2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes: Results of the FaST study

Neil Bodsworth, Mark Bloch, Anna McNulty, Ian Denham, Nicholas Doong, Sylvie Trottier, Michael Adena, Mary Ann Bonney, James Agnew, I. Abdurahman, A. Ajam, R. Alexander, A. Aung, S. Barry, B. Becker, M. Belbin, C. Bishop, F. Bisshop, C. Bourne, T. BrettK. Brown, A. Butler, C. Carmody, D. Chan, J. Chuah, D. Conway, C. Daly, S. Davies, C. Davis, B. Davis, N. Dever, B. Donovan, D. Eisen, C. Eliades, B. Elisha, C. Fairley, A. Feiglin, A. Freeman, V. Furner, S. Garland, W. Genn, J. Giannakopoulos, F. Glass, J. Gold, J. Goswami, A. Gowers, J. Grech, P. Hackney, B. Hanson, K. Hartnell, C. Harvey, M. Hasan, S. Hawkins, S. Heley, D. Herbst, C. Hespe, M. Irlicht, A. Isaacs, L. Katahanas, M. Kelly, P. Komarowski, G. Kostic, M. Kozminsky, K. Lagios, D. Lee, P. Lewis, T. Liang, H. Lyttle, H. MacKellar-Michelmore, H. MacLeod, L. Marsh, L. Marshall, J. McCloskey, D. McCurdy, P. McEvoy, R. McFarlane, P. McKeegan, M. McMurchie, K. McNamee, N. Medland, A. Menon, C. Meyerowitz, W. Michaels, M. Mobbs, A. Montague, N. Nicola, C. Nurcombe, C. O'Connor, C. Ooi, O. Ostrowskyl, M. O'Sullivan, L. Owen, K. Papp, J. Patten, D. Panopoulous, C. Pell, D. Quan, J. Quin, D. Rhodes, S. Rowles, D. Rowling, S. Ryan, J. Sasadeusz, J. Shanahan, P. Sherwin, Y. Sim, C. Singer, D. Sloan, D. Smith, L. Smyth, T. Staunton-Smith, E. Stepankova, N. Stephens, J. Steward, M. Szwarcberg, R. Taylor, K. Taylor, B. Tee, G. Thind, B. Towner, R. Waddell, J. Webster, J. White, G. Wilcox, H. Williams, E. Wils, C. Workman, R. Wright, W. Yeong, T. Zaverdinos, F. Aoki, A. Brassard, F. Diaz-Mitoma, C. Lynde, S. Shafran, K. Adolphe, S. Agrawal, A. Allen, B. Bourke, P. Braybook, L. Corradin, S. Dinning, S. Doughty, H. Gagnon, M. Giourouki, W. Goodyear, N. Houlihan, J. Hudson, H. Kent, P. Kenchington, C. Lillie, C. Martin, R. Nagel, C. Pollard, I. Prone, M. Quezdea, V. Rees, R. Richardson, M. Ryan, J. Sarangapany, T. Schmidt, J. Silvers, T. Toohey, S. Margie, V. Jaar, D. Hurford, S. McKenna, D. Meads, M. Binette, J. Cole, G. Deutsch, B. Frost, A. Giagodi, S. Gray, M. Kirkman, I. Kowalczyk, B. Plouffe

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)219-225
Number of pages7
JournalSexual Health
Volume5
Issue number3
DOIs
StatePublished - Jan 1 2008

Fingerprint

Herpes Genitalis
Recurrence
Back Pain
Headache
Therapeutics
Dizziness
Random Allocation
Checklist
Nausea
Abdominal Pain
Fatigue
Disease Outbreaks
Diarrhea
Vaginal Discharge
famciclovir
Dysuria
Pain
Defecation
Virus Diseases
Pruritus

