Laboratory Testing
Laboratory Testing for Initial Assessment and Monitoring of People With HIV
Several laboratory tests are important for initial evaluation of people with HIV upon entry into care. Some tests should be performed before and after initiation or modification of antiretroviral therapy (ART) to assess the virologic and immunologic efficacy of ART and to monitor for laboratory abnormalities that may be associated with antiretroviral (ARV) drugs.
Two surrogate markers have been used to monitor people with HIV: (1) plasma HIV RNA (viral load) to assess the level of HIV viremia and (2) CD4 T lymphocyte (CD4) cell count to assess immune function. Standard (reverse transcriptase and protease) genotypic drug-resistance testing should be used to guide selection of an ARV regimen; if integrase strand transfer inhibitor (INSTI) resistance is a concern due to potential transmitted resistance or previous use of an INSTI for pre-exposure prophylaxis (e.g., long-acting cabotegravir), post-exposure prophylaxis, or treatment, providers should ensure that genotypic resistance testing also includes the integrase gene (see Drug-Resistance Testing). For guidance on the choice of ARV regimens before drug-resistance testing results become available, clinicians should consult the What to Start and Early (Acute or Recent) HIV Infection sections. A viral tropism assay should be performed before initiation of a CCR5 antagonist or at the time of virologic failure if a person is receiving a CCR5 antagonist. HLA-B*5701 testing should be performed before initiation of abacavir (ABC) to reduce the risk of hypersensitivity reaction, and HLA-B*5701-positive people should not be prescribed ABC. People should be screened for hepatitis B virus (HBV) and hepatitis C virus infections before initiating ART and, if indicated, periodically after ART initiation, because treatment of these coinfections may affect the choice of ART and likelihood of drug-induced hepatotoxicity. Before initiating nucleoside reverse transcriptase inhibitor (NRTI)–sparing or NRTI-limited ARV regimens, HBV serology testing should be performed in people who are not known to have chronic HBV (see Hepatitis B Virus/HIV Coinfection). The rationale for and utility of some of these laboratory tests are discussed in the corresponding sections of the guidelines.
Currently available newer ARVs are generally easy to take and typically do not cause significant laboratory abnormalities. Most people with HIV achieve and maintain viral suppression and have improvement in CD4 count within 1 year after starting ART. Table 3 provides general guidance on the frequency of laboratory monitoring before initiation of and throughout treatment with ART. However, more frequent monitoring of selected tests may be needed as clinically indicated, based on issues such as responses to therapy, underlying medical conditions, drug-related adverse effects, engagement in care, and adherence to therapy. ART is recommended for all people with HIV (AI); Table 4 provides guidance for laboratory monitoring in the rare occasions when ART initiation is deferred.
Table 3. Laboratory Testing Schedule Before and After Antiretroviral Therapy Initiationa
This table provides general guidance for laboratory monitoring for people with HIV before and after antiretroviral therapy (ART) initiation. Clinicians should use their clinical judgment to determine the monitoring frequency for an individual person based on clinical needs. This schedule is not intended to be a guide on how often people with HIV should undergo clinical evaluation, as some individuals may need to be seen more frequently to accomplish other aspects of clinical care. Please refer to Table 4 for laboratory monitoring guidance if ART initiation is deferred.
| Table 3. Laboratory Testing Schedule Before and After Antiretroviral Therapy Initiationa | |
|---|---|
Table 4. Laboratory Monitoring If ART Is Deferred
Antiretroviral therapy (ART) is recommended for all people with HIV (AI). People with HIV should be advised to begin ART as soon as feasible to reduce morbidity and mortality and to prevent transmission of HIV to others. This table provides guidance for laboratory monitoring in the rare occasions when ART initiation is deferred.
