Brivudine versus famciclovir for treating shingles

Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster: A Multicenter, Randomized, Prospective Clinical Trial

This will see if brivudine or famciclovir reduces pain more by 30 days in adults with shingles.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University Third Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Beijing and 3 other locations)
• Trial ID: NCT07099157 on ClinicalTrials.gov

What this trial studies

This randomized, multicenter trial enrolls 140 adults with herpes zoster at five centers in China and compares brivudine (125 mg/day) with famciclovir (dose adjusted for kidney function) for seven days. Participants are followed at Days 3, 7, 14, 30, and 90 to measure pain (Numeric Pain Rating Scale), time to lesion healing, postherpetic neuralgia incidence, and adverse events. The primary endpoint is pain score on Day 30, with secondary endpoints including earlier pain scores, lesion resolution time, PHN rate, and safety. Results will show whether one antiviral provides faster pain relief or lowers the risk of postherpetic neuralgia.

Who should consider this trial

Good fit: Adults aged 18 or older with acute herpes zoster who can give informed consent, agree to required contraception measures, and meet safety criteria (no allergies or contraindicated medications) are appropriate candidates.

Not a fit: Patients with known allergy to brivudine, famciclovir, or penciclovir, those currently using fluorouracil agents, or others with contraindications to the study drugs are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the better-performing antiviral could provide faster pain relief and reduce the risk of postherpetic neuralgia for adults with shingles.

How similar studies have performed: Antiviral therapy for acute herpes zoster is well established and drugs like famciclovir have shown effectiveness, but direct head-to-head data comparing brivudine and famciclovir are limited.

Eligibility criteria

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.

Where this trial is running

Beijing and 3 other locations

• Peking University Third Hospital — Beijing, China (RECRUITING)
• Beijing Hospital of Traditional Chinese Medicine, Capital Medical University — Beijing, China (RECRUITING)
• Peking University First Hospital — Beijing, China (RECRUITING)
• Xuanwu Hospital, Capital Medical University — Beijing, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Jin-Zhu Guo, M.D.

Conditions: Herpes Zoster, Brivudine, pain, treatment