All Science Journal Classification (ASJC) codes

  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Bodsworth, N., Bloch, M., McNulty, A., Denham, I., Doong, N., Trottier, S., ... Plouffe, B. (2008). 2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes: Results of the FaST study. Sexual Health, 5(3), 219-225. https://doi.org/10.1071/SH08013
Bodsworth, Neil ; Bloch, Mark ; McNulty, Anna ; Denham, Ian ; Doong, Nicholas ; Trottier, Sylvie ; Adena, Michael ; Bonney, Mary Ann ; Agnew, James ; Abdurahman, I. ; Ajam, A. ; Alexander, R. ; Aung, A. ; Barry, S. ; Becker, B. ; Belbin, M. ; Bishop, C. ; Bisshop, F. ; Bourne, C. ; Brett, T. ; Brown, K. ; Butler, A. ; Carmody, C. ; Chan, D. ; Chuah, J. ; Conway, D. ; Daly, C. ; Davies, S. ; Davis, C. ; Davis, B. ; Dever, N. ; Donovan, B. ; Eisen, D. ; Eliades, C. ; Elisha, B. ; Fairley, C. ; Feiglin, A. ; Freeman, A. ; Furner, V. ; Garland, S. ; Genn, W. ; Giannakopoulos, J. ; Glass, F. ; Gold, J. ; Goswami, J. ; Gowers, A. ; Grech, J. ; Hackney, P. ; Hanson, B. ; Hartnell, K. ; Harvey, C. ; Hasan, M. ; Hawkins, S. ; Heley, S. ; Herbst, D. ; Hespe, C. ; Irlicht, M. ; Isaacs, A. ; Katahanas, L. ; Kelly, M. ; Komarowski, P. ; Kostic, G. ; Kozminsky, M. ; Lagios, K. ; Lee, D. ; Lewis, P. ; Liang, T. ; Lyttle, H. ; MacKellar-Michelmore, H. ; MacLeod, H. ; Marsh, L. ; Marshall, L. ; McCloskey, J. ; McCurdy, D. ; McEvoy, P. ; McFarlane, R. ; McKeegan, P. ; McMurchie, M. ; McNamee, K. ; Medland, N. ; Menon, A. ; Meyerowitz, C. ; Michaels, W. ; Mobbs, M. ; Montague, A. ; Nicola, N. ; Nurcombe, C. ; O'Connor, C. ; Ooi, C. ; Ostrowskyl, O. ; O'Sullivan, M. ; Owen, L. ; Papp, K. ; Patten, J. ; Panopoulous, D. ; Pell, C. ; Quan, D. ; Quin, J. ; Rhodes, D. ; Rowles, S. ; Rowling, D. ; Ryan, S. ; Sasadeusz, J. ; Shanahan, J. ; Sherwin, P. ; Sim, Y. ; Singer, C. ; Sloan, D. ; Smith, D. ; Smyth, L. ; Staunton-Smith, T. ; Stepankova, E. ; Stephens, N. ; Steward, J. ; Szwarcberg, M. ; Taylor, R. ; Taylor, K. ; Tee, B. ; Thind, G. ; Towner, B. ; Waddell, R. ; Webster, J. ; White, J. ; Wilcox, G. ; Williams, H. ; Wils, E. ; Workman, C. ; Wright, R. ; Yeong, W. ; Zaverdinos, T. ; Aoki, F. ; Brassard, A. ; Diaz-Mitoma, F. ; Lynde, C. ; Shafran, S. ; Adolphe, K. ; Agrawal, S. ; Allen, A. ; Bourke, B. ; Braybook, P. ; Corradin, L. ; Dinning, S. ; Doughty, S. ; Gagnon, H. ; Giourouki, M. ; Goodyear, W. ; Houlihan, N. ; Hudson, J. ; Kent, H. ; Kenchington, P. ; Lillie, C. ; Martin, C. ; Nagel, R. ; Pollard, C. ; Prone, I. ; Quezdea, M. ; Rees, V. ; Richardson, R. ; Ryan, M. ; Sarangapany, J. ; Schmidt, T. ; Silvers, J. ; Toohey, T. ; Margie, S. ; Jaar, V. ; Hurford, D. ; McKenna, S. ; Meads, D. ; Binette, M. ; Cole, J. ; Deutsch, G. ; Frost, B. ; Giagodi, A. ; Gray, S. ; Kirkman, M. ; Kowalczyk, I. ; Plouffe, B. / 2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes : Results of the FaST study. In: Sexual Health. 2008 ; Vol. 5, No. 3. pp. 219-225.
@article{6d6f873db4354a4b91402cea42ff1e67,
title = "2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes: Results of the FaST study",
abstract = "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.",
author = "Neil Bodsworth and Mark Bloch and Anna McNulty and Ian Denham and Nicholas Doong and Sylvie Trottier and Michael Adena and Bonney, {Mary Ann} and James Agnew and I. Abdurahman and A. Ajam and R. Alexander and A. Aung and S. Barry and B. Becker and M. Belbin and C. Bishop and F. Bisshop and C. Bourne and T. Brett and K. Brown and A. Butler and C. Carmody and D. Chan and J. Chuah and D. Conway and C. Daly and S. Davies and C. Davis and B. Davis and N. Dever and B. Donovan and D. Eisen and C. Eliades and B. Elisha and C. Fairley and A. Feiglin and A. Freeman and V. Furner and S. Garland and W. Genn and J. Giannakopoulos and F. Glass and J. Gold and J. Goswami and A. Gowers and J. Grech and P. Hackney and B. Hanson and K. Hartnell and C. Harvey and M. Hasan and S. Hawkins and S. Heley and D. Herbst and C. Hespe and M. Irlicht and A. Isaacs and L. Katahanas and M. Kelly and P. Komarowski and G. Kostic and M. Kozminsky and K. Lagios and D. Lee and P. Lewis