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Arathoon E, Bhorat A, Silaghi R, et al. Etravirine combined with antiretrovirals other than darunavir/ritonavir for HIV-1-infected, treatment-experienced adults: Week 48 results of a phase IV trial. SAGE Open Med. 2017;5:2050312116686482doi: 10.1177/2050312116686482.
Arathoon, E., Bhorat, A., Silaghi, R., Crauwels, H., Lavreys, L., Tambuyzer, L., Van Baelen, B., Vanveggel, S., & Opsomer, M. (2017). Etravirine combined with antiretrovirals other than darunavir/ritonavir for HIV-1-infected, treatment-experienced adults: Week 48 results of a phase IV trial. SAGE open medicine, 52050312116686482. https://doi.org/10.1177/2050312116686482
Arathoon, Eduardo, et al. "Etravirine combined with antiretrovirals other than darunavir/ritonavir for HIV-1-infected, treatment-experienced adults: Week 48 results of a phase IV trial." SAGE open medicine vol. 5 (2017): 2050312116686482. doi: https://doi.org/10.1177/2050312116686482
Arathoon E, Bhorat A, Silaghi R, Crauwels H, Lavreys L, Tambuyzer L, Van Baelen B, Vanveggel S, Opsomer M. Etravirine combined with antiretrovirals other than darunavir/ritonavir for HIV-1-infected, treatment-experienced adults: Week 48 results of a phase IV trial. SAGE Open Med. 2017 Jan 18;5:2050312116686482. doi: 10.1177/2050312116686482. eCollection 2017. PMID: 28382208; PMCID: PMC5367767.
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SAGE Open Med. 2017 Jan 18;5:2050312116686482. doi: 10.1177/2050312116686482. eCollection 2017.

Etravirine combined with antiretrovirals other than darunavir/ritonavir for HIV-1-infected, treatment-experienced adults: Week 48 results of a phase IV trial.

SAGE open medicine

Eduardo Arathoon, Asad Bhorat, Rodica Silaghi, Herta Crauwels, Ludo Lavreys, Lotke Tambuyzer, Ben Van Baelen, Simon Vanveggel, Magda Opsomer

Affiliations

  1. La Clinica Familiar de Luis Angel Garcia, Guatemala City, Guatemala.
  2. Soweto Clinical Trials Centre, Johannesburg, South Africa.
  3. Infectious Diseases Hospital, Bra?ov, Romania.
  4. Janssen Pharmaceutica NV, Beerse, Belgium.

PMID: 28382208 PMCID: PMC5367767 DOI: 10.1177/2050312116686482

Abstract

OBJECTIVE: VIOLIN (TMC125IFD3002; NCT01422330) evaluated the safety, tolerability, and pharmacokinetics of etravirine with antiretrovirals other than darunavir/ritonavir in HIV-1-infected patients.

METHODS: In a 48-week, phase IV, single-arm, multicenter study, patients on prior antiretroviral therapy (⩾8 weeks) who needed to change regimen for virologic failure (viral load ⩾ 500 copies/mL) or simplification/adverse events (viral load < 50 copies/mL) received etravirine 200 mg bid with ⩾1 other active antiretroviral, excluding darunavir/ritonavir or only nucleoside/tide reverse transcriptase inhibitors.

RESULTS: Of 211 treated patients, 73% (n = 155) had baseline viral load ⩾ 50 copies/mL and 27% (n = 56) had baseline viral load < 50 copies/mL. Protease inhibitors were the most common background antiretrovirals (83%). Diarrhea was the most frequent adverse event (17%). Serious adverse events (no rash) occurred in 5% of patients; none were etravirine related. Overall, median etravirine AUC

CONCLUSION: Etravirine 200 mg bid in combination with antiretrovirals other than darunavir/ritonavir was well tolerated in the studied treatment-experienced HIV-1-infected population. The overall etravirine safety and tolerability profile and pharmacokinetics (specifically in those patients who were adherent) were similar to those previously observed for etravirine in HIV-1-infected adults. The relatively high level of non-adherence, also observed in the pharmacokinetic assessments, negatively impacted virologic response, especially in patients with ⩾50 copies/mL at baseline.

Keywords: Etravirine; efficacy; pharmacokinetics; safety; virology

Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: H.C., L.T., S.V

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