FDA updates guidance for use of HIV and hepatitis C protease inhibitors with statins

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Medicine regulatory authorities in the US have updated their recommendations concerning possible interactions between statins and protease inhibitors used to treat HIV and hepatitis C.

Guidance from the Food and Drug Administration (FDA) emphasises that lovastatin (Mevacor) and simvastatin (Zocor) should never be taken with either HIV or hepatitis C protease inhibitors.

Statins are a class of drug used to reduce levels of cholesterol in the blood. They are widely used by patients taking protease inhibitors, which can cause metabolic disturbances, including an increase in both cholesterol and triglycerides.

Glossary

myopathy

Muscle wastage or disease.

contraindication

A specific situation or circumstance which means that a drug or medical procedure should not be used because it may be harmful. For example, it may be contraindicated to provide drug A to someone who is already taking drug B.

cholesterol

A waxy substance, mostly made by the body and used to produce steroid hormones. High levels can be associated with atherosclerosis. There are two main types of cholesterol: low-density lipoprotein (LDL) or ‘bad’ cholesterol (which may put people at risk for heart disease and other serious conditions), and high-density lipoprotein (HDL) or ‘good’ cholesterol (which helps get rid of LDL).

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

statin

Drug used to lower cholesterol (blood fats).

Several statins and protease inhibitors are metabolised by the body using the same pathway. This can mean that blood levels of statins may be increased, potentially leading to muscle damage, or myopathy. The most severe form of myopathy is called rhabdomyolysis. This can damage the kidneys, leading to kidney failure, which can be fatal.

Specific information on potential interactions and how to manage them is provided in the table below.

Statin

Interacting protease inhibitors

Prescribing recommendation

Atorvastatin

·      tipranavir/ritonavir

·      telaprevir

Avoid atorvastatin

 

·      lopinavir/ritonavir

Use with caution, prescribing lowest does of atorvastatin

 

·      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

·      hepatitis C protease inhibitors

Contraindicated

Pitavastatin

·      atazanavir

·      atazanavir/ritonavir

·      darunavir/ritonavir

·      lopinavir/ritonavir

No dose limitations

Pravastatin

·      darunavir/ritonavir

·      lopinavir/ritonavir

No dose limitations

Rosuvastatin

·      atazanavir

·      atazanavir/ritonavir

·      lopinavir/ritonavir

Limit rosuvastatin dose to 10 mg once daily

simvastatin

·      HIV protease inhibitors

·      hepatitis C protease inhibitors

Contraindicated

The FDA recommendations also emphasise the importance of HIV-positive patients informing their doctors of all medications they are taking.