What is the next step for a patient on Pre-Exposure Prophylaxis (PrEP) with a transient increase in serum creatinine and a slightly decreased Creatinine Clearance (CrCl) but still above 60 ml/min?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: November 25, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

Management of Mild Creatinine Elevation in PrEP User

Reassure the patient that this increase can be transient and check for proteinuria today, then recheck kidney function in 1 to 3 months. 1, 2, 3

Rationale for This Approach

The observed creatinine increase from 0.80 to 1.00 mg/dL (a 0.20 mg/dL or 25% increase) with CrCl remaining above 60 mL/min represents an expected, typically transient change associated with TDF-based PrEP initiation that does not require discontinuation. 4, 5

Why This Change is Expected and Generally Benign

  • Mean creatinine increases of 0.03 mg/dL (4.6%) occur by week 12 of TDF/FTC PrEP and stabilize thereafter without progression. 4

  • Small declines in CrCl (approximately 2-3 mL/min) are documented in placebo-controlled trials and reverse within 4 weeks of discontinuation if PrEP is stopped. 5, 6

  • This change reflects tubular secretion effects rather than true glomerular injury—TDF inhibits creatinine tubular secretion, causing creatinine to rise without actual kidney damage. 4, 5

  • More than 96% of participants show >75% eGFR rebound to baseline within 8 weeks after drug discontinuation, confirming reversibility. 5

Why Proteinuria Assessment is Critical Today

  • The CDC and NIH recommend checking for proteinuria when creatinine changes occur during PrEP monitoring to identify the rare cases of true proximal tubular dysfunction. 2, 3

  • Approximately 15.7% of PrEP users develop worsening proteinuria at week 12, though this typically remains stable and nonprogressive. 4

  • Proteinuria provides additional prognostic information about kidney function and helps distinguish benign creatinine elevation from clinically significant kidney injury. 7

Why PrEP Should NOT Be Stopped

  • TDF-based PrEP is only contraindicated when CrCl falls below 60 mL/min—this patient remains above that threshold. 1, 8

  • The FDA label specifies dose adjustment or discontinuation only when CrCl drops to <50 mL/min, not for mild elevations with CrCl >60 mL/min. 8

  • Stopping PrEP prematurely exposes the patient to HIV acquisition risk without medical justification, as these changes are typically nonprogressive after 12 weeks. 4, 9

Appropriate Monitoring Schedule Going Forward

  • Increase creatinine monitoring frequency to every 3 months (rather than every 6 months) for this patient, as she now has a risk factor for kidney changes. 1, 2, 3

  • The CDC and NIH recommend more frequent monitoring (every 3-6 months) for patients with baseline CrCl <90 mL/min or those who develop creatinine changes. 2, 3

  • Continue quarterly HIV testing, STI screening, and adherence counseling as per standard PrEP protocols. 2, 3

Risk Stratification for Future Monitoring

  • Independent predictors of developing eGFR <70 mL/min include age ≥40 years (OR 3.79) and baseline eGFR <90 mL/min (OR 9.59). 4

  • Older individuals (>50 years), those with diabetes, hypertension, or baseline CrCl <90 mL/min require closer monitoring every 3 months. 1, 2, 9

  • Younger individuals without comorbidities and baseline CrCl >90 mL/min can continue standard 6-month monitoring if creatinine stabilizes. 9

Common Pitfalls to Avoid

  • Do not discontinue PrEP based solely on mild creatinine elevation with CrCl >60 mL/min—this represents overreaction to expected pharmacologic effects. 1, 4, 5

  • Do not delay proteinuria assessment—checking today allows early detection of the rare cases requiring intervention. 2, 3, 4

  • Do not refer to nephrology at this stage unless proteinuria is significant or CrCl continues declining below 60 mL/min on repeat testing. 1, 8

  • Do not simply "reassure and recheck in 1-3 months" without checking proteinuria today—this misses the opportunity to identify true tubular dysfunction early. 2, 3

Related Questions

What is the recommended pre-exposure prophylaxis (PrEP) regimen for an HIV negative patient with impaired renal function (creatinine clearance < 60)?
What are the serum creatinine and creatinine clearance (CrCL) requirements for initiating oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF)?
What other laboratory findings would be expected in a 50-year-old male with high-grade lymphoma undergoing aggressive chemotherapy who develops impaired renal function, as evidenced by an elevation in creatinine from 1 to 2.1?
What are the risks of using a lamivudine (NRTI) 150mg and zidovudine (NRTI) 300mg combination pill in patients with impaired renal function, specifically those with a creatinine clearance of 30 mL/min?
How do I manage a patient with elevated creatinine levels, indicating impaired renal function?
What is the definition of surgical abdomen and acute abdomen?
What is the initial management for a patient with nephrotic syndrome?
What is the recommended reduction in daunorubicin (anthracycline antibiotic) dosage for a B-cell Acute Lymphoblastic Leukemia (B-ALL) patient with hyperdiploidy and intermediate risk due to significant toxicity?
What is the management of splenic infarcts?
What is the best course of action for a patient with a history of antiphospholipid syndrome, deep vein thrombosis (DVT), hypertension, depression, and noncompliance with Eliquis (apixaban) and Plavix (clopidogrel), presenting with acute non-occlusive DVT, sepsis of unknown origin, lymphadenopathy, shortness of breath, and hypoxemia?
What is the initial workup for a patient with suspected renal agenesis (absence of one kidney)?

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.