Navigation Links
Study examines effect on pregnancy of receiving antiretroviral therapy for preventing HIV
Date:7/19/2014

Among heterosexual African couples in which the male was HIV positive and the female was not, receipt of antiretroviral pre-exposure preventive (PrEP) therapy did not result in significant differences in pregnancy incidence, birth outcomes, and infant growth compared to females who received placebo, according to a study in the July 23/30 issue of JAMA, a theme issue on HIV/AIDS. The authors note that these findings do not provide a definitive conclusion regarding the safety of PrEP therapy prior to pregnancy. The issue is being released early to coincide with the International AIDS Conference.

Antiretroviral pre-exposure prophylaxis as daily oral tenofovir disoproxil fumarate (TDF) and co-formulated emtricitabine/tenofovir disoproxil fumarate (FTC+TDF) has been demonstrated to be efficacious for the prevention of human immunodeficiency virus (HIV) acquisition in diverse populations. PrEP could be an important component of safer conception strategies for women at risk for HIV infection, including those in HIV-serodiscordant couples (i.e., in which only one member is HIV infected), but the effect on pregnancy outcomes is not well defined, according to background information in the article.

Nelly R. Mugo, M.B.Ch.B., M.P.H., of the Kenya Medical Research Institute, Nairobi, Kenya, and University of Washington, Seattle, and colleagues conducted further follow-up of the Partners PrEP Study, a randomized, placebo-controlled trial of PrEP for HIV prevention among HIV-serodiscordant couples conducted between July 2008 and June 2013. For this analysis, which included 1,785 couples in Kenya and Uganda, the researchers assessed pregnancy incidence and outcomes among women using PrEP during the periconception period. Females had been randomized to daily oral TDF (n = 598), combination FTC+TDF (n = 566), or placebo (n = 621) through July 2011, when PrEP demonstrated efficacy for HIV prevention. Thereafter, participants continued receiving active PrEP without placebo.

A total of 431 pregnancies occurred. The researchers found that pregnancy incidence did not differ significantly by study group, and that there was no statistically significant association between women receiving PrEP and those receiving placebo and the occurrence of pregnancy losses, which was 42.5 percent for women receiving FTC+TDF, 32.3 percent for those receiving placebo, and 27.7 percent for those receiving TDF alone. After July 2011 (when the placebo group was discontinued), the frequency of pregnancy loss was 37.5 percent for FTC+TDF and 36.7 percent for TDF alone.

Occurrence of preterm birth, congenital anomalies, kidney function and growth throughout the first year of life did not differ significantly for infants born to women who received PrEP vs placebo.

The authors write that for some outcomes, including pregnancy loss, preterm birth, congenital anomalies, and infant mortality, confidence intervals were wide (suggesting uncertainty in the result and the need for more data), including both a null effect and potential harm, and thus definitive statements about safety of PrEP in the periconception period cannot be made.

"These results should be discussed with HIV-uninfected women receiving PrEP who are considering becoming pregnant."

(doi:10.1001/jama.2014.8735; Available pre-embargo to the media at http://media.jamanetwork.com)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Integrating HIV Prevention Into Practice

Bradley M. Mathers, M.B.Ch.B., M.D., and David A. Cooper, M.D., D.Sc., of the University of New South Wales, Sydney, Australia, comment on the findings of this study in an accompanying editorial.

" it appears (from the magnitude and asymmetry of the confidence intervals) that there may be a signal suggesting potential harm as pregnancy loss based on the emtricitabine/tenofovir vs placebo comparison (absolute difference ending in pregnancy loss of 10.2 percent) and on the post hoc emtricitabine/tenofovir vs tenofovir alone comparison (absolute difference ending in pregnancy loss of 9.2 percent)."

"These intriguing findings reported by Mugo et al provide important information from one of the largest studies of exposure to these nucleoside analogues in HIV-negative persons and therefore must be considered carefully. Tenofovir and emtricitabine are both category B drugs, but this signal suggesting a possible association with pregnancy loss has not to date appeared in studies of HIV-infected persons, suggesting that this observation deserves evaluation in future studies. Moreover, the nucleosides were stopped according to the trial protocol no later than 6 weeks into the pregnancy, albeit this period is highly sensitive to subsequent adverse pregnancy outcomes, but exposure to these drugs may be longer in the real-world setting."


'/>"/>

Contact: Bobbi Nodell
bnodell@uw.edu
206-543-7129
The JAMA Network Journals
Source:Eurekalert

Related medicine news :

1. Medical Devices Market in India 2014 Trends and Analysis in Study Available at MarketReportsOnline.com
2. Testosterone Lawsuit News: Bernstein Liebhard LLP Notes Recent Study Finding Dramatic Rise in Canadian Men Taking Hormone Therapy Treatments
3. Consuming probiotics for a month helps diminish fat accumulation in the liver, new study says
4. Soldiers Use of Mental Health Services Up, Stigma Down, Study Finds
5. College Alcohol Violations Often Draw a Slap on the Wrist: Study
6. With ERs, the Busier, the Better, Study Finds
7. Tak Mak study in Cancer Cell maps decade of discovery to potential anticancer agent
8. Study: Hour-long home coaching decreases re-admission, costs for Medicare patients
9. Even Mild Concussion Can Cause Thinking, Memory Problems: Study
10. Removing Healthy Breast of Little Benefit to Breast Cancer Patients: Study
11. Study Finds Many Flu Patients Not Treated Appropriately
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... BASKING RIDGE, N.J. (PRWEB) , ... October 13, 2017 , ... ... second annual Holly Day Market. Featuring a collection of specialty vendors and unique items ... myriad of personalized and quality-focused health and wellness services offered by the VNA. ...
(Date:10/13/2017)... ... 13, 2017 , ... Coveros, a leader in agile coaching ... contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile ... of Agile methodologies in a consistent and high value manner across CMS programs. ...
(Date:10/12/2017)... ... , ... Planet Fitness, one of the largest and fastest growing franchisors and ... flagship location in Covington, LA at 401 N. U.S. Highway 190, in January of ... Depot in the Holiday Square shopping center. Its location allows it to serve both ...
(Date:10/12/2017)... Rockville, Maryland (PRWEB) , ... October 12, 2017 ... ... a magnetic drug delivery system that we intend to develop to enable prevention ... regimens can lead to severe hearing loss, especially in pediatric patients. For cisplatin, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Women-owned and ... 2017 Best and Brightest in Wellness® by Best and Brightest. OnSite Wellness will ... Friday, Oct. 20 from 7:30 a.m. to 2 p.m. at the Henry Autograph ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... Pa. , Oct. 12, 2017 ... leader in innovative solutions for injectable drug administration, today ... before the market opens on Thursday, October 26, 2017, ... the results and business expectations at 9:00 a.m. Eastern ... (U.S.) or 253-336-8738 (International). The conference ID is 94093362. ...
(Date:10/11/2017)...  Caris Life Sciences ® , a leading innovator ... precision medicine, today announced that St. Jude Medical Center,s ... (POA) as its 17 th member. Through participation ... Cancer Institute will help develop standards of care and ... making cancer treatment more precise and effective. ...
(Date:10/11/2017)... 2017  Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today ... Las Piedras, Puerto Rico , where ... Following a comprehensive ... minor structural damage, temporary loss of power and minimal ... completed, manufacturing operations have resumed, and the company expects ...
Breaking Medicine Technology: