HIV-1感染者檢查指引

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

Medical and Scientific Affairs,
Roche Diagnostics Corporation


The Department of Health and Human Services (DHHS) Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents* (Updated: March 27, 2012) provides recommendations for HIV care practitioners for the management and treatment of HIV-infected patients. The guidelines recognize the critical role of laboratory tests and discuss the management of treatment-experienced patients with low-level, detectable viral loads. The following summary includes recommendations for the frequency of HIV-1 viral load monitoring, along with definitions for interpretation of low-level test results.

Laboratory Monitoring Schedule for Patients Prior to and After Initiation of Antiretroviral Therapy (Table 3, page C-2)

	Entry into care	Follow-up before ART	ART Initiation or modificationa	2-8 weeks post-ART initiation or modification	Every 3-6 months	Every 6 months	Every 12 months	Treatment failure	Clinically indicated
Viral Load	√	Every 3-6 months	√	√b	√c			√	√

a ARV modification may be done for treatment failure, adverse effects, or simplification. b If HIV RNA is detectable at 2-8 weeks, repeat every 4-8 weeks until suppression to <200copies/mL, then every 3-6 months. c For adherent patients with suppressed viral load and stable clinical and immunologic status for >2-3 years, some expert may extend the interval for HIV RNA monitoring to every 6 months.

HHS Panel recommendations for the frequency of viral load monitoring (page C-6).

•

At Initiation or Change in Therapy. Plasma viral load should be measured before initiation of therapy and preferably within 2–4 weeks, and not more than 8 weeks, after treatment initiation or after treatment modification. Repeat viral load measurement should be performed at 4–8-week intervals until the level falls below the assay's limit of detection.

•	In Patients Who Have Viral Suppression but Therapy Was Modified Due to Drug Toxicity or Regimen Simplification. Viral load measurement should be performed within 2–8 weeks after changing therapy. The purpose of viral load monitoring at this point is to confirm potency of the new regimen.

•

In Patients on a Stable ARV Regimen. Viral load should be repeated every 3–4 months or as clinically indicated. Some clinicians may extend the interval to every 6 months for adherent patients who have suppressed viral loads for more than 2–3 years and whose clinical and immunologic status is stable.

HHS Panel recommendations for low level, detectable viral load values using HIV RNA real-time PCR testing (page C-6).

•

Low level positive viral load results (typically <200 copies/mL) have been commonly reported with some viral load assays. For patient monitoring, the Panel defines virologic failure as a confirmed viral load >200 copies/mL, which eliminates most cases of viremia caused by isolated blips or assay variability.

•	Optimal viral suppression is generally defined as a viral load persistently below the level of detection (<20–75 copies/mL, depending on the assay used).

•	Isolated "blips" (transiently detectable viral loads typically <400 copies/mL) are not uncommon in successfully treated patients and are not thought to represent viral replication or to predict virologic failure.

•	Low level positive viral load results (typically <200 copies/mL) appear to be more common with some viral load assays than others, and there is no definitive evidence that patients with viral loads quantified as <200 copies/mL using these assays are at increased risk for virologic failure.

•	For the purposes of clinical trials, the AIDS Clinical Trials Group (ACTG) currently defines virologic failure as a confirmed viral load >200 copies/mL, which eliminates most cases of apparent viremia caused by blips or assay variability. This definition may also be useful in clinical practice.

Roche Diagnostics recognizes that HIV patient management is complex and rapidly evolving. Advances in viral load monitoring provide additional information which may lead to increases in the understanding of disease progression and improvements in patient management and adherence.

As with all viral load monitoring tests, clinical viral load results must be interpreted in the contest of the patient's clinical manifestations and other markers of disease.

As advances occur, it's important for HIV providers, laboratories, and manufacturers to work closely together to ensure the highest level of care for HIV patients. Roche is a global leader in diagnostics and pharmaceuticals; our focus, like yours, is to improve the lives of patients, one test result at a time.

* Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. 1-239. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Section accessed, April 17, 2012, [page C-2, Table 3; Page C-6].