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  16th CROI
Conference on Retroviruses and Opportunistic Infections Montreal, Canada
February 8-11, 2009
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HIV Progression Not Affected by Hormonal Contraception in Africa Study
  "This study was a large multi-country cohort with a diversity of patients, viral-subtypes and contraceptive measures. The data is observational, patient self-report. There is no evidence of hormonal contraception accelerating HIV disease Progression in this dataset. Study conducted in 14 sites in Africa"
HIV Progression Not Affected by Hormonal Contraception
Hormonal contraceptives do not speed the progression of HIV disease, researchers found.
The "encouraging" finding is important for most of the 15 million women worldwide who have HIV and are of child-bearing age, according to Elizabeth Stringer, M.D., of the University of Alabama.
"Our study shows these drugs are safe for women with HIV infection," Dr. Stringer said at the Conference on Retroviruses and Opportunistic Infections here.
Although the study took place in the developing world, it should be reassuring for all women with HIV, she said.
The issue arose, Dr. Stringer said, because some animal and human studies had suggested that hormonal contraception speeded the progression of HIV. But the findings were incidental observations in studies aimed at other issues, she said.
To clarify the matter, she and her colleagues analyzed outcomes in 4,350 HIV-positive women who were not on antiretroviral therapy and were not pregnant in nine developing countries in Africa and Asia.
The participants, part of a larger trial investigating mother-to-child transmission, were followed from 2003 to 2008, Dr. Stringer said. Disease progression in the study was defined as death or becoming eligible for highly active antiretroviral therapy (HAART).
The women in the study were stratified according to what form of contraception they used -- 830 used progesterone-based injectable or implant methods and 230 used progesterone-estrogen oral contraceptives, while the vast majority (3,099) used nonhormonal methods or no contraception.
The latter group was used as a reference to calculate multivariate hazard ratios for death or eligibility for treatment. Compared with the reference group:
* Those on a progesterone contraception had an adjusted hazard ratio of 1.0 for disease progression, with a 95% confidence interval from 0.8 to 1.2.
* Women on oral progesterone-estrogen contraception had a hazard ratio of 0.9 for disease progression, with a 95% confidence interval from 0.6 to 1.2.
* When the risk was considered on a time-varying basis, the corresponding hazard ratios were 0.9 and 0.8, and both confidence intervals crossed unity.
Factors that did increase the risk of disease progression included a CD4 count of between 200 and 350 cells per cubic millimeter (all participants started above 200) and disease at WHO stages II and III.
Dr. Stringer said the study's strengths include its large, multicountry cohort, with a diversity of patients and contraceptive methods.
On the other hand, she said, contraceptive exposure was based on self-report, the data is observational, and there is a potential for self-selection bias.
"Women with HIV, like any women, have to be given options for family planning," said Wafaa El-Sadr, M.D., of New York's Columbia University, who chaired a press conference at which the research was discussed.
"The concern has been that some (healthcare) providers were reluctant to prescribe hormonal contraception to women with HIV," she said. "So this is very reassuring data."

Effect of Hormonal Contraception on HIV Disease Progression: A Multi-Country Cohort Analysis
Elizabeth Stringer*1,2, M Sinkala1,3, M Giganti1,2, R Carter4, P Toro4, W El-Sadr4, J Stringer1,2, E Abrams4, and the MTCT Plus Initiative 1Univ of Alabama at Birmingham, US; 2Ctr for Infectious Disease Res in Zambia, Lusaka; 3Catholic Med Missions Board, Lusaka, Zambia; and 4Columbia Univ, New York, NY, US
Background: The majority of the world?s 20 million HIV-infected women are of childbearing age and need access to safe and effective contraception. Animal and human studies suggest that hormonal contraception may accelerate HIV disease progression among women not yet on ART.
Methods: We studied women enrolled in the MTCT Plus Initiative, a multi-country program of family-based HIV care and treatment. We included women who were not yet on ART, were not pregnant or at least 3 months post partum, and had documentation of exposure to contraceptive methods (hormonal or non-hormonal). HIV disease progression was defined as death, becoming eligible for ART, or a composite of the 2. We used Cox regression and categorized exposure by the method reported at the time of entry into the cohort. Since some women switched methods over time, we also performed a separate time-varying analysis where women who switched contributed person-time to each exposure category.
Results: Between August 2002 and December 2006, 5993 women were enrolled.. Of these, 3837 (64%) fit our criteria for inclusion in this analysis. At baseline 2577 of 3837 (72%) reported using no or non-hormonal contraception and 1106 of 3837 (28%) reported use of hormonal contraception. Of the latter group, 800 of 1106 (79%) used injectables or implants and 216 of 1106 (21%) used oral contraceptive pills (OCP). Risk factors for HIV disease progression were CD4 count >200 to <350 cells/mm3 (AHR 5..69, 95%CI 4.83 to 6.71) and WHO Stage II (AHR 1.52, 95%CI 1.23 to 1.88) and WHO Stage III (AHR 3.46, 95%CI 2.51 to 4.75). Exposure to hormonal contraceptives was not associated with HIV disease progression (see the table).