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Dolutegravir Treatment Response and Safety by Key Subgroups in Treatment Naive HIV Infected Individuals
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Reported by Jules Levin
20th Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta, GA
Cynthia Brinson,1 Sharon Walmsley,2 Keikawus Arasteh,3 Miguel Gorgolas,4 Lothar Schneider,5 Clare Brennan,6 Keith Pappa,6 Steve Almond,7 Catherine Granier,8 Francois Raffi9
1Central Texas Clinical Research, Austin, TX, USA; 2University Health Network, Toronto, ON, Canada; 3EPIMED/Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany; 4Fundacion Jimenez Diaz, Madrid, Spain; 5Internistische Praxis, Fuerth, Germany; 6-8GlaxoSmithKline, 6Research Triangle Park, NC, USA; 7Mississauga, ON, Canada; 8Stockley Park, UK; 9University of Nantes, Nantes, France
Discussion
·SPRING-2: DTG administered once daily with 2 NRTIs demonstrated noninferiority to RAL and was associated with good treatment response.
·The proportion of subjects with HIV-1 RNA <50 c/mL (88%) compares favorably with RAL (85%).
·DTG performed as well as RAL regardless of baseline viral load (VL) or background dual NRTI.5
·In both treatment groups, the rate of AEs leading to withdrawal was similar across demographic subgroups.
·SINGLE: 88% receiving DTG + ABC/3TC and 81% receiving Atripla achieved the primary endpoint of HIV-1 RNA <50 c/mL, indicating noninferiority. Superiority was demonstrated (P=0.003), as prespecified.
·DTG + ABC/3TC had higher response rates than Atripla across VL, CD4 strata and demographic subgroups.
·Differences in efficacy were driven primarily by a higher rate of discontinuation due to AEs in the Atripla arm.
·DTG + ABC/3TC consistently outperformed Atripla across VL, CD4 strata and demographic subgroups for AEs leading to withdrawals.
Conclusions
·DTG 50 mg once daily was as effective as RAL 400 mg twice daily when coadministered with 2 NRTIs.
·DTG 50 mg + ABC/3TC was superior to Atripla.
·Clinical efficacy was demonstrated in all subgroups in both studies, including baseline HIV-1 RNA, CD4 cell count, gender, age, race and HIV risk factor.
·DTG was well tolerated in both studies and in all subgroups.
·DTG could represent a new once-daily, unboosted integrase-based option that can be used effectively and safely for first-line antiretroviral therapy.
References
1. Min S, Song I, Borland J, et al. Antimicrob Agents Chemother. 2010;54(1):254-258.
2. Powderly WG. J Antimicrob Chemother. 2010;65(12):2485-2488.
3. Raffi F, Rachlis A, Stellbrink H-J, et al. Lancet. January 8, 2013 [Epub ahead of print].
4. Walmsley S, Antela A, Clumeck N, et al. Abstract H-556b. 52nd ICAAC. September 9-12, 2012; San Francisco, CA.
5. Eron J Jr, Rockstroh J, Pozniak A, et al. Abstract #P204. HIV11. November 11-15, 2012; Glasgow, UK.
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