European activists highlight importance of gender based research: women experience HIV differently

Differences between men and women need to be pertinently highlighted in the process of making new HIV medicines available to the public. This is the demand of the European Community Advisory Board (ECAB), which held a three-day meeting in Brussels in February exclusively dedicated to women and regulatory issues in the development and approval of HIV-treatments.

Founded in 1997, the ECAB is a Working Group of the European AIDS Treatment Group (EATG), a pan-European non-profit organisation comprising more than 100 members from virtually every country of the new and the old Europe. The ECAB is involved in treatment activism, community-based research and treatment training programmes at national and international levels.

Within the ECAB, 40 members are working together with pharmaceutical companies, researchers, investigators and the European HIV-positive communities to improve the research and development of new agents to combat HIV, the understanding of their complications and the access to therapy for people living with HIV/AIDS all over Europe.

More than 30 Pan-European treatment activists worked together with research experts and representatives of pharmaceutical companies and the European Agency for the Evaluation of Medicinal Products (EMEA). The focus of the meeting was to identify current gaps concerning sex and gender in the clinical evaluation of drugs and to provide suggestions for the ‘Note for Guidance on the Clinical Development of HIV-Medicinal Products’ issued by the EMEA.

“Even though globally more than 50% of HIV-positive people are women, HIV medicine is tested mainly in men’s bodies,” explained Heidemarie Kremer, EATG and ECAB member. “The numbers of women enrolled in clinical trials should be statistically relevant to the patient populations in which the drugs will be used in order to draw meaningful conclusions about their efficacy and safety in different groups,” she added.

Although HIV-therapy has dramatically reduced the number of deaths due to AIDS in industrialised countries, lack of knowledge about sex and gender differences in response to therapy has led to severe life-threatening side effects and death. In Europe, women account on average for only 12% of the participants in clinical trials. “HIV trials are not enrolling enough women to answer gender-specific questions. In order to avoid therapies failing women, we need more gender based research to optimise treatment for everybody”, said Kremer.