The main objective of monitoring PWH receiving ART is to optimise the efficacy of ART while minimising ART-related adverse drug reactions and toxicities. HIV RNA (viral load) and CD4+ T cell (CD4) count are the two surrogate markers of ART response and HIV disease progression. In addition to the CD4 count and viral load, a number of other laboratory monitoring tests and investigations are recommended to aid in assessing the efficacy and tolerability of ART.
The table below summarises the main monitoring recommendations. (Adapted from BHIVA guidelines on the routine investigation and monitoring of HIV-1-positive adults[1] and other international guidelines[2,3]).
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Main HIV Laboratory Tests |
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HIV serology |
At entry into care |
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HIV plasma viral load |
At entry into care |
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2 to 8 weeks after ART initiation or modification |
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During first 2 years on ART every 3 to 6 months |
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After 2 years of ART with consistently suppressed VL every 6 months |
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Treatment failure or otherwise clinically Indicated |
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CD4+ T cell count (and percentage of lymphocytes) |
At entry into care |
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During first 2 years of ART: every 3 to 6 months, or if viremia develops while on ART, or CD4 count <300/mL |
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After 2 years on ART with consistently suppressed VL: CD4 Count 300–500/mL: every 12 months CD4 Count >500/mL: CD4 monitoring is optional |
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Virological failure or otherwise clinically indicated |
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HIV genotypic resistance test |
At entry into care /before ART initiation, according to local guidelines and if test is available |
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Repeat in treatment failures or as otherwise clinically indicated |
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HLA-B*5701 testing |
At ART initiation or modification if considering use of abacavir therapy (one test only) |
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Tests for co-infections |
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Hepatitis B virus serology |
HBsAg, HBsAb, HBcAb |
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At entry into care. Vaccination if not immune (refer to subsection on Vaccines in people with HIV infection) and repeat HBsAb to confirm seroconversion |
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Hepatitis A virus (HAV) |
HAV IgG or total Ab At entry into care. Vaccination if not immune (refer to subsection on Vaccines in people with HIV infection) and repeat test to confirm seroconversion |
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Hepatitis C virus (HCV) |
HCAb or plasma HCV RNA (qualitative) if past infection |
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At entry into care. Repeat annually as clinically indicated |
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TB risk assessment |
In addition to a clinical assessment of risk factors for Mycobacterium tuberculosis infection, investigations pre-ART might include chest X-ray, interferon-y release assay (IGRA), such as the Quantiferon (QIFN) TB-Gold assay, or Tuberculin skin test (TST), as per local guidelines. |
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STIs testing |
As per national guidelines http://www.sti.guidelines.org.au/populations-and-situations/plwhiv-people-living-with-hiv |
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Medical History |
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Review all prescribed and over the counter medications and other supplements. |
Up to date medication history At every visit; at minimum every 12 months |
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Document allergies |
At entry to care and update as necessary |
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Review treatment adherence, adverse effects and DDIs |
At every visit; at minimum every 12 months |
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Check the need for antiretroviral drug dose adjustment as a consequence of change in kidney and liver function |
At every visit; at minimum every 12 months |
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Recreational drug use and MSM “Chem Sex“ |
Assessment of alcohol, tobacco and other recreational drug use as per local guidelines e.g. https://yourroom.health.nsw.gov.au/ MSM “Chem Sex” assessment as per guidelines e.g. |
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Other laboratory test monitoring
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Full blood count |
At entry into care /before ART initiation 2 to 8 weeks after ART Initiation or modification Every 6 months More frequent monitoring as clinically indicated |
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Kidney and liver function tests |
At entry into care /before ART initiation 2 to 8 weeks after ART Initiation or modification Every 6 months |
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Random or Fasting Glucose |
More frequent monitoring may be indicated for patients with evidence of kidney disease or at increased risk of kidney disease |
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Urine analysis |
Urine dipsticks, urine Pr /Cr ratio, urine Alb/Cr ratio At entry into care Every 12 months for those receiving TDF version of tenofovir or those who have risk factors for CKD4 |
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Pregnancy test for women |
At entry into care and during long-term care, as clinically indicated and with consent |
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Chronic Disease Risk Assessment |
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CVD risk over next 5 years |
All PWH older than 45 years (or >35 years for Aboriginal people) without existing cardiovascular disease or not already known to be at increased risk of cardiovascular disease: Australian absolute CVD risk calculator https://www.cvdcheck.org.au/ |
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Osteoporosis risk calculation for next 5 and 10 years |
Assess for risk factors every 12 months in women older than 45 years, men >50 years; consider BMD measurement Australian Bone Fracture Risk Calculator https://www.garvan.org.au/promotions/bone-fracture-risk/calculator/ |