Women are underrepresented in all clinical trials. Trials testing the effectiveness of antiretroviral therapies against HIV are no exception. Yet, as gender medicine has demonstrated in recent years, studying how therapies act on the female organism is of extreme importance. “When faced with HIV, women are more fragile from several points of view: 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. This is why it is important that the health of HIV positive women is adequately monitored and preserved.” This was said by Annamaria Cattelan, director of the Infectious Diseases Operational Unit of the Padua hospital, on the occasion of National Women's Health Day which is celebrated on 22 April.
In 2022, in Italy, 1,888 new diagnoses of HIV infection were made – we read in a note – of these 402 were women (21.3%): 116 were aged equal to or greater than 50 years, 209 were between 30 and 49 years old, and 71 between 20 and 29 years old. The share of women who arrive late at diagnosis continues to increase (around 60%) and the median age at which diagnosis is reached increases (36 years in 2012 vs 41 years in 2022). A fact that should not be underestimated since in the female population the infection leads to an acceleration of aging which exposes them to an increased risk of fractures and weakening of the muscles.
“The HIV infection – continues Cattelan – 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 higher prevalence of myocardial infarction among HIV positive women not only compared to HIV negative women, but also HIV positive men. Then there is data showing extremely higher immune system activation in women with HIV compared to men. In women we find greater cognitive deterioration – explains the expert – depression, anxiety, post-traumatic stress disorders, conditions which in turn are influenced and worsened by other cofactors such as alcohol abuse, narcotic substances or the use of drugs psychiatric. 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”.
Although on average only 20% women are present in the sample analyzed in the registration trials, in recent years specific analyzes and investigations have been conducted on the female population. A review of some phase 3 studies, for example, analyzed the combination bictegravir/emtricitabine/tenofovir alafenamide (B/F/Taf) in the female subpopulation involved in the trials, confirming its tolerability and efficacy in all age groups (girls/ adolescents/adults/elderly). There were no cases of emerging resistance and there was a low discontinuation rate.
An Italian real life retrospective study conducted 48 weeks after the start of treatment with the B/F/Taf combination, in which data relating to viro-immunological and metabolic parameters were collected, showed a significant increase in the Cd4/Cd8 ratio . To further confirm the effectiveness in women, there are also the results of a vast real life study which highlight how even the switch of therapy in favor of B/F/Taf induces a marked improvement in the immune status in women and people over sixty after 48 or 96 weeks of treatment. “And then – concludes Cattelan – there is an extremely important aspect. Bictegravir has been shown to be a therapeutic option even in pregnant women. So much so that the American Dhhs Guidelines added a statement in January 2024 stating that bictebgravir can be taken during pregnancy as it is not associated with increased risks of congenital anomalies and without the need for dosage adjustment”.
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