Abstract
Efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (E/C/F/TDF) in treatment-naïve and experienced patients with HIV infection was demonstrated in phase 3 trials. The primary objective of this study was to evaluate effectiveness and safety of E/C/F/TDF in real world settings. Retrospective, observational data collected by the Turkish ACTHIV-IST study group between May 2015 and December 2016 were analysed. A total of 387 patients were prescribed E/C/F/TDF; 210 patients with available data at 6th month were eligible; 91.5% were male, and mean age was 35.2 (SD: 10.8) years; 54.0% of males identified themselves as MSM. Sixty-three percent (133) of the study population were treatment-naïve patients, and 37% (77) were treatment experienced. HIV RNA level was below 100 copies/mL in 78.9% of treatment-naïve patients and 89.9% of treatment experienced patients at month 6. Median increase in CD4 T lymphocyte count was 218 copies/mL in treatment-naïve patients and remained stable or increased in treatment experienced patients. Adverse events were observed in 15% of the patients, and the regimen was discontinued in only six patients. Real world data on the effectiveness and safety of E/C/F/TDF is comparable with the phase 3 trial results Adverse events are uncommon and manageable.
Highlights
The World Health Organisation (WHO) estimates that 36.7 million people were living with human immunodeficiency virus (HIV) in 2016, and 1.8 million of them were newly infected in that year
In 2016, 69.5% othe people living with HIV (PLWH) were diagnosed, of whom 76.5% were on antiretroviral ther
91.0% were male, mean age was 35.0 (SD: 10.7) years, and 53.4% of males described themselves as men who have sex with men (MSM)
Summary
The World Health Organisation (WHO) estimates that 36.7 million people were living with human immunodeficiency virus (HIV) in 2016, and 1.8 million of them were newly infected in that year. The results of the phase 3 trials revealed that E/C/F/TDF was effective in more than 80% of treatment-naïve and 78-87% of treatment experienced patients[7,8,9,10,11]. Efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (E/C/F/TDF) in treatment-naïve and experienced patients with HIV infection was demonstrated in phase 3 trials. Conclusion: Real world data on the effectiveness and safety of E/C/F/TDF is comparable with the phase 3 trial results Adverse events are uncommon and manageable.
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