Darunavir in experienced patients

Purpose of the study

This study aims to assess the performance of DRV in clinical practice, as part of salvage therapy strategies.

Methods

We did retrospective assessment of HIV+ patients who received DRV at our institution, prescribed as part of a salvage regimen since 2006. Liver, metabolic and renal profile were assessed at baseline, after 1 month and every 3 months. 52 HIV1+ patients have been enrolled; mean age was 48 (IQR 44-54) years, male 82%, IDUs 29%, MSM 37%, heterosexuals 33%; 15 patients were HCV or HBV co-infected. All but one were subtype B. Median CD4 nadir was 82 (IQR 27-234). Thirty-one patients had AIDS history. Mean time on ARVs was 15 (IQR14-17) years; major mutations were: 8 for NRTI, 2 for NNRTI and 5 for PI.

Results

Median follow-up was 104 weeks (IQR 60—139). Two patients died: one following a car accident, the other one due to disseminated Kaposi's sarcoma. Four patients stopped DRV: one lost to follow-up, one developed decompensated diabetes, one rash, one virological failure. Companion drugs with DRV were NRTI (71%), etravirine (14%), maraviroc (33%), raltegravir (RAL) (33%), enfuvirtide (ENF) (33%). Seventeen patients had changes in therapy during follow up, four patients stopped NRTIs, among 13 patients who stopped ENF, 5 replaced with RAL. Mean CD4 and HIV-RNA values at baseline were 251 cells/mm3 and 4.3 log10 copies/ml, respectively; CD4 median monthly increase was 9 (IQR 5.1-14.5) cells/mm3. After 1 month, 49 % had HIV-RNA <50 copies/ml; after 12, 24 and 33 months 91% of patients were still undetectable. No statistically significant modification were seen in transaminases, creatinine, glucose, triglycerides values.

Conclusions

Darunavir was highly effective and well tolerated in most of patients and showed good metabolic, renal and liver profile in our cohort where the rate of co-infected patients was high.