brl 42810 has been researched along with Genital Herpes in 82 studies
Excerpt | Relevance | Reference |
---|---|---|
"In this multicenter, multinational, double-blind, parallel-group study, 1179 adults with a history of recurrent genital herpes were randomized 1:1 to receive either famciclovir or valacyclovir." | 9.13 | Single-day, patient-initiated famciclovir therapy versus 3-day valacyclovir regimen for recurrent genital herpes: a randomized, double-blind, comparative trial. ( Abudalu, M; Bodsworth, N; Hamed, K; Koltun, W; Tyring, S, 2008) |
"Valacyclovir appear to be somewhat better than famciclovir for suppression of genital herpes and associated shedding." | 9.12 | Comparative efficacy of famciclovir and valacyclovir for suppression of recurrent genital herpes and viral shedding. ( Aoki, FY; Corey, L; Diaz-Mitoma, F; Sacks, S; Selke, S; Wald, A; Warren, T, 2006) |
"In this multicenter, multinational, double-blind, parallel-group study, 1179 adults with a history of recurrent genital herpes were randomized 1:1 to receive either famciclovir or valacyclovir." | 5.13 | Single-day, patient-initiated famciclovir therapy versus 3-day valacyclovir regimen for recurrent genital herpes: a randomized, double-blind, comparative trial. ( Abudalu, M; Bodsworth, N; Hamed, K; Koltun, W; Tyring, S, 2008) |
"Valacyclovir appear to be somewhat better than famciclovir for suppression of genital herpes and associated shedding." | 5.12 | Comparative efficacy of famciclovir and valacyclovir for suppression of recurrent genital herpes and viral shedding. ( Aoki, FY; Corey, L; Diaz-Mitoma, F; Sacks, S; Selke, S; Wald, A; Warren, T, 2006) |
"We selected parallel-group and cross-over randomized controlled trials including patients with recurrent genital herpes caused by HSV, whatever the type (HSV-1, HSV-2, or undetermined), with at least four recurrences per year (trials concerning human immunodeficiency virus (HIV)-positive patients or pregnant women were not eligible) and comparing suppressive oral antiviral treatment with oral acyclovir, famciclovir, and valacyclovir versus placebo or another suppressive oral antiviral treatment." | 4.90 | Oral antiviral therapy for prevention of genital herpes outbreaks in immunocompetent and nonpregnant patients. ( Chosidow, O; Do, G; Le Cleach, L; Lebrun-Vignes, B; Maruani, A; Ravaud, P; Trinquart, L, 2014) |
"Efficacy of oral antiviral therapies, ie, acyclovir, valacyclovir (VACV), and famciclovir, for suppression of recurrent genital herpes was studied at different doses and regimens." | 4.84 | A meta-analysis to assess the efficacy of oral antiviral treatment to prevent genital herpes outbreaks. ( Bouzamondo, A; Chosidow, O; Dupuy, A; Guillaume, JC; Lebrun-Vignes, B; Lechat, P, 2007) |
"The episodic and daily suppressive treatment of genital herpes is safe and effective with the currently available antiviral agents: acyclovir, valacyclovir and famciclovir." | 4.83 | Genital herpes: antiviral therapy for symptom relief and prevention of transmission. ( Gupta, R; Wald, A, 2006) |
" Acyclovir, first synthesized in 1974, has proved to be an effective and safe drug for the treatment of primary and frequently recurring genital herpes, according to the various medical publications over the last 10 years." | 4.79 | Developments in the antiviral treatment of genital herpes. ( Cheong, WK, 1995) |
"For the primary infection of genital herpes, antiviral therapy with acyclovir is the gold standard." | 3.70 | Update on antiviral therapy for genital herpes infection. ( Geers, TA; Isada, CM, 2000) |
"To assess time to next recurrence and development of antiviral resistance in patients with recurrent genital herpes treated with either single-day famciclovir (1 g twice-daily) or 3-day valacyclovir (500 mg twice-daily)." | 2.74 | Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance. ( Abudalu, M; Bodsworth, N; Fife, K; Hamed, K; Koltun, W; Prichard, M; Tyring, S, 2009) |
"Genital herpes is a lifelong incurable viral infection that can have a significant psychological and emotional impact on patients." | 2.72 | Single-day famciclovir therapy for recurrent genital herpes. ( Diaz-Mitoma, F; Hamed, K; Whitley, R, 2006) |
" Although traditional therapy for a recurrent episode for healthy adults has consisted of twice-daily dosing for 5 days, recent studies have indicated that shorter courses of antiviral therapy are effective." | 2.72 | Single-day, patient-initiated famciclovir therapy for recurrent genital herpes: a randomized, double-blind, placebo-controlled trial. ( Aoki, FY; Diaz-Mitoma, F; Gao, J; Gross, G; Hamed, K; Tyring, S, 2006) |
"Genital herpes is most often transmitted while the patient is asymptomatic, presumably during episodes of viral shedding." | 2.71 | Famciclovir suppression of asymptomatic and symptomatic recurrent anogenital herpes simplex virus shedding in women: a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single-center trial. ( Sacks, SL, 2004) |
