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On October 21, 2008, the FDA approved the use of darunavir (800 mg daily, plus 100 mg of ritonavir) for HIV-infected, antiretroviral-naive patients. Notably, the International AIDS Society (IAS)–USA began recommending this PI for initial treatment regimens more than 2 months ago (JW Infect Dis Aug 27 2008) based on positive results from the ARTEMIS study, which compared ritonavir-boosted darunavir with lopinavir/ritonavir (AIDS Clin Care Aug 11 2008).
The FDA also downgraded the pregnancy category of darunavir from B to C, indicating that the drug should be used in pregnant women only if the potential benefit justifies the potential risk. This rating is comparable to those of some of the other boosted PIs (fosamprenavir, indinavir, lopinavir…