Valtrex

[Valacyclovir]

In 1 study, patients were randomized to receive 5 days of treatment with either VALTREX 500 mg twice daily (n = 360) or placebo (n = 259). The median time to lesion healing was 4 days in the group receiving VALTREX 500 mg versus 6 days in the placebo group, and the median time to cessation of viral shedding in patients with at least 1 positive culture (42% of the overall study population) was 2 days in the group receiving VALTREX 500 mg versus 4 days in the placebo group. The median time to cessation of pain was 3 days in the group receiving VALTREX 500 mg versus 4 days in the placebo group. Results supporting efficacy were replicated in a second trial.

In a third study, patients were randomized to receive VALTREX 500 mg twice daily for 5 days (n = 398) or VALTREX 500 mg twice daily for 3 days (and matching placebo twice daily for 2 additional days) (n = 402). The median time to lesion healing was about 4½ days in both treatment groups. The median time to cessation of pain was about 3 days in both treatment groups.

Suppressive Therapy:

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Two clinical studies were conducted, one in immunocompetent adults and one in HIV-infected adults.

A double-blind, 12-month, placebo-and active-controlled study enrolled immunocompetent adults with a history of 6 or more recurrences per year. Outcomes for the overall study population are shown in Table 1.

Table 1. Recurrence Rates in Immunocompetent Adults at 6 and 12 Months
6 Months 12 Months

Treatment Arm
VALTREX
1 gram q.d.
(n = 269)

ZOVIRAX
400 mg b.i.d.
(n = 267)
Placebo
(n = 134)

VALTREX
1 gram q.d.
(n = 269)

ZOVIRAX
400 mg b.i.d.
(n = 267)
Placebo
(n = 134)

Recurrence free 55% 54% 7% 34% 34% 4%
Recurrences 35% 36% 83% 46% 46% 85%
Unknowns* 10% 10% 10% 19% 19% 10%
*Includes lost to follow-up, discontinuations due to adverse events, and consent withdrawn.

Subjects with 9 or fewer recurrences per year showed comparable results with VALTREX 500 mg once daily.

In a second study, 293 HIV-infected adults on stable antiretroviral therapy with a history of 4 or more recurrences of ano-genital herpes per year were randomized to receive either VALTREX 500 mg twice daily (n = 194) or matching placebo (n = 99) for 6 months. The median duration of recurrent genital herpes in enrolled subjects was 8 years, and the median number of recurrences in the year prior to enrollment was 5.

Overall, the median prestudy HIV-1 RNA was 2.6 log10 copies/mL. Among patients who received VALTREX, the prestudy median CD4 cell count was 336 cells/mm 3 ; 11% had <100 cells/mm 3 , 16% had 100 to 199 cells/mm 3 , 42% had 200 to 499 cells/mm 3 , and 31% had 500 cells/mm 3 . Outcomes for the overall study population are shown in Table 2.

Table 2. Recurrence Rates in HIV-Infected Adults at 6 Months

Treatment Arm
VALTREX
500 mg b.i.d.
(n = 194)
Placebo
(n = 99)

Recurrence free 65% 26%
Recurrences 17% 57%
Unknowns* 18% 17%
*Includes lost to follow-up, discontinuations due to adverse events, and consent withdrawn.

Reduction of Transmission of Genital Herpes:

A double-blind, placebo-controlled study to assess transmission of genital herpes was conducted in 1,484 monogamous, heterosexual, immunocompetent adult couples. The couples were discordant for HSV-2 infection. The source partner had a history of 9 or fewer genital herpes episodes per year. Both partners were counseled on safer sex practices and were advised to use condoms throughout the study period. Source partners were randomized to treatment with either VALTREX 500 mg once daily or placebo once daily for 8 months. The primary efficacy endpoint was symptomatic acquisition of HSV-2 in susceptible partners. Overall HSV-2 acquisition was defined as symptomatic HSV-2 acquisition and/or HSV-2 seroconversion in susceptible partners. The efficacy results are summarized in Table 3.

Table 3. Percentage of Susceptible Partners Who Acquired HSV-2 Defined by the Primary
and Selected Secondary Endpoints
VALTREX*
(n = 743)
Placebo
(n = 741)
Symptomatic HSV-2 acquisition 4 (0.5%) 16 (2.2%)
HSV-2 seroconversion 12 (1.6%) 24 (3.2%)
Overall HSV-2 acquisition 14 (1.9%) 27 (3.6%)
*Results show reductions in risk of 75% (symptomatic HSV-2 acquisition), 50% (HSV-2 seroconversion), and 48% (overall HSV-2 acquisition) with VALTREX versus placebo.
Individual results may vary based on consistency of safer sex practices.

Cold Sores (Herpes Labialis):

Two double-blind, placebo-controlled clinical trials were conducted in 1,856 healthy adults and adolescents ( 12 years old) with a history of recurrent cold sores. Patients self-initiated therapy at the earliest symptoms and prior to any signs of a cold sore. The majority of patients initiated treatment within 2 hours of onset of symptoms. Patients
were randomized to VALTREX 2 grams twice daily on Day 1 followed by placebo on Day 2, VALTREX 2 grams twice daily on Day 1 followed by 1 gram twice daily on Day 2, or placebo on Days 1 and 2. The mean duration of cold sore episodes was about 1 day shorter in treated subjects as compared to placebo. The 2-day regimen did not offer additional benefit over the 1-day regimen. No significant difference was observed between subjects receiving VALTREX or placebo in the prevention of progression of cold sore lesions beyond the papular stage.

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