Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience

Condition(s) studied

Investigational drug(s) / intervention(s)

DTG/3TC: Dual therapy of 2 drugs co-formulated in 1 tablet: Dolutegravir 50 mg/ lamivudine 300 mg, it is the experimental group

Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF): It is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains bictegravir 50 mg, tenofovir alafenamide 25 mg, and emtricitabine 200 mg. It is the standard therapy.

Study summary

Background: The primary goal of antiretroviral therapy is to prevent HIV-associated morbidity and mortality. The effectiveness of first-line regimens is supported by a large number of clinical trials; current concerns focus on the long-term adverse effects of antiretrovirals, especially integrase strand transfer inhibitors, as they have been associated with significant weight gain, which may be associated with increased cardiovascular risk.

Objective: To determine the effectiveness, safety, and tolerability of Dolutegravir/Lamivudine (DTG/3TC) compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/TAF/FTC) in treatment-naive people living with HIV (PWH). Materials and methods: With prior approval from the Ethics and Scientific Research Committee 3502, an open-label, randomized clinical trial will be conducted at the Infectious Diseases Hospital of the National Medical Center "La Raza" from November 2024 to May 2026. Recently diagnosed PWH with no history of PrEP and/or PeP use, without hospitalization criteria, and without a diagnosis of metabolic syndrome based on ATP-III criteria will be identified. They will be invited to participate in the study and, if they accept, they will sign an informed consent form. They will be randomized to start a BIC/TAF/FTC or DTG/3TC 1:1 regimen. Laboratory studies, vital signs, and somatometry including bioimpedance will be performed at 4, 12, 24, 36, 48, 72, 96, 120, 144 weeks of follow-up; viral load and CD4+ count will be measured at weeks 12, 24, 48, 72, 96, 120, 144 weeks after the start of treatment. Sampling will be non-probabilistic; the distribution will be identified using the Kolmogorov-Smirnoff test, and measures of central tendency and percentages will be expressed. Comparisons will be made using the Mann-Whitney U test. Qualitative data will be analyzed using the x2 or Fisher's exact test. Group analysis will be performed at 12, 24, 48, 96 and 144 weeks using the Wilcoxon test. A P value ≤0.05 with a 95% confidence interval will be considered statistically significant.

Eligibility

Primary outcome measure(s)

• To determine the effectiveness of Dolutegravir/Lamivudine compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine in ART-naive people with HIV at 144 weeks of treatment. — 144 weeks of follow-up with interim analysis at 48 and 96 weeks
  -Effectiveness: Number of participants with viral load measurement (HIV-1 RNA) \<50 copies/mL at 144 weeks of follow-up for PWH treated with DTG/3TC or BIC/FTC/TAF, expressed in proportions.
• To determine the safety of Dolutegravir/Lamivudine compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine in ART-naive people living with HIV at 144 weeks of treatment. — 144 weeks, with intermediate measurements at 48 and 96 weeks
  Number of participants with treatment-related adverse events as assessed of serious adverse events (WHO grade 3 or 4) for PWH treated with DTG/3TC or BIC/FTC/TAF at 144 weeks, expressed in proportions of new cases.
• To determine the tolerability of Dolutegravir/Lamivudine compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine in ART-naive people living with HIV at 144 weeks of treatment. — 144 weeks, intermediate measurements at 48 and 96 weeks
  Number of participants with secondary events associated with ART for PWH treated with DTG/3TC or BIC/FTC/TAF at 144 weeks expressed in proportions and percentages, graded from 1 to 4 according to DAIDS: Grade I: mild Grade II: moderate Grade III: severe Grade IV: life-threatening

Trial sites (1)

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