US HHS adult treatment guidelines updated (March 2012)

Updated US guidelines from the DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents are available online.

Key additions and revisions to the guidelines include: • New section on HIV and the older patient

Effective antiretroviral therapy (ART) has led to greater longevity in HIV-infected individuals resulting in an increasing number of older individuals living with HIV infection. Compared with younger HIV-infected patients, older patients may have more comorbidities, which can complicate treatments of HIV and other diseases. This section focuses on HIV diagnosis and treatment considerations in the older HIV-infected patient.

  • New table on cost of antiretroviral drugs

This new table lists the monthly average wholesale price (AWP) for U.S. Food and Drug Administration (FDA)-approved brand and generic antiretroviral (ARV) drugs, including fixed-dose combination products. (The AWP listed for an ARV may not represent the pharmacy acquisition price or the price paid by consumers for that drug.)

  • Updated recommendations on initiation of antiretroviral therapy (ART) in treatment-naive individuals

The changes are primarily based on increasing evidence showing the harmful impact of ongoing HIV replication on AIDS and non-AIDS disease progression. In addition, the updated recommendations reflect emerging data showing the benefit of effective ART in preventing secondary transmission of HIV. The updated section includes more in- depth discussion on the rationale for these recommendations and on the risks and benefits of long-term ART.

ART is recommended for all HIV-infected individuals. The strength of this recommendationa varies on the basis of pretreatment CD4 cell count: CD4 count <350 cells/mm3 (AI); CD4 count 350 to 500 cells/mm3 (AII); CD4 count >500 cells/mm3 (BIII).

Regardless of CD4 count, initiation of ART is strongly recommended for individuals with the following conditions: Pregnancy (AI), AIDS- defining illness (AI), HIV-associated nephropathy (HIVAN) (AII) and HIV/hepatitis B virus (HBV) coinfection (AII).

  • Effective ART also has been shown to prevent transmission of HIV from an infected individual to a sexual partner. Therefore, ART should be offered to patients who are at risk of transmitting HIV to sexual partners (AI [heterosexuals] or AIII [other transmission risk groups]).
  • Patients starting ART should be willing and able to commit to treatment and should understand the benefits and risks of therapy and the importance of adherence (AIII). Patients may choose to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy on the basis of clinical and/or psychosocial factors.
  • Expanded discussion of use of hormonal contraceptives in HIV-infected women

This revised section includes an expanded discussion on the use of hormonal contraception in HIV-infected women. The discussion focuses on drug-drug interactions between combined oral contraceptives and ARV drugs as well as on recent data showing a possible association between hormonal contraceptive use and acquisition or transmission of HIV.

  • Preliminary recommendations on coadministration of the newly approved hepatitis C virus (HCV) NS3/4A protease inhibitors (PIs) boceprevir and telaprevir
  • Recommendations on “when to start” ART in HIV-infected individuals diagnosed with tuberculosis but not receiving ART
  • Discussion of the role of effective ART in preventing HIV transmission

Ref: Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents (March 2012) campaign=Adult%2BGuidelines%2B1


It is always particularly helpful that these guidelines clearly highlight all changes in the text from the previous edition. There are several notable differences compared to the UK BHIVA guidelines (March 2012 draft).

This includes the new US section on HIV and ageing, with age >50 years being an independent factor for starting treatment. Although UK guidelines included this recommendation in 2008 it has been dropped from the 2012 draft.

Also, for starting treatment at higher CD4 counts (at 500 compared to 350) with the US also having a stronger indication for starting at higher than 500, with no CD4 exclusion criteria. This last difference is not based on new evidence about the short-term risk of disease progression, AIDS events or mortality from randomised studies – this will come from the ongoing START study – but from accumulating concerns about uncontrolled viraemia and it’s impact on immune inflammation, and also on the benefit of ARV treatment to reduce further transmission.

The latest BHIVA guideline were released in draft format last month for comment and are still online while the final version is in press.

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