You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.
Please do not reply to this message.
On October 14, 2011, updated Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents were made available through the AIDSinfo web site.
Guidelines for treating HIV-infected adults and adolescents, including utilization of resistance testing, initiation of treatment, preferred first-line regimens, adverse events to antiretroviral medications, managing treatment-experienced patients, and considerations for special populations.
This revision to the guidelines is focused on What to Start: Initial Combination Regimens for the Antiretroviral-Naive Patient. Additions and key changes to the section are outlined below. More detailed discussion of the rationale for changes to the What to Start recommendations can be found in the updated section. Tables in the guidelines corresponding to the What to Start section have also been updated to reflect changes.
Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based Regimens
Rilpivirine added as an alternative NNRTI option for initial therapy in treatment-naive patients.
All nevirapine-based regimens reclassified as acceptable options for treatment-naive patients (females with pretreatment CD4 count <250 cells/mm3 or males with pretreatment CD4 count <400 cells/mm3). Previously, “nevirapine + zidovudine/lamivudine” was classified as an alternative regimen and “nevirapine + abacavir/lamivudine” and “nevirapine + tenofovir/emtricitabine” were recommended as regimens that may be acceptable but should be used with caution.
Protease Inhibitor (PI)-Based Regimens
“Ritonavir-boosted darunavir + abacavir/lamivudine” reclassified as an alternative regimen (BIII); previously the regimen was recommended as a regimen that may be acceptable but more definitive data are needed (CIII).
Regimens with unboosted fosamprenavir removed as PI options for treatment-naive patients. The Panel removed the regimens because they have inferior potency compared with other PI-based regimens and because of the potential for selection of mutations that confer resistance to darunavir in patients who experience virologic failure while on these regimens.
Raltegravir-Based Regimens
“Raltegravir + abacavir/lamivudine” reclassified as an alternative regimen (BIII); previously, the regimen was classified as a regimen that may be acceptable but more definitive data are needed (CIII).
Dual-Nucleoside Reverse Transcriptase Inhibitor (NRTI) Options
“Zidovudine + lamivudine” reclassified from an alternative dual-NRTI option to an acceptable option because the combination has greater toxicities compared with tenofovir/emtricitabine and abacavir/lamivudine and requires twice daily dosing. However, zidovudine + lamivudine remains as the preferred dual-NRTI for pregnant women receiving antiretroviral therapy (ART) for prevention of perinatal transmission of HIV.
“Didanosine + lamivudine” removed as a dual-NRTI option for initial therapy because the combination has the least clinical trial experience and greater toxicity compared with other available dual-NRTI options.
Discussion on the association between abacavir use and the risk of a cardiovascular event updated.
In addition to the changes highlighted above, the following tables are updated with information relevant to rilpivirine:
• Tables 14, 15b, and 16b – Drug interaction tables
• Appendix B, Table 2 – Drug characteristic table
• Appendix B, Table 7 – Dosing recommendation for patients with renal or hepatic insufficiency
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
