Updated Recommendations on INSTI-Based Regimens for ART-Naive Patients

Guideline Watch |
November 4, 2013

Updated Recommendations on INSTI-Based Regimens for ART-Naive Patients

  1. Charles B. Hicks, MD

All three licensed HIV integrase inhibitors are now listed as preferred antiretroviral agents for initial treatment of HIV-infected individuals.

  1. Charles B. Hicks, MD

Sponsoring Organization: Department of Health and Human Services (DHHS)

Target Population: Healthcare providers who prescribe antiretroviral therapy (ART) for HIV-infected patients

Background and Objective

Based on data from recently published and presented clinical trials, the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents updated its recommendations for initial ART to include all three currently licensed HIV integrase strand transfer inhibitors (INSTIs), in combination with tenofovir/FTC or abacavir/3TC, as components of preferred regimens.

Key Recommendations

The DHHS Antiretroviral Treatment Guidelines include recommendations for initial treatment of HIV infection with preferred and alternative combination regimens. Previous versions of the guidelines listed four preferred regimens: efavirenz, atazanavir/ritonavir, darunavir/ritonavir, or raltegravir — each in combination with tenofovir/FTC.

The new guidelines add the following three regimens to the preferred list:

  • Tenofovir/FTC/elvitegravir/cobicistat (previously an alternative regimen; approved only for patients with estimated creatinine clearance ≥70 mL/min)

  • Tenofovir/FTC plus dolutegravir

  • Abacavir/3TC plus dolutegravir (in patients who are HLA-B5701 negative)

What's Changed

Previous versions of the guidelines listed four preferred initial ART regimens, with raltegravir plus tenofovir/FTC as the only INSTI-based option. Recent FDA approval of dolutegravir plus favorable longer-term safety and efficacy data for this agent combined with either tenofovir/FTC or abacavir/3TC prompted the committee to add these regimens to the list of preferred initial options. Similarly, favorable longer-term (96- and 144-week) safety/efficacy data for the single-tablet INSTI-based regimen of tenofovir/FTC/elvitegravir/cobicistat convinced the committee to add this combination tablet as well. The lack of drug–drug interactions (raltegravir, dolutegravir), the absence of food requirements (raltegravir, dolutegravir), the simplicity of once-daily dosing (elvitegravir, dolutegravir), and the availability of a once-daily, single-tablet regimen (elvitegravir) are additional factors that make these drugs attractive options for initial ART.


The addition of elvitegravir- and dolutegravir-based regimens to the preferred list of initial antiretroviral treatment options reflects the popularity of these new agents with both patients and prescribers. The low rate of side effects, dosing simplicity, durable safety and efficacy, and infrequency of drug resistance with treatment failure (particularly with the newer agents) make these combinations particularly appealing.

  • Disclosures for Charles B. Hicks, MD at time of publication Consultant / Advisory board Bristol-Meyers Squibb; Gilead; Janssen Virology; ViiV Grant / research support NIH; Argos; Bristol-Myers Squibb; Gilead; Janssen Virology; ViiV Editorial boards UpToDate


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