"In immunocompetent adults with recurrent genital herpes, a 5-day course of famciclovir at a dosage of 125 mg, 250 mg, or 500 mg twice per day was significantly more effective than was placebo in reducing the duration of viral shedding and symptoms and in accelerating lesion healing." | 2.71 | Clinic-initiated, twice-daily oral famciclovir for treatment of recurrent genital herpes: a randomized, double-blind, controlled trial. ( Aoki, FY; Lassonde, M; Martel, AY; Sacks, SL; Shafran, SD, 2005) |
"Time to the first recurrence of genital HSV infection; the proportion of patients remaining free of HSV recurrence at 6 months; frequency of adverse events." | 2.69 | Oral famciclovir for the suppression of recurrent genital herpes: a randomized controlled trial. Collaborative Famciclovir Genital Herpes Research Group. ( Boon, R; Diaz-Mitoma, F; Saltzman, RL; Shafran, SD; Sibbald, RG, 1998) |
"The median time to first recurrence was 82 days in the placebo group, 114 days in those receiving famciclovir, 125 mg once daily, and more than 120 days in the other treatment groups." | 2.68 | Oral famciclovir for suppression of recurrent genital herpes simplex virus infection in women. A multicenter, double-blind, placebo-controlled trial. Collaborative Famciclovir Genital Herpes Research Group. ( Fowler, SL; Goade, D; Kraus, SJ; Levin, MJ; Loveless, MO; Mertz, GJ; Tyring, SK, 1997) |
" The most common adverse experiences reported as related to study medication (famciclovir and placebo) were headache, nausea, and diarrhea." | 2.67 | Safety of famciclovir in patients with herpes zoster and genital herpes. ( Boon, R; Jurewicz, R; Saltzman, R, 1994) |
"Genital and labial herpes simplex virus infections are frequently encountered by primary care physicians in the United States." | 2.44 | The treatment of herpes simplex infections: an evidence-based review. ( Brodell, RT; Cernik, C; Gallina, K, 2008) |
"One common method for treating recurrent genital herpes outbreaks is 3-5 day episodic therapy with nucleoside analogues." | 2.44 | Single-day therapy: an expert opinion on a recent development for the episodic treatment of recurrent genital herpes. ( Hamed, K; Richwald, G; Tyring, S, 2007) |
" Famciclovir has received single-day dosing indications for both of these entities." | 2.44 | Famciclovir for cutaneous herpesvirus infections: an update and review of new single-day dosing indications. ( Chacko, M; Weinberg, JM, 2007) |
" Its pharmacokinetics allow for administration in a convenient dosing regimen compared with acyclovir, which may improve compliance." | 2.43 | Famciclovir for the treatment of recurrent genital herpes: a clinical and pharmacological perspective. ( Aoki, FY; Vinh, DC, 2006) |
" Convenient patient-initiated single-day (for recurrent genital herpes) and single-dose (for orolabial herpes) dosage regimens may contribute to treatment compliance, patient acceptability and subsequent treatment outcomes." | 2.43 | Famciclovir: a review of its use in herpes zoster and genital and orolabial herpes. ( Lyseng-Williamson, KA; Simpson, D, 2006) |
"Herpes genitalis is one of the most common viral sexually transmitted diseases in the world, with an estimated seroprevalence in the US of greater than 20%." | 2.42 | Recurrent genital herpes treatments and their impact on quality of life. ( Brentjens, MH; Lee, PC; Tyring, SK; Yeung-Yue, KA, 2003) |
" These compounds offer high oral bioavailabilty and deliver acyclovir and penciclovir, respectively, to the target cells by means of more convenient dosing schedules." | 2.42 | Recent clinical experience with famciclovir--a "third generation" nucleoside prodrug. ( Beutner, K; Chakrabarty, A; Rauser, M; Tyring, SK, 2004) |
" Choice of therapy would then depend on convenience of dosing and cost." | 2.42 | Antiviral treatment of genital herpes. ( Apoola, A; Radcliffe, K, 2004) |
"Genital herpes is one of the most widespread sexually transmitted diseases in the world." | 2.41 | [Genital herpes: epidemiology, transmission, clinic, asymptomatic viral excretion, impact on other sexually transmitted diseases, prevention, and treatment]. ( Bossi, P, 2002) |
" The prodrugs valacyclovir and famciclovir offer easier, less-frequent dosing than required for acyclovir." | 2.41 | Progress in meeting today's demands in genital herpes: an overview of current management. ( Patel, R, 2002) |
" Famciclovir and valacyclovir offer improved oral bioavailability and convenient oral dosing schedules but are more expensive than acyclovir." | 2.41 | Treatment of common cutaneous herpes simplex virus infections. ( Emmert, DH, 2000) |
"Genital herpes is one of the most common sexually transmitted diseases, affecting about 20% of sexually active people; up to 80% of cases are undiagnosed." | 2.41 | Recent advances in management of genital herpes. ( Boivin, G; Tétrault, I, 2000) |
