Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster

A randomized controlled trial enrolling 140 participants from 5 centers in China. Patients receive either Brivudine (125mg/day) or Famciclovir (dose-adjusted by creatinine clearance) for 7 days. Follow-ups occur at Day 3, Day 7, Day 14, Day 30, Day 90. Primary endpoint: Numeric Pain Rating Scale (NPRS) at Day 30; secondary endpoints: NPRS at other timepoints, lesion healing time, Postherpetic Neuralgia (PHN) rate, and adverse events.

Inclusion criteria

• Age ≥18 years, regardless of gender;
• Signed Informed Consent Form;
• Female subjects must not plan for pregnancy or oocyte donation from screening until 1 week after the last dose and must voluntarily adopt highly effective physical contraception; male subjects must not plan for fertility or sperm donation during the same period and must voluntarily adopt highly effective physical contraception. Methods include:

• Barrier methods: Condom or barrier cap (diaphragm or cervical cap);
• Intrauterine device (IUD) or intrauterine system (IUS);
• Surgical sterilization (bilateral oophorectomy with/without hysterectomy, total hysterectomy, bilateral tubal ligation, or vasectomy) performed ≥6 months prior to the first dose in the subject or their partner;
• Other investigator-confirmed highly effective physical contraception.

Exclusion criteria

• Allergy to brivudine, famciclovir, or penciclovir;
• Current use of fluorouracil agents (e.g., 5-fluorouracil, capecitabine, tegafur, flucytosine);
• Cancer patients currently undergoing chemotherapy;
• Pregnant or lactating women;
• Parkinson's disease;
• Any condition deemed inappropriate for study participation by the investigator.