Treating acyclovir-resistant HSV infection
Herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) infections lead to lifelong persistence of the virus, with frequent and sometimes painful recurrences, and carry the risk of serious complications in immune-compromised patients. Pritelivir is a highly potent inhibitor of HSV replication. It belongs to a new chemical class and acts via a novel mechanism of action (inhibition of the viral helicase-primase enzyme complex). In contrast to currently used nucleoside analogues, Pritelivir does not require activation by viral enzymes and can thus protect uninfected cells. Pritelivir is being developed for the treatment of acyclovir-resistant and dual-resistant (resistant to acyclovir and intolerant or resistant to foscarnet) infections in immune-compromised patients. The development of Pritelivir for patients with high medical need is in clinical Phase 3 and Pritelivir is not yet available as a marketed product.
Please visit www.clinicaltrials.gov (study identifier: NCT03073967) to see whether your patient meets trial criteria and to find contact details of a potential trial site. It has received the US FDA Breakthrough Therapy Designation.
Early Access to Pritelivir oral tablets for immunocompromised patients with resistant HSV infections
AiCuris develops Pritelivir oral tablets for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections. A phase 2/3 trial in immunocompromised patients is ongoing. AiCuris also supports expanded access requests for Pritelivir oral tablets for the treatment of eligible patients and collaborates with myTomorrows to facilitate early access to Pritelivir for acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. EAPs (also known as “Expanded Access Program” or “Named-Patient Use”) offer an ethical, compliant, and controlled way of providing treatment with a medicine currently not licensed in a patient’s country of residence. Eligible patients for an EAP are in high medical need, cannot participate in a Clinical Trial, and have exhausted all registered treatment options. More information can be requested here.
To get access, patients need to consult with their treating physician to explore all treatment options. If the physician agrees to a treatment with Pritelivir oral tablets and to oversee the patient's treatment, the
physician should contact the myTomorrows medical team for more information on this EAP. When providing medical information about the patient, please note that only anonymized data shall be included in any patient information. Due to EU data protection law this shall not be accompanied by personal data.