A Randomized, Placebo-Controlled Comparison of Oral Valacyclovir and Acyclovir in Immunocompetent Patients With Recurrent Genital Herpes Infections

Tyring, Stephen K.; Douglas, John M.; Corey, Lawrence; Spruance, Spotswood L.; Esmann, Jørgen

doi:10.1001/archderm.134.2.185

Cited by 108 publications

(60 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…For many clinicians, hazard ratio is a relative speed. Words found in the literature that describe the effect of treatments on the resolution of viral diseases when the hazard ratio was significantly greater than one have included "accelerated time [hazard ratio shown]," "resolved [hazard ratio shown] times faster," "hazard ratios indicate a 1.3 to 1.5-fold faster time," "more than twice as fast [hazard ratio ϭ 2.13]," and "healing time was 15% shorter [hazard ratio ϭ 0.85]" (9)(10)(11)(12).…”

Section: Use Of the Cox Model In Trials Of Disease Durationmentioning

confidence: 99%

Hazard Ratio in Clinical Trials

Spruance

Reid

Grace

et al. 2004

Antimicrob Agents Chemother

418

279

View full text Add to dashboard Cite

3Time-to-event curves analyzed by Cox proportional hazards regression are commonly used to describe the outcome of drug studies. This methodology has the advantage of using all available information, including patients who fail to complete the trial, such as in cancer chemotherapy or human immunodeficiency virus antiviral treatment studies. The goal of treatment in such studies may be to prevent the development of a complication, for example, Pneumocystis carinii pneumonia, and to describe the likelihood of this complication's developing in the treatment group compared to the control group. The hazard ratio describes the relative risk of the complication based on comparison of event rates.Hazard ratios have also been used to describe the outcome of therapeutic trials where the question is to what extent treatment can shorten the duration of the illness. However, the hazard ratio, a type of relative risk, does not always accurately portray the degree of abbreviation of the illness that occurred. In these circumstances, time-based parameters available from the time-to-event curve, such as the ratio of the median times of the placebo and drug groups, should be used to describe the magnitude of the benefit to the patient. The difference between hazard-based and time-based measures is analogous to the odds of winning a race and the margin of victory. The hazard ratio is the odds of a patient's healing faster under treatment but does not convey any information about how much faster this event may occur.We have observed that there is substantial confusion among clinicians and clinical investigators about the difference between the hazard ratio and the median ratio. This report presents examples of this confusion, the exact distinction between the two statistics, and proper use of the hazard ratio and median ratio when interpreting the results of clinical trials to patients. COX PROPORTIONAL HAZARDS MODELTime-to-event analysis. Clinical trials commonly record the length of time from study entry to a disease endpoint for a treatment and a control group. These data are commonly depicted with a Kaplan-Meier curve (Fig. 1), from which the median (time at which 50% of cases are resolved) and the mean (average resolution time) can be derived. The groups are compared by a time-to-event analysis (survival analysis) (1, 7). Time-to-event analysis provides a method to include patients who fail to complete the trial or do not reach the study endpoint (censored data) by making comparisons between the number of survivors in each group at multiple points in time. The alternative approach, excluding patients who are lost to follow-up, may introduce considerable bias because the data that these patients generate prior to their exit are important to the power and validity of the study. Time-to-event analysis can also incorporate information about subjects that may change over time (time-dependent covariates). Clinically important differences in the effect of treatment may be obscured if the proportions of survivors or recovered individu...

show abstract

Section: Use Of the Cox Model In Trials Of Disease Durationmentioning

confidence: 99%

Hazard Ratio in Clinical Trials

Spruance

Reid

Grace

et al. 2004

Antimicrob Agents Chemother

418

279

View full text Add to dashboard Cite

show abstract

“…Recurrences still occur after cessation of episodic therapy and sometimes even during suppressive treatment (2,3). Acute symptoms are significantly reduced only when treatment is initiated early in the course of the disease (4).…”

mentioning

confidence: 99%

Pharmacokinetics-Pharmacodynamics of the Helicase-Primase Inhibitor Pritelivir following Treatment of Wild-Type or Pritelivir-Resistant Virus Infection in a Murine Herpes Simplex Virus 1 Infection Model

