What is the approach to managing a patient presenting for a 3-month refill of Descovy (emtricitabine and tenofovir alafenamide) for HIV treatment?

Managing a 3-Month Descovy Refill Visit for HIV Treatment

For a patient presenting for a routine 3-month Descovy refill, confirm viral suppression with HIV RNA testing, assess adherence, screen for side effects, monitor renal and bone health markers, and verify hepatitis B status before continuing therapy. 1

Pre-Refill Assessment Requirements

Mandatory Laboratory Testing

• Check HIV RNA viral load at this visit to confirm continued virologic suppression (target <50 copies/mL), as monitoring every 3 months is recommended for patients on antiretroviral therapy 1
• Measure serum creatinine and calculate estimated glomerular filtration rate (eGFR) to monitor renal function, particularly important with tenofovir-containing regimens 1, 2
• Assess hepatitis B surface antigen (HBsAg) status if not previously documented, as Descovy contains agents active against HBV and discontinuation can cause severe HBV flare-ups 2, 1

Critical Adherence Evaluation

• Directly ask the patient about missed doses in the past 3 days and since the last visit, as patient self-reporting of suboptimal adherence is a strong predictor of treatment failure even when overall estimates are unreliable 1
• Inquire about specific circumstances of any missed doses and develop concrete strategies to prevent future lapses 1
• Review pharmacy refill records to objectively assess adherence patterns 1

Confirming Appropriate Regimen Composition

Verify Complete ART Regimen

• Descovy (emtricitabine/tenofovir alafenamide) is NOT a complete HIV treatment regimen by itself and must be combined with a third agent, typically an integrase strand transfer inhibitor like bictegravir or dolutegravir 1
• Confirm the patient is taking their complete regimen including the third agent, as Descovy alone provides only the NRTI backbone 1
• If the patient is on bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) as a single-tablet regimen, this contains Descovy plus bictegravir and represents complete therapy 1, 3

Safety Monitoring Specific to Descovy

Renal Function Assessment

• Tenofovir alafenamide (TAF) in Descovy achieves 90% lower plasma tenofovir concentrations compared to tenofovir disoproxil fumarate (TDF), resulting in superior renal safety 4, 5
• Monitor for changes in eGFR, though clinically significant renal toxicity is rare with TAF compared to TDF 5, 6
• Assess urine protein-to-creatinine ratio if baseline renal impairment exists 1

Bone Health Considerations

• TAF demonstrates superior bone safety compared to TDF, with stable or improved bone mineral density over time 5, 4, 6
• For patients at high risk of bone disease, continuation of TAF-based therapy is preferred over TDF-based alternatives 1

Hepatitis B Coinfection Management

• If the patient has chronic HBV, never discontinue Descovy without ensuring alternative HBV-active therapy, as abrupt cessation can cause severe and potentially fatal HBV reactivation 2, 1
• Descovy provides dual activity against both HIV and HBV through its emtricitabine and tenofovir alafenamide components 1
• Monitor liver function tests (AST, ALT, bilirubin) at this visit if HBV coinfection is present 2

Side Effect Screening

Common Adverse Effects to Assess

• Ask specifically about headache, diarrhea, nausea, fatigue, and dizziness, which are the most common side effects of emtricitabine-containing regimens 2
• Inquire about any new or worsening symptoms since the last visit 2
• Assess for signs of lactic acidosis (weakness, shortness of breath, cold extremities, unusual muscle pain, abdominal pain with nausea) though this is rare 2

Weight and Metabolic Monitoring

• Measure current weight, as modest weight gain (<1 kg per year) has been observed with long-term TAF use 6
• Check fasting lipid panel and glucose if not done recently, as cholesterol concentrations remain generally stable on TAF 6

Resistance Considerations

When Viral Suppression is Maintained

• If HIV RNA remains <50 copies/mL, continue current regimen without modification 1
• No resistance testing is needed when virologic suppression is maintained 1

If Virologic Failure is Detected

• Perform resistance testing immediately while the patient continues the failing regimen or within 4 weeks of stopping 1
• Do not add a single active agent to a failing regimen 1
• Switch promptly to a new regimen based on resistance testing results to prevent accumulation of additional mutations 1

Immune Reconstitution Syndrome Awareness

• Ask about new infections or inflammatory symptoms, as immune reconstitution syndrome can occur when HIV-infected patients maintain viral suppression on antiretroviral therapy 2
• New symptoms may represent previously hidden infections being unmasked by improved immune function 2

Refill Authorization Algorithm

Authorize 3-month refill if:

• HIV RNA <50 copies/mL 1
• Patient reports good adherence with no pattern of missed doses 1
• No new concerning symptoms or side effects 2
• Renal function stable (eGFR change <25% from baseline) 1
• Patient is taking complete ART regimen including third agent 1
• If HBV coinfected, liver function tests are stable 2

Do NOT refill and reassess if:

• HIV RNA ≥50 copies/mL (obtain resistance testing) 1
• Significant decline in renal function (eGFR decrease >25%) 1
• Patient reports poor adherence or multiple missed doses 1
• New symptoms suggesting lactic acidosis or severe liver problems 2
• Patient is taking Descovy without a third antiretroviral agent 1

Patient Education at Refill Visit

• Emphasize that missing doses can lead to resistance development and treatment failure 1
• Remind patient not to run out of medication and to refill before supply is exhausted 2
• Reinforce that if HBV coinfected, stopping Descovy without medical supervision can cause life-threatening HBV flare 2
• Discuss the importance of keeping all scheduled appointments for ongoing monitoring 1