Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States

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The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Preconception Counseling and Care for Women of Childbearing Age Living with HIV

Reproductive Options for Couples in Which One or Both Partners are Living with HIV

Last Updated: December 7, 2018; Last Reviewed: December 7, 2018

Panel's Recommendations Regarding Reproductive Options for Couples in Which One or Both Partners are Living with HIV
Panel's Recommendations

For Couples Who Want to Conceive When One or Both Partners are Living with HIV:

  • Expert consultation is recommended so that approaches can be tailored to couples’ specific needs (AIII)
  • Partners should be screened and treated for genital tract infections before attempting to conceive (AII).
  • Partners living with HIV infection should attain maximum viral suppression before attempting conception to prevent HIV sexual transmission (AI) and, for women living with HIV, to minimize the risk of HIV transmission to the infant (AII)
  • For couples with differing HIV statuses, when the partner living with HIV is on ART and has achieved sustained viral suppression, sexual intercourse without a condom limited to the 2 to 3 days before and the day of ovulation (peak fertility) is an approach to conception with effectively no risk of sexual HIV transmission to the partner without HIV (BII).
  • For couples with differing HIV statuses who attempt conception via sexual intercourse without a condom (despite counseling) when the partner living with HIV has not been able to achieve viral suppression or when the viral suppression status is not known, administration of antiretroviral pre-exposure prophylaxis (PrEP) to the partner without HIV is recommended to reduce the risk of sexual transmission of HIV (AI). Couples should still be counseled to limit sex (without condoms) to the period of peak fertility (AIII).
  • When the woman is living with HIV, assisted insemination at home or in a provider’s office with semen from a partner without HIV during the periovulatory period is an option for conception that eliminates the risk of HIV transmission to the partner without HIV (AIII).
  • When the man is living with HIV, the use of donor sperm from a man without HIV is an option for conception that eliminates the risk of HIV transmission to the partner without HIV (BIII).
  • For couples with differing HIV status who attempt conception (sexual intercourse without a condom limited to peak fertility) when the partner living with HIV has achieved viral suppression, it is unclear whether administering PrEP to the partner without HIV further reduces the risk of sexual transmission (CIII).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II = One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = Expert opinion

Table 4. Clinical Trials of Pre-Exposure Prophylaxis
Trial Study Population Location Intervention Outcome Comments
TDF2 1,219 sexually active adults; 55% male, 45% female; 94 % unmarried; approximately 90% aged 21–29 years
Botswana Daily oral TDF/FTC
63% protection
>30% did not complete study; cannot draw definitive conclusions for women and men separately.
PIP 4,758 serodiscordant heterosexual couples; 38% HIV-negative female, 68% HIV-negative male partner; 98% married; median age 33 years
Botswana, Kenya, Rwanda, South Africa, Tanzania, Uganda, Zambia
Daily oral TDF or TDF/FTC
67% protection with TDF alone; 75% protection with TDF/FTC
Serodiscordant couples may be a distinct, unique population.
FEM-PrEP
1,951 heterosexual women aged 18–35 years at high risk of infection 
Kenya, South Africa, Tanzania
Daily oral TDF/FTC
Trial discontinued for futility in April 2011.
Adherence assessment with monthly clinical samples to measure drug concentration is pending.
VOICE
MTN-003
5,029 heterosexual women aged 18–45 years in high prevalence areas of HIV
Uganda, South Africa, Zimbabwe 
Daily oral TDF or daily oral TDF/FTC or daily topical TFV gel
No study drug significantly reduced the risk of HIV acquisition. Estimates of effectiveness were <0 for TDF and TDF/FTC daily oral dosing (negative 48.8% and negative 4.2% TDF/FTC respectively), and reduced risk of HIV infection of 14.7% for TFV gel. 
Adherence to study drugs was low; TFV was detected in 30% of the oral TFV arm, 29% in the oral TDF/FTC arm, and 25% in the TFV gel arm.
Adapted from: Kashuba et al., Pre-exposure prophylaxis for HIV prevention: how to predict success: Table Antiretroviral-based HIV prevention studies. Lancet. 2012;379(9835): 2409-2411.

Key to Acronyms: FTC = emtricitabine; TDF = tenofovir disoproxil fumarate; TFV = tenofovir

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