"Prevention of recurrences in pregnancy is also a topic under investigation, with a view to reducing the medical need for Cesarean section, or alternatively (and far less likely to be accomplished) to protect the neonate." | 2.41 | Current recommendations for the treatment of genital herpes. ( Leung, DT; Sacks, SL, 2000) |
"Successful management of genital herpes simplex infections involves patient education and psychological support, as well as antiviral agents." | 2.40 | A review of famciclovir in the management of genital herpes. ( Faro, S, 1998) |
"Famciclovir, a synthetic acyclic guanine derivative, is a prodrug which, after oral administration, is rapidly metabolised to the highly bioavailable antiviral compound penciclovir." | 2.39 | Famciclovir. A review of its pharmacological properties and therapeutic efficacy in herpesvirus infections. ( Perry, CM; Wagstaff, AJ, 1995) |
"Famciclovir is the well-absorbed oral form of penciclovir, an antiviral agent with potent activity against varicella-zoster virus (VZV) and herpes simplex virus (HSV-1) and 2 (HSV-2)." | 2.39 | Famciclovir: review of clinical efficacy and safety. ( Cirelli, R; Herne, K; Lee, P; McCrary, M; Tyring, SK, 1996) |
" However, drug concentrations were noninhibitory during 42% of the dosing cycle." | 1.39 | Rapid viral expansion and short drug half-life explain the incomplete effectiveness of current herpes simplex virus 2-directed antiviral agents. ( Corey, L; Schiffer, JT; Swan, DA; Wald, A, 2013) |
" Its bioavailability means that it can be taken less frequently than acyclovir, the only other approved herpes treatment." | 1.29 | Drug effective against herpes. ( , 1996) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 27 (32.93) | 18.2507 |
2000's | 49 (59.76) | 29.6817 |
2010's | 6 (7.32) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Schiffer, JT | 2 |
Swan, DA | 1 |
Corey, L | 5 |
Wald, A | 5 |
Le Cleach, L | 1 |
Trinquart, L | 1 |
Do, G | 1 |
Maruani, A | 1 |
Lebrun-Vignes, B | 2 |
Ravaud, P | 1 |
Chosidow, O | 3 |
Polansky, H | 1 |
Javaherian, A | 1 |
Itzkovitz, E | 1 |
Cernik, C | 1 |
Gallina, K | 1 |
Brodell, RT | 1 |
Bartlett, BL | 1 |
Tyring, SK | 6 |
Fife, K | 3 |
Gnann, JW | 1 |
Hadala, JT | 1 |
Kianifard, F | 1 |
Berber, E | 1 |
Abudalu, M | 3 |
Tyring, S | 6 |
Koltun, W | 2 |
Bodsworth, N | 3 |
Hamed, K | 8 |
Bloch, M | 1 |
McNulty, A | 1 |
Denham, I | 1 |
Doong, N | 1 |
Trottier, S | 1 |
Adena, M | 1 |
Bonney, MA | 1 |
Agnew, J | 1 |
Prichard, M | 1 |
Leone, P | 2 |
Mitha, E | 1 |
Gani, M | 1 |
Zhou, W | 1 |
Kang, SH | 1 |
Chua-Gocheco, A | 1 |
Bozzo, P | 1 |
Einarson, A | 1 |
Magaret, A | 1 |
Selke, S | 2 |
Hiltunen-Back, E | 1 |
Whitley, RJ | 1 |
Bossi, P | 1 |
Brown, TJ | 1 |
McCrary, M | 2 |
Patel, R | 2 |
Danielsen, AG | 1 |
Petersen, CS | 1 |
Iversen, J | 1 |
Glad'ko, VV | 1 |
Akovbian, VA | 1 |
Masiukova, SA | 1 |
Zudin, AB | 1 |
Glad'ko, OV | 1 |
Egorova, IuS | 1 |
Omarova, MKh | 1 |
Brentjens, MH | 1 |
Yeung-Yue, KA | 1 |
Lee, PC | 1 |
Abashin, VG | 1 |
Berlev, IV | 1 |
Pushkarev, AS | 1 |
Sacks, SL | 7 |
Apoola, A | 1 |
Radcliffe, K | 1 |
Chakrabarty, A | 1 |
Beutner, K | 1 |
Rauser, M | 1 |
O'Mahony, C | 1 |
Griffiths, P | 1 |
Jungmann, E | 2 |
Aoki, FY | 6 |
Martel, AY | 1 |
Shafran, SD | 3 |
Lassonde, M | 1 |
Diaz-Mitoma, F | 6 |
Gross, G | 1 |
Gao, J | 1 |
Warren, T | 2 |
Sacks, S | 2 |
Gupta, R | 1 |
Sugase, M | 1 |
Fife, KH | 1 |
Whitley, R | 1 |
Berger, T | 1 |
Yen-Moore, A | 1 |
Tharp, M | 1 |
Richwald, G | 1 |
Vinh, DC | 1 |
Simpson, D | 1 |
Lyseng-Williamson, KA | 1 |
Bouzamondo, A | 1 |
Dupuy, A | 1 |
Guillaume, JC | 1 |
Lechat, P | 1 |
Rutland, E | 1 |
Chacko, M | 1 |
Weinberg, JM | 1 |
Stanberry, L | 1 |
Saltzman, R | 1 |
Jurewicz, R | 1 |
Boon, R | 2 |
Perry, CM | 1 |
Wagstaff, AJ | 1 |
Sellors, J | 1 |
Cirelli, R | 1 |
Herne, K | 1 |
Lee, P | 1 |
Cheong, WK | 1 |
Ruben, M | 1 |
MacPherson, P | 1 |
Caissie, G | 1 |
Brown, D | 2 |
Goldman, BD | 1 |
Mertz, GJ | 1 |
Loveless, MO | 1 |
Levin, MJ | 1 |
Kraus, SJ | 1 |
Fowler, SL | 1 |
Goade, D | 1 |
Scoular, A | 1 |
Barton, S | 1 |
Wutzler, P | 1 |
Faro, S | 1 |
Sibbald, RG | 1 |
Saltzman, RL | 1 |
Engel, JP | 1 |
Jarvest, RL | 1 |
Sutton, D | 1 |
Vere Hodge, RA | 1 |
Ritzmann, P | 1 |
Wilson, B | 1 |
Thackray, AM | 1 |
Field, HJ | 1 |
Volpi, A | 1 |
Testore, GP | 1 |
Sarrecchia, C | 1 |
Emmert, DH | 1 |
Geers, TA | 1 |
Isada, CM | 1 |
Tétrault, I | 1 |
Boivin, G | 1 |
Drake, S | 1 |
Taylor, S | 1 |
Pillay, D | 1 |
Leung, DT | 1 |
Drouault, Y | 1 |
Leconte-Veyriac, F | 1 |
Aymard, M | 1 |
Ortonne, JP | 1 |
Pouget, F | 1 |
Revuz, J | 1 |
Decazes, JM | 1 |
Malkin, JE | 1 |
Stanberry, LR | 1 |
Rosenthal, SL | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction[NCT00219310] | Phase 4 | 0 participants | Interventional | 2003-06-30 | Completed | ||
A Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Patient-initiated Famciclovir 1000 mg b.i.d. x 1 Day to Valacyclovir 500 mg b.i.d. x 3 Days in Immunocompetent Adults With Recurrent Genital Herpes[NCT00306787] | Phase 3 | 1,179 participants (Actual) | Interventional | 2006-03-31 | Completed | ||
A Randomized, Multicenter, Double-blind Study to Compare the Efficacy of Single-day Treatment (1000 mg b.i.d.) With Famciclovir Compared to That of Placebo in Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Immunocompetent Black Patien[NCT00477334] | Phase 4 | 463 participants (Actual) | Interventional | 2007-06-30 | Completed | ||
An Open Label Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants[NCT00942084] | Phase 1 | 32 participants (Actual) | Interventional | 2011-09-30 | Completed | ||
Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women[NCT02053142] | 74 participants (Actual) | Interventional | 2009-01-31 | Completed | |||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. The median time was estimated using Kaplan-Meier method. (NCT00306787)
Timeframe: 72 hours after initiation of study medication up to Day 20
Intervention | days (Median) |
---|---|
Famciclovir | 3.07 |
Valacyclovir | 3.01 |
Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation. (NCT00306787)
Timeframe: 72 hours after initiation of study medication up to Day 20
Intervention | days (Median) |
---|---|
Famciclovir | 4.25 |
Valacyclovir | 4.08 |
Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. (NCT00306787)
Timeframe: Up to 6 months after investigator assessed healing of first recurrence of genital herpes
Intervention | participants (Number) | |
---|---|---|
Patients continued in follow up period | Patients with 2nd recurrence in follow up period | |
Famciclovir | 324 | 226 |
Valacyclovir | 342 | 231 |
Lesions that developed no further than the papule stage (erythema may have been present) were considered as aborted lesions. Prodrome also was considered the sign of aborted lesions in this study. Lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing were considered as non-aborted lesions. (NCT00306787)
Timeframe: 72 hours after initiation of study medication up to Day 20
Intervention | Percentage of participants (Number) | |
---|---|---|
Aborted Lesions | Non-Aborted lesions | |
Famciclovir | 32.7 | 67.3 |
Valacyclovir | 33.6 | 66.4 |
"Patients who experienced a first recurrence of genital herpes and took study medication were followed for a period of up to 6 months to the second recurrence. Time to a second recurrence of genital herpes was calculated in 2 ways as follows:~From the date of treatment initiation no earlier than the recurrence of genital herpes to the date of onset for the second recurrence, or~From the date of healing of non-aborted lesions or confirmation of aborted lesions to the date of onset for the second recurrence." (NCT00306787)
Timeframe: Up to 6 months after investigator assessed healing of first recurrence of genital herpes
Intervention | days (Median) | |
---|---|---|
From treatment initiation | From date of healing /confirmation | |
Famciclovir | 33.5 | 27.5 |
Valacyclovir | 38.0 | 32.0 |
Kaplan-Meier estimated time in hours of the resolution of all symptoms (pain, burning, itching, tingling and tenderness) associated with recurrent genital herpes. Kaplan-Meier method is used to estimate the time to resolution of symptoms. (NCT00306787)
Timeframe: 72 hours after initiation of study medication up to Day 20
Intervention | hours (Median) | ||||
---|---|---|---|---|---|
Pain (n = 220, 228) | Burning (n = 221, 218) | Itching (n = 309, 297) | Tingling (n = 266, 275) | Tenderness (n = 298, 311) | |
Famciclovir | 18.0 | 16.1 | 43.9 | 23.8 | 55.2 |
Valacyclovir | 20.3 | 12.6 | 43.5 | 23.0 | 48.0 |
Kaplan-Meier estimation. (NCT00477334)
Timeframe: 21 days
Intervention | Days (Median) |
---|---|
Famciclovir 1000 mg | 4.13 |
Placebo Comparator | 4.06 |
Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present). (NCT00477334)
Timeframe: 21 days
Intervention | Days (Median) |
---|---|
Famciclovir 1000 mg | 5.38 |
Placebo Comparator | 4.79 |
Number of participants with a second recurrence of genital herpes in the follow-up period. (NCT00477334)
Timeframe: 6 months
Intervention | Participants (Number) |
---|---|
Famciclovir 1000 mg | 141 |
Placebo Comparator | 75 |
(NCT00477334)
Timeframe: 21 days
Intervention | Percentage of Participants (Number) | |
---|---|---|
Percentage with aborted lesions (n=49,20) | Percentage with non-aborted lesions (n= 152,78) | |
Famciclovir 1000 mg | 24.4 | 75.6 |
Placebo Comparator | 20.4 | 79.6 |
"The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.~SGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)" (NCT00477334)
Timeframe: Baseline, Day 2
Intervention | Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
