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Guidelines for the Use of Antiretroviral Agents
in HIV-1-Infected Adults and Adolescents
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What's New in the Guidelines?
http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-treatment-guidelines/0
(Last updated: April 8, 2015; last reviewed: April 8, 2015)
Revisions to the May 1, 2014, version of the guidelines include key updates to several existing sections and the addition of two new tables. Significant updates are highlighted throughout the document.
Key Updates
The following are key updates to existing sections of the guidelines.
What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient
Since the last version of these guidelines, data from clinical trials and cohort studies, as well as experience in clinical practice, have prompted significant changes to the list of Recommended, Alternative, and Other regimens for treatment-naive patients (Table 6). Additionally, a new table, titled "Antiretroviral (ARV) Regimen Considerations as Initial Therapy Based on Specific Clinical Scenarios," has been created to guide clinicians on the selection of an initial ARV regimen based on specific clinical scenarios and ARV-related considerations (Table 7).
· There are now five Recommended regimens for antiretroviral therapy (ART)-naive patients-four integrase strand transfer inhibitor (INSTI)-based regimens and one ritonavir-boosted protease inhibitor (PI/r)-based regimen, as listed below:
INSTI-Based Regimens:
· Dolutegravir/abacavir/lamivudine (DTG/ABC/3TC)-only for patients who are HLA-B*5701 negative (AI)
· DTG plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (AI)
· Elvitegravir/cobicistat/TDF/FTC (EVG/c/TDF/FTC)-only for patients with pre-ART CrCl >70 mL/min (AI)
· Raltegravir (RAL) plus TDF/FTC (AI)
PI/r-Based Regimen:
Darunavir/ritonavir (DRV/r) plus TDF/FTC (AI)
· Two regimens previously classified as Recommended regimens have been moved to the Alternative regimens category, with the rationale stated below:
Atazanavir/ritonavir (ATV/r) plus TDF/FTC (BI)-Based on the results of a large comparative clinical trial showing a greater rate of discontinuation with ATV/r plus TDF/FTC because of toxicities when compared to (DRV/r or RAL) plus TDF/FTC
Efavirenz/TDF/FTC (EFV/TDF/FTC) (BI)-Based on concerns about the tolerability of EFV in clinical trials and practice, especially the high rate of central nervous system (CNS)-related toxicities and a possible association with suicidality
· Three regimens (ATV/r plus ABC/3TC, EFV plus ABC/3TC, and rilpivirine/TDF/FTC) that were previously listed as Recommended regimens for baseline HIV RNA <100,000 copies/mL or CD4 T lymphocyte (CD4) count >200 cells/mm3 are now in the Alternative or Other category, with the same caveat about limiting their use in these populations.
· Two regimens that use fewer than two nucleoside reverse transcriptase inhibitors (DRV/r plus RAL and lopinavir/ritonavir plus 3TC) are now listed among the Other regimens, with the caveat that their use would be limited to those patients who cannot take either TDF or ABC.
· Coformulations of atazanavir (ATV) and darunavir (DRV) with the pharmacokinetic (PK) enhancer cobicistat (COBI) have been added to the Alternative regimen options.
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Considerations for Antiretroviral Use in Patients with Coinfections
Hepatitis C (HCV)/HIV Coinfection
http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/26/hiv-hcv
(Last updated: April 8, 2015; last reviewed: April 8, 2015)
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