Healthcare providers in the US have been notified of a possible connection between treatment with the protease inhibitor fosamprenavir (Lexiva in the US, Telzir in Europe) and heart attack. There is also a caution that therapy with the drug can cause increases in cholesterol.
GlaxoSmithKline (GSK), who make the drug, notified healthcare professionals that myocardial infarction (heart attack) and increases in cholesterol have been added to the list of possible side-effects on fosamprenavir’s product label.
The move comes after a French study (FHDH ANRS CO4) presented to the Conference on Retroviruses and Opportunistic Infections earlier this year showed that each year of therapy with the drug increased the risk of heart attack by 54%.
GSK are also reminding healthcare professionals of the importance of monitoring cholesterol and triglycerides before and during treatment with fosamprenavir. The company also recommends that other risk factors for cardiovascular disease, such as high blood pressure, diabetes and smoking should also be evaluated.
Results from the D:A:D study have previously identified therapy with protease inhibitors generally as a risk factor for heart attack. More recent results from this study group found an independent association between therapy with Kaletra (lopinavir/ritonavir) and myocardial infarction.
Neither fosamprenavir nor Kaletra are “preferred” options in the most recent US antiretroviral treatment guidelines for patients starting HIV therapy for the first time.