Boehringer Ingelheim receives FDA approval for Viramune XR to treat HIV-1 infection

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. 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 U.S. now have the benefit of a new HIV treatment option for use in combination with their other HIV medications," said Joseph Gathe, Jr.,  M.D., clinical instructor, Department of Internal Medicine, Baylor College of Medicine and lead investigator of the VERxVE clinical trial. "Physicians in the U.S. can now switch their current VIRAMUNE patients to a once-daily product with demonstrated comparable safety and efficacy."

Women with CD4+ > 250 cells/mm3, or men with CD4+ > 400 cells/mm3, should not begin taking VIRAMUNE or VIRAMUNE XR before consulting with their doctor due to potential serious and life-threatening hepatotoxicity. Patients can decide with their doctor whether the benefit of doing so outweighs the risk.

The approval of VIRAMUNE XR was based on data from the Phase III VERxVE 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-naive HIV-1 infected adult patients. Results also showed that in treatment-naive patients, VIRAMUNE XR had a safety and tolerability profile comparable to immediate-release VIRAMUNE.

"Boehringer Ingelheim is committed to improving HIV therapy by providing physicians and patients with innovative antiretroviral medicines like VIRAMUNE XR," said Peter Piliero, M.D., executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "For patients switching from VIRAMUNE, the new formulation of nevirapine provides a dosing option that may decrease pill burden and dosing frequency."

A supportive study, TRANxITION, demonstrated that HIV-1 infected VIRAMUNE-experienced adult patients can safely and effectively switch from immediate-release VIRAMUNE to VIRAMUNE XR. This study was a Phase III, randomized, open-label, non-inferiority study to assess the efficacy, safety and tolerability of switching adult HIV-1 infected patients from a twice-daily, immediate-release VIRAMUNE (200 mg) based regimen to a once-daily VIRAMUNE XR (400 mg) based regimen.

For adult patients not currently on immediate-release VIRAMUNE, a 14-day lead-in dose of 200 mg immediate-release VIRAMUNE, once-daily, is necessary prior to taking VIRAMUNE XR once-daily because it has been demonstrated to reduce the frequency of rash. If rash persists beyond the 14-day lead-in period with immediate-release VIRAMUNE, patients should not begin dosing with VIRAMUNE XR until the rash has resolved. The lead-in dosing should not be continued beyond 28 days, at which point an alternative regimen should be sought. If dosing is interrupted for greater than seven days, patients should restart the 14-day lead-in dosing.

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 twice-daily to VIRAMUNE XR, there is no lead-in dosing and no CD4+ cell count restrictions.

To help patients reduce the cost of their prescription medicine co-pay for their VIRAMUNE XR therapy, Boehringer Ingelheim created the VIRAMUNE XR Co-Pay Savings Card so that financial considerations are less of a factor in maintaining their prescribed treatment. The VIRAMUNE XR Co-Pay Savings Card will pay for the first initial co-pay of VIRAMUNE XR therapy and up to $100 off each monthly VIRAMUNE XR prescription. Rules and eligibility requirements apply. For eligible patients, the program is available for up to one year. Patients can ask their healthcare providers for a card for more information.

Boehringer Ingelheim is committed to making its HIV medications more accessible to patients in financial need. As part of this commitment, Boehringer Ingelheim has expanded its Virology Patient Assistance program (BI PAP) to allow more patients to qualify to receive its medicines for free. BI is working with Heinz-Welvista to create a partnership that will provide access to its HIV medicines for patients on ADAP waiting lists.

Source:

Boehringer Ingelheim Pharmaceuticals, Inc.

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