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Issue No. 9 | March 2, 2012

News and Features

FDA Issues Safety Announcement About Interactions Between Certain HIV or Hepatitis C Drugs and Cholesterol-Lowering Statin Drugs

“The U.S. Food and Drug Administration (FDA) is issuing updated recommendations concerning drug-drug interactions between drugs for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) known as protease inhibitors and certain cholesterol-lowering drugs known as statins. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.

“The labels for both the HIV protease inhibitors and the affected statins have been updated to contain consistent information about the drug-drug interactions. These labels also have been updated to include dosing recommendations for those statins that may safely be co-administered with HIV or HCV protease inhibitors … .

“Healthcare professionals should refer to the current drug labels for protease inhibitors and statins for the latest recommendations on prescribing these drugs.

“Patients should contact their healthcare professional if they have any questions or concerns about taking protease inhibitors and statins.”
More information is available:

Study Examines Effect of HIV Infection, Immunodeficiency, and Antiretroviral Therapy on the Risk of Hepatic Dysfunction

“Limited data exists regarding the effect of chronic HIV infection on the liver. We sought to characterize the hepatic risks of HIV infection, immunodeficiency and cumulative use of antiretroviral therapy (ART). …

“Adult HIV-infected and 10:1 age- and sex-matched HIV-uninfected individuals were followed for incident hepatic dysfunction or hepatic dysfunction-related death. Multivariable Poisson regression models were used to obtain incident rate ratios, adjusting for multiple hepatic risk factors including alcohol/drug abuse, hepatitis B and C, and diabetes. …

“We identified 20,775 HIV-infected and 215,158 HIV-uninfected individuals. HIV-infected individuals had a significantly greater overall risk compared with HIV-uninfected individuals of both hepatic dysfunction and hepatic dysfunction-related death. The highest risk was seen in patients with low CD4 cell counts not on ART (adjusted rate ratio (aRR) of hepatic dysfunction-related death 59.4; (95% confidence interval [CI]: 39.3-89.7), P< 0.001; hepatic dysfunction, aRR 15.7 (95% CI: 11.4-21.6), P<0.001. In an HIV-infected only model, factors that increased risk included low CD4 cell count, high HIV RNA level, alcohol/drug abuse, hepatitis B or C co-infection, and diabetes. Longer cumulative exposure to ART did not increase risk, regardless of therapy class. …

“HIV-infected individuals have a higher risk of hepatic dysfunction and hepatic dysfunction-related death compared with HIV-uninfected individuals, even with adjustment for known hepatic risk factors. Hepatic outcomes were associated with lower CD4+ T-cell counts, but not with longer cumulative ART exposure. These findings provide indirect evidence supporting early use of ART to reduce the risk for hepatic-related complications.”

More information is available: