Why Females Can Take Descovy for HIV Prevention
Females can take Descovy (emtricitabine/tenofovir alafenamide) for HIV treatment, but it is NOT currently recommended for cisgender women for HIV prevention (PrEP) from receptive vaginal sex. 1
Descovy for HIV Treatment in Females
- Descovy (emtricitabine/tenofovir alafenamide) is approved as part of antiretroviral therapy regimens for HIV treatment in both males and females 2
- Tenofovir alafenamide (TAF) combined with emtricitabine (FTC) is recommended as a nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) backbone component for HIV treatment regimens in all populations, including women 2
- Dolutegravir with tenofovir alafenamide/emtricitabine is specifically recommended for pregnant women with HIV and women planning to become pregnant due to its high antiviral efficacy and low rates of adverse birth outcomes 2
Descovy for HIV Prevention (PrEP) in Females
- Descovy is NOT currently recommended for cisgender women for prevention of HIV-1 infection from receptive vaginal sex 1
- The FDA approval for Descovy as PrEP is specifically limited to men who have sex with men (MSM) and transgender women who have sex with men 1
- This limitation is due to insufficient clinical trial data demonstrating efficacy in cisgender women 3
Safety in Pregnancy
- Available data from the Antiretroviral Pregnancy Registry show no increase in the overall risk of major birth defects with first trimester exposure to emtricitabine (2.3%) compared with the background rate of 2.7% 4
- Animal reproduction studies of emtricitabine showed no adverse developmental effects when administered at exposures significantly higher than human therapeutic doses 4
- For pregnant women with HIV, dolutegravir with tenofovir alafenamide/emtricitabine is recommended as the antiretroviral regimen of choice 2
Pharmacokinetic Considerations in Females
- A Phase I study in women showed that tenofovir-diphosphate (TFV-DP) concentrations in vaginal tissue were approximately 6-fold higher with tenofovir alafenamide compared to tenofovir disoproxil fumarate 5
- However, tenofovir and tenofovir-diphosphate were lower with tenofovir alafenamide versus tenofovir disoproxil fumarate in rectal tissue 5
- These pharmacokinetic differences may impact the effectiveness of Descovy for PrEP in different anatomical sites of HIV exposure 5
Safety Advantages of Descovy
- Tenofovir alafenamide shows improved renal and bone safety compared with tenofovir disoproxil fumarate 3
- In clinical trials, Descovy demonstrated more favorable effects on bone mineral density and biomarkers of renal safety than Truvada (emtricitabine/tenofovir disoproxil fumarate) 3
- These safety advantages may be particularly beneficial for women with renal impairment or bone health concerns 6
Important Limitations and Monitoring
- Descovy should not be initiated in persons with suspected or confirmed HIV infection 1
- Before initiating Descovy, patients should undergo HIV testing, renal function assessment, hepatitis B screening, and STI testing 1
- During treatment, regular monitoring should include HIV testing, creatinine clearance assessment, and STI screening 1
Conclusion
While Descovy is approved and recommended for HIV treatment in females, including pregnant women, it is not currently recommended for HIV prevention (PrEP) in cisgender women due to limited efficacy data in this population. Additional research is needed to establish its effectiveness for PrEP in women.