DosageDuration:Single dose of 500 mg, then 250 mg bid (= 500 mg daily) for 2 days; 125 mg bid (= 250 mg daily) for 5 days.
Patients:873 outpatients. 2-day Famvir course: n=433, of whom 315 had relapse (180 males and 135 females, mean age 40 years; 289 Caucasian) and 289 entered second randomization (137 on 2-day and 152 on 5-day). 5-day Famvir course: n=440, of whom 301 had relapse (165 males and 136 females, mean age 40 years; 273 Caucasian) and 277 entered second randomization (148 on 2-day and 129 on 5-day).
Results:Overall, 253 (29%) patients did not experience a relapse during the study. The proportion of relapses with lesions present 5.5 days after initiating Famvir treatment was less in the 2-day arm compared to the 5-day arm (24% vs 28%). A similar proportion of relapse was aborted in the 2-day arm (7.6%) as in the 5-day arm (9.5%, P = 0.31). No significant difference was noted in time to next relapse by treatment assignment of first relapse. The resolution of symptoms and improvement in patient functioning was similar in both groups, with little difference in the mean total HSC and HOIQ scores between Days 1 and 5. Adverse events (AEs) in both groups were similar. Overall, AEs were infrequent and of mild to moderate intensity. Headache was the most common AE reported in 16% of 2-day treatments and 18% of 5-day treatments, followed by nausea (3%, 4%), back pain (3%, 2%), diarrhea (2%, 3%), fatigue (2%, 3%), dizziness (2%, 2%) and abdominal pain (2%, 1%).
FreeText:Primary efficacy endpoint: probability of having lesions ("not lesion free") at 5.5 elapsed days after initiation of therapy. Secondary efficacy variables: proportion of relapse that were aborted (failure to progress beyond the papule stage), the time between consecutive relapses, the change from baseline in the scores for pain and other individual symptoms, and change in the total Herpes Symptom Checklist (HSC) and Herpes Outbreak Impact Questionnaire (HOIQ). Symptoms included tingling, burning, pain, aching (including backache), itching, tenderness, dysuria, painful defecation, penile or vaginal discharge, headache, tiredness, urinary frequency, and bowel frequency.
AdverseEffects:104 (50 on 2-day course and 54 on 5-day course) patients developed headache, 21 (9 and 12) nausea, 15 (9 and 6) back pain, 15 (6 and 9) diarrhea, 15 (6 and 9) fatigue, 12 (6 and 6) dizziness, and 9 (6 and 3) abdominal pain.
AuthorsConclusions:In summary, this clinical trial has added another abbreviated alternative to the previously standard 5-day treatments for episodes of recurrent genital herpes without compromise to either efficacy or safety.
TypeofStudy:A randomized, double-blind, multicenter, multinational, active-controlled study of patient-initiated therapy comparing Famvir 500 mg statim (single dose) then 250 mg twice daily (bid) for 2 days (2-day course) versus Famvir 125 mg bid for 5 days (5-day course) in immunocompetent adults with relapsing herpes genitalis.
Indications:873 immunocompetent patients with relapsing herpes genitalis. Coexisting disease: human immunodeficiency virus infection.
All Science Journal Classification (ASJC) codes
- Public Health, Environmental and Occupational Health
- Infectious Diseases