Laboratory Test | Timepoint or Frequency of Testing | |||||||
|---|---|---|---|---|---|---|---|---|
Entry Into Care | ART Initiationb or Modification | After ART Initiation or Modification | Every 3-4 Months | Every 6 Months | Every 12 Months | Treatment Failure | Clinically Indicated | |
| HIV Antigen/ Antibody Test | ✓ If HIV diagnosis not confirmed | |||||||
| HIV Viral Load | ✓ | ✓ | ✓c At 4-8 weeks | ✓d | ✓d |
| ✓ | ✓ |
| CD4 Count | ✓ | ✓ | ✓ 3 months (after ART initiation only) | ✓e If CD4 count is <300 cells/mm3 | ✓ During the First 1-2 Years on ART and With Viral Suppression, if CD4 count is ≥ 300 cells/mm3:
After 1-2 Years on ART With Consistently Suppressed Viral Load and CD4 Count >300 cells/mm3:
| ✓ Monitor CD4 count every 3-6 months. | ✓ | |
| Genotypic Resistance Testing (PR/RT Genes)f | ✓ | ✓ |
|
|
|
| ✓ | ✓ |
| Genotypic Resistance Testing (Integrase Genes)f | ✓ If transmitted INSTI resistance is suspected or if there is a history of CAB-LA use for PrEP or INSTI use for PEP | ✓ If transmitted INSTI resistance is suspected or if there is a history of INSTI use | ✓ If there is a history of INSTI use for treatment or prevention | ✓
| ||||
| Tropism Testing | ✓ If considering a CCR5 antagonist | ✓ If considering a CCR5 antagonist, or upon virologic failure on a CCR5 antagonist | ✓ | |||||
| HLA-B*5701 Testing | ✓ If considering ABC (perform once; keep result in health record) | |||||||
Hepatitis B Serology (HBsAb, HBsAg, HBcAb total)g,h,i Also see Hepatitis B Virus/HIV Coinfection | ✓ | ✓ In people not immune to HBV, repeat testing if switching to a regimen that does not contain TDF or TAF. | ✓ Before starting HCV DAA In people not immune to HBV and at high risk for HBV,j periodic testing may be considered. | |||||
Hepatitis C Screening (HCV antibody or, if indicated, HCV RNA)k | ✓ | ✓ Repeat HCV screening for at-risk people.j
| ✓ | |||||
| Basic Metabolic Panell,m | ✓ | ✓ | ✓ At 4-8 weeks For people with preexisting conditions or at risk of laboratory changes after ART initiation |
| ✓ Every 6-12 months |
| ✓ | |
| ALT, AST, Total Bilirubin | ✓ | ✓ | ✓ At 4-8 weeks For people with preexisting conditions, at risk for laboratory changes after ART initiation, or with HBV coinfection |
| ✓ Every 6-12 months |
| ✓ | |
| CBC with Differentialn | ✓ | ✓ |
| ✓ When monitoring CD4 count (if required by lab) | ✓ When monitoring CD4 count (if required by lab) | ✓ When no longer monitoring CD4 count | ✓ | |
| Lipid Profileo | ✓ | ✓ | At 3-6 months once viral suppression is reached | ✓ If aged >40 years or on a statin (Every 1-3 years if aged <40 years and not on a statin) | ✓ If there are changes in CV risk factorsp | |||
| Random or Fasting Glucoseq | ✓ | ✓ |
|
|
|
|
| ✓ |
| Urinalysism,r | ✓ | ✓ e.g., in people with CKD or DM | ||||||
| Pregnancy Testss | ✓ | ✓ |
|
|
|
|
| ✓ |
a This table pertains to laboratory tests done to select an ARV regimen and monitor for treatment responses or ART toxicities. Please refer to the HIV Medicine Association of the Infectious Diseases Society of America’s (HIVMA/IDSA) Primary Care Guidance for Providers Who Care for Persons With HIV for other laboratory tests generally recommended for primary health care maintenance of HIV people.1
b If ART is initiated soon after HIV diagnosis and entry into care, repeat baseline laboratory testing is not necessary.
c If HIV RNA is detectable at 4–8 weeks, repeat testing every 4–8 weeks until viral load is suppressed to <50 copies/mL. Thereafter, repeat testing every 3–6 months.
d For people on ART, viral load is typically measured every 3–6 months. More frequent monitoring may be considered in individuals having difficulties with ART adherence or at risk for nonadherence. However, for adherent people with consistently suppressed viral load and stable immunologic status for more than 1 year, monitoring can be extended to 6-month intervals.
e After 1–2 years of consistently suppressed HIV RNA, less frequent monitoring (e.g., every 6 months) may be considered.
