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FDA
Approves New Zerit (Stavudine; D4T) Extended Release (XR) Capsules
for Once Daily Dosing
On New Year's Eve (December 31, 2002), the US FDA approved Bristol-Myers
Squibb's Zerit XR (stavudine; d4T) Extended Release Capsules (37.5
mg, 50 mg, 75 mg, and 100 mg). Zerit XR is indicated for the treatment
of HIV in combination with other antiretrovirals.
The extended release (XR) formulation of Zerit maintains measurable
plasma concentrations for 24 hours after once daily dosing. The
recommended doses of Zerit XR are 100 mg once daily for individuals
weighing at least 60 kg and 75 mg once daily for individuals weighing
less than 60 kg.
Once Daily
Zerit Studies
In a randomized, controlled clinical study conducted in 783 treatment-naïve,
HIV-infected individuals, Zerit XR was comparable to the previously
approved twice daily formulation of the drug, according to Bristol-Myers
Squibb. In this study, participants were randomized to either the
extended release or standard formulation, in combination with lamivudine
and efavirenz. The proportion of patients with HIV viral load levels
below 400 copies/mL at 48 weeks was 79% and 76% for the extended
release and immediate release-containing regimens, respectively.
For viral load under 50, the response rates were 55% and 57% for
the new and old formulations, respectively. The tolerability and
safety profile of the new once daily, extended release formulation
is comparable to that of the previously approved twice daily formulation,
according to the company.
The study results
were supported by a second, smaller study in 150 treatment naïve
patients. It is widely believed that once daily formulations (such
as Zerit XR) may help patients with HIV to adhere more readily to
anti-HIV treatment regimens due to the increased convenience of
the dosing schedule.
The full label for Zerit XR will soon be available
at the FDA
website.
Summary
Information on Zerit at HIV and Hepatitis.
Recent News Reports on Zerit on HIV and Hepatitis.com
New
Findings Suggest Significant Amount of AZT (Zidovudine, Retrovir)
AZT May Be Metabolized to D4T (Stavudine, Zerit) 11/27/02
Videx
(Didanosine) and Zerit (Stavudine) More Potent Than Retrovir
(Zidovudine) as Monotherapy 10/11/02
Stavudine
XR Once-Daily (QD) Is as Effective as Twice-Daily (BID) 7/15/02
No
Meal Restrictions Required for Extended Release Zerit (Zerit
XR) 07/12/02
Available
Zerit XR Doses Show Dose Proportionality and Tolerability
07/12/02
Once-Daily
Zerit (d4T) Extended Release Shows Results Similar to Current
Zerit Twice-Daily Formulation 3/04/02
1/03/03
Sources
Richard Klein. Office of Special Health Issues. US Food and Drug
Administration.
HIVandHepatitis.com
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