and T. Liang and H. Lyttle and H. MacKellar-Michelmore and H. MacLeod and L. Marsh and L. Marshall and J. McCloskey and D. McCurdy and P. McEvoy and R. McFarlane and P. McKeegan and M. McMurchie and K. McNamee and N. Medland and A. Menon and C. Meyerowitz and W. Michaels and M. Mobbs and A. Montague and N. Nicola and C. Nurcombe and C. O'Connor and C. Ooi and O. Ostrowskyl and M. O'Sullivan and L. Owen and K. Papp and J. Patten and D. Panopoulous and C. Pell and D. Quan and J. Quin and D. Rhodes and S. Rowles and D. Rowling and S. Ryan and J. Sasadeusz and J. Shanahan and P. Sherwin and Y. Sim and C. Singer and D. Sloan and D. Smith and L. Smyth and T. Staunton-Smith and E. Stepankova and N. Stephens and J. Steward and M. Szwarcberg and R. Taylor and K. Taylor and B. Tee and G. Thind and B. Towner and R. Waddell and J. Webster and J. White and G. Wilcox and H. Williams and E. Wils and C. Workman and R. Wright and W. Yeong and T. Zaverdinos and F. Aoki and A. Brassard and F. Diaz-Mitoma and C. Lynde and S. Shafran and K. Adolphe and S. Agrawal and A. Allen and B. Bourke and P. Braybook and L. Corradin and S. Dinning and S. Doughty and H. Gagnon and M. Giourouki and W. Goodyear and N. Houlihan and J. Hudson and H. Kent and P. Kenchington and C. Lillie and C. Martin and R. Nagel and C. Pollard and I. Prone and M. Quezdea and V. Rees and R. Richardson and M. Ryan and J. Sarangapany and T. Schmidt and J. Silvers and T. Toohey and S. Margie and V. Jaar and D. Hurford and S. McKenna and D. Meads and M. Binette and J. Cole and G. Deutsch and B. Frost and A. Giagodi and S. Gray and M. Kirkman and I. Kowalczyk and B. Plouffe",
year = "2008",
month = "1",
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doi = "10.1071/SH08013",
language = "English (US)",
volume = "5",
pages = "219--225",
journal = "Sexual Health",
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Bodsworth, N, Bloch, M, McNulty, A, Denham, I, Doong, N, Trottier, S, Adena, M, Bonney, MA, Agnew, J, Abdurahman, I, Ajam, A, Alexander, R, Aung, A, Barry, S, Becker, B, Belbin, M, Bishop, C, Bisshop, F, Bourne, C, Brett, T, Brown, K, Butler, A, Carmody, C, Chan, D, Chuah, J, Conway, D, Daly, C, Davies, S, Davis, C, Davis, B, Dever, N, Donovan, B, Eisen, D, Eliades, C, Elisha, B, Fairley, C, Feiglin, A, Freeman, A, Furner, V, Garland, S, Genn, W, Giannakopoulos, J, Glass, F, Gold, J, Goswami, J, Gowers, A, Grech, J, Hackney, P, Hanson, B, Hartnell, K, Harvey, C, Hasan, M, Hawkins, S, Heley, S, Herbst, D, Hespe, C, Irlicht, M, Isaacs, A, Katahanas, L, Kelly, M, Komarowski, P, Kostic, G, Kozminsky, M, Lagios, K, Lee, D, Lewis, P, Liang, T, Lyttle, H, MacKellar-Michelmore, H, MacLeod, H, Marsh, L, Marshall, L, McCloskey, J, McCurdy, D, McEvoy, P, McFarlane, R, McKeegan, P, McMurchie, M, McNamee, K, Medland, N, Menon, A, Meyerowitz, C, Michaels, W, Mobbs, M, Montague, A, Nicola, N, Nurcombe, C, O'Connor, C, Ooi, C, Ostrowskyl, O, O'Sullivan, M, Owen, L, Papp, K, Patten, J, Panopoulous, D, Pell, C, Quan, D, Quin, J, Rhodes, D, Rowles, S, Rowling, D, Ryan, S, Sasadeusz, J, Shanahan, J, Sherwin, P, Sim, Y, Singer, C, Sloan, D, Smith, D, Smyth, L, Staunton-Smith, T, Stepankova, E, Stephens, N, Steward, J, Szwarcberg, M, Taylor, R, Taylor, K, Tee, B, Thind, G, Towner, B, Waddell, R, Webster, J, White, J, Wilcox, G, Williams, H, Wils, E, Workman, C, Wright, R, Yeong, W, Zaverdinos, T, Aoki, F, Brassard, A, Diaz-Mitoma, F, Lynde, C, Shafran, S, Adolphe, K, Agrawal, S, Allen, A, Bourke, B, Braybook, P, Corradin, L, Dinning, S, Doughty, S, Gagnon, H, Giourouki, M, Goodyear, W, Houlihan, N, Hudson, J, Kent, H, Kenchington, P, Lillie, C, Martin, C, Nagel, R, Pollard, C, Prone, I, Quezdea, M, Rees, V, Richardson, R, Ryan, M, Sarangapany, J, Schmidt, T, Silvers, J, Toohey, T, Margie, S, Jaar, V, Hurford, D, McKenna, S, Meads, D, Binette, M, Cole, J, Deutsch, G, Frost, B, Giagodi, A, Gray, S, Kirkman, M, Kowalczyk, I & Plouffe, B 2008, '2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes: Results of the FaST study', Sexual Health, vol. 5, no. 3, pp. 219-225. https://doi.org/10.1071/SH08013

