Safety of hydroxyurea in the treatment of HIV infection.

Lifelong adherence to very complex anti-HIV therapy presents drawbacks such as drug resistance and chronic drug-related toxicity, underscoring the need for innovative therapeutic options. As it is becoming increasingly evident that immune activation may be responsible for immune pathology, novel approaches to limit immune activation are under investigation. Hydroxyurea is the prototype of a new family of anti-HIV drugs called virostatics, acting both as an antiviral (directly suppressing HIV) and cytostatic (preventing immune system overactivation). Data from in vitro and clinical studies have proven that hydroxyurea-based regimens are effective options for patients with HIV. However, concerns over hydroxyurea toxicity have limited its use. This review critically examines the role of hydroxyurea for HIV-infected patients, focusing on past and recent clinical trials including the RIGHT 702 study, which identified the safest and most efficacious hydroxyurea dose.