SGPT(ALT)-Famciclovir (n=183) | SGPT(ALT)-Placebo (n=92) | SGOT(AST)-Famciclovir (n=190) | SGOT(AST)-Placebo (n=92) | Blood Urea Nitrogen-Famciclovir (n=196) | Blood Urea Nitrogen-Placebo (n=95) | Creatinine-Famciclovir (n=182) | Creatinine-Placebo (n=90) | Bilirubin(total)-Famciclovir (n=192) | Bilirubin(total)-Placebo (n=93) | Amylase-Famciclovir (n=152) | Amylase-Placebo (n=72) | Lipase-Famciclovir (n=190) | Lipase-Placebo (n=90) | |
Grade 1 Toxicity | 3 | 1 | 4 | 0 | 0 | 0 | 16 | 5 | 1 | 1 | 6 | 3 | 2 | 1 |
Grade 2 Toxicity | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 3 | 1 |
Grade 3 Toxicity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Grade 4 Toxicity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful. (NCT00477334)
Timeframe: Baseline, Day 2
Intervention | Participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Haematocrit-Famciclovir (n=186) | Haematocrit-Placebo (n=87) | Haemoglobin-Famciclovir (n=183) | Haemoglobin-Placebo(n=88) | Absolute Neutrophils-Famciclovir (n=177) | Absolute Neutrophils-Placebo (n=83) | WBC(total)-Famciclovir (n=163) | WBC(total)-Placebo(n=98) | Platelet count-Famciclovir (n=184) | Platelet count-Placebo (n=88) | |
Grade 1 Toxicity | 0 | 0 | 2 | 3 | 6 | 0 | 15 | 6 | 0 | 0 |
Grade 2 Toxicity | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 1 | 0 | 0 |
Grade 3 Toxicity | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
Grade 4 Toxicity | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method. (NCT00477334)
Timeframe: 72 hour after initiation of study medication up to 21 days
Intervention | Days (Median) | |||||
---|---|---|---|---|---|---|
All symptoms (n=195/98) | Pain (n=141,69) | Burning (n=126,65) | Itching (n=168,86) | Tingling (n=141,70) | Tenderness (n=147/74) | |
Famciclovir 1000 mg | 4.5 | 3.0 | 2.3 | 3.2 | 2.0 | 3.4 |
Placebo Comparator | 5.7 | 2.6 | 2.5 | 3.5 | 2.3 | 2.9 |
Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions. (NCT00477334)
Timeframe: 6 months
Intervention | Days (Median) | |
---|---|---|
Time from initiation of treatment | Time from healing of non-aborted lesion | |
Famciclovir 1000 mg | 69.0 | 63.0 |
Placebo Comparator | 81.0 | 75.0 |
"Timeframe:~Version 1:0-5 min,2-4 hrs,6-8 hrs post doses 1 and 5-15; prior to doses 5-15 Version 2:0-15 min post doses 1 and 5-15; within 30 min prior to doses 2 and 5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose" (NCT00942084)
Timeframe: V1:0-5 min,2-4 hrs,6-8 hrs post Doses 1&5-15;prior to doses 5-15; V2:0-15 min post doses 1&5-15; within 30 min prior to doses 2&5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose
Intervention | L/h/kg (Median) |
---|---|
Acyclovir Study Design | 0.278 |
(NCT00942084)
Timeframe: up to 3 days of study drug administration and 10 days of safety monitoring
Intervention | h (Median) |
---|---|
Acyclovir Study Design | 7.07 |
(NCT00942084)
Timeframe: up to 3 dasy of study drug administration and 10 days of safety monitoring
Intervention | mg/L (Median) |
---|---|
Acyclovir Study Design | 11.1 |
(NCT00942084)
Timeframe: up to 3 days of study drug administration and 10 days of safety monitoring
Intervention | mg/L (Median) |
---|---|
Acyclovir Study Design | 4.15 |
(NCT00942084)
Timeframe: up to 3 days of study drug administration and 10 days of safety monitoring
Intervention | mg/L (Median) |
---|---|
Acyclovir Study Design | 6.33 |
(NCT00942084)
Timeframe: up to 3 days of study drug administration and 10 days of safety monitoring
Intervention | L/kg (Median) |
---|---|
Acyclovir Study Design | 3.34 |
39 reviews available for brl 42810 and Genital Herpes
Article | Year |
---|---|
Oral antiviral therapy for prevention of genital herpes outbreaks in immunocompetent and nonpregnant patients.
Topics: 2-Aminopurine; Acyclovir; Administration, Oral; Adult; Antiviral Agents; Famciclovir; Female; Herpes | 2014 |
The treatment of herpes simplex infections: an evidence-based review.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Drug Resistance, Viral; Evidence-Based Medicine; Famcicl | 2008 |
Herpes simplex virus infection.
Topics: 2-Aminopurine; Acquired Immunodeficiency Syndrome; Acyclovir; Administration, Oral; Adult; Antiviral | 2002 |
[Genital herpes: epidemiology, transmission, clinic, asymptomatic viral excretion, impact on other sexually transmitted diseases, prevention, and treatment].
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Drug Therapy, Combination; Famciclovir; Female; France; | 2002 |
Antiviral agents: Non-antiretroviral [correction of Nonantiviral] drugs.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Chickenpox; Cytomegalovirus Infections; Famciclovir; Fos | 2002 |
Challenges in genital herpes simplex virus management.
Topics: 2-Aminopurine; Acyclovir; Antibodies, Viral; Antiviral Agents; Condoms; Counseling; Famciclovir; Fem | 2002 |
Progress in meeting today's demands in genital herpes: an overview of current management.
