Raltegravir 1200 mg once daily as maintenance therapy in virologically suppressed HIV-1 infected adults: QDISS open-label trial

Nolwenn Hall, Clotilde Allavena, Christine Katlama, Alexandra Jobert, Jean-Michel Molina, Eric Cua, Firouzé Bani-Sadr, Laurent Hocqueloux, Claudine Duvivier, Dominique Merrien, Hitoto Hikombo, Elisabeth André-Garnier, Aurélie Gaultier, François Raffi, QDISS Study Group, Olivier Bollengier, Thomas Guimard, Sophie Leautez, Sophie Blanchi, Agathe Becker, Laurent Cotte, Tristan Ferry, Thomas Perpoint, Marie-Anne Trabaud, Laetitia Biron, Virginie Ferré, Laurent Flet, Véronique Reliquet, Audrey Rodalec, Christèle Volteau, Sophie Breaud, Pascal Puglièse, Eric Rosenthal, Barbara De Dieuleveult, Thierry Prazuck, Antoine Bachelard, Sylvie Legac, Yazdan Yazdanpanah, Jade Ghosn, Myriam Kalambay, Laurence Slama, Jean-Paul Viard, Jérémy Lourenco, Nadine Ktorza, Romain Palich, Luminita Schneider, Alexandre Aslan, Mariagrazia Tateo, Jeremy Zeggagh, Véronique Brodard, Maxime Hentzien, Isabelle Kmiec, Yohan N'Guyen, Faïza Ajana, Laurence Bocket, Thomas Huleux, Agnes Meybeck, Nolwenn Hall, Clotilde Allavena, Christine Katlama, Alexandra Jobert, Jean-Michel Molina, Eric Cua, Firouzé Bani-Sadr, Laurent Hocqueloux, Claudine Duvivier, Dominique Merrien, Hitoto Hikombo, Elisabeth André-Garnier, Aurélie Gaultier, François Raffi, QDISS Study Group, Olivier Bollengier, Thomas Guimard, Sophie Leautez, Sophie Blanchi, Agathe Becker, Laurent Cotte, Tristan Ferry, Thomas Perpoint, Marie-Anne Trabaud, Laetitia Biron, Virginie Ferré, Laurent Flet, Véronique Reliquet, Audrey Rodalec, Christèle Volteau, Sophie Breaud, Pascal Puglièse, Eric Rosenthal, Barbara De Dieuleveult, Thierry Prazuck, Antoine Bachelard, Sylvie Legac, Yazdan Yazdanpanah, Jade Ghosn, Myriam Kalambay, Laurence Slama, Jean-Paul Viard, Jérémy Lourenco, Nadine Ktorza, Romain Palich, Luminita Schneider, Alexandre Aslan, Mariagrazia Tateo, Jeremy Zeggagh, Véronique Brodard, Maxime Hentzien, Isabelle Kmiec, Yohan N'Guyen, Faïza Ajana, Laurence Bocket, Thomas Huleux, Agnes Meybeck

Abstract

Background: Raltegravir (RAL) has favorable tolerability and safety profile, with few and manageable drug interactions. The use of RAL 1200 mg once daily (qd) for first-line therapy is well established. We assessed efficacy and safety of RAL 1200 mg qd, as part of triple combined antiretroviral therapy (cART), for maintenance strategy.

Methods: The QDISS trial (NCT03195452) was a 48-week multicenter, single-arm, open-label study designed to evaluate the ability of 2 NRTIs + RAL 1200 mg qd to maintain virological suppression in HIV-1 infected subjects on a stable cART with 2 NRTIs and a third agent for at least 6 months. The primary endpoint was the proportion of participants with HIV-1 RNA < 50 copies/mL at week 24, by the FDA snapshot algorithm.

Results: Of 100 participants 91% maintained viral suppression (95% CI: 83.6-95.8) at week 24 and 89% (81.2-94.4) at week 48. At week 24, there was one virological failure, without emergence of resistance-associated mutation and 10 participants had discontinued, 4 because of adverse events (AEs). Over 48 weeks, 7 AEs of grade 3-4 were reported, one possibly study-drug related (spontaneous abortion). BMI remained stable regardless of previous therapy or baseline BMI category. Over 48 weeks, total cholesterol (p = 0.023) and LDL-cholesterol (p = 0.009) decreased, lifestyle and ease subscale significantly improved (p = 0.04). The quality of life and Patients Reported Outcomes (PROs) also improved at W12 (p = 0.007).

Conclusion: RAL 1200 mg qd as part of a maintenance triple therapy showed a high efficacy in virologically suppressed HIV-1 infected subjects, with good safety profile and improved lipid profile and patient reported outcomes.

Trial registration: Clinical trials.gov NCT03195452 and EudraCT 2016-003702-13.

Keywords: HIV-1 infection; Integrase inhibitor; Maintenance; Once daily; Quality of life; Raltegravir; Switch.

Conflict of interest statement

All authors declare that they have no competing interests in relation to this work.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study flow chart

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