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New HHS HIV ART Guidelines for Adults, Adolescents
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On May 1, 2014, the revised Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents was made available..
Additionally the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV infection were revised in February 2014 and the Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1 Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States were released in March 2014
"On the basis of this data, as well as from long-term follow-up of these studies and experience in clinical practice, the Panel recognizes that options for initial therapy have expanded. Consequently, the Panel now refers to these options for initial treatment as "Recommended" rather than "Preferred" regimens.....The list of Alternative regimens has been shortened because with more Recommended options, clinicians should be able to choose a Recommended regimen for most treatment-nave patients.....
........Table 7 lists the potential advantages and disadvantages of the components used in Recommended and Alternative regimens. Table 8 lists agents or regimens not recommended for initial treatment. Appendix B, Tables 1-6 lists characteristics of individual ARV agents, such as formulations, dosing recommendations, pharmacokinetics (PKs), and common adverse effects. Appendix B, Table 7 provides ARV dosing recommendations for patients who have renal or hepatic insufficiency."
Change in Classification of Recommendations for Initial Treatment From "Preferred Regimens" to "Recommended Regimens"
This change can be found in the "What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient" section.
· In the past few years, the FDA has approved several new antiretroviral (ARV) agents and co-formulations for treatment-naive individuals. On the basis of data from long-term follow-up studies and experience in clinical practice, the Panel recognizes that options for initial therapy have expanded. Consequently, the Panel now refers to options for initial treatment as "Recommended" rather than "Preferred" regimens.
· Recommended regimens are further divided into two categories:
1. Regimens for ART-naive patients regardless of baseline viral load or CD4 cell count. These regimens include those previously termed "Preferred," namely tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) with either efavirenz (EFV); ritonavir-boosted atazanavir (ATV/r) or darunavir (DRV/r); or raltegravir (RAL). In addition, 3 new regimens have been added to this category:
· Dolutegravir (DTG) + abacavir/lamivudine (ABC/3TC): only for patients who are HLA-B*5701 negative
· DTG + TDF/FTC
· Elvitegravir (EVG)/cobicistat (cobi)/TDF/FTC: only for patients with pre-ART creatinine clearance ≥70 mL/min
2. Regimens that are also recommended, but only for patients with pre-ART plasma HIV RNA <100,000 copies/mL. These regimens include the following:
· EFV + ABC/3TC: only for patients who are HLA-B*5701 negative
· Rilpivirine (RPV)/TDF/FTC: only for patients with CD4 count >200 cells/mm3
· ATV/r + ABC/3TC: only for patients who are HLA-B*5701 negative
· The Panel has revised its list of Alternative Regimens (Table 6). Those listed as Alternative Regimens are effective and tolerable but, when compared with Recommended options, have potential disadvantages or fewer data supporting their use.
· Given the large number of Recommended and Alternative options, a number of ARV drugs are no longer recommended for initial therapy; these drugs include zidovudine (ZDV), nevirapine (NVP), unboosted ATV, ritonavir-boosted fosamprenavir (FPV/r) or saquinavir (SQV/r), and maraviroc (MVC).
· A new subsection has been added summarizing clinical trial data on antiretroviral strategies for initial therapy when ABC or TDF cannot be used.
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