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Randomized Controlled Trial
. 2016 Apr 15;71(5):538-43.
doi: 10.1097/QAI.0000000000000904.

Brief Report: Switch to Ritonavir-Boosted Atazanavir Plus Raltegravir in Virologically Suppressed Patients With HIV-1 Infection: A Randomized Pilot Study

Jan van Lunzen  1 , Anton Pozniak, Jose M Gatell, Andrea Antinori, Isabelle Klauck, Oscar Serrano, Adyb Baakili, Olayemi Osiyemi, Heather Sevinsky, Pierre-Marie Girard
Affiliations
Randomized Controlled Trial

Brief Report: Switch to Ritonavir-Boosted Atazanavir Plus Raltegravir in Virologically Suppressed Patients With HIV-1 Infection: A Randomized Pilot Study

Jan van Lunzen et al. J Acquir Immune Defic Syndr. .

Abstract

This open-label, multinational, pilot study randomized (1:2 ratio) adults with HIV-1 RNA <40 copies per milliliter and nucleos(t)ide-related safety/tolerability issues to switch to ritonavir-boosted atazanavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (n = 37) or the nucleos(t)ide reverse transcriptase inhibitor-sparing regimen of ATV/r plus raltegravir (RAL) (n = 72). At 24 weeks, 35/37 (94.6%) and 58/72 (80.6%) of patients, respectively, maintained virological suppression, the primary endpoint, and 1 (2.7%) and 7 (9.7%), respectively, experienced virological rebound. Corresponding 48-week proportions were 86.5%, 69.4%, 2.7%, and 12.5%, respectively. Adherence was lower and treatment discontinuation was higher with ATV/r+RAL. In conclusion, switching to ATV/r+RAL resulted in a higher virological rebound rate than switching to ATV/r plus tenofovir disoproxil fumarate/emtricitabine.

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Conflict of interest statement

J.v.L. was a study investigator and his institution received a research grant from Bristol-Myers Squibb for the conduct of this study; he has received personal fees from Bristol-Myers Squibb for consultancy during the planning of this study, and for attendance at investigator meetings, advisory boards, and conferences to present study data; his institution has received or is currently receiving research grants from Abbvie, Bionor AS, Boehringer, Bristol-Myers Squibb, Genetic Immunity, Gilead Sciences, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, Roche, Vision7, and ViiV Healthcare; he has received personal fees for speakers' bureaus from Abbvie, Bionor AS, Boehringer, Bristol-Myers Squibb, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare; he has received personal fees for the development of educational materials from Abbvie, Bristol-Myers Squibb, and ViiV Healthcare; he has also received personal fees for conference attendance from Gilead Sciences (at manuscript submission); he is now an employee of ViiV Healthcare (at manuscript acceptance). A.P. was a study investigator and his institution received a research grant from Bristol-Myers Squibb for the conduct of this study and for attendance at investigator meetings; he has received personal fees for attendance at advisory boards from Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck, and ViiV Healthcare; his institution is receiving ongoing research grants from Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck, and ViiV Healthcare; and he has received personal fees for speakers' bureaus from Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck, and ViiV Healthcare. J.M.G. was a study investigator and his institution received a research grant from Bristol-Myers Squibb for the conduct of this study and for attendance at investigator meetings; he has received personal fees for attendance at advisory boards from Abbvie, Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck Sharpe & Dohme, and ViiV Healthcare; and his institution has received research grants from Abbvie, Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck Sharpe & Dohme, and ViiV Healthcare. A.A. was a study investigator and his institution received a research grant from Bristol-Myers Squibb for the conduct of this study and for attendance at investigator meetings; he has received personal consultancy fees from Abbvie, Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Meck, and ViiV Healthcare; his institution is currently receiving research grants from Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, and ViiV Healthcare; and he has received personal fees from Abbvie and ViiV Healthcare for conference attendance. O.O. was a study investigator and his institution received a research grant from Bristol-Myers Squibb for the conduct of this study and for attendance at investigator meetings; he has received personal fees for attendance at advisory/review boards from Abbvie, Bristol-Myers Squibb, Durata, Gilead Sciences, and Janssen-Cilag; his institution currently receives research grants from Forrest and Gilead Sciences; and he has received personal fees for speakers' bureaus from Gilead Sciences and Janssen-Cilag. I.K., O.S., A.B., and H.S. are employees of and own stock in Bristol-Myers Squibb, the manufacturers of atazanavir. P.-M.G. was a study investigator and his institution received a research grant from Bristol-Myers Squibb for the conduct of this study and for attendance at investigator meetings; he has received personal fees for attendance at advisory boards from Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, and Merck Sharp & Dohme; his institution is receiving ongoing research grants from Gilead Sciences and Roche; he has received personal fees for speakers' bureaus from Bristol-Myers Squibb, Janssen-Cilag, and ViiV Healthcare; he has received personal fees for the development of educational materials from ViiV Healthcare; and his institution has received payment for conference attendance from Gilead Sciences.

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