Approximately half of HIV-discordant heterosexual couples in the United States want children. Oral antiretroviral preexposure prophylaxis, if effective in reducing heterosexual HIV transmission, might be an option for discordant couples wanting to conceive. Couples should receive services to ensure they enter pregnancy in optimal health and receive education about all conception methods that reduce the risk of HIV transmission. In considering whether preexposure prophylaxis is indicated, the question is whether it contributes to lowering risk in couples who have decided to conceive despite known risks. If preexposure prophylaxis is used, precautions similar to those in the current heterosexual preexposure prophylaxis trials would be recommended, and the unknown risks of preexposure prophylaxis used during conception and early fetal development should be considered. Anecdotal reports suggest that oral preexposure prophylaxis use is already occurring. It is time to have open discussions of when and how preexposure prophylaxis might be indicated for HIV-discordant couples attempting conception.
The reproductive health needs of HIV-uninfected men and women in the United States with HIV-infected spouses/partners have not been fully recognized or met. Data to estimate the number of such couples in the United States are available from a population-based sample of HIV-infected persons in care in 1996. Most HIV-infected men (58%) and women (70%) had a primary partner or a spouse: of those, 54% of the men and 52% of the women reported that the primary partner or spouse was HIV-negative, and another 20% of the men and 22% of the women reported that the primary partner or spouse was of unknown HIV serostatus. Of the men and women with an HIV-negative primary partner or spouse, 46% of the men and 51% of the women intended to have one or more children. In 2006, of an estimated 1.1 million persons living with HIV infection, approximately 239,600 heterosexuals were of peak reproductive age, namely, 13-49 years. These 2 reports together suggest that there are more than 140,000 HIV-serodiscordant heterosexual couples in the United States, approximately half of whom want additional children.
Some HIV-discordant couples seek reproductive assistance, and many practice unsafe measures to conceive. According to one survey, among 50 HIV-discordant couples interested in undergoing assisted reproduction to avoid transmission to the negative partner, 20% engaged in unprotected intercourse with the intent to achieve pregnancy.
Several assisted reproductive technology (ART) approaches have been developed to reduce the risk of HIV transmission during attempted conception. However, barriers such as expense, lack of fertility clinics offering services to couples affected by HIV, state laws and regulations barring access to some ART approaches for persons affected by HIV, conflicting professional and governmental guidelines, and societal stigmas, mitigate against access and use. HIV-discordant couples in the United States need more accessible options for safer conception. Oral antiretroviral preexposure prophylaxis (PrEP) may be one such option.
PrEP
Safety and efficacy trials of a once-daily oral dose of tenofovir disoproxil fumarate (TDF, brand name Viread; Gilead Sciences, Inc, Foster City, CA) or tenofovir combined with emtricitabine (FTC, brand name Truvada; Gilead Sciences, Inc) for the prevention of HIV acquisition by uninfected persons are currently underway. The first phase-III trial recently showed that PrEP was safe and provided an average of 44% (95% confidence interval [CI], 15–63%) additional protection against HIV infection for men who have sex with men (MSM). Among those using PrEP on 90% or more days in a visit interval, HIV risk was reduced by roughly 73% (95% CI, 41–88%), but it was reduced by only about 21% (95% CI, from a 52% reduction to a 31% increase) when used less than 90% of days in a visit interval. Phase III trial results for men and women at risk of acquisition during heterosexual intercourse are not expected until 2013. A phase II trial among high-risk women in West Africa showed preliminary safety and another safety study among young adults in Botswana is expected to report results in 2011. It is important to consider the possibilities PrEP presents for HIV-discordant couples, and what additional information may be required.
Many preventive public health achievements, such as the use of antiretrovirals (ARVs) to prevent mother-to-child HIV transmission (PMTCT), are believed to have been successful because of well coordinated and timely planning for translation from trials to programs. Following that model, the Centers for Disease Control and Prevention (CDC) has engaged city and state health departments, professional associations, academic researchers, and clinical and nonclinical providers, advocacy organizations and other stakeholders in discussions to guide planning activities to assist with the safe, appropriate, equitable and effective introduction of PrEP into prevention activities for various populations if proven effective and safe. In 2009 and again in 2010, research clinicians from CDC participated in meetings of technical experts and stakeholders to discuss the potential use of PrEP by serodiscordant couples wanting to conceive. In these meetings, the term “PrEP-ception” has been used to describe PrEP’s use for safer conception. Attendees at one or both meetings included representatives from several agencies in the US Department of Health and Human Services (eg, Food and Drug Administration, National Institutes of Health), members from national medical associations (eg, American Academy of Family Physicians, Society of Maternal-Fetal Medicine), National Association of State and Territorial AIDS Directors, obstetric and pediatric clinicians, infectious disease specialists, an ethicist, and others. This article presents some of the key topics discussed during those meetings.
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