Details

Autor(en) / Beteiligte

• Braun, Dominique L
• Turk, Teja
• Tschumi, Fabian
• Grube, Christina
• Hampel, Benjamin
• Depmeier, Carsten
• Schreiber, Peter W
• Brugger, Silvio D
• Greiner, Michael
• Steffens, Daniela
• De Torrenté-Bayard, Cornelia
• Courlet, Perrine
• Neumann, Kathrin
• Kuster, Herbert
• Flepp, Markus
• Bertisch, Barbara
• Decosterd, Laurent
• Böni, Jürg
• Metzner, Karin J
• Kouyos, Roger D
• Günthard, Huldrych F

Titel

Noninferiority of Simplified Dolutegravir Monotherapy Compared to Continued Combination Antiretroviral Therapy That Was Initiated During Primary Human Immunodeficiency Virus Infection: A Randomized, Controlled, Multisite, Open-label, Noninferiority Trial

Ist Teil von

• Clinical infectious diseases, 2019-10, Vol.69 (9), p.1489-1497

Ort / Verlag

US: Oxford University Press

Erscheinungsjahr

2019

Link zum Volltext

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• We randomized 101 patients (2:1) who started combination antiretroviral therapy (cART) during primary human immunodeficiency virus infection and were virologically suppressed for >48 weeks to dolutegravir monotherapy or continuation of cART. At week 48, both groups had 100% virological response. Abstract Background Patients who start combination antiretroviral therapy (cART) during primary human immunodeficiency virus type 1 (HIV-1) infection show a smaller HIV-1 latent reservoir, less immune activation, and less viral diversity compared to patients who start cART during chronic infection. We conducted a pilot study to determine whether these properties would allow sustained virological suppression after simplification of cART to dolutegravir monotherapy. Methods EARLY-SIMPLIFIED is a randomized, open-label, noninferiority trial. Patients who started cART <180 days after a documented primary HIV-1 infection and had an HIV-1 RNA <50 copies/mL plasma for at least 48 weeks were randomized (2:1) to monotherapy with dolutegravir 50 mg once daily or to continuation of cART. The primary efficacy endpoint was the proportion of patients with <50 HIV-1 RNA copies/mL on or before week 48; noninferiority margin 10%. Results Of the 101 patients randomized, 68 were assigned to simplification to dolutegravir monotherapy and 33 to continuation of cART. At week 48 in the per-protocol population, 67/67 (100%) had virological response in the dolutegravir monotherapy group vs 32/32 (100%) in the cART group (difference, 0.00%; 95% confidence interval, –100%, 4.76%). This showed noninferiority of the dolutegravir monotherapy at the prespecified level. Conclusion In this pilot study consisting of patients who initiated cART during primary HIV-1 infection and had <50 HIV-1 RNA copies/mL for at least 48 weeks, monotherapy with once-daily dolutegravir was noninferior to cART. Our results suggest that future simplification studies should use a stratification according to time of HIV infection and start of first cART. Clinical Trials Registration NCT02551523.