Antiretroviral Lab Monitoring

Antiretroviral Lab Monitoring
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)