Is Descovy (emtricitabine/tenofovir alafenamide) approved for both HIV pre‑exposure prophylaxis and HIV treatment, and what are the recommended dosing and monitoring?

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Descovy for HIV: Pre-Exposure Prophylaxis and Treatment

Descovy (emtricitabine/tenofovir alafenamide) is FDA-approved for HIV pre-exposure prophylaxis (PrEP) in specific populations, but it is NOT approved for PrEP in cisgender women or transgender men at risk through vaginal exposure. 1

Approved Indications for Descovy

PrEP Approval (Limited Population)

  • Descovy is approved for PrEP only in cisgender men who have sex with men (MSM) and transgender women who have sex with men 2, 3
  • The DISCOVER trial demonstrated non-inferiority to Truvada (TDF/FTC) for HIV prevention in MSM and transgender women, with an incidence rate ratio of 0.47 (95% CI 0.19-1.15) 3
  • At 96 weeks, Descovy maintained efficacy with only 0.16 infections per 100 person-years compared to 0.30 with Truvada 4

Critical Limitation for PrEP Use

  • Descovy is absolutely NOT recommended for cisgender women or transgender men at risk through vaginal exposure 1, 2, 5
  • For females requiring PrEP, Truvada (TDF/FTC) remains the only approved and effective option with proven efficacy 5
  • Descovy is also NOT recommended for event-driven "2-1-1" dosing 2

When to Choose Descovy Over Truvada for PrEP

Use Descovy as an alternative to Truvada specifically for MSM or transgender women with:

  • Creatinine clearance 30-60 mL/min (Truvada requires ≥60 mL/min) 1, 2
  • Osteopenia or osteoporosis 1, 2
  • Age >50 years with renal risk factors 1

Safety Advantages of Descovy

  • Superior bone mineral density outcomes compared to Truvada across all six prespecified endpoints 3
  • Superior renal biomarker safety profile compared to Truvada 4, 3
  • Well-tolerated with only 1% discontinuation rate due to adverse events 3

Important Caveat

  • More weight gain observed with Descovy (median 1.7 kg vs 0.5 kg with Truvada at 96 weeks, p<0.0001) 4

Dosing and Administration

PrEP Dosing

  • Descovy: emtricitabine 200 mg/tenofovir alafenamide 25 mg once daily 2
  • Requires 1-week lead-in period before adequate tissue levels are achieved for rectal and penile exposures 2
  • Continue for 1 week after the last sexual exposure when discontinuing 2

Pre-Initiation Requirements

Before starting Descovy for PrEP, obtain:

  • Combined HIV antibody and antigen testing (if acute HIV suspected, add HIV RNA testing) 2
  • Serum creatinine and estimated creatinine clearance (do not start if <30 mL/min for Descovy) 1, 2
  • Hepatitis B surface antigen (HBsAg) 2
  • Hepatitis C antibody 2
  • Three-site STI screening (rectal, pharyngeal, urogenital) for gonorrhea and chlamydia by NAAT 2
  • Pregnancy testing for individuals of childbearing potential 1

Ongoing Monitoring Schedule

Every 3 Months

  • Combined HIV antibody and antigen testing 1, 2
  • Three-site STI screening (rectal, pharyngeal, urogenital) for gonorrhea and chlamydia 1, 2
  • Syphilis testing 1
  • Pregnancy testing for individuals of childbearing potential 1
  • Assessment of adherence and risk behaviors 1

Every 6-12 Months

  • Serum creatinine and estimated glomerular filtration rate 1, 2
  • More frequent renal monitoring (every 3-6 months) required for patients >50 years, taking hypertension/diabetes medications, or baseline eGFR <90 mL/min 2

Absolute Contraindications

Do not prescribe Descovy for PrEP if:

  • HIV status is positive or unknown 1
  • Creatinine clearance <30 mL/min 1
  • Patient is a cisgender woman or transgender man at risk through vaginal exposure 1, 2, 5
  • PrEP prescriptions should not exceed 90 days without interval HIV testing 1

Management of HIV Infection During PrEP

If HIV infection occurs while on Descovy:

  • Immediately add a boosted protease inhibitor (darunavir/ritonavir or darunavir/cobicistat) and/or dolutegravir to the current regimen while awaiting HIV RNA and resistance testing 2
  • Switch to a recommended initial antiretroviral regimen once HIV is confirmed 2
  • Drug resistance when using PrEP is rare (<0.1%) and usually occurs when PrEP is inadvertently prescribed to individuals with undiagnosed acute HIV infection 6

Special Hepatitis B Caution

  • Use caution when discontinuing tenofovir-based PrEP in patients with chronic hepatitis B—risk of acute flares or hepatic decompensation, particularly with cirrhosis 2
  • Hepatitis B surface antigen testing should be completed for all patients prior to initiating PrEP 1

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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.

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