenavir Fosamprenavir + ritonavir Saquinavir + ritonavirNelfinavirHIV protease inhibitorsAtazanavir ± ritonavir Darunavir ‡ ritonavir Lopinavir ‡ ritonavirDarunavir + ritonavir Lopinavir + ritonavirAtazanavir ‡ ritonavir Lopinavir ‡ ritonavirHIV protease inhibitors Atorvastatin Fluvastatin Lovastatin Pitavastatin § Pravastatin Rosuvastatin Simvastatin Avoid atorvastatin Use with caution and use with the lowest atorvastatin dose necessary Do not exceed 20 mg atorvastatin daily Do not exceed 40 mg atorvastatin daily No data available Contraindicated No dose limitations No dose limitations Limit rosuvastatin dose to 10 mg once daily Contraindicated Statin Interactingproteaseinhibitor(s) Prescribingrecommendation Lopin avir + ritonavir

The Infectious Diseases Society of America also cautions on the use of statins with HIV protease inhibitors6

  • Some statins can have potentially serious drug-drug interactions with HIV protease inhibitors, resulting in contraindications or dose limitations6
  • Unlike other commonly prescribed statins, LIVALO and Pravachol® (pravastatin) do not have contraindications or dose limitations when prescribed with HIV protease inhibitors1,6,7
  • In head-to-head studies, LIVALO demonstrated statistically superior LDL-C reductions vs Pravachol® (pravastatin) in both HIV-positive and HIV-negative patients with dyslipidemia1,8-10

Pravachol is a registered trademark of Bristol-Myers Squibb Company.

AUC=area under the curve. Cmax=maximum concentration observed. ASCVD=atherosclerotic cardiovascular disease.

*LIVALO has only been evaluated with certain HIV protease inhibitors.

HIV protease inhibitors are a common component in highly active antiretroviral therapy (HAART), a complex drug regimen used to treat patients living with HIV.

Chart is modified from FDA statin-prescribing recommendations for concomitant HIV and hepatitis C virus therapy. No head-to-head studies were performed with the statins to determine dosing limitations or restrictions.

§Pitavastatin row not highlighted in original FDA chart.

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. FDA Drug Safety Communication: Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury. https://www.fda.gov/Drugs/DrugSafety/ucm293877.htm. Accessed August 11, 2017.
  3. Neuvonen PJ. Drug interactions with HMG-CoA reductase inhibitors (statins): the importance of CYP enzymes, transporters and pharmacogenetics. Curr Opin Investig Drugs. 2010;11(3):323-332.
  4. Corsini A, Ceska R. Drug-drug interactions with statins: will pitavastatin overcome the statins’ Achilles’ heel? Curr Med Res Opin. 2011;27(8):1551-1562.
  5. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2018; https://www.ahajournals.org/doi/suppl/10.1161/CIR.0000000000000625.
  6. Aberg JA, Gallant JE, Ghanem KG, Emmanuel P, Zingman BS, Horberg MA. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2014;58(1):1-10.
  7. Pravachol (pravastatin) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company, Inc.; July 2016.
  8. Kowa Research Institute, Inc. A 12-week study comparing pitavastatin 4 mg vs. pravastatin 40 mg in HIV-infected subjects. https://clinicaltrials.gov/ct2/show/NCT01301066. NLM identifier: NCT01301066. Accessed August 11, 2017. Final CSR. December 2013. DOF07232015.
  9. Sponseller CA, Morgan RE, Kryzhanovski VA, Campbell SE, Davidson MH. Comparison of the lipid-lowering effects of pitavastatin 4 mg versus pravastatin 40 mg in adults with primary hyperlipidemia or mixed (combined) dyslipidemia: a Phase IV, prospective, US, multicenter, randomized, double-blind, superiority trial. Clin Ther. 2014;36(8):1211-1222.
  10. Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013;20(1):40-53.

See adverse reactions and discontinuation rates per dosage.

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