Quality of Life in HIV Clinical Trials: Why Sexual Health Must Not Be Ignored

Currently more than 20 antiretrovirals are commercially available for treatment of HIV infection [1]. Using them in combination therapy, we are able to treat HIV-infected patients with highly potent regimens and suppress the virus below detectable levels. Correct adherence to these regimens is important to ensure that the viral load will remain undetectable and that the disease does not progress. Moreover, even if adherence is not perfect and the virus becomes resistant to a first-line regimen, there are other treatment options to suppress the virus again to undetectable levels. Given the choice of several different potent antiretroviral regimens, doctors and patients will tend to prefer those regimens that are easy to take and that have limited short-term and long-term side effects. One potential side effect of antiretroviral treatment that has received very little scientific attention so far is sexual dysfunction. Sexual dysfunction is defined as difficulty during any stage of the sexual act, including desire, arousal, orgasm, and resolution, that prevents the individual or couple from enjoying sexual activity [2], and, according to DSM-IV (the Diagnostic and Statistical Manual of Mental Disorders, fourth edition) criteria, causing ‘‘marked level of distress or interpersonal difficulty’’ [3]. Sexual dysfunction disorders are generally classified into four categories: sexual desire disorders, sexual arousal disorders, orgasm disorders, and sexual pain disorders [2,3]. Most data relating to the association between antiretroviral therapy and sexual dysfunction are based on cross-sectional studies or case series, and have emerged from industrialised countries [4–12]. Some studies have suggested that antiretrovirals, in particular certain protease inhibitors, may cause sexual problems or dysfunction [4–10]; however, other studies have not confirmed this observation [11,12]. Furthermore, sexual dysfunctions in people infected with HIV may be caused by many different factors. Both organic and psychological factors have been identified, including coping with HIV, pre-existing sexual dysfunctions, sex hormone abnormalities, neuropathy from HIV itself (or related treatment for HIVcaused illnesses), and other iatrogenic causes [13]. Sexual dysfunctions are conceptualised as one component of sexual health, which is an essential element of overall healthrelated quality of life (HRQOL). While it may include a variety of diverse issues, comprehensive definitions such as the World Health Organization’s (WHO) working definition define sexual health as a state of physical, emotional, mental, and social well-being, and not merely the absence of disease, dysfunction, or infirmity. Sexual health encompasses the possibility of having pleasurable and safe sexual experiences [14]. The essence of such lengthy definitions has been summarised in one single statement as ‘‘the enjoyment of sexual activity of one’s choice, without causing or suffering physTable 1. Overview of the Most Commonly Used Questionnaires in Clinical HIV Trials