Local tolerance and systemic safety of pegaptanib sodium in the dog and rabbit.

Purpose: To evaluate the local tolerance, systemic toxicity, and toxicokinetics in dogs and rabbits of pegaptanib sodium, an aptamer that targets vascular endothelial growth factor (VEGF(165)).

Methods: Dogs received biweekly, bilateral, intravitreous (IVT) injections of pegaptanib sodium for 9 months at doses of 0.3 (n = 10), 1 (n = 10), or 3 mg (n = 14); 14 control dogs received phosphate-buffered saline (PBS).

Pegaptanib 1-year systemic safety results from a safety-pharmacokinetic trial in patients with neovascular age-related macular degeneration.

Objective: To characterize the safety, tolerability, and pharmacokinetics of the pegylated anti-vascular endothelial growth factor (VEGF) aptamer pegaptanib sodium in subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Design: Prospective 2-cohort study: (1) open-label cohort and (2) randomized, double-masked, uncontrolled multicenter trial.

Participants: In the combined cohorts, 147 subjects with any angiographic subtype of subfoveal choroidal neovascularization secondary to AMD and best-corrected visual acuities (VAs) in the study eye of 20/40 to 20/320 and in the fellow eye of 20/800 or better received pegaptanib sodium.

Effect of ribavirin on hepatitis C viral kinetics in patients treated with pegylated interferon.

A dynamic equilibrium between viral production and clearance characterizes untreated chronic hepatitis C viral infection. After initiating antiviral treatment, a typical multiphasic decay of viremia can be observed and analyzed using mathematical models. To elucidate the antiviral mechanism of ribavirin when used in combination with (pegylated) interferon alfa, we investigated kinetic parameters in patients with chronic hepatitis C treated with either peginterferon alpha-2a with or without ribavirin and standard interferon alpha-2b plus ribavirin for 48 weeks.

Use of peginterferon alfa-2a (40 KD) (Pegasys) for the treatment of hepatitis C.

Thrice-weekly interferon alfa-2b plus ribavirin has been the standard of care for chronic hepatitis C; however, a majority of patients fail to achieve a sustained virological response with this treatment. Peginterferon alfa-2a (40 KD), interferon alfa-2a conjugated to a 40 kDa branched polyethylene glycol moiety, exhibits sustained absorption and reduced renal clearance, resulting in antiviral pressure throughout a once-weekly dosing schedule. Peginterferon alfa-2a (40 KD) has superior virological efficacy to interferon alfa-2a, and elicits histological improvements in patients with and without sustained virological response.