treatmentnaive

Treatment-naive, often written as treatment-naïve, is a medical term used to describe a patient who has not received prior treatment for a specific disease or condition. This designation usually refers to systemic therapies such as medications, biologic agents, or targeted treatments, although it may not exclude prior diagnostic procedures, surgery, or radiotherapy. The exact definition can vary by disease and study protocol, and prior exposure to related therapies may be omitted or noted separately.

In research and clinical practice, treatment-naive status helps characterize study populations and interpret outcomes. It can influence expected response rates, safety profiles, and the need for resistance testing in infectious diseases. Trials and guidelines often compare treatment-naive patients with those who are treatment-experienced to determine the effectiveness and tolerability of first-line therapies. The designation also affects inclusion criteria and stratification in studies.

Examples include HIV/AIDS, where ART-naive patients have not previously taken antiretroviral therapy; guidelines typically emphasize initiating therapy promptly and selecting regimens with favorable tolerability and resistance considerations. In oncology, treatment-naive patients are those receiving their first systemic therapy for a given cancer, and their responses and side effects may differ from those with prior treatments or relapsed disease.

Limitations exist, as the classification depends on accurate medical history and a well-defined disease scope. Misclassification can occur if prior therapies are unreported or if local versus systemic treatments are counted differently, and naive status does not necessarily reflect the underlying biology or prior exposures that could influence outcomes.