Pregnancy and Contraceptive Use Among Women Participating in the FEM-PrEP Trial

Callahan, Rebecca L.; Nanda, Kavita; Kapiga, Saidi; Malahleha, Mookho; Mandala, Justin; T, Ogada; L, Van Damme; Taylor, Doug

doi:10.1097/qai.0000000000000413

Cited by 34 publications

(38 citation statements)

References 19 publications

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“…Nevertheless, as Callagan et al, it appears to interfere with oral contraceptives, and unwanted pregnancies were found among users of oral contraceptives who had received PrEP [16].…”

Section: Resultsmentioning

confidence: 90%

Sexually Transmitted Infections in the PReP Era. Are Family Doctors Ready to Give Advice?

Cerdeira¹,

E²,

B³

et al. 2017

TODJ

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Background:Pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) as a method of HIV prevention is not without controversy, and there has been concern that it may lead its users to think that they no longer need other preventive measures such as condoms. Thus, healthcare providers are convinced that PrEP decreases condom use and increases sexually transmitted infections (STIs). This treatment has been studied in men who have sex with men, men and women in heterosexual HIV-discordant couples, and heterosexual men and women. Objective:The objective of this study was to review the current state of evidence on the association of PrEP with condom use, the incidence of STIs, and the change in sexual behaviours in populations with risky practices. Materials and Methods:PubMed (National Center for Biotechnology Information, Bethesda, MD, USA), Science Direct (Elsevier Ltd., Oxford, UK), and Google Scholar (Google Inc., Mountain View, CA, USA) search engines were used during the study. We used the terms HIV, PrEP, sexually transmitted infections (STIs), MSM, condom, heterosexual men / women to search the databases. Results:Here, we present evidence that daily oral treatment is safe and effective in these populations studied, especially when medication adherence is high. STI testing should include extra-genital testing regardless of PrEP use to prevent health deficits and onward transmission. Conclusion:Despite this safety and efficacy, we strongly advise that patients continue to use condoms as a prophylactic measure against other sexually transmitted diseases. This update addresses the benefits and precautions that must be taken when establishing PrEP treatment, focusing mainly on family doctorswho are best positioned to provide follow-up and advice to patients and their relatives.

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“…Nevertheless, as Callagan et al, it appears to interfere with oral contraceptives, and unwanted pregnancies were found among users of oral contraceptives who had received PrEP [16].…”

Section: Resultsmentioning

confidence: 90%

Sexually Transmitted Infections in the PReP Era. Are Family Doctors Ready to Give Advice?

Cerdeira¹,

E²,

B³

et al. 2017

TODJ

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“…Analyses of two large trials of hormonal contraceptives and NRTIs used for PrEP found that use of tenofovir/emtricitabine did not affect pregnancy rates among users of COCs, injectables, or implants [40,41]. …”

Section: Resultsmentioning

confidence: 99%

Drug interactions between hormonal contraceptives and antiretrovirals

Nanda

Stuart

Robinson³

et al. 2017

Aids

Self Cite

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Objective:To summarize published evidence on drug interactions between hormonal contraceptives and antiretrovirals.Design:Systematic review of the published literature.Methods:We searched PubMed, POPLINE, and EMBASE for peer-reviewed publications of studies (in any language) from inception to 21 September 2015. We included studies of women using hormonal contraceptives and antiretrovirals concurrently. Outcomes of interest were effectiveness of either therapy, toxicity, or pharmacokinetics. We used standard abstraction forms to summarize and assess strengths and weaknesses.Results:Fifty reports from 46 studies were included. Most antiretrovirals whether used for therapy or prevention, have limited interactions with hormonal contraceptive methods, with the exception of efavirenz. Although depot medroxyprogesterone acetate is not affected, limited data on implants and combined oral contraceptive pills suggest that efavirenz-containing combination antiretroviral therapy may compromise contraceptive effectiveness of these methods. However, implants remain very effective despite such drug interactions. Antiretroviral plasma concentrations and effectiveness are generally not affected by hormonal contraceptives.Conclusion:Women taking antiretrovirals, for treatment or prevention, should not be denied access to the full range of hormonal contraceptive options, but should be counseled on the expected rates of unplanned pregnancy associated with all contraceptive methods, in order to make their own informed choices.

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“…This rate of pregnancy loss has been seen in other studies with sensitive testing that detects early pregnancy [15]. Two additional PrEP clinical trials, FEM-PrEP conducted among 2,120 women in Kenya, South Africa, and Tanzania and VOICE among 3,019 women from South Africa, Zimbabwe, and Uganda, observed substantial numbers of pregnancies among women randomized to active PrEP agents as well as placebo and observed no indications of pregnancy-related safety concerns among those in the active PrEP arms [12, 13, 16, 17]. However, adherence to daily PrEP medication was extremely low in these two trials and results based on randomization arm would be better supplemented by data from the subgroup of women who were highly adherent [16, 17].…”

Section: Peri-conception Prep Use – Including Use During Early Pregnamentioning

confidence: 88%

PrEP as Peri-conception HIV Prevention for Women and Men

et al. 2016

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Daily oral tenofovir (TDF)-based pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy and recommended for men and women with substantial risk of HIV acquisition. The peri-conception period, the stage prior to pregnancy when condom use is necessarily reduced, has elevated HIV risk that can be mitigated by PrEP use. Data from a randomized trial suggest that peri-conception PrEP use by HIV-seronegative women does not increase the risk of pregnancy loss, birth defects or congenital anomalies, preterm birth, or infant growth faltering. Women considering PrEP use throughout pregnancy must weigh the known increased risk of HIV acquisition with unknown risks of drug effects on infant growth. PrEP has been used safely by HIV-seronegative men with HIV-seropositive female partners who have become pregnant. As an effective user-controlled HIV prevention strategy, PrEP offers autonomy and empowerment for HIV prevention and can be recommended alongside antiretroviral therapy, fertility screening, vaginal self-insemination, intercourse timed to peak fertility, medically assisted reproduction, and other safer conception strategies to provide multiple options. The integration of PrEP into safer conception programs is warranted and will safely reduce HIV transmission to women, men and children during the peri-conception period.

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Pregnancy and Contraceptive Use Among Women Participating in the FEM-PrEP Trial

Abstract: Women using COCs during FEM-PrEP, particularly new adopters, were more likely to become pregnant and less likely to adhere to study product than injectable users. HIV prevention trials should consider requiring long-acting methods, including injectables, for study participation.

Cited by 34 publications

References 19 publications

Sexually Transmitted Infections in the PReP Era. Are Family Doctors Ready to Give Advice?

Sexually Transmitted Infections in the PReP Era. Are Family Doctors Ready to Give Advice?

Drug interactions between hormonal contraceptives and antiretrovirals

PrEP as Peri-conception HIV Prevention for Women and Men

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