ANTIRETROVIRAL LAB MONITORING | |||||||||
---|---|---|---|---|---|---|---|---|---|
Laboratory Monitoring Schedule for Patients Before and After Initiation of Antiretroviral Therapy | |||||||||
Entry Into Care |
ART Initiation or modificationa |
Follow-up 4−8 weeks after initiation or modification |
Every 3 months |
Every 6 months |
Every 12 months |
Treatment failure |
Clinically indicated |
If ART initiation delayede |
|
HIV Antigen/ Antibody Test | If diagnosis has not been confirmed | ||||||||
CD4 count | ✓ | ✓ | If CD4 count <300 cells/mm3. Consider less frequent monitoring (eg, every 6mos) after 2yrs of consistently suppressed HIV RNA | During first 2yrs of ART: if CD4 count ≥300 cells/mm3 | After 2yrs on ART with consistently suppressed viral load: if CD4 count 300–500 cells/mm3, monitor every 12 months. CD4 count >500 cells/mm3, monitoring is optional | ✓ | ✓ | Every 3−6mos | |
HIV viral load | ✓ | ✓ | ✓b | ✓c | ✓c | ✓ | ✓ | Repeat testing is optional | |
Genotypic resistance testing (PR/RT genes)d | ✓ | ✓ | ✓ | ✓ | ✓ | ||||
Genotypic resistance testing (Integrase genes)d | If transmitted INSTI resistance suspected or has a history of CAB-LA use for PrEP | If transmitted INSTI resistance suspected or history of INSTI usec | If history of INSTI use | If history of INSTI use | |||||
HLA-B*5701 testing | If consi- dering ABC | ||||||||
Tropism testing | If consi- dering CCR5 antagonist | If consi- dering CCR5 antagonist or CCR5 antagonist-based regimen failed | ✓ | ||||||
Hepatitis B serology (HBsAb, HBsAg, HBcAb, total)i,j,k | ✓ | If switching to a regimen that does not contain TDF or TAF, consider retesting if not immune to HBV | Including prior to starting HCV DAA | ||||||
Hepatitis C screening (HCV antibody or, if indicated, HCV RNA)l | ✓ | Repeat HCV screening for at-risk patientsm | ✓ | ||||||
Basic metabolic panelf,g | ✓ | ✓ | ✓ | ✓ | ✓ | Every 6−12mos | |||
ALT, AST, T. bilirubin | ✓ | ✓ | ✓ | ✓ | ✓ | Every 6−12mos | |||
CBC with differentialp | ✓ | ✓ | When monitoring CD4 count (if required by lab) | When monitoring CD4 count (if required by lab) | When no longer monitoring CD4 count | ✓ | |||
Lipid profilen | ✓ | Consider 1-3mos after ARV initiation or modification | If normal at baseline but with CV risk | If normal at baseline, every 5yrs or if clinically indicated | |||||
Random or fasting glucoseq | ✓ | ✓ | ✓ | ✓ | |||||
Urinalysisg,h | ✓ | In CKD or DM patients | |||||||
Pregnancy testo | ✓ | ✓ | ✓ | ||||||
NOTES | |||||||||
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 Primary Care guidelines for guidance on other laboratory tests generally recommended for primary health care maintenance of HIV patients. a If ART initiation occurs soon after HIV diagnosis, repeat baseline testing is not necessary. b If HIV RNA is detectable at 4−8 weeks, repeat every 4−8 weeks until suppression to <50 copies/mL, then every 3−6 months. c Viral load typically is measured every 3−6 months in patients on ART. Consider more frequent monitoring in patients with adherence difficulties or at risk for nonadherence. However, for adherent patients with consistently suppressed viral load and stable immunologic status for >1yr, may extend monitoring to 6-month intervals. d Standard genotypic drug-resistance testing in ARV-naive patients should focus on mutations in the reverse transcriptase and protease genes. Test for resistance mutations in the IN gene if transmitted INSTI resistance is a concern, if has a history of INSTI use as PrEP or treatment, or a person presents with viremia while on an INSTI. In ARV-naive patients who do not immediately begin ART, if resistance testing was performed at entry into care, repeat testing before initiation of ART is optional. For virologically suppressed patients who are switching therapy for toxicity or convenience, viral amplification will not be