Laboratory Test | Initial Assessment | Monitoring Frequency If ART Is Deferred | Comments |
|---|---|---|---|
| CD4 Count |
✓
| Every 3–6 months | To assess for urgency of ART initiation and the need for OI prophylaxis |
| HIV Viral Load | ✓ | Every 3–6 months | |
Genotypic Resistance Testing (PR/RT +/- integrase gene) See Drug Resistance Testing for more information. | ✓ | Repeat genotypic resistance testing at the time of ART initiation is optional. | |
Hepatitis B Serology (HBsAb, HBsAg, HBcAb) See Hepatitis B in the Adult OI Guidelines for more detailed guidance. | ✓ | Clinically indicated | Before starting HCV DAA If HBsAg Positive:
If Not Immune at Baseline:
|
| Hepatitis C Screening (HCV antibody, or, if indicated, HCV RNA) | ✓ | Every 12 months for at-risk people, or if clinically indicated | |
| Basic Metabolic Panel | ✓ | Every 6-12 months or if clinically indicated | |
| ALT, AST, Total Bilirubin | ✓ | Every 6-12 months or if clinically indicated | |
| CBC With Differential | ✓ | When monitoring CD4 count or if clinically indicated | |
| Pregnancy Test (when pregnancy is possible) | ✓ | If clinically indicated | ART should be initiated as soon as possible after confirming pregnancy to prevent perinatal HIV transmission. |
| Key: ALT = alanine aminotransferase; ART = antiretroviral therapy; AST = aspartate aminotransferase; CBC = complete blood count; CD4 = CD4 T lymphocyte; DAA = direct-acting antiviral; HBcAb = hepatitis B core antibody; HBsAb = hepatitis B surface antibody; HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCV = hepatitis C virus; NRTI = nucleoside reverse transcriptase inhibitor; OI = opportunistic infection; PR = protease; RT = reverse transcriptase; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate | |||
References
- Horberg M, Thompson M, Agwu A, et al. Primary care guidance for providers of care for persons with human immunodeficiency virus: 2024 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2024. Available at: https://pubmed.ncbi.nlm.nih.gov/39393187.
- Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV. 2024. Available at: https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/whats-new.
- Lucas GM, Ross MJ, Stock PG, et al. Clinical practice guideline for the management of chronic kidney disease in patients infected with HIV: 2014 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(9):e96-138. Available at: https://www.ncbi.nlm.nih.gov/pubmed/25234519.
- Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. Available at: https://www.ncbi.nlm.nih.gov/pubmed/30586774.
- American Diabetes Association. Classification and diagnosis of diabetes: standards of medical care in diabetes–2019. Diabetes Care. 2019;42(Suppl 1):S13-S28. Available at: https://www.ncbi.nlm.nih.gov/pubmed/30559228.
Laboratory Testing
Laboratory Testing for Initial Assessment and Monitoring of People With HIV
Table 3. Laboratory Testing Schedule Before and After Antiretroviral Therapy Initiationa
This table provides general guidance for laboratory monitoring for people with HIV before and after antiretroviral therapy (ART) initiation. Clinicians should use their clinical judgment to determine the monitoring frequency for an individual person based on clinical needs. This schedule is not intended to be a guide on how often people with HIV should undergo clinical evaluation, as some individuals may need to be seen more frequently to accomplish other aspects of clinical care. Please refer to Table 4 for laboratory monitoring guidance if ART initiation is deferred.
| Table 3. Laboratory Testing Schedule Before and After Antiretroviral Therapy Initiationa | |
|---|---|
Table 4. Laboratory Monitoring If ART Is Deferred
Antiretroviral therapy (ART) is recommended for all people with HIV (AI). People with HIV should be advised to begin ART as soon as feasible to reduce morbidity and mortality and to prevent transmission of HIV to others. This table provides guidance for laboratory monitoring in the rare occasions when ART initiation is deferred.
Laboratory Test | Initial Assessment | Monitoring Frequency If ART Is Deferred | Comments |
|---|---|---|---|
| CD4 Count | ✓ | Every 3–6 months | To assess for urgency of ART initiation and the need for OI prophylaxis |
| HIV Viral Load | ✓ | Every 3–6 months | |
Genotypic Resistance Testing (PR/RT +/- integrase gene) See Drug Resistance Testing for more information. | ✓ | Repeat genotypic resistance testing at the time of ART initiation is optional. | |
Hepatitis B Serology (HBsAb, HBsAg, HBcAb) See Hepatitis B in the Adult OI Guidelines for more detailed guidance. | ✓ | Clinically indicated | Before starting HCV DAA If HBsAg Positive:
If Not Immune at Baseline:
|
| Hepatitis C Screening (HCV antibody, or, if indicated, HCV RNA) | ✓ | Every 12 months for at-risk people, or if clinically indicated | |
| Basic Metabolic Panel | ✓ | Every 6-12 months or if clinically indicated | |
| ALT, AST, Total Bilirubin | ✓ | Every 6-12 months or if clinically indicated | |
| CBC With Differential | ✓ | When monitoring CD4 count or if clinically indicated | |
| Pregnancy Test (when pregnancy is possible) | ✓ | If clinically indicated | ART should be initiated as soon as possible after confirming pregnancy to prevent perinatal HIV transmission. |
| Key: ALT = alanine aminotransferase; ART = antiretroviral therapy; AST = aspartate aminotransferase; CBC = complete blood count; CD4 = CD4 T lymphocyte; DAA = direct-acting antiviral; HBcAb = hepatitis B core antibody; HBsAb = hepatitis B surface antibody; HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCV = hepatitis C virus; NRTI = nucleoside reverse transcriptase inhibitor; OI = opportunistic infection; PR = protease; RT = reverse transcriptase; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate | |||
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