HHS Panel Updates Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

HHS Panel Updates Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

A What’s New in the Guidelines? section summarizes key changes in the current edition of the guidelines, dated January 10, 2011. Throughout the revised guidelines, significant updates are highlighted and fully discussed.

Here are a few highlights:
Frequency of CD4 determinations can be decreased in stable patients who are virologically suppressed, down to every 6 to 12 months (instead of every 3 to 6 months).

Virologic failure is now defined as a confirmed viral load >200 copies/mL; this is in response to the higher rates of detection of lower level viremia using the newer assays.

Timing of antiretroviral (ARV) therapy initiation with TB is updated to reflect results from the SAPiT and CAMELIA studies.

A new table format provides clinicians with a list of the most common and/or severe known ARV-associated adverse events listed by ARV drug class.

Guidelines:
http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf?source=govdelivery

N Engl J Med. 2010 Feb 25;362(8):697-706.

Timing of initiation of antiretroviral drugs during tuberculosis therapy.
Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, Gengiah T, Nair G, Bamber S, Singh A, Khan M, Pienaar J, El-Sadr W, Friedland G, Abdool Karim Q.

Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa. caprisa@ukzn.ac.za

Comment in:

N Engl J Med. 2010 Jun 3;362(22):2137; author reply 2138-9.
N Engl J Med. 2010 Jun 3;362(22):2137-8; author reply 2138-9.
N Engl J Med. 2010 Jun 3;362(22):2138; author reply 2138-9.

Abstract
BACKGROUND: The rates of death are high among patients with coinfection with tuberculosis and the human immunodeficiency virus (HIV). The optimal timing for the initiation of antiretroviral therapy in relation to tuberculosis therapy remains controversial.

METHODS: In an open-label, randomized, controlled trial in Durban, South Africa, we assigned 642 patients with both tuberculosis and HIV infection to start antiretroviral therapy either during tuberculosis therapy (in two integrated-therapy groups) or after the completion of such treatment (in one sequential-therapy group). The diagnosis of tuberculosis was based on a positive sputum smear for acid-fast bacilli. Only patients with HIV infection and a CD4+ cell count of less than 500 per cubic millimeter were included. All patients received standard tuberculosis therapy, prophylaxis with trimethoprim-sulfamethoxazole, and a once-daily antiretroviral regimen of didanosine, lamivudine, and efavirenz. The primary end point was death from any cause.

RESULTS: This analysis compares data from the sequential-therapy group and the combined integrated-therapy groups up to September 1, 2008, when the data and safety monitoring committee recommended that all patients receive integrated antiretroviral therapy. There was a reduction in the rate of death among the 429 patients in the combined integrated-therapy groups (5.4 deaths per 100 person-years, or 25 deaths), as compared with the 213 patients in the sequential-therapy group (12.1 per 100 person-years, or 27 deaths); a relative reduction of 56% (hazard ratio in the combined integrated-therapy groups, 0.44; 95% confidence interval, 0.25 to 0.79; P=0.003). Mortality was lower in the combined integrated-therapy groups in all CD4+ count strata. Rates of adverse events during follow-up were similar in the two study groups.

CONCLUSIONS: The initiation of antiretroviral therapy during tuberculosis therapy significantly improved survival and provides further impetus for the integration of tuberculosis and HIV services. (ClinicalTrials.gov number, NCT00398996.)

2010 Massachusetts Medical Society
PMID: 20181971 [PubMed - indexed for MEDLINE]
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Timing of initiation of antiretroviral drugs durin... [N Engl J Med. 2010] - PubMed result


▲ full-text:
Timing of Initiation of Antiretroviral Drugs during Tuberculosis Therapy — NEJM


► AIDS 2010 Abstract - Significant enhancement in survival with early (2 weeks) vs. late (8 weeks) initiation of highly active antiretroviral treatment (HAART) in severely immunosuppressed HIV-infected adults with newly diagnosed tuberculosis
AIDS 2010 Abstract - Significant enhancement in survival with early (2 weeks) vs. late (8 weeks) initiation of highly active antiretroviral treatment (HAART) in severely immunosuppressed HIV-infected adults with newly diagnosed tuberculosis