Biswas

Sukla

Goldner

et al. 2014

Antimicrob Agents Chemother

View full text Add to dashboard Cite

“…В рандомизированном исследовании с плацебо-контролем, в котором сравнивалась эффективность обоих препаратов, бы-ло показано уменьшение выраженности и продол-жительности болевого синдрома [21].…”

Section: Abstract: Recurrent Genital Herpes Treatment Valacyclovir unclassified

Genital herpes: the efficacy of anti-viral therapy

Орлов¹,

Котельникова²,

Vasil’yev-stupal’skiy³

et al. 2015

Klin. dermatol. venerol.

View full text Add to dashboard Cite

Генитальный герпес -хроническое рецидиви-рующее вирусное заболевание, передаваемое пре-имущественно половым путем, которое вызывается вирусом простого герпеса (ВПГ) 1-го и/или 2-го ти-пов (ВПГ-1 и/или ВПГ-2) [1].Данное инфекционное заболевание характери-зуется поражением кожи и слизистых оболочек мо-чеполовых органов и аноректальной области. Воз-будителем генитального герпеса в большинстве слу-чаев является ВПГ-2, однако, как показывает миро-вая практика, у 25-30% пациентов выявляют ВПГ-1, заражение которым происходит при орально-ге-нитальных, генитально-анальных и орально-аналь-ных контактах. Возможна передача инфекции быто-вым путем через предметы личной гигиены. Зараже-ние возможно как при наличии клинических прояв-лений болезни у полового партнера, так и при их отсутствии, что особенно важно в эпидемиологиче-ском отношении [2]. Плохо контролируемый и постоянно увеличивающийся рост герпетической инфекции, развитие рецидивов генитального герпеса у пациентов, перенесших первичную инфекцию, требуют оценки эффективности лечения. Цель исследования -оценить эффективность ациклических нуклеозидов ацикловир и валацикловир (Валвир) в лечении рецидивирующей герпетической инфекции, а также комплаентность лечению. Материал и методы. 67 пациентов с рецидивирующим генитальным герпесом во время рецидива получали валацикловир (Валвир) по 500 мг 2 раза в сутки (n=34) и ацикловир по 200 мг 5 раз в сутки в течение 5 дней (n=33). Результаты. Отмечено некоторое ускорение разрешения клинических проявлений в группе принимавших валацикловир. Заключение. Ацикловир и валацикловир (Валвир) эффективны в лечении рецидивирующего генитального герпеса. Меньшая частота применения валацикловира (Валвира) увеличивает его комплаентность. Ключевые слова: рецидивирующий генитальный герпес, лечение, валацикловир, ацикловир.Poorly controlled and steadily increasing growth of the herpetic infection and development of genital herpes relapses in patients after a primary infection require evaluation of the treatment efficacy. Aim. The aim of the study was to assess the efficacy of acyclic nucleosides Acyclovir and valacyclovir (Valvir) in the treatment of recurrent genital herpes as well as compliance with the treatment. Material and methods. 67 patients with recurrent genital herpes during relapse were treated with valacyclovir (Valvir), 500 mg 2 times a day (n=34), and Acyclovir, 200 mg 5 times a day, during 5 days (n=33). Results. Certain acceleration of resolving of clinical manifestations was observed in the group of patients treated with valacyclovir. Conclusion. Acyclovir and valacyclovir (Valvir) are effective in the management of recurrent genital herpes. The lower application rate of valacyclovir (Valvir) increases its compliance.

show abstract

A Randomized, Placebo-Controlled Comparison of Oral Valacyclovir and Acyclovir in Immunocompetent Patients With Recurrent Genital Herpes Infections

Cited by 108 publications

References 19 publications

Hazard Ratio in Clinical Trials

Hazard Ratio in Clinical Trials

Pharmacokinetics-Pharmacodynamics of the Helicase-Primase Inhibitor Pritelivir following Treatment of Wild-Type or Pritelivir-Resistant Virus Infection in a Murine Herpes Simplex Virus 1 Infection Model

Genital herpes: the efficacy of anti-viral therapy

Contact Info

Product

Resources

About