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:
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Authors | Ameet N Dravid, Anant S Pilawan, S Anuradha, Dnyanesh N Morkar, John T Ramapuram, Kulkarni Milind Madhukarrao, K Sunil Naik, Milind Bhrusundi, K R Raveendra, Siddabathuni Nageswaramma, Vinay Kulkarni |
Journal | Medicine
(Medicine (Baltimore))
Vol. 102
Issue 44
Pg. e35643
(Nov 03 2023)
ISSN: 1536-5964 [Electronic] United States |
PMID | 37933062
(Publication Type: Randomized Controlled Trial, Clinical Trial, Phase IV, Journal Article)
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Copyright | Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc. |
Chemical References |
- Anti-HIV Agents
- Benzoxazines
- efavirenz
- Lamivudine
- Tenofovir
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Topics |
- Adult
- Humans
- Anti-HIV Agents
(therapeutic use)
- Benzoxazines
- HIV Infections
(drug therapy)
- HIV-1
- Lamivudine
(therapeutic use)
- Tenofovir
(therapeutic use)
- Treatment Outcome
- Viral Load
- Drug Therapy, Combination
(adverse effects)
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