"Patients experiencing a first episode of genital herpes should be advised that suppressive therapy is effective in reducing the frequency of recurrences and that episodic antiviral therapy is effective in shortening the duration of recurrent episodes".1
Outbreak Reduction
In patients newly diagnosed with genital herpes, VALTREX 1 g once daily significantly reduces outbreak frequency compared to placebo.
In a parallel-group, double-blind, placebo-controlled, multicenter study, 384 immunocompetent, newly diagnosed patients with genital herpes (patients started daily therapy within 6 months of diagnosis) were randomized to receive VALTREX 1 g once daily (n=256) or placebo (n=128) for 6 months. The percentages above represent outbreak reduction in subjects in the ITT population who completed the study.
52% of patients on VALTREX 1 g QD were outbreak free at 6 months vs 32% of those on placebo.2
Adverse events reported with VALTREX vs placebo included headache (23% vs 30%), nasopharyngitis (14% vs 10%), and cold sores (9% vs 6%).
- In a separate study of patients newly diagnosed with genital herpes, patients on VALTREX 1 g once daily had a 54% reduction in frequency of outbreaks vs placebo (2.0 vs 4.3 outbreaks, respectively) P=0.010*3
Viral Shedding
Viral shedding occurs when HSV-2 is released on the surface of the skin/mucosa. Shedding can be measured by PCR or culture.
- Clinical shedding is shedding during the presence of a genital herpes lesion
- Subclinical shedding† is shedding in the absence of lesion; may include days with symptoms (eg, prodrome)
- Asymptomatic viral shedding† is shedding in the absence of signs or symptoms
VALTREX 1 g once daily can reduce total viral shedding (symptomatic and asymptomatic) in newly diagnosed patients.2
Results from a randomized, double-blind, placebo-controlled, multicenter crossover study comparing the effect of VALTREX 1 g QD vs placebo on total HSV-2 shedding (primary end point). Patients were immunocompetent, newly diagnosed with genital herpes (N=70) and were followed for 60 days during each treatment period. Enrolled patients had signs and symptoms of genital HSV-2 infection at screen or within 4 months of randomization, and laboratory confirmation of genital HSV-2 infection.
- 78% reduction in asymptomatic viral shedding vs placebo (2.4% vs 11.0% [mean % of days]) (P<0.001)2
- 60% of patients taking VALTREX experienced 0 days of total viral shedding vs 29% of patients taking placebo (P<0.001)2
The most frequently reported adverse events among VALTREX and placebo recipients, respectively, were fungal infection (5%, 10%), upper respiratory tract infection (5%, 2%), sinusitis (3%, 2%), and bacterial vaginitis (3%, 2%).
The clinical significance of reducing viral shedding has not been established.
