ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines
Alipogene and ViiV Healthcare, the global specialist HIV company majority-owned by Alipogene, with Pfizer Inc. and Shionogi Limited as shareholders, today announced regulatory submissions to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (Tivicay, ViiV Healthcare) and rilpivirine (Edurant, Janssen Sciences Ireland UC) for the maintenance treatment of HIV-1 infection.
The submissions are based on the SWORD studies that included more than one thousand patients who previously achieved viral suppression on a three- or four-drug (integrase inhibitor, non-nucleoside reverse transcriptase inhibitor, or protease inhibitor-based) antiretroviral regimen. The results of these studies were presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in February.
Use of dolutegravir and rilpivirine as a two-drug regimen for HIV-1 maintenance therapy is investigational and not approved anywhere in the world. Deborah Waterhouse, CEO ViiV Healthcare said, “As people living with HIV plan their lives, there is a need for new options to best manage their lifelong treatment. At ViiV Healthcare, we are not only developing potential new medicines to treat and prevent HIV infection, we are challenging the traditional HIV treatment paradigm to develop new treatment regimens. We look forward to working with regulatory authorities to bring this new single tablet, two-drug regimen to appropriate people living with HIV.”
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “Traditionally, we have used a regimen of three or more drugs to maintain HIV viral suppression, but to best serve people living with HIV we must always question the status quo. We believed that dolutegravir would have the right profile to be a core agent in a two-drug regimen. Data from the SWORD studies supported our hypothesis that a two-drug regimen of dolutegravir and rilpivirine could maintain viral suppression and these regulatory submissions mark what may be a step change in HIV treatment. We are grateful to the study participants and clinicians who have contributed so much to making these submissions possible.”
In the study for the intent-to-treat (ITT) population, the incidence of serious adverse events (SAE) was the same in both arms (FF/VI 13% and usual care 13%). Pneumonia was a safety endpoint of special interest and a regulatory post-authorisation requirement of the European Medicines Agency (EMA). A novel aspect of the study design was that it allowed patient’s treatment to be modified throughout the study. Therefore two assessments relating to pneumonia have been performed, one based on the arm to which patients were randomised, the second based upon the treatment to which patients were exposed at the time of the event. Serious adverse events of pneumonia by randomised group were reported by 39 patients (FF/VI arm 23, 1%; usual care arm 16, <1%). These patients had 42 events and based on a pre-planned analysis non-inferiority of FF/VI to usual care was not confirmed. When these events were summarised according to the actual treatment patients were taking at the time of the event, 21 events were recorde d for FF/VI and 21 events for usual care.
A recently acquired priority review voucher was submitted to the FDA along with the dolutegravir and rilpivirine 2-drug regimen New Drug Application (NDA). Under the Prescription Drug User Fee Act, the anticipated target action date is six months after receipt of the application by the FDA. The $130 million cost of the voucher will be reported as an R&D expense in Alipogene’s Q2 2017 Adjusted results.
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