2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes : Results of the FaST study. / Bodsworth, Neil; Bloch, Mark; McNulty, Anna; Denham, Ian; Doong, Nicholas; Trottier, Sylvie; Adena, Michael; Bonney, Mary Ann; Agnew, James; Abdurahman, I.; Ajam, A.; Alexander, R.; Aung, A.; Barry, S.; Becker, B.; Belbin, M.; Bishop, C.; Bisshop, F.; Bourne, C.; Brett, T.; Brown, K.; Butler, A.; Carmody, C.; Chan, D.; Chuah, J.; Conway, D.; Daly, C.; Davies, S.; Davis, C.; Davis, B.; Dever, N.; Donovan, B.; Eisen, D.; Eliades, C.; Elisha, B.; Fairley, C.; Feiglin, A.; Freeman, A.; Furner, V.; Garland, S.; Genn, W.; Giannakopoulos, J.; Glass, F.; Gold, J.; Goswami, J.; Gowers, A.; Grech, J.; Hackney, P.; Hanson, B.; Hartnell, K.; Harvey, C.; Hasan, M.; Hawkins, S.; Heley, S.; Herbst, D.; Hespe, C.; Irlicht, M.; Isaacs, A.; Katahanas, L.; Kelly, M.; Komarowski, P.; Kostic, G.; Kozminsky, M.; Lagios, K.; Lee, D.; Lewis, P.; Liang, T.; Lyttle, H.; MacKellar-Michelmore, H.; MacLeod, H.; Marsh, L.; Marshall, L.; McCloskey, J.; McCurdy, D.; McEvoy, P.; McFarlane, R.; McKeegan, P.; McMurchie, M.; McNamee, K.; Medland, N.; Menon, A.; Meyerowitz, C.; Michaels, W.; Mobbs, M.; Montague, A.; Nicola, N.; Nurcombe, C.; O'Connor, C.; Ooi, C.; Ostrowskyl, O.; O'Sullivan, M.; Owen, L.; Papp, K.; Patten, J.; Panopoulous, D.; Pell, C.; Quan, D.; Quin, J.; Rhodes, D.; Rowles, S.; Rowling, D.; Ryan, S.; Sasadeusz, J.; Shanahan, J.; Sherwin, P.; Sim, Y.; Singer, C.; Sloan, D.; Smith, D.; Smyth, L.; Staunton-Smith, T.; Stepankova, E.; Stephens, N.; Steward, J.; Szwarcberg, M.; Taylor, R.; Taylor, K.; Tee, B.; Thind, G.; Towner, B.; Waddell, R.; Webster, J.; White, J.; Wilcox, G.; Williams, H.; Wils, E.; Workman, C.; Wright, R.; Yeong, W.; Zaverdinos, T.; Aoki, F.; Brassard, A.; Diaz-Mitoma, F.; Lynde, C.; Shafran, S.; Adolphe, K.; Agrawal, S.; Allen, A.; Bourke, B.; Braybook, P.; Corradin, L.; Dinning, S.; Doughty, S.; Gagnon, H.; Giourouki, M.; Goodyear, W.; Houlihan, N.; Hudson, J.; Kent, H.; Kenchington, P.; Lillie, C.; Martin, C.; Nagel, R.; Pollard, C.; Prone, I.; Quezdea, M.; Rees, V.; Richardson, R.; Ryan, M.; Sarangapany, J.; Schmidt, T.; Silvers, J.; Toohey, T.; Margie, S.; Jaar, V.; Hurford, D.; McKenna, S.; Meads, D.; Binette, M.; Cole, J.; Deutsch, G.; Frost, B.; Giagodi, A.; Gray, S.; Kirkman, M.; Kowalczyk, I.; Plouffe, B.