Topics: 2-Aminopurine; Acute Disease; Acyclovir; Adult; AIDS-Related Opportunistic Infections; Antibodies, V | 2002 |
Recurrent genital herpes treatments and their impact on quality of life.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Drugs, Investigational; Famciclovir; Herpes Genitalis; H | 2003 |
[Prophylaxis and treatment of herpes in women].
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Famciclovir; Female; Herpes Genitalis; Herpes Simplex; H | 2003 |
Antiviral treatment of genital herpes.
Topics: 2-Aminopurine; Acyclovir; Administration, Oral; Antiviral Agents; Famciclovir; Herpes Genitalis; Hum | 2004 |
Recent clinical experience with famciclovir--a "third generation" nucleoside prodrug.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Biological Availability; Clinical Trials as Topic; Famci | 2004 |
Is viral shedding a surrogate marker for transmission of genital herpes? A discussion document.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Biomarkers; Famciclovir; Herpes Genitalis; Humans; Valac | 2004 |
Genital herpes.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Cesarean Section; Condoms; Famciclovir; Female; Herpes G | 2005 |
Genital herpes: antiviral therapy for symptom relief and prevention of transmission.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Clinical Trials as Topic; Famciclovir; Female; Herpes Ge | 2006 |
[Suppressive therapy for genital herpes simplex virus infections].
Topics: 2-Aminopurine; Acyclovir; Antibodies, Viral; Antiviral Agents; Biomarkers; Enzyme-Linked Immunosorbe | 2006 |
Genital herpes.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Cesarean Section; Condoms; Famciclovir; Female; Herpes G | 2005 |
Single-day therapy for recurrent genital herpes.
Topics: 2-Aminopurine; Antiviral Agents; Dose-Response Relationship, Drug; Famciclovir; Herpes Genitalis; Hu | 2006 |
Single-day therapy: an expert opinion on a recent development for the episodic treatment of recurrent genital herpes.
Topics: 2-Aminopurine; Antiviral Agents; Drug Administration Schedule; Famciclovir; Herpes Genitalis; Humans | 2007 |
Famciclovir for the treatment of recurrent genital herpes: a clinical and pharmacological perspective.
Topics: 2-Aminopurine; Animals; Famciclovir; Herpes Genitalis; Humans; Secondary Prevention | 2006 |
Famciclovir: a review of its use in herpes zoster and genital and orolabial herpes.
Topics: 2-Aminopurine; Animals; Antiviral Agents; Famciclovir; Herpes Genitalis; Herpes Labialis; Herpes Zos | 2006 |
A meta-analysis to assess the efficacy of oral antiviral treatment to prevent genital herpes outbreaks.
Topics: 2-Aminopurine; Acyclovir; Administration, Oral; Antiviral Agents; Disease Outbreaks; Drug Administra | 2007 |
Has episodic treatment of recurrent genital herpes come of age?
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Drug Administration Schedule; Famciclovir; Herpes Genita | 2007 |
Famciclovir for cutaneous herpesvirus infections: an update and review of new single-day dosing indications.
Topics: 2-Aminopurine; Administration, Oral; Antiviral Agents; Drug Administration Schedule; Famciclovir; He | 2007 |
The continuing evolution of antiviral therapy for recurrent genital herpes: 1-day patient-initiated treatment with famciclovir.
Topics: 2-Aminopurine; Antiviral Agents; Famciclovir; Female; Herpes Genitalis; Herpesvirus 2, Human; Humans | 2007 |
Famciclovir. A review of its pharmacological properties and therapeutic efficacy in herpesvirus infections.
Topics: 2-Aminopurine; Absorption; Administration, Oral; Aging; Antiviral Agents; Controlled Clinical Trials | 1995 |
Famciclovir: review of clinical efficacy and safety.
Topics: 2-Aminopurine; Animals; Antiviral Agents; Drug Resistance, Microbial; Famciclovir; Hepatitis B; Herp | 1996 |
Use of penciclovir and famciclovir in the management of genital herpes.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Famciclovir; Guanine; Herpes Genitalis; Humans; Recurren | 1996 |
Genital herpes simplex virus and its treatment: focus on famciclovir.
Topics: 2-Aminopurine; Antiviral Agents; Famciclovir; Herpes Genitalis; Humans; Recurrence | 1996 |
Developments in the antiviral treatment of genital herpes.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Child; Famciclovir; Female; Herpes Genitalis; Humans; Hy | 1995 |
Antiviral therapy of herpes simplex and varicella-zoster virus infections.
Topics: 2-Aminopurine; Acyclovir; Administration, Oral; Antiviral Agents; Arabinofuranosyluracil; Bromodeoxy | 1997 |
A review of famciclovir in the management of genital herpes.
Topics: 2-Aminopurine; Antiviral Agents; Famciclovir; Female; Herpes Genitalis; Herpesvirus 2, Human; Humans | 1998 |
Famciclovir. Discovery and development of a novel antiherpesvirus agent.
Topics: 2-Aminopurine; Animals; Antiviral Agents; Biological Availability; Famciclovir; Herpes Genitalis; He | 1998 |
Update on drugs for herpes zoster and genital herpes.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Famciclovir; Herpes Genitalis; Herpes Zoster; Humans; Pr | 1998 |
Famciclovir/penciclovir.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Famciclovir; Guanine; Herpes Genitalis; Herpes Labialis; | 1999 |
Treatment of common cutaneous herpes simplex virus infections.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Chronic Disease; Diagnosis, Differential; Drug Costs; Fa | 2000 |
Recent advances in management of genital herpes.
