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Table 2. Trials of Suppressed Antiviral Therapy in Adolescents and Adults

Study/Year N Population Antiviral/Dose Design Length of Trial Main Outcomes/Results Quality Rating/ Limitations
Corey,33 2004 1,484
2 groups		 Adult heterosexual monogamous couples (1 HSV seropositive partner and 1 HSV seronegative susceptible partner) Oral valacyclovir 500 mg 1 time daily or placebo DB RCT 8 mos
  1. Clinical symptoms of HSV-2 infection developed in 4/743 (0.5%) of treated partners compared to 16/741 (2.2%) of untreated partners (HR, 0.25; 95% CI, 0.08-0.75; P = 0.008).
  2. HSV-2 was observed in 14 (1.9%) of treated partners compared with 27 (3.6%) untreated partners (HR, 0.52; 95% CI, 0.27-0.99; P = 0.04).
  3. HSV DNA using PCR was detected in samples of genital secretions on 2.9% of the days among the HSV-2 treated partners compared with 10.8% of days among untreated partners (P < 0.001).
  4. Viral shedding was detected in 48.7% of treated partners compared with 82% of untreated partners (RR, 0.60; 95% CI, 0.43-0.83; P = 0.002).
  5. The lowest observed rates of transmission were among couples who reported almost always using condoms during intercourse and the source partner was taking once-daily valacyclovir.
  6. The frequency of adverse effects was similar in both treatment and placebo groups.
 Good
Diaz-Mitoma,28 1998 455
4 groups		 Adult males and females with history of 6 or more episodes of genital HSV in past 12-24 mos, in the absence of antiviral therapy Oral famciclovir 125 mg or 250 mg 3 times a day, or 250 mg twice a day, or placebo DB RCT, parallel groups 52 wks
  1. Famciclovir significantly delayed the time to first recurrence at all dose regimens (P < 0.001); median time to recurrence was 222 to 336 days compared to 47 days for placebo group.
  2. Proportion of patients remaining free of HSV recurrence; proportion 3 times higher in famciclovir group (79%-86%) than in placebo group (27%) at 6 mos.
  3. Frequency of harms, safety profiles were comparable between groups.
 Good
Reitano,30 1998 1,479
5 groups		 Adult males and females with history of 6 or more episodes of genital HSV in past year Oral valacyclovir 250 mg, 500 mg, or 1 g once daily, or 250 mg twice daily; oral acyclovir, 400 mg twice daily, or placebo DB RCT 1 yr
  1. Dose related response (P < 0.0001) across the 1 daily valacyclovir regimens.
  2. Twice daily regimens of acyclovir and valacyclovir were similar in effectiveness.
  3. 500 mg of valacyclovir once daily was most effective at managing patients with < 10 recurrences per year and 1 g of valacyclovir once daily, 250 mg of valacyclovir twice daily, or 400 mg of acyclovir twice daily were more effective in patients with > 10 recurrences per year. Safety profiles for all treatments were comparable.
 Good
Patel,31 1997 382
2 groups		 Adult males and females with a history of 8 or more recurrences annually Oral valacyclovir 500 mg once daily or placebo DB RCT 16 wks
  1. First recurrence; significant difference was found between valacyclovir and placebo in the time to 1st recurrence (P < 0.0001).
  2. Efficacy of valacyclovir; valacyclovir prevented or delayed 85% of the recurrences and at 16 wks, 69% of treatment group were recurrence free and 9.5% of placebo group were recurrence free.
  3. Safety profiles were comparable between groups.
 Fair
Mertz,29 1997 375
6 groups		 Adult women, 6 or more episodes of genital HSV during a 12-24 mo period Oral famciclovir 125 mg once or twice daily, 250 mg once or twice daily, 500 mg once daily, or placebo DB RCT 4 mos
  1. Time to 1st recurrence of genital HSV, significantly prolonged in patients who received famciclovir, 125 mg twice daily (P = 0.03), and in those who received famciclovir 250 mg twice daily (P < 0.001).
  2. Safety profiles between groups were comparable.
 Good
Wald,32 1996 34 Adult women with HSV-2 antibody and genital herpes of less than 2 yrs' duration Oral acyclovir 400 mg twice daily for 70 days, 2 week washout, followed by 70 days of placebo, or reverse order DB RCT, with crossover 140 days
  1. Frequency of subclinical viral shedding in genital tract; 15/17 women who received placebo and 3/17 women who received acyclovir had at least 1 day of subclinical shedding (P < 0.001).
  2. Subclinical shedding occurred on 6.9% of days in placebo women and 0.3% of days in treatment women (P < 0.001).
  3. Acyclovir resulted in a 94% reduction in viral shedding among the 26 women who completed both arms of the study.
 Good/single research clinic site

Notes: CI, confidence interval; DB, double blind; HR, hazard ratio; HSV, herpes simplex virus; PCR, polymerase chain reaction; RCT, randomized controlled trials; RR, relative risk.

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