Major Advancement in HIV Treatment: GSK/Janssen's Once-Monthly Long-Acting Injectable CAB/RPV Set for Year-End Approval, Reducing Annual Treatment Days from 365 to 12

July 09, 2019/BioValleyBIOON/--ViiV Healthcare is a company byGlaxoSmithKline(GSK) Holding,Pfizera HIV/AIDS drug development company held by Pfizer and Shionogi. Recently, the company announced the initiation of the CUSTOMIZE clinical study, a single-arm, multicenter study aimed at identifying and evaluating methods for implementing once-monthly long-acting injectable HIV therapy CAB/RPV (cabotegravir/rilpivirine) in clinical practice.

In this one-year study, a team from ViiV Healthcare will collaborate with clinical staff at various clinics across the United States, where healthcare providers and patients will play equally important roles. The aim of the study is to identify the most practical and effective methods for implementing monthly injectable treatment regimens following regulatory approval of CAB/RPV, including strategies to address the increased frequency of outpatient visits.

Harmony P. Garges, Global Head of Medical Affairs at ViiV Healthcare, stated: “Through the CUSTOMIZE study, ViiV aims to identify and evaluate different approaches to implementing once-monthly injectable HIV therapy in real-world settings, which may be associated with”Clinical Trial“...different from the control group established in China. Experts believe that the effective implementation of HIV therapy may make the greatest contribution to ending the HIV epidemic, and we consider this study an important step toward that goal.”

Currently, the New Drug Application (NDA) for CAB/RPV is under review by the U.S.FDAPriority Review, with a Prescription Drug User Fee Act (PDUFA) target date of December 29, 2019. This NDA seeks approval for CAB/RPV for the treatment of HIV-1-infected adults who are virologically suppressed and have no resistance to cabotegravir or rilpivirine.

If approved, CAB/RPV will become the first long-acting injectable regimen for the treatment of adult patients with HIV, revolutionizing HIV therapy by shifting from daily oral administration 365 days a year to once-monthly injections, totaling 12 injections per year.

The long-acting injectable HIV therapy comprising cabotegravir (CAB) from ViiV Healthcare and rilpivirine (RPV) from Johnson & Johnson is administered via once-monthly intramuscular (IM) injection. Rilpivirine (RPV) is a long-acting non-nucleoside reverse transcriptase inhibitor, while cabotegravir (CAB) is a long-acting HIV-1 integrase strand transfer inhibitor. Currently, this long-acting injectable HIV therapy is being co-developed by ViiV Healthcare and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

The submission of the New Drug Application (NDA) for CAB/RPV is based on data from the global, pivotal Phase III clinical studies ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen). These studies enrolled more than 1,100 patients across 16 countries worldwide. The results confirmed that, over 48 weeks of treatment, once-monthly injections of CAB/RPV demonstrated consistent efficacy in maintaining virologic suppression in adults with HIV-1 infection compared to the standard-of-care, once-daily oral three-drug regimen. These data were presented in March this year at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) held in Seattle, United States.Meetingpublished above.

Deborah Waterhouse, CEO of ViiV Healthcare, previously stated, “CAB/RPV is a long-acting, once-monthly injectable therapy that provides efficacy and safety consistent with the current standard-of-care regimen of once-daily oral three-drug therapy. ViiV Healthcare is proud to be at the forefront of this innovation in HIV treatment, and we look forward to working withFDAcollaboration, providing this new option for people living with HIV in the United States.” (Bioon.com)

Original Source:ViiV Healthcare announces start of first-ever study to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in clinical practice