Daily 800 mg versus 600 mg Efavirenz for HIV Patients Treating Tuberculosis with a Rifampicin-Based Regimen: An Open Label Randomized Controlled Trial
Daily 800 mg versus 600 mg Efavirenz for HIV Patients Treating Tuberculosis with a Rifampicin-Based Regimen: An Open Label Randomized Controlled Trial
Data
2018
Autores
Xavier, Mariana S.
Trajman, Anete
Schmaltz, Carolina A. S.
Sant’anna, Flavia M.
Maia, Ivan R.
Hadad, David J.
Brasil, Pedro Emmanuel A. A. do
Rolla, Valeria
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Research International
Resumo
Objectives. Pharmacokinetics studies recommend increasing efavirenz dosage in tuberculosis/HIV patients using rifampicin. We
aimed to evaluate efcacy and safety of 600 versus 800 mg of efavirenz in tuberculosis/HIV patients using rifampicin. Design. We
conducted an open label, multicentre, randomized trial from 2006 to 2012.Te primary outcome was the proportion of undetectable
viral load (HIV-VL) within six months. Secondary outcomes were time to achieve primary endpoint, trajectories of HIV-VL,
proportion of any adverse events (AE), proportion of severe and serious AE (SSAE), and time to treatment interruption due
to SSAE. Methods. Efavirenz-na ̈ıve patients were randomized 30 days afer rifampicin-containing regimens initiation to receive
600 (comparison arm) or 800 mg (intervention arm) efavirenz-based regimens and followed-up for 180 days. Results. Sixty-fve
and 67 participants were respectively included in the comparison and intervention arms with 64.6% (52.5%-65.1%) and 62.7%
(50.7%-73.3%) attaining undetectable HIV-VL in six months. Median time to attain undetectable HIV-VL was 70 days in both
arms, with HIV-VL overlapping trajectories during follow-up. Cough, acne, and dizziness were more frequent in the intervention
arm. SSAE were observed in 19.1% (13.8%-25.8%) and 25.0% (18.9%-33.2%), respectively. Survival curves up to the frst SSAE-
attributed treatment interruption were similar. None of the diferences were statistically signifcant. Conclusion. Efcacy of efavirenz
was similar regardless of dosage. Diferences regarding safety occurred as mild and transient events, which did not interfere with
treatment. Similar efcacy and safety (SSAE) and lower tolerance (minor AE) in the intervention group favour the use of 600 mg
efavirenz in patients using rifampicin.
Description
Palavras-chave
Adult, Alkynes, Benzoxazines / administration & dosage*, Benzoxazines / adverse effects, Cyclopropanes, Female, Follow-Up Studies, HIV Infections / complications, HIV Infections / drug therapy*, HIV-1*, Humans, Male, Middle Aged, Rifampin / administration & dosage*, Rifampin / adverse effects, Tuberculosis / complications, Tuberculosis / drug therapy*.
Citação
Xavier MS, Trajman A, Schmaltz CAS, Sant'anna FM, Maia IR, Hadad DJ, do Brasil PEAA, Rolla V. Daily 800 mg versus 600 mg Efavirenz for HIV Patients Treating Tuberculosis with a Rifampicin-Based Regimen: An Open Label Randomized Controlled Trial. Biomed Res Int. 2018 Dec 25;2018:9231835. doi: 10.1155/2018/9231835.