Safety and Effectiveness of Darunavir in Korean Patients with Human Immunodeficiency Virus 1 Infection: A Post-Marketing Observational Study.

We aimed to evaluate the safety and effectiveness of darunavir (DRV) in the treatment of human immunodeficiency virus-1 (HIV-1) infection in Korea. From October 29, 2010, 225 eligible patients with HIV-1 infection receiving DRV were enrolled. DRV was administered with other antiretroviral agents, and followed for 24 weeks. The primary objective was safety evaluation, and effectiveness was assessed by viral load and CD4 T cell counts after 12 weeks and 24 weeks. Adverse drug reactions occurred in 18 patients (9.2%); diarrhea was the most common. Viral load was controlled (<400 copies/mL) in 90.9% of patients. CD4 T cell counts were increased 45.0/mm³ significantly at Week 12 (P = 0.0002), and 70.5/mm³ at Week 24 (P <0.0001). DRV safety and effectiveness was consistent with previous studies.