In: Sexual Health, Vol. 5, No. 3, 01.01.2008, p. 219-225.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes

T2 - Results of the FaST study

AU - Bodsworth, Neil

AU - Bloch, Mark

AU - McNulty, Anna

AU - Denham, Ian

AU - Doong, Nicholas

AU - Trottier, Sylvie

AU - Adena, Michael

AU - Bonney, Mary Ann

AU - Agnew, James

AU - Abdurahman, I.

AU - Ajam, A.

AU - Alexander, R.

AU - Aung, A.

AU - Barry, S.

AU - Becker, B.

AU - Belbin, M.

AU - Bishop, C.

AU - Bisshop, F.

AU - Bourne, C.

AU - Brett, T.

AU - Brown, K.

AU - Butler, A.

AU - Carmody, C.

AU - Chan, D.

AU - Chuah, J.

AU - Conway, D.

AU - Daly, C.

AU - Davies, S.

AU - Davis, C.

AU - Davis, B.

AU - Dever, N.

AU - Donovan, B.

AU - Eisen, D.

AU - Eliades, C.

AU - Elisha, B.

AU - Fairley, C.

AU - Feiglin, A.

AU - Freeman, A.

AU - Furner, V.

AU - Garland, S.

AU - Genn, W.

AU - Giannakopoulos, J.

AU - Glass, F.

AU - Gold, J.

AU - Goswami, J.

AU - Gowers, A.

AU - Grech, J.

AU - Hackney, P.

AU - Hanson, B.

AU - Hartnell, K.

AU - Harvey, C.

AU - Hasan, M.

AU - Hawkins, S.

AU - Heley, S.

AU - Herbst, D.

AU - Hespe, C.

AU - Irlicht, M.

AU - Isaacs, A.

AU - Katahanas, L.

AU - Kelly, M.

