| Study/Year |
N |
Population |
Antiviral/Dose |
Design |
Length of Trial |
Main Outcomes/Results |
Quality Rating/Limitations |
| Watts,42 2003 |
162 2 groups |
Adult women with recurrent genital HSV at gestational age < 36 wks |
Oral acyclovir 400 mg 3 times daily or placebo |
DB RCT |
36 wks' gestation to delivery |
- 5% of patients treated with acyclovir, and 14% of patients treated with placebo had HSV lesions at delivery (P = 0.08).
- 7% in the acyclovir group had positive HSV cultures and PCR, compared with 34% of placebo-treated patients (P = 0.03 and < 0.01 respectively).
- 4% of women in the acyclovir group delivered by cesarean, and 10% of women in the placebo group delivered by cesarean (P = 0.17).
- Neonatal outcomes were similar between groups.
- Importantly, 6% of the women in the study had persistent detection of HSV by PCR on > 20% of days, despite reporting taking 90%-100% of the acyclovir doses.
- The study did not examine safety of the neonate.
|
Good |
| Scott,43 2002 |
234 2 groups |
Adult women with recurrent genital HSV at gestational age < 36 wks |
Oral acyclovir 400 mg 3 times daily or placebo |
DB RCT |
36 wks' gestation to delivery |
- Decreased frequency of clinical recurrences, 6% of treatment and 14% of placebo group had clinical HSV at delivery (P = 0.046).
- No women had positive HSV cultures in treatment group compared with 6% positives in placebo group (P = 0.029).
- No significant difference in subclinical HSV shedding in the treatment group compared with placebo group.
- The study did not examine safety of the neonate.
|
Fair/loss to followup not reported |
| Scott,47 2001 |
96 |
Adult women with first diagnosis of genital HSV in index pregnancy, 36 wks' gestation |
Oral acyclovir 400 mg 3 times daily |
Open-label trial with historical controls |
36 wks' gestation to delivery |
- 85% of patients adhered to treatment, 1% had clinical HSV at delivery.
- 4% of the cohort had clinical recurrences compared with 18%-37% of historical controls.
- Asymptomatic shedding occurred in 1% of women without lesions at delivery.
- No harms (neurological, hepatic, renal complications) were attributable to acyclovir during the neonatal period.
|
Poor/not randomized or blinded, groups not similar at baseline, and comparable groups not maintained |
| Braig,46 2001 |
489 3 groups |
Adult women with at least 1 episode of genital HSV at gestational age < 36 wks |
Group 1 (n = 167) received oral acyclovir 200 mg 4 times daily; Group 2 (n = 121) received no treatment; Group 3 (n = 201), historical controls, women not given prophylaxis who had a history of genital HSV |
RCT with historical controls (Group 3) |
36 wks' gestation to delivery |
- The rate of cesarean delivery was 8.4% in treatment group (Group 1), 16.5% in no treatment group (Group 2), and 9.9% in historical controls (Group 3) (P < 0.001).
- 75% of cesarean deliveries in Group 2 and 10% of cesarean deliveries in Group 3 were done because of genital HSV.
- Percentage of viral shedding was 0% in Group 1, 5% in Group 2, and 0.5% in Group 3.
- No neonatal herpes were diagnosed during the study period and no harms for the newborn related to antiviral therapy were reported.
|
Poor/not randomized or blinded, not intention-to-treat, maintenance of comparable groups not reported |
| Brocklehurst,44 1998 |
63 2 groups |
Adult women with recurrent genital HSV at gestational age < 36 wks |
Oral acyclovir 200 mg 4 times daily or placebo |
DB RCT |
36 wks' gestation to delivery |
- The number of clinical recurrences of genital HSV was significantly reduced in the treatment group compared with placebo (OR, 0.10; 95% CI, 0.00-0.86).
- This trial did not demonstrate that acyclovir use in late pregnancy reduced cesarean delivery.
- No HSV among neonates were reported, and no adverse complications were reported for the infants at 1-yr followup.
|
Poor/groups not similar at baseline, not blinded, maintenance of comparable groups not reported, loss to followup not reported |
| Scott,45 1996 |
46 2 groups |
Adult women with recurrent genital HSV at gestational age < 36 wks |
Oral acyclovir 400 mg 3 times daily or placebo |
DB RCT |
36 wks' gestation to delivery |
- None of the treatment group and 35% of the placebo group had clinical evidence of recurrent genital HSV at delivery (OR, 0.04; 95% CI, 0.002-0.745; P = 0.002).
- Women treated with acyclovir had no cesareans for genital herpes compared with 36% of placebo group (OR, 0.04; 95% CI, 0.002-0.745; P = 0.002).
- No neonates had evidence of herpes infection or harms from acyclovir.
|
Poor/not intention-to-treat analysis, maintenance of comparable groups and loss to followup not reported |
Notes: CI, confidence interval; DB, double blind; HSV, herpes simplex virus; OR, odds ratio; PCR, polymerase chain reaction; RCT, randomized controlled trials. |