Community group cautions WHO on communication of its guidance on hormonal contraceptives and HIV

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The International Community of Women Living with HIV (ICW) expressed concern Monday over the World Health Organization’s (WHO’s) Technical Statement on Hormonal Contraceptives and HIV and its accompanying press release. WHO released the statement last week – concluding that women living with HIV or at high risk of HIV can safely continue to use hormonal contraceptives to prevent pregnancy. This decision was reached after a technical panel of 75 members from 18 countries met for a two-day period to discuss recent studies offering conflicting evidence that use of certain hormonal contraceptives might actually increase a woman’s risk of acquiring HIV infection, increase progression of disease in women infected with HIV, or increase an HIV-infected woman’s chances of spreading her infection to an uninfected sexual partner by as much as 100 percent.

The ICW is pushing for more research on the subject and increased communication to explain the risks involved to potential users of hormonal contraceptives. The ICW also “urgently” demanded that the WHO correct the note for media the WHO released along with the technical statement, calling it inconsistent with the findings of the technical review panel.

According to the executive summary in the WHO report:

          Some studies suggest that women using progestogen-only injectable contraception may be at increased risk of HIV acquisition, other studies do not show this association. A WHO expert group reviewed all the available evidence and agreed that the data were not sufficiently conclusive to change current guidance. However, because of the inconclusive nature of the body of evidence on possible increased risk of HIV acquisition, women using progestogen-only injectable contraception should be strongly advised to also always use condoms, male or female, and other HIV preventive measures. Expansion of contraceptive method mix and further research on the relationship between hormonal contraception and HIV infection is essential. These recommendations will be continually reviewed in light of new evidence.

ICW expressed concern that the WHO’s website fails to communicate these points clearly in its media note, which states, “…that women living with HIV or at high risk of HIV can safely continue to use hormonal contraceptives to prevent pregnancy. … Couples seeking to prevent both unintended pregnancy and HIV should be strongly advised to use dual protection – condoms and another effective contraceptive method, such as hormonal contraceptives.”

“We fear that a blanket statement about the ‘safety’ of all hormonal contraceptives without mentioning the available observational and theoretical evidence downplays the severity and complexity of the situation,” said ICW Global Advocacy Officer Beri Hull in the release. “Saying that women can ‘safely’ use all contraceptives, including depo medroxyprogesterone (DMPA), in the media statement suggests that there is no need for further research and that the potential increased HIV risks associated with the drug has been resolved.”

Representatives from the WHO, UNAIDS, program implementers, policymakers and others gathered via teleconference Thursday to discuss the WHO decision to uphold its guidance. Mary Lyn Gaffield, an epidemiologist at the WHO, described the WHO technical panel’s process of reaching their recommendation and next steps.

The panel reviewed the evidence available, both animal and biological, assessed the quality of the epidemiological data, and considered the risks and benefits to country programs if certain contraceptive methods were no longer made available — maternal outcomes related to pregnancy as well as HIV.  Studies have shown that access to contraception is closely associated with prevention of maternal and child mortality, poverty alleviation and other critical health outcomes.  Specifically, the group evaluated oral contraceptives (combination pills and progestogen-only pills), injectable contraceptives (including DMPA or “depo”) and hormone-containing implants. Intra-uterine devices were not addressed. It is worth noting that hormonal contraceptives, particularly injectables, constitute a large proportion of the modern contraceptive options available in countries challenged by both high rates of HIV infection and maternal mortality.

The group determined that data on oral contraceptives was very limited, but since evidence thus far is generally reassuring, its safety recommendation remained intact, Gaffield said. 

The complex discussion on injectable hormonal contraceptives, specifically DMPA, required panelists to review data from 20 studies. Approximately 12 million women in sub-Saharan Africa rely on injectable birth control, as compared to about half that number among women in the U.S.  Panelists were unable to establish, “a clear link of DMPA increasing risk of acquisition,” Gaffield said. However, they couldn’t definitively rule out the possibility of an effect, therefore their decision to uphold the WHO safety recommendations was reinforced with communication of the need to use dual protection (condoms). After a discussion on whether hormonal contraceptives increased transmission risk to uninfected partners – which relied on data on from one study in particular that contained numerous strengths and weaknesses–  panelists determined it did not warrant further restrictions on the use of DMPA.

The evidence, Gaffield said, is reassuring that there is no connection between hormonal contraceptive use and disease progression. “One trial showed an increase [in HIV disease progression] in patients using [DMPA] or oral contraceptives, but the data was not conclusive enough,” she said. “In the end – use of hormonal contraception in any of these forms should not be limited for either group.”

Dr. Helen Rees, a participant in the consultation and executive director of the Wits Institute for Sexual & Reproductive Health, HIV and Related Diseases of the University of the Witwatersrand in South Africa, agreed that this was difficult science to wade through. “We’re sitting in this gray area – and in this context we have to make recommendations.”

In South Africa – which would be true for most other sub-Saharan African countries — this is particularly difficult, she said. They face high HIV prevalence and don’t want to do anything to increase the population’s HIV acquisition risk. On the other hand, there is also high maternal mortality. And with limited contraceptive choices available, doing something that might remove a contraceptive option that many women like and many women are choosing to use could increase maternal death, she said, which is an outcome nobody would want.

“If in the future data persuades us that there are problems with [DMPA], we really want to have other methods available and rapidly, so women have other options – including access to the female condom, [which] becomes even more of an imperative now,” Rees said. She added that given the fairly heavy dose of hormone in DMPA, empirically doctors should be moving toward lower-dose methods anyway.

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