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HIV: more fragile women, more attention is needed

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HIV: more fragile women, more attention is needed

The insufficient presence of women in clinical trials has serious health consequences as can be easily understood if we consider that, roughly speaking, 53% of the Italian population, the female gender, will take drugs whose safety and effectiveness have been studied on the other gender. Many pathological mechanisms, symptoms, progression and severity of diseases, effectiveness of treatments and side effects are different between the two genders. Prevention is also different. How is personalized medicine and interventions suited to the individual and even to their DNA achievable, if differences such as those between men and women are not adequately considered and the gender-specific approach in medicine is still so far from being achieved? Its implementation is urgent both for a principle of scientific validity and for a reason of equal access to therapeutic innovation, the one studied in the trials.

This is one of the topics we will talk about today, April 22, National Women’s Health Day. An example of the greater fragility of women is HIV, which still constitutes a major health problem today, particularly for the informal sector. «They are more fragile from an immune point of view, because they become infected more easily and, in the absence of treatments, they have a greater risk of developing AIDS; from a social point of view, because the stigma towards an HIV-positive woman is greater, even in Italy and not only in low-income countries”, underlines Annamaria Cattelan, director of the Infectious Diseases operational unit of the Padua hospital. “This is why it is important that the health of HIV+ women is adequately monitored and preserved.”

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In 2022, in Italy, 1,888 new diagnoses of HIV infection were made, of these 402 were women (21.3%): 116 were aged 50 years or older, 209 were between 30 and 49 years old, and 71 between 20 and 29 years old. In Italy, 58.1% of new HIV diagnoses are late, of which 42% already have AIDS, a much higher number than the European average, and the average age at diagnosis is also increasing.

In the female population, the infection leads to an acceleration of aging which exposes to a increased risk of fractures and muscle weakness: «HIV infection is responsible for an acceleration of the aging process linked to the chronic inflammatory state in both men and women, but with different accents. For example, we have a prevalence of myocardial infarction higher among HIV+ women not only compared to HIV negative women, but also HIV+ men. Then there is data that shows an activation of the immune system extremely higher in women with HIV than in men. In women we find greater cognitive impairment, depression, anxiety, post-traumatic stress disorder, conditions which in turn are influenced and worsened by other cofactors such as the abuse of alcohol, narcotic substances or the use of psychiatric drugs”, explains Cattelan. «Finally, particular attention must be given to bone health, which is already put at risk after menopause and which the action of some drugs can worsen».

Precisely the activism of AIDS sufferers and HIV-positive people in the United States in the 1980s pushed against the stigma, which still hits these people hard today, but above all for the participation of patients in studies, without excluding anyone, drug addicts and women in childbearing age included. In light of all this, it is striking that clinical trials in this area involve only 20% of women, in line with other areas of biomedical research.

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While awaiting the inclusion of a certain number of women in clinical trials, mandatory in the American National Institutes of Health only since 1993, an attempt is made to remedy it analyze data already collected, for example by conducting subgroup analyses, looking specifically at the female population involved in the studies. This was done for the combination bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), confirming its tolerability and effectiveness in all age groups, or a study relating to the switch to this triplet, effective in improving the immune status of women.

The challenge is not over, HIV is still present and threatening, we must not lower our guard but do prevention, talk about sex and risky behavior and normalize the execution of tests, say the infectious disease specialists concerned for those 15 thousand Italians who have the virus without knowing it and therefore can favor its spread.

Photo from the National Cancer Institute on Unsplash: the HIV virus (in yellow) infecting a cell

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