Topics: 2-Aminopurine; Acyclovir; Adolescent; Adult; Antiviral Agents; Blotting, Western; Child; Enzyme-Link | 2000 |
Improving the care of patients with genital herpes.
Topics: 2-Aminopurine; Acyclovir; Adult; Antiviral Agents; Cesarean Section; Drug Administration Schedule; F | 2000 |
Current recommendations for the treatment of genital herpes.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Drug Resistance, Microbial; Famciclovir; Female; Herpes | 2000 |
Genital herpes simplex virus infection in the adolescent: special considerations for management.
Topics: 2-Aminopurine; Acyclovir; Adolescent; Antiviral Agents; Complementary Therapies; Famciclovir; Female | 2002 |
20 trials available for brl 42810 and Genital Herpes
Article | Year |
---|---|
Famciclovir treatment options for patients with frequent outbreaks of recurrent genital herpes: the RELIEF trial.
Topics: 2-Aminopurine; Adolescent; Adult; Aged; Antiviral Agents; Famciclovir; Female; Herpes Genitalis; Her | 2008 |
Single-day, patient-initiated famciclovir therapy versus 3-day valacyclovir regimen for recurrent genital herpes: a randomized, double-blind, comparative trial.
Topics: 2-Aminopurine; Acyclovir; Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Double-Blind | 2008 |
2-day versus 5-day famciclovir as treatment of recurrences of genital herpes: results of the FaST study.
Topics: 2-Aminopurine; Administration, Oral; Adult; Antiviral Agents; Dose-Response Relationship, Drug; Doub | 2008 |
Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance.
Topics: 2-Aminopurine; Antiviral Agents; Drug Resistance, Viral; Famciclovir; Herpes Genitalis; Humans; Recu | 2009 |
One-day famciclovir vs. placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients.
Topics: 2-Aminopurine; Adolescent; Adult; Aged; Antiviral Agents; Black People; Double-Blind Method; Famcicl | 2010 |
Famciclovir suppression of asymptomatic and symptomatic recurrent anogenital herpes simplex virus shedding in women: a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single-center trial.
Topics: 2-Aminopurine; Adult; Antiviral Agents; Dose-Response Relationship, Drug; Double-Blind Method; Famci | 2004 |
Clinic-initiated, twice-daily oral famciclovir for treatment of recurrent genital herpes: a randomized, double-blind, controlled trial.
Topics: 2-Aminopurine; Adult; Aged; Antiviral Agents; Dose-Response Relationship, Drug; Double-Blind Method; | 2005 |
Single-day, patient-initiated famciclovir therapy for recurrent genital herpes: a randomized, double-blind, placebo-controlled trial.
Topics: 2-Aminopurine; Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Double-Blind Method; Fa | 2006 |
Comparative efficacy of famciclovir and valacyclovir for suppression of recurrent genital herpes and viral shedding.
Topics: 2-Aminopurine; Acyclovir; Adult; Antiviral Agents; Double-Blind Method; Drug Administration Schedule | 2006 |
Single-day famciclovir therapy for recurrent genital herpes.
Topics: 2-Aminopurine; Administration, Oral; Antiviral Agents; Famciclovir; Herpes Genitalis; Humans; Recurr | 2006 |
Single-day therapy for recurrent genital herpes.
Topics: 2-Aminopurine; Antiviral Agents; Dose-Response Relationship, Drug; Famciclovir; Herpes Genitalis; Hu | 2006 |
Famciclovir reduces viral mucosal shedding in HSV-seropositive persons.
Topics: 2-Aminopurine; Adolescent; Adult; Aged; Antiviral Agents; Cross-Over Studies; DNA, Viral; Double-Bli | 2007 |
Safety of famciclovir in patients with herpes zoster and genital herpes.
Topics: 2-Aminopurine; Adult; Aged; Antiviral Agents; Double-Blind Method; Famciclovir; Female; Herpes Genit | 1994 |
Patient-initiated, twice-daily oral famciclovir for early recurrent genital herpes. A randomized, double-blind multicenter trial. Canadian Famciclovir Study Group.
Topics: 2-Aminopurine; Administration, Oral; Adult; Antiviral Agents; Double-Blind Method; Drug Administrati | 1996 |
Detection of viral DNA to evaluate outcome of antiviral treatment of patients with recurrent genital herpes.
Topics: 2-Aminopurine; Antiviral Agents; DNA, Viral; Famciclovir; Herpes Genitalis; Humans; Polymerase Chain | 1996 |
Oral famciclovir for suppression of recurrent genital herpes simplex virus infection in women. A multicenter, double-blind, placebo-controlled trial. Collaborative Famciclovir Genital Herpes Research Group.
Topics: 2-Aminopurine; Acyclovir; Administration, Oral; Adult; Antigen-Antibody Complex; Antiviral Agents; D | 1997 |
Oral famciclovir for the suppression of recurrent genital herpes: a randomized controlled trial. Collaborative Famciclovir Genital Herpes Research Group.
Topics: 2-Aminopurine; Administration, Oral; Adult; Aged; Antiviral Agents; Double-Blind Method; Famciclovir | 1998 |
[Expensive long-term care with virustatic drugs frequently reduces herpes genitalis episodes].
Topics: 2-Aminopurine; Adult; Antiviral Agents; Cost-Benefit Analysis; Double-Blind Method; Drug Costs; Famc | 1999 |
Famciclovir vs. aciclovir in immunocompetent patients with recurrent genital herpes infections: a parallel-groups, randomized, double-blind clinical trial.
