Assessing the Gender Differences of Adverse Effects in HIV Infection Treatment Based on FDA AERS Database.

Adverse effects of HIV infection treatment cannot be ignored because the occurrences of undesired adverse effects will result in low drug adherence and influence the outcome of HIV treatment. Adverse effects are significantly associated with gender. However, the role of gender in the occurrences of adverse effects has not been clearly explored. In order to provide additional guidance to prescription, we analyzed the adverse effects in HIV treatment aiming to find some gender-based differences using FDA AERS database. Interestingly, women and men performed differently in almost all the HIV-therapy adverse effects, among which adverse effects associated with skin and subcutaneous tissues occurred more frequently in male among younger adults while more frequently in female among older adults. The different occurrences of skin and subcutaneous adverse effects in men and women indicated that estrogen and androgen might function differently on skin during HIV therapy. Gender differences exist in both inter-groups and intra-groups of HIV medications. The drug NNRTI induced more adverse effects in female, but PI and INI more in male. Two NNRTI medications, namely efavirenz and nevirapine, caused different adverse effects between the two genders. Efavirenz induced more adverse effects in males and mainly affected nervous system whereas nevirapine caused more adverse effects in females and mainly affected skin and subcutaneous tissues. The gender of female is a risk factor for nevirapine, which is closely related to adverse effects associated with skin. Therefore, the recognition of gender differences in adverse effects may be helpful in prescribing medications to HIV-infected patients, e.g. greater caution should be taken when prescribing nevirapine to women. Keywords: Adverse effect, AERS, efavirenz, gender difference, HIV infection, nevirapine.