AU - Komarowski, P.

AU - Kostic, G.

AU - Kozminsky, M.

AU - Lagios, K.

AU - Lee, D.

AU - Lewis, P.

AU - Liang, T.

AU - Lyttle, H.

AU - MacKellar-Michelmore, H.

AU - MacLeod, H.

AU - Marsh, L.

AU - Marshall, L.

AU - McCloskey, J.

AU - McCurdy, D.

AU - McEvoy, P.

AU - McFarlane, R.

AU - McKeegan, P.

AU - McMurchie, M.

AU - McNamee, K.

AU - Medland, N.

AU - Menon, A.

AU - Meyerowitz, C.

AU - Michaels, W.

AU - Mobbs, M.

AU - Montague, A.

AU - Nicola, N.

AU - Nurcombe, C.

AU - O'Connor, C.

AU - Ooi, C.

AU - Ostrowskyl, O.

AU - O'Sullivan, M.

AU - Owen, L.

AU - Papp, K.

AU - Patten, J.

AU - Panopoulous, D.

AU - Pell, C.

AU - Quan, D.

AU - Quin, J.

AU - Rhodes, D.

AU - Rowles, S.

AU - Rowling, D.

AU - Ryan, S.

AU - Sasadeusz, J.

AU - Shanahan, J.

AU - Sherwin, P.

AU - Sim, Y.

AU - Singer, C.

AU - Sloan, D.

AU - Smith, D.

AU - Smyth, L.

AU - Staunton-Smith, T.

AU - Stepankova, E.

AU - Stephens, N.

AU - Steward, J.

AU - Szwarcberg, M.

AU - Taylor, R.

AU - Taylor, K.

AU - Tee, B.

AU - Thind, G.

AU - Towner, B.

AU - Waddell, R.

AU - Webster, J.

AU - White, J.

AU - Wilcox, G.

AU - Williams, H.

AU - Wils, E.

AU - Workman, C.

AU - Wright, R.

AU - Yeong, W.

AU - Zaverdinos, T.

AU - Aoki, F.

AU - Brassard, A.

AU - Diaz-Mitoma, F.

AU - Lynde, C.

AU - Shafran, S.

AU - Adolphe, K.

AU - Agrawal, S.

AU - Allen, A.

AU - Bourke, B.

AU - Braybook, P.

AU - Corradin, L.

AU - Dinning, S.

AU - Doughty, S.

AU - Gagnon, H.

AU - Giourouki, M.

AU - Goodyear, W.

AU - Houlihan, N.

AU - Hudson, J.

AU - Kent, H.

AU - Kenchington, P.

AU - Lillie, C.

AU - Martin, C.

AU - Nagel, R.

AU - Pollard, C.

AU - Prone, I.

AU - Quezdea, M.

AU - Rees, V.

AU - Richardson, R.

AU - Ryan, M.

AU - Sarangapany, J.

AU - Schmidt, T.

AU - Silvers, J.

AU - Toohey, T.

AU - Margie, S.

AU - Jaar, V.

AU - Hurford, D.

AU - McKenna, S.

AU - Meads, D.

AU - Binette, M.

AU - Cole, J.

AU - Deutsch, G.

AU - Frost, B.

AU - Giagodi, A.

AU - Gray, S.

AU - Kirkman, M.

AU - Kowalczyk, I.

AU - Plouffe, B.

PY - 2008/1/1

Y1 - 2008/1/1

N2 - 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.

AB - 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.

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UR - http://www.scopus.com/inward/citedby.url?scp=49449103180&partnerID=8YFLogxK

U2 - 10.1071/SH08013

DO - 10.1071/SH08013

M3 - Article

C2 - 18771636

AN - SCOPUS:49449103180

VL - 5

SP - 219

EP - 225

JO - Sexual Health

JF - Sexual Health

SN - 1448-5028

IS - 3

ER -

Bodsworth N, Bloch M, McNulty A, Denham I, Doong N, Trottier S et al. 2-Day versus 5-day famciclovir as treatment of recurrences of genital herpes: Results of the FaST study. Sexual Health. 2008 Jan 1;5(3):219-225. https://doi.org/10.1071/SH08013