Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has approved Viramune XR (nevirapine) extended-release tablets — a one-pill, once-daily (400 mg) formulation of nevirapine — for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
“With the approval of once-daily Viramune XR, patients in the USA now have the benefit of a new HIV treatment option for use in combination with their other HIV medications,” said Joseph Gathe, Jr., MD, clinical instructor, Department of Internal Medicine, Baylor College of Medicine and lead investigator of the VERxVE clinical trial. “Physicians in the USA can now switch their current Viramune patients to a once-daily product with demonstrated comparable safety and efficacy.”
The approval of Viramune XR was based on data from the phase III VERxVE 1 study, which demonstrated that Viramune XR achieved a virologic response non-inferior to twice-daily immediate-release Viramune (200 mg) through 48 weeks, both used in combination with Truvada, in treatment-naïve HIV-1 infected adult patients. Results also showed that in treatment-naïve patients, Viramune XR had a safety and tolerability profile comparable to immediate-release Viramune which was first approved in 1996.
“Pill burden is an important consideration for patients in need of HIV therapy. Boehringer Ingelheim is committed to not only improving HIV therapy by providing physicians and patients with innovative antiretroviral medicines like Viramune, but also by providing therapies that may improve treatment adherence,” said Professor Klaus Dugi, Corporate senior vice president Medicine, Boehringer Ingelheim. “For patients in the USA switching to once-daily Viramune extended-release, the new tablet provides a treatment option with less frequent dosing that will help to reduce the patient’s pill burden.”
The results of the supportive open-label study TRANxITION 2 showed that patients can be safely switched from the current available formulation of Viramune to Viramune XR.
The recommended dose for Viramune XR is one 400 mg tablet taken once daily, with or without food, in combination with other antiretroviral agents. For adult patients switching from immediate-release Viramune to Viramune XR, there is no lead-in dosing.
VERxVE is a randomized, double-blind, double-dummy, parallel group, active controlled, multinational trial conducted to evaluate the antiviral efficacy and safety of once-daily Viramune XR (400 mg) compared to twice-daily, immediate-release Viramune (200 mg). A total of 1,011 adult patients were randomized to receive either Viramune XR or immediate-release Viramune after a 14-day lead-in period with immediate-release Viramune for all patients. All patients also received a nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NRTI) backbone of Truvada.
The TRANxITION study examined the efficacy and safety of switching virologically-suppressed patients (viral load < 50 copies/ml) from Viramune immediate release 200mg twice daily to Viramune XR 400mg once daily.
The Boehringer Ingelheim group operates globally and has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.