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Viruses 2014, 6(7), 2858-2879; doi:10.3390/v6072858

Resistance Analyses of Integrase Strand Transfer Inhibitors within Phase 3 Clinical Trials of Treatment-Naive Patients

1
Department of Clinical Virology, Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA
2
Department of Infectious Diseases, University Hospital, Hotel-Dieu, 1 Place Ricordeau, Nantes 44093, France
*
Author to whom correspondence should be addressed.
Received: 23 May 2014 / Revised: 10 July 2014 / Accepted: 10 July 2014 / Published: 22 July 2014
(This article belongs to the Special Issue HIV Drug Resistance)
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Abstract

The integrase (IN) strand transfer inhibitors (INSTIs), raltegravir (RAL), elvitegravir (EVG) and dolutegravir (DTG), comprise the newest drug class approved for the treatment of HIV-1 infection, which joins the existing classes of reverse transcriptase, protease and binding/entry inhibitors. The efficacy of first-line regimens has attained remarkably high levels, reaching undetectable viral loads in 90% of patients by Week 48; however, there remain patients who require a change in regimen due to adverse events, virologic failure with emergent resistance or other issues of patient management. Large, randomized clinical trials conducted in antiretroviral treatment-naive individuals are required for drug approval in this population in the US, EU and other countries, with the primary endpoint for virologic success at Week 48. However, there are differences in the definition of virologic failure and the evaluation of drug resistance among the trials. This review focuses on the methodology and tabulation of resistance to INSTIs in phase 3 clinical trials of first-line regimens and discusses case studies of resistance. View Full-Text
Keywords: HIV; drug resistance; integrase; clinical trial HIV; drug resistance; integrase; clinical trial
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MDPI and ACS Style

White, K.L.; Raffi, F.; Miller, M.D. Resistance Analyses of Integrase Strand Transfer Inhibitors within Phase 3 Clinical Trials of Treatment-Naive Patients. Viruses 2014, 6, 2858-2879.

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