US guidelines (DHHS) update recommendations for first-line combinations (October 2011)

In October the US Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents were updated and posted online to the AIDSinfo web site.

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 can be found in the updated section. Related tables have also been updated.

Table 1: Key changes to DHHS guidelines (October 2011)
NNRTI-based combinations
Rilpivirine	Added as an alternative NNRTI option for initial therapy in treatment-naive patients.
Nevirapine-based combinations (NVP)	All reclassified as acceptable for naive patients (women with CD4 count <250 cells/mm3 or men with CD4 count <400 cells/mm3). Previously, NVP+ AZT/3TC was an alternative regimen and NVP + abacavir/3TC and NVP + tenofovir/FTC were ?acceptable but should be used with caution’.
PI-based combinations
Darunavir/ritonavir + abacavir/3TC	Reclassified as an alternative regimen (BIII) – was ?acceptable but needed more data (CIII)’.
Unboosted fosamprenavir	Removed as a PI option for naive patients (inferior potency and potential for cross-resistance to darunavir).
Raltegravir-based combinations
Raltegravir + abacavir/3TC	Reclassified as an alternative regimen (BIII) – was ?acceptable but needed more data (CIII)’.
Dual NRTI options
AZT/3TC	Reclassified to ?acceptable’ from ?alternative’ because of greater toxicities compared with tenofovir/FTC and abacavir/3TC and twice-daily dosing. However, AZT+3TC remains as the preferred dual-NRTI during pregnancy.
ddI/3TC	Removed for initial therapy due to poor data and higher toxicity.
abacavir	Discussion on the association between abacavir use and the risk of a cardiovascular event updated.

Table 1: Key changes to DHHS guidelines (October 2011)

NNRTI-based combinations

Rilpivirine

Added as an alternative NNRTI option for initial therapy in treatment-naive patients.

Nevirapine-based combinations (NVP)

All reclassified as acceptable for naive patients (women with CD4 count <250 cells/mm3 or men with CD4 count <400 cells/mm3). Previously, NVP+ AZT/3TC was an alternative regimen and NVP + abacavir/3TC and NVP + tenofovir/FTC were ?acceptable but should be used with caution’.

PI-based combinations

Darunavir/ritonavir + abacavir/3TC

Reclassified as an alternative regimen (BIII) – was ?acceptable but needed more data (CIII)’.

Unboosted fosamprenavir

Removed as a PI option for naive patients (inferior potency and potential for cross-resistance to darunavir).

Raltegravir-based combinations

Raltegravir + abacavir/3TC

Reclassified as an alternative regimen (BIII) – was ?acceptable but needed more data (CIII)’.

Dual NRTI options

AZT/3TC

Reclassified to ?acceptable’ from ?alternative’ because of greater toxicities compared with tenofovir/FTC and abacavir/3TC and twice-daily dosing. However, AZT+3TC remains as the preferred dual-NRTI during pregnancy.

ddI/3TC

Removed for initial therapy due to poor data and higher toxicity.

abacavir

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:

The DHHS guidelines are online in PDF and html page formats. The PDF file helpful highlight all recent changes in yellow.
http://www.aidsinfo.nih.gov/guidelines/