GlaxoSmithKline plc (GSK) and Boehringer Ingelheim have signed a letter of intent for an accelerated development programme for a co-package for Combivir (lamivudine/zidovudine) and Viramune (nevirapine) for chronic treatment of HIV infection in the developing world, according to a GSK release.
Given the complexities of providing HIV care and treatment in the developing world, GSK and Boehringer Ingelheim support efforts to simplify treatment regimens and improve access to antiretrovirals (ARV) to people living with HIV.
GSK and Boehringer Ingelheim have initiated contact with the US Food & Drug Administration (FDA) on development of the co-package under the new draft FDA guidance1 designed ultimately to increase treatment options for HIV in the developing world. The availability of the Combivir-Viramune co-package is contingent upon approval by appropriate regulatory authorities and execution of a definitive agreement.
"We have made substantial progress with our strategy to co-package Combivir and Viramune," said Lynn Marks, MD, Senior Vice President of Infectious Diseases, GlaxoSmithKline. "We continue our commitment to address the HIV/AIDS challenges in the developing world. Both companies believe that patients can benefit from a co-package that simplifies treatment."
"The co-package of Viramune and Combivir is the most expeditious strategy for facilitating access to HIV treatment in the developing world. In practice, the Viramune- Combivir co-package will facilitate distribution and delivery of a recognised triple therapy to patients in need," said Dr. Alessandro Banchi, chairman of the Board of managing directors at Boehringer Ingelheim.
The Combivir and Viramune combination is recommended by the World Health Organization as a first-line regimen in its treatment guidelines for developing countries published in December 2003.
Combivir is a combination tablet containing Epivir (lamivudine, 3TC) and Retrovir (zidovudine, AZT). It is indicated in combination with other antiretroviral agents for the treatment of HIV infection. Viramune (nevirapine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.