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.

• Brivudine (Drug): brivudine 125 mg per dose, once daily, 7 days
• Famciclovir (Drug): orally receive famciclovir at doses adjusted based on creatinine clearance (CrCl), 7 days

Primary outcomes

• Day 30 numeric pain rating scale (NPRS) [Day 30]: Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.

Secondary outcomes

• numeric pain rating scale (NPRS) on Day 3, Day 7, Day 14, Day 90 [Day 3, Day 7, Day 14, Day 90]: Scores range from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
• Incidence of PHN [Day 90]: Incidence of Postherpetic Neuralgia
• skin lesion on Day 3, Day 7, Day 14, Day 30, Day 90 [Day 3, Day 7, Day 14, Day 30, Day 90]: whether the presence of hemorrhagic bullae, bullae, erosions, or ulcers
• Lesion area on Day 3, Day 7, Day 14, Day 30 and Day 90 [Day 3, Day 7, Day 14, Day 30 and Day 90]: Percentage of body surface area (BSA%) affected by lesions on Day 3, Day 7, Day 14, Day 30 and Day 90
• cessation of new lesion formation [Day 3, Day 7, Day 14, Day 30 and Day 90]: whether cessation of new papule/vesicle formation on Day 3, Day 7, Day 14, Day 30 and Day 90
• complete crusting of all lesions [Day 3, Day 7, Day 14, Day 30 and Day 90]: whether complete crusting of all lesions Day 3, Day 7, Day 14, Day 30 and Day 90
• Adverse Events (AEs) and Serious Adverse Events (SAEs) [From baseline to Day 30]: Adverse Events (AEs) and Serious Adverse Events (SAEs) in 30 days

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Age ≥18 years, regardless of gender;
2. Signed Informed Consent Form;
3. 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:

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