EARLY-SIMPLIFIED
Trial question
Is switching to dolutegravir monotherapy noninferior to continuation of combination antiretroviral therapy in patients starting combination antiretroviral therapy during primary HIV infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
4.0% female
96.0% male
N = 101
101 patients (4 female, 97 male).
Inclusion criteria: patients who started combination antiretroviral therapy < 180 days after documented primary HIV infection with suppressed viral load.
Key exclusion criteria: pregnancy or lactation; receipt of drugs contraindicated with dolutegravir; dolutegravir intolerance.
Interventions
N=68 dolutegravir monotherapy (at a dose of 50 mg daily).
N=33 combination antiretroviral therapy (continuation of combination antiretroviral therapy).
Primary outcome
Virological response at week 96, per-protocol analysis
100%
100%
100.0 %
75.0 %
50.0 %
25.0 %
0.0 %
Dolutegravir
monotherapy
Combination antiretroviral
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in virological response at week 96, per-protocol analysis (100% vs. 100%).
Secondary outcomes
No significant difference in virological response at week 96, intention-to-treat analysis (98.53% vs. 100%; AD 1.47%, 95% CI -100 to 7.59).
No significant difference in blips (4.4% vs. 9.1%; PD 4.7, 95% CI -8.5 to 17.9).
Safety outcomes
No significant difference in study drug-related adverse events and serious adverse events.
Conclusion
In patients who started combination antiretroviral therapy < 180 days after documented primary HIV infection with suppressed viral load, dolutegravir monotherapy was noninferior to combination antiretroviral therapy with respect to virological response at week 96, per-protocol analysis.
Reference
Emily West, Marius Zeeb, Christina Grube et al. Sustained Viral Suppression With Dolutegravir Monotherapy Over 192 Weeks in Patients Starting Combination Antiretroviral Therapy During Primary Human Immunodeficiency Virus Infection (EARLY-SIMPLIFIED): A Randomized, Controlled, Multi-site, Noninferiority Trial. Clin Infect Dis. 2023 Oct 5;77(7):1012-1020.
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