There are places where discrepancies between couples when it comes to HIV infection can lead to modifications in pregnancy incidences. A new study has been conducted to analyze the whether antiretroviral pre-exposure preventive therapy (PreP) would be effective in couples where the men are HIV positive and the women HIV negative.
The study included 1785 participants belonging to serodiscordant couples from 9 sites across Uganda and Kenya. The female partners were HIV uninfected and received PrEP to prevent HIV infection (598 women received tenofovir disoproxil fumarate while 566 women received emtricitabine/tenofovir disoproxil fumarate and 621 women were on placebo). Participants were tested monthly for pregnancy and their study medication was discontinued if pregnancy was detected.
The results showed no significant modification in pregnancy incidence for the women who had been receiving PreP. Results showed a total of 431 pregnancies that occurred. Pregnancy incidence is 10.0 per 100 person-years among women assigned placebo. Results didn’t vary greatly for the women on PreP: 11.9 for those receiving tenofovir disoproxil fumarate and 8.8 for those on emtricitabine/tenofovir disoproxil fumarate.
Pregnancy loss incidence was also similar in women receiving placebo as compared to those receiving antiretroviral pre-exposure preventive therapy. Pregnancy loss in the placebo treatment group was 32.3% as opposed to that in the emtricitabine/tenofovir disoproxil fumarate group: 42.5% (that corresponds to 96 out of 288 pregnancies) and 27.7% for those receiving tenofovir disoproxil fumarate alone.
The study also concluded that there were no higher occurrences of preterm births, congenital defects or discrepancies of growth throughout the first year of life between the infants born to women who had received antiretroviral pre-exposure preventive therapy as opposed to those who had received placebo.
Statistically there was no difference in pregnancy incidence, birth outcome and infant growth for women receiving antiretroviral pre-exposure preventive therapy with TDF alone or a combination of FTC and TDF as compared to women on placebo where HIV serodiscordant African couples were concerned.
While the incidence itself did not vary, the study could not make definitive statements about the safety of antiretroviral pre-exposure preventive therapy during the peri-conception period as the treatment was discontinued as soon as the pregnancy diagnosis was made.
The authors of the study also stated that these results should be communicated to HIV uninfected female patients who are considering becoming pregnant but face the issue of serodiscordancy within their marriage (they are HIV uninfected while their husbands are HIV positive).