possible and therefore resistance testing should not be performed. Results from prior resistance testing can be used to help in the construction of a new regimen. e ART is indicated for all patients with HIV and should be started as soon as possible. If ART initiation is delayed, patients should be retained in care, with periodic monitoring as noted above. f Serum Na, K, HCO3, Cl, BUN, creatinine, glucose (preferably fasting), and creatinine-based estimated GFR. Monitor serum phosphorus in patients with CKD who are on TDF-based regimens. g For patients with renal disease, consult the Guidelines for the Management of Chronic Kidney Disease in HIV-Infected Patients: Recommendations of the HIV Medicine Association of the Infectious Diseases Society of America. More frequent monitoring may be indicated for patients with evidence of kidney disease (eg, proteinuria, decreased glomerular dysfunction) or increased risk of renal insufficiency (eg, patients with diabetes, hypertension). h Assess urine glucose and protein before initiating TAF- or TDF-based regimens, and monitor during treatment. i If patient has HBV infection (as determined by a positive HBsAG or HBV DNA test), TDF or TAF plus either FTC or 3TC should be used as part of the ARV regimen to treat both HBV and HIV infections. j If HBsAg, HBsAb, and HBcAb are negative, HBV vaccine series should be given. k Most patients with isolated HBcAb have resolved HBV infection with loss of HBsAb. Consider performing an HBV viral load for confirmation. If HBV viral load is positive, patient may be acutely infected (and will usually display other signs of acute hepatitis) or chronically infected. If negative, patient should be vaccinated. l The HCV antibody test may not be adequate for screening in recent HCV infection (within the past 6mos), or advanced immunodeficiency (CD4 <100cells/mm3). HCV RNA screening is indicated in patients who have been successfully treated for HCV or who spontaneously cleared prior infection. HCV antibody-negative patients with elevated ALT may need HCV RNA testing. m At-risk patients for HCV infection include injection drug users, persons with a history of incarceration, men with HIV who have unprotected sex with men, and persons with percutaneous/parenteral exposure to blood in unregulated settings. n Obtain fasting lipids if random lipids are abnormal. Consult the 2018 Guideline on the Management of Blood Cholesterol for patients with dyslipidemia. o This applies to patients of childbearing potential. p CBC with differential should be done when a CD4 count is performed. When no longer monitoring CD4 count, monitor CBC with differential once a year. More frequent monitoring may be needed for patients who are on medications that potentially cause cytopenia (e.g., TMP-SMX). q Obtain fasting glucose if random glucose is abnormal. HbA1C is no longer recommended for diabetes diagnosis in HIV patients on ART. ACRONYMS: 3TC = lamivudine, ABC = abacavir, ALT = alanine aminotransferase, ART = antiretroviral therapy, ARV = antiretroviral, AST = aspartate aminotranserase, BUN = blood urea nitrogen, CAB-LA = cabotegravir long-acting, CBC = complete blood count, CCR5 = cysteine-cysteine chemokine receptor 5, CKD = chronic kidney disease, Cl = chloride, CV = cardiovascular, DAA = direct-acting antiviral, DM = diabetes mellitus, FTC = emtricitabine, GFR = glomerular filtration rate, 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, IN = integrase, INSTI = integrase strand transfer inhibitor, PrEP = pre-exposure prophylaxis, TAF = tenofovir alafenamide, TDF = tenofovir disoproxil fumarate, TMP-SMX = trimethoprim-sulfamethoxazole |
|||||||||
REFERENCES | |||||||||
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv. Updated December 6, 2023. Accessed December 14, 2023 [Table 3]. (Rev. 1/2024) |
Antiretroviral Lab Monitoring