Background Darunavir/cobicistat (DRV/COBI) is an antiviral medicine recently approved in our hospital for simplifying the posology of patients previously treated with darunavir 800 mg and ritonavir 100 mg, in combination with other medicines.
Purpose To evaluate the short term efficacy and safety of DRV/COBI in the treatment of HIV-1 infection.
Material and methods A retrospective observational study was conducted in all patients who initiated therapy with DRV/COBI between November 2015 and July 2016. Data were collected from electronic clinical history and the hospital’s electronic prescribing software. The following variables were collected: sex, age, viral load (VL), creatinine (Cr), transaminases (ALT, AST), and cholesterol (CHO) and triglyceride (TG) blood levels before starting treatment, and 4–8 weeks afterwards. Safety was measured from reported side effects and blood data. Effectiveness was measured by a reduction in VL to <50 copies/mL.
Results 38 patients started treatment (28 men and 10 women), median age 49 years (23–70). Except for 1 patient, all patients had undetectable VL before starting treatment. After 8 weeks, 4 patients had detectable VL (median value: 178 copies/mL (84–421)). After 20 weeks of treatment, 2 achieved undetectable VL. Cr, GOT, GPT, TG and CHO median values pretreatment and after 4–8 of treatment, were, respectively: 0.86 (0.57–1.44) vs 0.92 mg/dL (0.5–1.42); 18 (7–105) vs 24 U/L (6–104); 20 (12–140) vs 24 U/L (12–90); 134 (57–362) vs 119 mg/Dl (54–306); and 190 (98–296) vs 181 mg/dL (114–310). 4 patients reported gastrointestinal side effects and 1 patient felt sick (reported nausea). 5 patients discontinued treatment: 2 because of gastrointestinal side effects, 1 due to nausea and 2 because of potential drug interactions.
Conclusion DRV/COBI is a good strategy for simplifying treatment because 89.5% of patients had undetectable VL after 4–8 weeks of treatment, but these results are still preliminary. Regarding safety, the main adverse effect was gastrointestinal, but in general DRV/COBI was well tolerated.
No conflict of interest
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