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Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
What's New in the Guidelines?
(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.
The following are key updates to existing sections of the guidelines.
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:
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)
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.
The text and table (Table 12) in this section have been updated with information on the concomitant use of different ARV drugs with the new HCV drug combination of ombitasvir, paritaprevir, ritonavir, and dasabuvir.
The text of this section has been updated to focus on mechanisms of interaction of ARV drugs.
A new table, titled “Mechanisms of Antiretroviral Associated Drug Interactions,” has been developed to provide clinicians with information on clinically relevant mechanisms of PK-associated interactions for individual ARV drugs (Table 17).
All the Drug Interaction tables have been updated; in particular, interactions related to ATV/c, DRV/c, and EVG plus PI/r have been added to these tables (see Tables 19a–e, 20a, and 20b).
Minor revisions have also been made to the following sections:
Discontinuation or Interruption of Antiretroviral Therapy
Exposure-Response Relationship and Therapeutic Drug Monitoring (TDM) for Antiretroviral Agents
Monthly Average Wholesale Price of Antiretroviral Drugs (Table 16)