Primary Endpoint Met in ViiV Healthcare's Two Phase III Trials of Two-Drug HIV Treatment Regimen
ViiV Healthcare announces positive results from first phase III studies of two-drug HIV treatment regimen
First phase III studies to show efficacy of two-drug regimen as maintenance therapy
London, UK
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that both of its Phase III studies to evaluate the safety and efficacy of switching virologically suppressed patients from a three or four-drug (integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based) antiretroviral regimen to a two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC) met the primary endpoint of non inferiority at Week 48.
The primary endpoint, based on FDA’s snapshot analysis, was evaluated as the proportion of patients with plasma HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48.
The safety profiles for dolutegravir and rilpivirine in these studies were consistent with the product labelling for each medicine. Detailed results from the studies will be presented at an upcoming scientific meeting.
Dominique Limet, CEO ViiV Healthcare, said “These are important results for the HIV scientific community and represent an important milestone in our understanding of how HIV can be treated. The results support our strategy of investigating two-drug regimens as innovative treatment options for people living with HIV and we are planning regulatory submissions for this two-drug regimen as a single tablet in 2017.”
The use of dolutegravir and rilpivirine as HIV maintenance treatment is investigational and not approved anywhere in the world.
First phase III studies to show efficacy of two-drug regimen as maintenance therapy
London, UK
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that both of its Phase III studies to evaluate the safety and efficacy of switching virologically suppressed patients from a three or four-drug (integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based) antiretroviral regimen to a two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC) met the primary endpoint of non inferiority at Week 48.
The primary endpoint, based on FDA’s snapshot analysis, was evaluated as the proportion of patients with plasma HIV-1 RNA <50 copies per milliliter (c/mL) at Week 48.
The safety profiles for dolutegravir and rilpivirine in these studies were consistent with the product labelling for each medicine. Detailed results from the studies will be presented at an upcoming scientific meeting.
Dominique Limet, CEO ViiV Healthcare, said “These are important results for the HIV scientific community and represent an important milestone in our understanding of how HIV can be treated. The results support our strategy of investigating two-drug regimens as innovative treatment options for people living with HIV and we are planning regulatory submissions for this two-drug regimen as a single tablet in 2017.”
The use of dolutegravir and rilpivirine as HIV maintenance treatment is investigational and not approved anywhere in the world.