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Clinical Trial
. 2023 Nov 3;102(44):e35643.
doi: 10.1097/MD.0000000000035643.

Safety of low dose efavirenz regimen in Indian adults with HIV-1 infection: Insights from a phase 4 interventional randomised trial

Ameet N Dravid  1 , Anant S Pilawan  2 , S Anuradha  3 , Dnyanesh N Morkar  4 , John T Ramapuram  5 , Kulkarni Milind Madhukarrao  6 , K Sunil Naik  7 , Milind Bhrusundi  8 , K R Raveendra  9 , Siddabathuni Nageswaramma  10 , Vinay Kulkarni  11
Affiliations
Clinical Trial

Safety of low dose efavirenz regimen in Indian adults with HIV-1 infection: Insights from a phase 4 interventional randomised trial

Ameet N Dravid et al. Medicine (Baltimore). .

Abstract

Background: A randomized interventional phase 4 study in the Indian population confirmed the non-inferiority of the combination tenofovir/lamivudine/efavirenz (TLE)-400 to TLE600. The current manuscript describes in detail the safety profile and patient-reported safety outcomes obtained from the phase 4 study.

Methods: This investigation was part of a phase 4 non-inferiority study with a blinded assessment, conducted across 17 sites in India. The duration of the study was 24 weeks. Safety endpoints assessed included all the adverse events (AEs) related to the study treatment (TLE400 and TLE600). The depression anxiety stress 21-item scale questionnaire and efavirenz-related symptom questionnaire were also used to measure depression, anxiety, stress, and patient experience.

Results: A total of 68 patients (52.3%) reported 261 AEs and 87 patients (64.9%) reported 379 AEs related to study treatment in TLE400 group and TLE600 group respectively, P = .037. The reported AEs associated with central nervous system disorders were lower in the TLE400 group with 41 patients (31.5%) to 61 patients (45.5%) in the TLE600 group. The change from mean baseline value for depression anxiety stress 21-item scale at week 28 in TLE400 group and TLE600 group was -5.1 and -6.2 respectively. Similarly, the mean change from baseline score of efavirenz-related symptoms at week 28 in TLE400 group and TLE600 group were -5.1 and -4.1 respectively.

Conclusion: The low dose efavirenz (400 mg) in combination with tenofovir and lamivudine had a better safety and tolerability profile than the standard dose of efavirenz (600 mg) in combination with tenofovir and lamivudine. Thus, low dose efavirenz should be preferred over the standard dose.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

References

    1. WHO. The Global Health Observatory: HIV. 2023. Available at: https://www.who.int/data/gho/data/themes/hiv-aids#:~:text=Global%20situa.... [access date Aug 16, 2023].
    1. Pebody R. Types of antiretroviral medications. 2021. Available at: https://www.aidsmap.com/about-hiv/types-antiretroviral-medications. [access date Aug 6, 2021].
    1. Hawkins T, Geist C, Young B, et al. . Comparison of neuropsychiatric side effects in an observational cohort of efavirenz- and protease inhibitor-treated patients. HIV Clin Trials. 2005;6:187–96. - PubMed
    1. Blanch J, Martinez E, Rousaud A, et al. . Preliminary data of a prospective study on neuropsychiatric side effects after initiation of efavirenz. J Acquir Immune Defic Syndr. 2001;27:336–43. - PubMed
    1. Perez-Molina JA. Safety and tolerance of efavirenz in different antiretroviral regimens: results from a national multicenter prospective study in 1,033 HIV-infected patients. HIV Clin Trials. 2002;3:279–86. - PubMed

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