In Brief Background: Antiviral suppressive therapy of genital herpes is often initiated based on the established pattern of recurrences in an individual. Because most persons with first episode herpes simplex virus type 2 (HSV-2) infection experience recurrences and because viral shedding occurs frequently in the first year after infection, we examined the strategy of initiating suppressive therapy shortly after diagnosis of genital HSV-2 infection. Subjects and Methods: From June 16, 2004 to July 26, 2006, 384 subjects from 74 sites in the United States, Canada, Argentina, Brazil, and Chile who were newly diagnosed with a first recognized episode of genital herpes at the time of the screening visit or within 3 months before the screening visit were randomized (2:1) to receive valacyclovir 1 g once daily or placebo for 24 weeks. Subjects were instructed to return to clinic during suspected genital herpes outbreaks for clinician confirmation of recurrences. Results: Valacyclovir significantly prolonged the time to first recurrence of HSV-2 genital herpes in newly diagnosed subjects compared with placebo, with approximately 43% of subjects on placebo and 71% of subjects on valacyclovir recurrence-free at 24 weeks (P <0.001). Valacyclovir significantly reduced the mean number of genital HSV-2 recurrences per month occurring during the 24-week study period (0.11 for valacyclovir, 0.48 for placebo, P <0.001). Adverse events were comparable in the valacyclovir and placebo arms. Conclusion: Valacyclovir 1 g once daily administered for 24 weeks was well-tolerated and effective in suppressing genital herpes recurrences in immunocompetent newly diagnosed persons without an established recurrence pattern. Subjects with newly diagnosed herpes simplex virus type 2 genital herpes randomized to daily valacyclovir suppression had prolonged time to first recurrence and fewer recurrences over 24 weeks than subjects randomized to placebo.
AbstractThe purpose of this study was to determine the safety and effectiveness of albuterol aerosol 180 μg and albuterol powder 200 μg in the prevention of exercise-induced bronchospasm in children. Forty-six patients aged 4-11 years with asthma and exercise-induced bronchospasm were enrolled in this randomized, double-blind, single-dose, three-way crossover study comparing albuterol aerosol, albuterol powder, and placebo. Exercise challenge was performed at the screening visit for qualifying and baseline determinations of pulmonary function and then 15 min after drug administration at each of three visits. Prevention of exercise-induced bronchospasm was assessed by comparing across all treatment groups the percentage change in FEV1 from pre- to postexercise, the percentage of patients protected by treatment, postexercise minimum FEV1, and postexercise change in FEV1. Safety was assessed by observation of clinical adverse events, laboratory tests, physical examination, electrocardiogram and rhythm strips, vital signs, and pulmonary auscultation. Forty-four patients completed the study. Mean postexercise FEV1 decreased 6% from preexercise values when patients were treated with either albuterol formulation; FEV1 decreased 23% when patients were treated with placebo. Exercise-induced bronchospasm was prevented in 95% of patients when treated with albuterol powder, in 91% treated with albuterol aerosol, and in 57% treated with placebo. Patients maintained significantly higher mean minimum FEV1 values after treatment with albuterol powder and albuterol aerosol than when treated with placebo. Treatment with either albuterol formulation produced a significantly smaller decrease in mean FEV1 from pre- to postexercise than treatment with placebo. No drug-related adverse events were reported, and safety assessments were within normal limits. Albuterol aerosol (180 μg) and the powder formulation, albuterol Rotacaps® (200 μg), are equally safe and effective in protecting against exercise-induced bronchospasm in children aged 4-11 years. When given albuterol, fewer than 10% of patients had a greater than 20% decrease in FEV1 as compared with 43% when given placebo. All safety assessments indicated that both albuterol formulations were well tolerated by all children.
We aimed to identify whether genital symptoms were associated with unrecognized herpes simplex virus type 2 (HSV-2) infection in a primary care population.Five thousand four hundred fifty-two individuals aged 18 to 59 seeking general care at 36 suburban medical offices in 6 U.S. cities were tested for HSV-2 antibody and asked about 10 types of genital symptoms. In patients with no known history of genital herpes, we assessed whether HSV-2 infection was independently associated with symptoms.HSV-2 infection was associated with increases in reports of "sores, blisters, ulcers, crusts, or small cuts/slits" in men [adjusted odds ratio (OR), 1.79; 95% CI, 1.24-2.58] and with increases in reports of "redness, irritation, or a rash" among women (adjusted OR, 1.50; 95% CI, 1.06-2.11). HSV-2 was not significantly associated with other types of genital symptoms.Primary-care physicians should consider unrecognized HSV-2 infection as a potential cause of some common genital symptoms.
The objective of this study was to estimate herpes simplex virus-2 (HSV-2) seroprevalence from a weighted sample of adults attending relatively affluent, suburban primary care physician (PCP) offices.Many PCPs in relatively affluent areas do not believe national estimates of HSV-2 seroprevalence are representative of their patient populations. This study aimed to measure HSV-2 seroprevalence in these patient populations.We conducted a cross-sectional study with approximately 5400 individuals aged 18 to 59 years. Individuals were recruited at 36 PCP offices in 6 U.S. cities and tested for HSV-2 using Focus enzyme-linked immunosorbent assay. A computer-assisted questionnaire was used to assess risk behaviors associated with genital herpes.Among 5452 individuals who provided an analyzable blood sample, the overall weighted HSV-2 seroprevalence was 25.5% (95% confidence interval, 20.2-30.8%). Only 11.9% of HSV-2-seropositive patients reported a history of genital herpes.Results illustrate the need for greater suburban PCP and patient awareness of the high HSV-2 seroprevalence in this setting.