Topics: 2-Aminopurine; Acyclovir; Adult; Aged; Aged, 80 and over; Antiviral Agents; Double-Blind Method; Fam | 2001 |
Famciclovir effective in suppressing recurrent genital herpes.
Topics: 2-Aminopurine; Antiviral Agents; Double-Blind Method; Famciclovir; Herpes Genitalis; Humans; Recurre | 1996 |
24 other studies available for brl 42810 and Genital Herpes
Article | Year |
---|---|
Rapid viral expansion and short drug half-life explain the incomplete effectiveness of current herpes simplex virus 2-directed antiviral agents.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Biological Availability; CD8-Positive T-Lymphocytes; Cli | 2013 |
Clinical study in genital herpes: natural Gene-Eden-VIR/Novirin versus acyclovir, valacyclovir, and famciclovir.
Topics: 2-Aminopurine; Acyclovir; Adult; Aged; Aged, 80 and over; Antiviral Agents; Drug Combinations; Famci | 2016 |
Safety of antiviral medication for the treatment of herpes during pregnancy.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Famciclovir; Female; Herpes Genitalis; Humans; Pregnancy | 2011 |
Detailed analysis of mucosal herpes simplex virus-2 replication kinetics with and without antiviral therapy.
Topics: 2-Aminopurine; Acyclovir; Adult; Aged; Antiviral Agents; Famciclovir; Female; Genitalia; Herpes Geni | 2011 |
[Treatment of genital herpes].
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Famciclovir; Female; Herpes Genitalis; Herpesvirus 1, Hu | 2001 |
Chronic erosive herpes simplex virus infection of the penis in a human immunodeficiency virus-positive man, treated with imiquimod and famciclovir.
Topics: 2-Aminopurine; Adult; AIDS-Related Opportunistic Infections; Aminoquinolines; Antiviral Agents; Drug | 2002 |
[Clinical and epidemiological aspects and current recommendations on treatment of genital herpes].
Topics: 2-Aminopurine; Acyclovir; Amantadine; Antiviral Agents; Famciclovir; Female; Health Planning Guideli | 2002 |
ACOG practice bulletin: Clinical management guidelines for obstetrician-gynecologists, number 57, November 2004. Gynecologic herpes simplex virus infections.
Topics: 2-Aminopurine; Acyclovir; Adult; Antiviral Agents; Famciclovir; Female; Herpes Genitalis; Herpesviru | 2004 |
Antiviral treatment of genital herpes.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Drugs, Generic; Famciclovir; Herpes Genitalis; Humans; V | 2004 |
Are the antiherpes nucleosides really all the same?
Topics: 2-Aminopurine; Acyclovir; Animals; Antiviral Agents; Famciclovir; Herpes Genitalis; Humans; Nucleosi | 2006 |
Recommendations for short-course therapies in herpes genitalis and herpes labialis.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Drug Administration Schedule; Education; Famciclovir; He | 2007 |
Oral famciclovir for recurrent genital herpes.
Topics: 2-Aminopurine; Acute Disease; Adult; Antiviral Agents; Double-Blind Method; Famciclovir; Herpes Geni | 1996 |
Famciclovir for genital herpes.
Topics: 2-Aminopurine; Antiviral Agents; Famciclovir; Herpes Genitalis; Humans; Prodrugs | 1997 |
Therapy for genital herpes in immunocompromised patients: a national survey. The Herpes Simplex Advisory Panel.
Topics: 2-Aminopurine; Acyclovir; AIDS-Related Opportunistic Infections; Antiviral Agents; Drug Resistance, | 1997 |
Long-term suppression of genital herpes.
Topics: 2-Aminopurine; Antiviral Agents; Famciclovir; Herpes Genitalis; Humans | 1998 |
Persistence of infectious herpes simplex virus type 2 in the nervous system in mice after antiviral chemotherapy.
Topics: 2-Aminopurine; Acyclovir; Animals; Antiviral Agents; Brain Stem; Ear; Famciclovir; Female; Herpes Ge | 2000 |
[Herpes genitalis].
Topics: 2-Aminopurine; Acyclovir; Adult; Antiviral Agents; Famciclovir; Female; Herpes Genitalis; Humans; Ma | 1999 |
National guideline for the management of genital herpes. Clinical Effectiveness Group (Association of Genitourinary Medicine and the Medical Society for the Study of Venereal Diseases).
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Famciclovir; Female; Herpes Genitalis; Herpesvirus 1, Hu | 1999 |
Update on antiviral therapy for genital herpes infection.
Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Famciclovir; Female; Herpes Genitalis; Herpes Simplex; H | 2000 |
Famvir effective in preventing genital herpes recurrences in people with HIV.
Topics: 2-Aminopurine; Antiviral Agents; Famciclovir; Herpes Genitalis; HIV Infections; Humans | 1999 |
Drug effective against herpes.
Topics: 2-Aminopurine; AIDS-Related Opportunistic Infections; Famciclovir; Herpes Genitalis; Humans; Recurre | 1996 |
Herpes study and resources.
Topics: 2-Aminopurine; Acyclovir; Adult; Antiviral Agents; Biopolymers; Catechin; Clinical Trials as Topic; | 1997 |
Herpes drug suppresses HSV in people with HIV.
Topics: 2-Aminopurine; Antiviral Agents; CD4 Lymphocyte Count; Drug Approval; Famciclovir; Female; Herpes Ge | 1999 |
Famiciclovir therapy (famvir) for herpes simplex and herpes zoster infections.
Topics: 2-Aminopurine; Antiviral Agents; Famciclovir; Herpes Genitalis; Herpes Zoster; Humans | 2001 |