Effect of Valacyclovir on Viral Shedding in Immunocompetent Patients With Recurrent Herpes Simplex Virus 2 Genital Herpes: A US-Based Randomized, Double-Blind, Placebo-Controlled Clinical Trial
To determine the efficacy of daily suppressive therapy with a 1-g dose of valacyclovir in reducing total (clinical and subclinical) herpes simplex virus 2 (HSV-2) shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes. From June 18, 2004, to Dec...
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| creator | Fife, Kenneth H. Warren, Terri J. Ferrera, R. David Young, Douglas G. Justus, Scott E. Heitman, Catherine K. Burroughs, Scott M. |
| description | To determine the efficacy of daily suppressive therapy with a 1-g dose of valacyclovir in reducing total (clinical and subclinical) herpes simplex virus 2 (HSV-2) shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.
From June 18, 2004, to December 17, 2004, patients from 27 US sites with a history of 6 or more genital herpes recurrences per year were randomized in a 3:1 ratio to receive 1 g/d of valacyclovir or placebo. During the double-blind suppressive therapy, patients were provided with the study drug (500-mg valacyclovir caplets or matching placebo) and instructed to take 2 caplets once daily without regard to meals for 60 days. Daily genital and anal or rectal swabs were self-collected during the 60-day study period for evaluation of HSV-2 viral shedding as determined by quantitative type-specific polymerase chain reaction assay.
One hundred fifty-two patients were randomized into this study, 43 to placebo and 109 to 1 g/d of valacyclovir. A total of 134 completed the study (40 placebo [93%], 94 valacyclovir [86%]), and 18 prematurely withdrew (3 placebo [7%], 15 valacyclovir [14%]). Valacyclovir significantly reduced the percentage of days with total (clinical and subclinical) HSV-2 shedding throughout 60 days compared with placebo. In the intent-to-treat population, a 71% reduction in total shedding (
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| doi_str_mv | 10.4065/81.10.1321 |
| format | Article |
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From June 18, 2004, to December 17, 2004, patients from 27 US sites with a history of 6 or more genital herpes recurrences per year were randomized in a 3:1 ratio to receive 1 g/d of valacyclovir or placebo. During the double-blind suppressive therapy, patients were provided with the study drug (500-mg valacyclovir caplets or matching placebo) and instructed to take 2 caplets once daily without regard to meals for 60 days. Daily genital and anal or rectal swabs were self-collected during the 60-day study period for evaluation of HSV-2 viral shedding as determined by quantitative type-specific polymerase chain reaction assay.
One hundred fifty-two patients were randomized into this study, 43 to placebo and 109 to 1 g/d of valacyclovir. A total of 134 completed the study (40 placebo [93%], 94 valacyclovir [86%]), and 18 prematurely withdrew (3 placebo [7%], 15 valacyclovir [14%]). Valacyclovir significantly reduced the percentage of days with total (clinical and subclinical) HSV-2 shedding throughout 60 days compared with placebo. In the intent-to-treat population, a 71% reduction in total shedding (
P<.001), a 58% reduction in subclinical shedding (
P<.001), and a 64% reduction in clinical shedding (
P=.01) were observed. Valacyclovir was not associated with any significant toxic effects compared with placebo.
This study demonstrated that 1 g/d of valacyclovir administered for 60 days was generally well tolerated and was an effective suppressive therapy that significantly reduced total (clinical and subclinical) HSV-2 shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.</description><identifier>ISSN: 0025-6196</identifier><identifier>EISSN: 1942-5546</identifier><identifier>DOI: 10.4065/81.10.1321</identifier><identifier>PMID: 17036557</identifier><identifier>CODEN: MACPAJ</identifier><language>eng</language><publisher>Rochester, MN: Elsevier Inc</publisher><subject>Acyclovir - adverse effects ; Acyclovir - analogs & derivatives ; Acyclovir - therapeutic use ; Adult ; Antiviral Agents - adverse effects ; Antiviral Agents - therapeutic use ; Biological and medical sciences ; Double-Blind Method ; Female ; General aspects ; Herpes Genitalis - drug therapy ; Herpesvirus 2, Human - drug effects ; Herpesvirus 2, Human - physiology ; Human viral diseases ; Humans ; Infectious diseases ; Male ; Medical sciences ; Middle Aged ; Patient Compliance ; Prodrugs - adverse effects ; Prodrugs - therapeutic use ; Recurrence ; Treatment Outcome ; United States ; Valine - adverse effects ; Valine - analogs & derivatives ; Valine - therapeutic use ; Viral diseases ; Viral diseases of the genital and urinary system ; Virus Shedding - drug effects</subject><ispartof>Mayo Clinic proceedings, 2006-10, Vol.81 (10), p.1321-1327</ispartof><rights>2006 Mayo Foundation for Medical Education and Research</rights><rights>2006 INIST-CNRS</rights><rights>Copyright Mayo Foundation for Medical Education and Research Oct 2006</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c387t-cb29d09d544f88bc845dff0dac7bf03e139b0df33a0530c2772afadacf98a8363</citedby><cites>FETCH-LOGICAL-c387t-cb29d09d544f88bc845dff0dac7bf03e139b0df33a0530c2772afadacf98a8363</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/216867836?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,64385,64389,72469</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18154165$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17036557$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fife, Kenneth H.</creatorcontrib><creatorcontrib>Warren, Terri J.</creatorcontrib><creatorcontrib>Ferrera, R. David</creatorcontrib><creatorcontrib>Young, Douglas G.</creatorcontrib><creatorcontrib>Justus, Scott E.</creatorcontrib><creatorcontrib>Heitman, Catherine K.</creatorcontrib><creatorcontrib>Burroughs, Scott M.</creatorcontrib><title>Effect of Valacyclovir on Viral Shedding in Immunocompetent Patients With Recurrent Herpes Simplex Virus 2 Genital Herpes: A US-Based Randomized, Double-Blind, Placebo-Controlled Clinical Trial</title><title>Mayo Clinic proceedings</title><addtitle>Mayo Clin Proc</addtitle><description>To determine the efficacy of daily suppressive therapy with a 1-g dose of valacyclovir in reducing total (clinical and subclinical) herpes simplex virus 2 (HSV-2) shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.
From June 18, 2004, to December 17, 2004, patients from 27 US sites with a history of 6 or more genital herpes recurrences per year were randomized in a 3:1 ratio to receive 1 g/d of valacyclovir or placebo. During the double-blind suppressive therapy, patients were provided with the study drug (500-mg valacyclovir caplets or matching placebo) and instructed to take 2 caplets once daily without regard to meals for 60 days. Daily genital and anal or rectal swabs were self-collected during the 60-day study period for evaluation of HSV-2 viral shedding as determined by quantitative type-specific polymerase chain reaction assay.
One hundred fifty-two patients were randomized into this study, 43 to placebo and 109 to 1 g/d of valacyclovir. A total of 134 completed the study (40 placebo [93%], 94 valacyclovir [86%]), and 18 prematurely withdrew (3 placebo [7%], 15 valacyclovir [14%]). Valacyclovir significantly reduced the percentage of days with total (clinical and subclinical) HSV-2 shedding throughout 60 days compared with placebo. In the intent-to-treat population, a 71% reduction in total shedding (
P<.001), a 58% reduction in subclinical shedding (
P<.001), and a 64% reduction in clinical shedding (
P=.01) were observed. Valacyclovir was not associated with any significant toxic effects compared with placebo.
This study demonstrated that 1 g/d of valacyclovir administered for 60 days was generally well tolerated and was an effective suppressive therapy that significantly reduced total (clinical and subclinical) HSV-2 shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.</description><subject>Acyclovir - adverse effects</subject><subject>Acyclovir - analogs & derivatives</subject><subject>Acyclovir - therapeutic use</subject><subject>Adult</subject><subject>Antiviral Agents - adverse effects</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>General aspects</subject><subject>Herpes Genitalis - drug therapy</subject><subject>Herpesvirus 2, Human - drug effects</subject><subject>Herpesvirus 2, Human - physiology</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Patient Compliance</subject><subject>Prodrugs - adverse effects</subject><subject>Prodrugs - therapeutic use</subject><subject>Recurrence</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>Valine - adverse effects</subject><subject>Valine - analogs & derivatives</subject><subject>Valine - therapeutic use</subject><subject>Viral diseases</subject><subject>Viral diseases of the genital and urinary system</subject><subject>Virus Shedding - drug effects</subject><issn>0025-6196</issn><issn>1942-5546</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNptkcFu1DAQhi0EokvhwgMgC4kLIq0dx4nDrV1KW6lSq25bjpFjj6krxw52UlHejjfD0a7UC6cZ-__0z4x-hN5TclCRmh8KepBbykr6Aq1oW5UF51X9Eq0IKXlR07beQ29SeiCENG1bvUZ7tCGs5rxZob8nxoCacDD4TjqpnpQLjzbi4PGdjdLhzT1obf1PbD0-H4bZBxWGESbwE76Sk8014R92usfXoOYYl_8ziCMkvLHD6OD3YjQnXOJT8HbKllv5Kz7Ct5viWCbQ-Fp6HQb7B_QX_C3MvYPi2FmfX1d5KehDsQ5-isG5DK-zYlU2uolWurfolZEuwbtd3Ue3309u1mfFxeXp-froolBMNFOh-rLVpNW8qowQvRIV18YQLVXTG8KAsrYn2jAmCWdElU1TSiOzbFohBavZPvq49R1j-DVDmrqHMEefR3YlrUXdbKHPW0jFkFIE043RDjI-dZR0S1idoEu7hJXhDzvHuR9AP6O7dDLwaQfIlO81UXpl0zMnKK9ozTNXbTnI9z9aiF1SORgF2sYcbqeD_d_8fyDXr3M</recordid><startdate>20061001</startdate><enddate>20061001</enddate><creator>Fife, Kenneth H.