f Standard genotypic drug-resistance testing in ARV-naive persons should focus on testing for mutations in the PR and RT genes. If transmitted INSTI resistance is a concern, or if a person may have a history of INSTI use as PrEP, PEP, or treatment, or a person presents with viremia while on an INSTI, providers also should test for resistance mutations in the integrase gene. In people who are ARV-naive and who do not immediately begin ART, repeat testing before initiation of ART is optional if drug-resistance testing was performed at entry into care. In people with virologic suppression who are switching therapy because of toxicity or for convenience, viral amplification will not be possible; see the Drug-Resistance Testing section for a discussion of the potential limitations and benefits of proviral DNA assays in this situation. Results from prior drug-resistance testing should be used in constructing a new regimen.
g If a person has HBV infection (as determined by a positive HBsAg or HBV DNA test result), TDF or TAF plus either FTC or 3TC should be used as part of the ARV regimen to treat both HBV and HIV infections (see the Hepatitis B Virus/HIV Coinfection section).
h If HBsAg, HBsAb, and HBcAb test results are negative, HBV vaccine series should be administered. Refer to the HIVMA/IDSA’s Primary Care Guidance for Persons With HIV and the Adult and Adolescent Opportunistic Infection Guidelines for detailed recommendations.1,2
i Most people with isolated HBcAb have resolved HBV infection with loss of HBsAb. Consider performing an HBV viral load test for confirmation. If the HBV viral load test is positive, the person may be acutely infected (and will usually display other signs of acute hepatitis) or chronically infected. If the test is negative, the person should be vaccinated. Refer to the HIVMA/IDSA’s Primary Care Guidance for Persons With HIV and the Adult and Adolescent Opportunistic Infection Guidelines for more detailed recommendations.2
j Injection drug users, people with a history of incarceration, men with HIV who have unprotected sex with men, and people with percutaneous/parenteral exposure to blood in unregulated settings are at risk of HBV or HCV infection.
k The HCV antibody test may not be adequate for screening in the setting of recent HCV infection (acquisition within the past 6 months) or advanced immunodeficiency (CD4 count <100 cells/mm3). HCV RNA screening is indicated in persons who have been successfully treated for HCV or who spontaneously cleared prior infection. HCV antibody-negative people with elevated ALT may need HCV RNA testing.
l Serum Na, K, HCO3, Cl, BUN, creatinine, glucose, and Cr-based eGFR. Serum P should be monitored in people with CKD who are on TDF-containing regimens.3
m Consult the HIVMA/IDSA’s Clinical Practice Guideline for the Management of Chronic Kidney Disease in People Infected With HIV for recommendations on managing people with renal disease.3 More frequent monitoring may be indicated for people with evidence of kidney disease (e.g., proteinuria, decreased glomerular dysfunction) or increased risk of renal insufficiency (e.g., people with diabetes, hypertension).
n CBC with differential should be done when a CD4 count is performed. When CD4 count is no longer being monitored, the recommended frequency of CBC with differential is once a year. More frequent monitoring may be indicated for people receiving medications that potentially cause cytopenia (e.g., TMP-SMX).
o If random lipids are abnormal, fasting lipids should be obtained. Consult the American College of Cardiology/American Heart Association’s 2018 Guideline on the Management of Blood Cholesterol for diagnosis and management of people with dyslipidemia.4
p Changes in CV risk factors such as new diagnosis of hypertension, weight gain, or new medications (including ART) that may raise lipid levels or overall CV risk.
q If random glucose is abnormal, fasting glucose should be obtained. HbA1C is no longer recommended for diagnosis of diabetes in people with HIV on ART (see the American Diabetes Association Guidelines).5
r Urine glucose and protein should be assessed before initiating TAF- or TDF-containing regimens and monitored during treatment with these regimens.
s For women of childbearing potential.
Key: 3TC = lamivudine; ABC = abacavir; ALT = alanine aminotransferase; ART = antiretroviral therapy; ARV = antiretroviral; AST = aspartate aminotransferase; BUN = blood urea nitrogen; CAB-LA = cabotegravir long-acting; CBC = complete blood count; CD4 = CD4 T lymphocyte; CKD = chronic kidney disease; Cl = chloride; Cr = creatinine; CV = cardiovascular; DAA = direct-acting antiviral; DM = diabetes mellitus; eGFR = estimated glomerular filtration rate; FTC = emtricitabine; HbA1C = hemoglobin A1c; HBcAb = hepatitis B core antibody; HBsAb = hepatitis B surface antibody; HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCO3 = bicarbonate; HCV = hepatitis C virus; INSTI = integrase strand transfer inhibitor; K = potassium; Na = sodium; P = phosphorus; PEP = post-exposure prophylaxis; PR = protease; PrEP = pre-exposure prophylaxis; RT = reverse transcriptase; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TMP-SMX = trimethoprim-sulfamethoxazole