DTG Monotherapy in Early HIV-1 Infection: Study Overview

Study investigating the efficacy of dolutegravir (DTG) monotherapy in early HIV-1 infection showed non-inferiority compared to standard combination antiretroviral therapy (cART). The EARLY-SIMPLIFIED study involved 68 patients on DTG monotherapy and 33 on cART, with both groups achieving HIV RNA suppression below 50 c/mL at 48 weeks. Adverse events and treatment discontinuations were minimal in both groups. DTG monotherapy was found to be a viable option for patients with early HIV-1 infection. (Word count: 76)

• DTG Monotherapy
• HIV-1 Infection
• Antiretroviral Therapy
• Clinical Study
• Efficacy

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1. Switch to DTG monotherapy DOMONO Study MONCAY Study EARLY-SIMPLIFIED Study

2. EARLY-SIMPLIFIED Study: DTG monotherapy for maintenance Design Randomisation 1:2 Open label 18 years Continuation cART (N = 33) Documented primary HIV-1 infection No previous treatment failure No major resistance mutations to INSTI On 2 NRTI + NNRTI or PI/r or INSTI HIV RNA < 50 c/mL 48 weeks Negative HBs Ag DTG monotherapy (N = 68) D1 W48 Objective Primary: % HIV RNA < 50 c/mL at W48, by ITT, LOCF ; non-inferiority if upper margin of a one-sided 95% CI for the difference = 10%, power 80% Braun DL, Clin Infect Dis 2019, Janv 2, Epub ahead of print EARLY-SIMPLIFIED

3. EARLY-SIMPLIFIED Study: DTG monotherapy for maintenance Baseline characteristics and patient disposition Continuation cART N = 33 DTG monotherapy N = 68 Median age, years 43 42 Female, % 3 4.4 Days from infection to ART start, median 36 39 Nadir CD4/mm3, median (IQR) 329 (269 - 442) 376 (263 - 496) Median duration on cART, years 3.3 3.8 Current CD4/mm3, median 669 730 ART regimen at baseline, % INSTI-based DTG-based 45.5 39.4 58.8 48.5 Discontinuation D1-W48, N 1 (moved abroad) 1 (protocol violation) Braun DL, Clin Infect Dis 2019, Janv 2, Epub ahead of print EARLY-SIMPLIFIED

4. EARLY-SIMPLIFIED Study: DTG monotherapy for maintenance HIV RNA < 50 c/mL at W48 Difference (95% CI) Continuation cART (N = 33) DTG monotherapy (N = 68) 1.47 ITT % 100 100 100 6.85 98.5 100 80 0.0 Per 60 protocol 4.76 40 + 10% 12% 0 20 DTG monotherapy Continuation cART 0 ITT Per protocol Non inferiority achieved at W48 Braun DL, Clin Infect Dis 2019, Janv 2, Epub ahead of print EARLY-SIMPLIFIED

5. EARLY-SIMPLIFIED Study: DTG monotherapy for maintenance Adverse events Continuation cART N = 33 DTG monotherapy N = 68 Adverse event related to study drug 18.2% 13.2% Adverse event leading to switch N = 3 N = 0 Any serious adverse event 6.1% 8.8% Serious adverse event related to study drug N = 0 N = 0 Braun DL, Clin Infect Dis 2019, Janv 2, Epub ahead of print EARLY-SIMPLIFIED

6. EARLY-SIMPLIFIED Study: DTG monotherapy for maintenance Conclusion In patients who initiated cART < 180 days after the estimated day of a document primary HIV-1 infection and had HIV-1 RNA < 50 c/mL for more than 48 weeks, DTG monotherapy was non-inferior to cART Braun DL, Clin Infect Dis 2019, Janv 2, Epub ahead of print EARLY-SIMPLIFIED