What are the guidelines for using Descovy (emtricitabine and tenofovir alafenamide) in females for HIV pre-exposure prophylaxis (PrEP) or treatment?

Guidelines for Descovy (Emtricitabine/Tenofovir Alafenamide) in Females for HIV PrEP

Tenofovir alafenamide/emtricitabine (Descovy) is not currently recommended for HIV pre-exposure prophylaxis (PrEP) in females as it has only been approved and studied for cisgender men and transgender women who have sex with men. 1, 2

Current PrEP Recommendations for Females

• Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) once daily is the recommended oral PrEP regimen for all individuals at risk for HIV infection through sexual exposure, including females 1
• Daily dosing is especially important for women, as tenofovir concentrates at 10-fold lower levels in vaginal tissue than in rectal tissue and clearance is faster 1
• PrEP is recommended for populations with an HIV incidence above 2% per year and for HIV-seronegative partners of HIV-infected persons who are not consistently virally suppressed 1

Evidence Gap for Descovy in Females

• The DISCOVER trial, which demonstrated non-inferiority of emtricitabine/tenofovir alafenamide (F/TAF) compared to emtricitabine/tenofovir disoproxil fumarate (F/TDF) for PrEP, only included cisgender men who have sex with men and transgender women 3, 4
• The trial did not include cisgender women or people at risk through vaginal sex or injection drug use 2, 3
• The pharmacokinetics of tenofovir alafenamide in vaginal tissue have not been adequately studied to ensure protection against HIV acquisition in females 1

Specific Recommendations for PrEP in Females

Pre-initiation Testing

• Combined HIV antibody and antigen testing (HIV RNA level if clinical suspicion of acute HIV) 1
• Serum creatinine level 1
• Hepatitis B surface antigen 1
• Hepatitis C IgG antibody (if not known to be previously positive) 1
• Genital and nongenital Neisseria gonorrhea and Chlamydia trachomatis testing by nucleic acid amplification test (NAAT) 1
• Pregnancy testing for individuals of childbearing potential 1

Monitoring During PrEP

• At 1 month: Combined HIV antibody and antigen test 1
• Quarterly:
  • Combined HIV antibody and antigen test 1
  • Estimated creatinine clearance rate (at first quarterly visit and annually thereafter) 1
  • Genital and nongenital gonorrhea and chlamydia testing by NAAT 1
  • Syphilis testing 1
  • Pregnancy testing 1
• Annually: Hepatitis C virus antibody test 1

Special Considerations for Females

• PrEP prescriptions should not exceed 90 days without interval testing for HIV infection 1
• Unlike condoms, PrEP does not prevent other sexually transmitted infections 1
• For women who inject drugs, clean injection equipment and access to substance use treatment should be available 1

Potential Future Use of Descovy in Females

• While Descovy shows improved renal and bone safety profiles compared to TDF/FTC in the populations studied 2, 3, 4, these benefits cannot yet be extrapolated to females for PrEP use
• Additional clinical trials specifically including females are needed before Descovy can be recommended for PrEP in this population 2, 5

Conclusion for Clinical Practice

• For females requiring PrEP, tenofovir disoproxil fumarate/emtricitabine remains the only recommended option with proven efficacy 1
• Daily dosing is critical for females to maintain adequate drug levels in vaginal tissue 1
• Regular monitoring for HIV, STIs, renal function, and pregnancy is essential 1