Chapter 7 162 Efficacy, safety, and tolerability of etravirine with and without darunavir/ ritonavir or raltegravir in treatment-experienced patients: analysis of the etravirine early access program in the USA Setup From September 2006 onwards, the international etravirine expanded access program provided access to etravirine in the US. Data were prospectively collected till week 48 and the protocol, any amendments and patient consent forms were approved by Institutional Review Boards. The study was conducted in accordance with the Guidelines for Good Clinical Practice and the ethical principles of the Declaration of Helsinki and editorial support was funded by the sponsor, Tibotec Therapeutics. Patients The expanded access program was open to patients with a proven HIV-infection being relapsed/ refractory to multiple conventional antiretroviral treatment options. Of 2969 screened patients for the expanded access program, 2578 patients were included in the analysis population. Patients had a median age of 47 years (range, 43-52). Interventions All patients received two 100 mg tablets of etravirine, a direct inhibitor of the reverse transcriptase enzyme of human immunodeficiency virus type 1 (HIV-1), twice daily. Etravirine treatment was continued until loss to follow-up, virologic failure, treatment-limiting toxicity, pregnancy, or until etravirine became commercially available. Outcome Plasma viral load and CD4+ count were evaluated, together with safety and tolerability of etravirine in combination with other ARVs. These outcomes were evaluated in several subgroups using different antiretroviral therapy combinations in addition to etravirine. In total, 62.3% of the patients achieved a viral load of <75 copies per milliliter by week 48. These viral response rates were similar across subgroups. Median CD4+ count steadily rose from baseline to week 48, resulting in a median change from baseline of more than 100 cells per cubic millimeter. Results in the subgroups ranged from approximately 80 cells per cubic millimeter to 130 cells per cubic millimeter. In the overall population, the incidence of serious adverse events was 2.0%. The most common AEs leading to discontinuation were rash (1.2%), diarrhea (0.3%), nausea (0.2%), sepsis (0.2%), and vomiting (0.2%).
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