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CP-033 Monitoring off-label use of rilpivirine in a University Hospital
  1. C Seguí Solanes,
  2. G Cardona Peitx,
  3. A Andreu Crespo,
  4. L Vilaró Jaques,
  5. X Bonafont Pujol
  1. Hospital Universitari Germans Trias i Pujol, Pharmacy, Badalona, Spain

Abstract

Background Rilpivirine (RPV) is a new non-nucleoside reverse transcriptase inhibitor (NNRTI) approved only in treatment-naïve patients although it is commonly used in switch strategy due to its efficacy, lack of side effects and cost.

Purpose To describe the characteristics, reasons for switching and outcomes from off-label use of RPV in HIV patients.

Materials and methods Data from new RPV treatments were retrospectively collected from electronic prescription and medical history between June and September 2013. We also assessed tolerability and viral load at 12 weeks.

Results 92 patients received RPV, 85% male, mean age 40.3 (21–73). In 89 (96%) patients RPV was associated with emtricitabine plus tenofovir, and in 3 (4%) with lamivudine plus abacavir. 17 (19%) were treatment-naïve patients and 75 (81%) were off-label treatments. Of those who had previously taken antiretroviral agents, 44% switched from NNRTI (79% from efavirenz), 41% from a protease inhibitor, 12% from integrase inhibitors and 3% from other antiretroviral treatments. The main reasons for switching were 47% pill burden, 25% central nervous system side effects, 22% other side effects (50% gastrointestinal toxicity, 38% lipid elevation), 1% resistance to efavirenz, 1% drug interactions and 4% not specified. During the first 12 weeks, 4% of patients discontinued treatment with RPV; 1% for resistance to lamivudine/abacavir, 1% for diarrhoea and 2% for withdrawal. Before switching the treatment, 83% had VL <50 copies/ml and 17% had VL >50 copies/ml, and after 12 weeks all of them were virologically suppressed except one who showed resistance to lamivudine/abacavir.

Conclusions In our hospital more than 80% of RPV treatments are off-label treatments. Clinicians use RPV in switching strategies, to simplify treatment and to avoid side effects. Treatment with RPV is well tolerated and effective. However, more robust clinical data are needed to establish the longer term efficacy, safety and tolerability of RVP as a switch option.

No conflict of interest.

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