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FDA Hearings to Review Atazanavir Protease Inhibitor for HIV & Valtrex For
Reduced Herpes Transmission May 13/14
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GlaxoSmithKline's supplemental NDA for use of Valtrex to reduce the risk of
transmission of genital herpes will be reviewed by FDA's Antiviral Drugs
Advisory Committee on May 14. On May 13, the committee will review
Bristol-Myers Squibb's Reyataz (atazanavir) for HIV infection.
The firm presented data in September 2002 at the Interscience Conference on
Antimicrobial Agents and Chemotherapy annual meeting showing a 77% reduction
in transmission of symptomatic genital herpes with use of Valtrex.
The proposed indication involves use of Valtrex (valacyclovir) as suppressive
therapy. Labeling currently recommends daily use of Valtrex for suppression
of recurrent genital herpes and three days of dosing for treatment of
recurrent episodes, or 10 days for initial episodes.
In September, Valtrex added an indication for treatment of herpes labialis
(cold sores). The drug also is indicated for treatment of herpes zoster
(shingles).
GlaxoSmithKline's Valtrex study showing a 50% reduction in genital herpes
virus transmission will be reviewed by FDA's Antiviral Drugs Advisory
Committee on May 14.
In the study of 1,484 heterosexual couples, transmission of the herpes
simplex virus type 2 from HSV-2 positive partners to HSV-2 seronegative
partners was reduced by 50% with Valtrex (valacyclovir) treatment compared to
placebo. Twenty-eight patients (3.8%) in the placebo group acquired HSV-2
infection compared to 14 patients (1.9%) in the Valtrex group.
The acquisition of the virus was defined as symptomatic genital herpes and/or
seroconversion in a previously negative partner. The HSV-2 seronegative
partners were monitored in a monthly visit to a clinic over eight months and
told to vist the clinic at the first sign of an outbreak.
In the trial, the transmission of symptomatic genital herpes alone was
reduced by 77% in the Valtrex group. Seventeen patients (2.3%) in the placebo
group were symptomatic compared to four patients (.5%) in the Valtrex group.
Valtrex is already approved for prevention of recurrent genital herpes,
herpes labialis (cold sores) and shingles.
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