</creator><creator>Warren, Terri J.</creator><creator>Ferrera, R. 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David</au><au>Young, Douglas G.</au><au>Justus, Scott E.</au><au>Heitman, Catherine K.</au><au>Burroughs, Scott M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Valacyclovir on Viral Shedding in Immunocompetent Patients With Recurrent Herpes Simplex Virus 2 Genital Herpes: A US-Based Randomized, Double-Blind, Placebo-Controlled Clinical Trial</atitle><jtitle>Mayo Clinic proceedings</jtitle><addtitle>Mayo Clin Proc</addtitle><date>2006-10-01</date><risdate>2006</risdate><volume>81</volume><issue>10</issue><spage>1321</spage><epage>1327</epage><pages>1321-1327</pages><issn>0025-6196</issn><eissn>1942-5546</eissn><coden>MACPAJ</coden><abstract>To determine the efficacy of daily suppressive therapy with a 1-g dose of valacyclovir in reducing total (clinical and subclinical) herpes simplex virus 2 (HSV-2) shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.
From June 18, 2004, to December 17, 2004, patients from 27 US sites with a history of 6 or more genital herpes recurrences per year were randomized in a 3:1 ratio to receive 1 g/d of valacyclovir or placebo. During the double-blind suppressive therapy, patients were provided with the study drug (500-mg valacyclovir caplets or matching placebo) and instructed to take 2 caplets once daily without regard to meals for 60 days. Daily genital and anal or rectal swabs were self-collected during the 60-day study period for evaluation of HSV-2 viral shedding as determined by quantitative type-specific polymerase chain reaction assay.
One hundred fifty-two patients were randomized into this study, 43 to placebo and 109 to 1 g/d of valacyclovir. A total of 134 completed the study (40 placebo [93%], 94 valacyclovir [86%]), and 18 prematurely withdrew (3 placebo [7%], 15 valacyclovir [14%]). Valacyclovir significantly reduced the percentage of days with total (clinical and subclinical) HSV-2 shedding throughout 60 days compared with placebo. In the intent-to-treat population, a 71% reduction in total shedding (
P<.001), a 58% reduction in subclinical shedding (
P<.001), and a 64% reduction in clinical shedding (
P=.01) were observed. Valacyclovir was not associated with any significant toxic effects compared with placebo.
This study demonstrated that 1 g/d of valacyclovir administered for 60 days was generally well tolerated and was an effective suppressive therapy that significantly reduced total (clinical and subclinical) HSV-2 shedding compared with placebo in immunocompetent patients diagnosed as having recurrent HSV-2 genital herpes.</abstract><cop>Rochester, MN</cop><pub>Elsevier Inc</pub><pmid>17036557</pmid><doi>10.4065/81.10.1321</doi><tpages>7</tpages></addata></record> |
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| ispartof | Mayo Clinic proceedings, 2006-10, Vol.81 (10), p.1321-1327 |
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| subjects | Acyclovir - adverse effects Acyclovir - analogs & derivatives Acyclovir - therapeutic use Adult Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Biological and medical sciences Double-Blind Method Female General aspects Herpes Genitalis - drug therapy Herpesvirus 2, Human - drug effects Herpesvirus 2, Human - physiology Human viral diseases Humans Infectious diseases Male Medical sciences Middle Aged Patient Compliance Prodrugs - adverse effects Prodrugs - therapeutic use Recurrence Treatment Outcome United States Valine - adverse effects Valine - analogs & derivatives Valine - therapeutic use Viral diseases Viral diseases of the genital and urinary system Virus Shedding - drug effects |
| title | Effect of Valacyclovir on Viral Shedding in Immunocompetent Patients With Recurrent Herpes Simplex Virus 2 Genital Herpes: A US-Based Randomized, Double-Blind, Placebo-Controlled Clinical Trial |
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