Oral Famciclovir for the Suppression of Recurrent Genital Herpes: The Combined Data from Two Randomized Controlled Trials
Bibliographic record
Abstract
Background: Genital herpes is a very common sexually transmitted disease. Safe and effective therapies are needed for patients with frequent recurrences. Objective: The aim of our study was to determine the efficacy and safety of famciclovir for suppression of herpes simplex virus (HSV) infection in patients with a history of clinically diagnosed recurrent genital HSV infection. Method: An analysis was conducted of the combined data from two randomized, double-blind, placebo-controlled studies of 52 weeks' duration involving a total of 469 patients (201 men, 268 women) from 47 university, hospital, or private referral centers in Europe and North America. The patients were 18 years or older with a history of six or more episodes of genital herpes during 12 of the 24 months prior to study entry and were not receiving suppressive therapy. They were randomized to receive oral famciclovir 250 mg twice daily or placebo for 52 weeks. The primary outcome measures were (1) the proportion of patients who remained free from clinical HSV recurrences, confirmed by viral culture, for at least 6 months after the start of study medication; (2) the time to first clinically confirmed lesional episode; and (3) the frequency of adverse events. Results: A significantly greater proportion of famciclovir-treated patients (151/191, 79%) were free from HSV recurrences at 6 months compared with placebo recipients (48/184, 26%) ( p < 0.001); efficacy was maintained at 12 months. The median time to the first clinically confirmed lesional episode was significantly prolonged for famciclovir recipients (more than one year) compared with placebo recipients (59 days; p < 0.0001). Famciclovir was well tolerated, with an adverse-experience profile comparable with placebo. Conclusions: Oral famciclovir 250 mg twice daily is an effective, well-tolerated treatment for the suppression of genital HSV infection in patients with frequent recurrences. Antécédents et objectifs: L'herpès génital est une maladie sexuellement transmissible très fréquente. Les patients qui présentent un niveau élevé de récurrence doivent recevoir des traitements efficaces et sécuritaires. La présente analyse vise l'établissement de l'efficacité et de l'innocuité du famciclovir, un antiviral destiné à supprimer l'infection au virus de l'herpès simplex (HSV) chez les patients ayant des antécédents cliniques d'infections génitales récidivantes au HSV. Méthodes: Analyse des données combinées de deux études randomisées, a double insu, contrôlées centre placebo. Les études étaient d'une durée de 52 semaines, et portaient sur 469 patients (201 hommes et 268 femmes) provenant de 47 universités, hôpitaux et centres privés en Europe et en Amérique du Nord. Les patients avaient au moins 18 ans et ont présenté des antécédents d'au moins six épisodes d'herpès génital au cours des 12 à 24 mois précédant l'étude. Ils ne suivaient aucun traitement suppressif. Durant 52 semaines, ils ont reçu soit 250 mg de famciclovir deux fois par jour, soft un placebo. Les principales mesures des résultats étaient: 1) la proportion de patients qui ne présentent pas une récidive clinique de HSV confirmée par culture virale, pendant au moins 6 mois après le début du traitement; 2) l'intervalle de temps avant le premier épisode cliniquement confirmé; et 3) la fréquence des événements indésirables. Résultats: Une proportion marquée de patients recevant le famciclovir (151/191, 79%) n'ont pas eu une récidive d'herpès au 6 e mois du traitement, comparativement aux patients recevant le placebo (48/184, 26%) ( p < 0.001); l'efficacité s'est maintenue au 12 e mois. Le temps moyen avant le premier épisode cliniquement confirmé a été considérablement plus long pour les patients traités au famciclovir (plus d'un an) que pour les patients au placebo (59 jours; p < 0.0001). Le famciclovir était bien toiéré et le profil des événements indésirables était comparable à celui du placebo. Conclusions: Une dose de 250 mg de famciclovir oral, prise deux fois par jour, représente un traitement efficace et bien toléré pour la suppression de l'infection au virus HSV de l'herpès génital, lorsque les patients ont des récidives fréquentes.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.012 | 0.018 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.010 | 0.009 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".