PMID- 37933062
OWN - NLM
STAT- MEDLINE
DCOM- 20231115
LR  - 20231129
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 102
IP  - 44
DP  - 2023 Nov 3
TI  - Safety of low dose efavirenz regimen in Indian adults with HIV-1 infection: 
      Insights from a phase 4 interventional randomised trial.
PG  - e35643
LID - 10.1097/MD.0000000000035643 [doi]
LID - e35643
AB  - 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.
CI  - Copyright (c) 2023 the Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Dravid, Ameet N
AU  - Dravid AN
AUID- ORCID: 0000-0002-1909-7530
AD  - Department of Medicine, Poona Hospital and Research Centre, Maharashtra, India.
FAU - Pilawan, Anant S
AU  - Pilawan AS
AD  - Department of Medicine, Government Medical College & Hospital, Maharashtra, 
      India.
FAU - Anuradha, S
AU  - Anuradha S
AD  - Department of Medicine, Maulana Azad Medical College, New Delhi, India.
FAU - Morkar, Dnyanesh N
AU  - Morkar DN
AD  - Department of Medicine, KLE Hospital, Karnataka, India.
FAU - Ramapuram, John T
AU  - Ramapuram JT
AD  - Department of Medicine, Kasturba Medical College, Karnataka, India.
FAU - Madhukarrao, Kulkarni Milind
AU  - Madhukarrao KM
AD  - Department of Medicine, Sahyadri Specialty Hospital, Maharashtra, India.
FAU - Naik, K Sunil
AU  - Naik KS
AD  - Department of Medicine, Rajiv Gandhi Institute of Medical Science and RIMS 
      Government General Hospital, Andhra Pradesh, India.
FAU - Bhrusundi, Milind
AU  - Bhrusundi M
AD  - Department of Medicine, NKP Salve Institute of Medical Sciences and Late 
      Mangeshkar Hospital, Maharashtra, India.
FAU - Raveendra, K R
AU  - Raveendra KR
AD  - Department of Medicine, Bangalore Medical College and Research Institute, 
      Karnataka, India.
FAU - Nageswaramma, Siddabathuni
AU  - Nageswaramma S
AD  - Department of Dermatology, Guntur Government General Hospital, Andhra Pradesh, 
      India.
FAU - Kulkarni, Vinay
AU  - Kulkarni V
AD  - Department of Dermatology, Deenanath Mangeshkar Hospital and Research Centre, 
      Maharashtra, India.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Benzoxazines)
RN  - JE6H2O27P8 (efavirenz)
RN  - 2T8Q726O95 (Lamivudine)
RN  - 99YXE507IL (Tenofovir)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Anti-HIV Agents/therapeutic use
MH  - Benzoxazines
MH  - *HIV Infections/drug therapy
MH  - *HIV-1
MH  - Lamivudine/therapeutic use
MH  - Tenofovir/therapeutic use
MH  - Treatment Outcome
MH  - Viral Load
MH  - Drug Therapy, Combination/adverse effects
PMC - PMC10627601
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2023/11/07 06:45
MHDA- 2023/11/08 06:42
PMCR- 2023/11/03
CRDT- 2023/11/07 01:12
PHST- 2023/11/08 06:42 [medline]
PHST- 2023/11/07 06:45 [pubmed]
PHST- 2023/11/07 01:12 [entrez]
PHST- 2023/11/03 00:00 [pmc-release]
AID - 00005792-202311030-00094 [pii]
AID - 10.1097/MD.0000000000035643 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2023 Nov 3;102(44):e35643. doi: 
      10.1097/MD.0000000000035643.