HIV post exposure prophylaxis (PEP) guidelines recommend routine glomerular filtration rate (GFR), aspartate aminotransferase (AST), and alanine transaminase (ALT) testing at PEP initiation and follow up visits. Once daily tenofovir (TDF)/emtricitabine (FTC)/ dolutegravir (DTV) is the first line PEP regimen in CDC guidelines and New York City (NYC) Sexual Health Clinics (SHC) due to its high safety profile. We assessed the prevalence of abnormal AST/ALT/ GFR at baseline (BL) and follow up (FU) testing among patients without self-reported kidney or liver disease who were provided 28 days of PEP at NYC SHC.
We extracted medical record data from PEP initiation visits during 9/2016-12/2017 with: TDF/FTC/DTV regimen, a baseline metabolic panel, and no HIV medication dispensed in the prior three months at NYC SHC. GFR/AST/ALT results were examined at BL and at the first FU testing 14-42 days. Normal renal function (RF) was defined as GFR ≥70 ml/min and normal liver function (LF) was defined as ALT and AST less < 50 U/L. Abnormal LF/RF tests were classified into grades based on the GFR and higher AST/ALT values (table). Chart review was done for visits ≥ grade 2 to determine whether PEP regimen was changed or discontinued.
Overall 1115 PEP initial visits were identified of 1051 unique patients. Median age was 29 years (IQR 25-35); 92% were male. At baseline, 3% of visits had an abnormal RF (33/1115) and 9% had an abnormal LF (95/1115). The majority of BL abnormal labs were grade 1(RF: 31/32; LF: 77/95). Among 575 BL visits with FU labs, 9% had abnormal RF (50/575) and 11% had an abnormal LF (64/575). The majority of FU abnormal labs were grade 1(RF: 49/50; LF: 51/64) (table). Visits with and without FU labs were similar with regards to age, gender, race, and baseline RF. Visits with abnormal BL LF were more likely to have FU lab visits (aOR 1.7;95%CI 1.1-2.6). Only twice was a PEP regimen changed based on BL grade 2 RF or LF abnormality and no PEP regimens were changed based on FU lab abnormalities.
Baseline renal and liver testing among PEP visits on TDF/FTC/DTV without known history of kidney and liver disease was normal in > 90 % and rarely resulted in changes in PEP regimen (0.2%). Follow up renal and liver testing did not result in any regimen change. As the safety profile of PEP regimens improves, routine renal and liver testing and monitoring for healthy patient population may not be necessary.