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. 2024 Mar 19;331(11):930-937.
doi: 10.1001/jama.2024.0464.

HIV Preexposure Prophylaxis With Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women

Jeanne Marrazzo  1   2 , Li Tao  3 , Marissa Becker  4 , Ashley A Leech  5 , Allan W Taylor  6 , Faith Ussery  6 , Michael Kiragu  7   8 , Sushena Reza-Paul  9 , Janet Myers  10 , Linda-Gail Bekker  11 , Juan Yang  3 , Christoph Carter  3 , Melanie de Boer  3 , Moupali Das  3 , Jared M Baeten  3 , Connie Celum  12
Affiliations

HIV Preexposure Prophylaxis With Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women

Jeanne Marrazzo et al. JAMA. .

Abstract

Importance: Emtricitabine and tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP) is highly effective in cisgender men who have sex with men (MSM) when adherence is high (>4 doses/week). Real-world effectiveness and adherence with F/TDF for PrEP in cisgender women is less well characterized.

Objective: To characterize the effectiveness of F/TDF for PrEP and its relationship with adherence in cisgender women.

Design, setting, and participants: Data were pooled from 11 F/TDF PrEP postapproval studies conducted in 6 countries that included 6296 cisgender women aged 15 to 69 years conducted from 2012 to 2020. HIV incidence was evaluated according to adherence level measured objectively (tenofovir diphosphate concentration in dried blood spots or tenofovir concentration in plasma; n = 288) and subjectively (electronic pill cap monitoring, pill counts, self-report, and study-reported adherence scale; n = 2954) using group-based trajectory modeling.

Exposures: F/TDF prescribed orally once a day. HIV incidence was analyzed in subgroups based on adherence trajectory.

Main outcomes and measures: HIV incidence.

Results: Of the 6296 participants, 46% were from Kenya, 28% were from South Africa, 21% were from India, 2.9% were from Uganda, 1.6% were from Botswana, and 0.8% were from the US. The mean (SD) age at PrEP initiation across all studies was 25 (7) years, with 61% of participants being younger than 25 years. The overall HIV incidence was 0.72 per 100 person-years (95% CI, 0.51-1.01; 32 incident HIV diagnoses among 6296 participants). Four distinct groups of adherence trajectories were identified: consistently daily (7 doses/week), consistently high (4-6 doses/week), high but declining (from a mean of 4-6 doses/week and then declining), and consistently low (less than 2 doses/week). None of the 498 women with consistently daily adherence acquired HIV. Only 1 of the 658 women with consistently high adherence acquired HIV (incidence rate, 0.13/100 person-years [95% CI, 0.02-0.92]). The incidence rate was 0.49 per 100 person-years (95% CI, 0.22-1.08) in the high but declining adherence group (n = 1166) and 1.27 per 100 person-years (95% CI, 0.53-3.04) in the consistently low adherence group (n = 632).

Conclusions and relevance: In a pooled analysis of 11 postapproval studies of F/TDF for PrEP among cisgender women, overall HIV incidence was 0.72 per 100 person-years; individuals with consistently daily or consistently high adherence (4-6 doses/week) to PrEP experienced very low HIV incidence.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Tao reported being employed by and holding stock in Gilead Sciences Inc. Dr Becker reported receiving grants from Bill & Melinda Gates Foundation and Gilead during the conduct of the study. Dr Kiragu reported receiving grants from Bill & Melinda Gates Foundation for project implementation during the conduct of the study. Dr Bekker reported receiving personal fees from ViiV Healthcare and Merck outside the submitted work. Dr Baeten reported receiving grants from NIH, USAID, and BMGF for original trial funding during the conduct of the study and having a patent for Gilead Sciences pending for HIV prevention. Dr Celum reported receiving grants from BMGF during the conduct of the study and personal fees from Merck outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. HIV Incidence in Postapproval Studies of Emtricitabine and Tenofovir Disoproxil Fumarate for Preexposure Prophylaxis in Cisgender Women in 6 Countries, 2012-2020
Figure 2.
Figure 2.. Adherence by Visit to Emtricitabine and Tenofovir Disoproxil Fumarate for Preexposure Prophylaxis in Cisgender Women (n = 2955)
Totals do not sum to 2955 because adherence data were collected at different time points in different studies. Across all time points a total of 288 participants had objective adherence data available and 2717 had only subjective adherence data available. In cases in which multiple measures were available within a single 16-week period, the highest level of adherence was used. A, Objective assessments of adherence included tenofovir concentration measurements in dried blood spots or plasma. B, Subjective assessment of adherence included electronic pill cap monitoring, pill counts, self-report, or a study-reported adherence scale.
Figure 3.
Figure 3.. Longitudinal Patterns of Adherence to Emtricitabine and Tenofovir Disoproxil Fumarate for Preexposure Prophylaxis in Cisgender Women (n = 2954)
A. Individual lines for each participant in the high but declining group are shown in gray, with the linear regression trendline for the group shown as a red line. B. Trendlines for all 4 groups, showing the 3 levels of stable adherence and contrast with the high but declining group.
Figure 4.
Figure 4.. HIV Incidence Rates Among Cisgender Women by Adherence Trajectory (n = 2954)
Adherence was categorized as consistently daily (7 doses/week), high (4-6 doses/week), moderate (2-3 doses/week), and low (less than 2 doses/week), as described in the Methods. The optimal (most stable) model from group-based trajectory modeling resulted in 4 groups with distinct patterns of adherence. Three groups had stable adherence over time, regardless of the model (3 or 4 groups) used: consistently daily (7 doses/week), consistently high (4-6 doses/week), and consistently low (less than 2 doses/week). The fourth group had dynamic adherence over time: initially high then declining (from 4-6 to 2-3 doses/week).
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References

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