FDA approves first two-drug regimen for the treatment of HIV

This week has seen the FDA approve Juluca®, the first two-drug regimen for the maintenance treatment of HIV-1 infection in virologically suppressed adults.

Juluca is a single pill, which can be taken once daily, and presents the first two-drug regemin for HIV, combining dolutegravir (an integrase inhibitor) and rilpivirine (a reverse transcriptase inhibitor).

The journey began in June 2014 when ViiV Healthcare (Brentford, UK), a global specialist HIV company, partnered with Johnson & Johnson (NJ, USA) to investigate the potential of combining dolutegravir and rilpivirine in a single tablet, with the aim of expanding treatment options for those living with HIV. Three years later, the regimen was FDA-approved on November 21st 2017.

Deborah Waterhouse, CEO of ViiV Healthcare, commented: “The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care.  This is the start of a new era in HIV treatment. We are delighted to be able to provide the first two-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term antiretroviral exposure as they receive life-long treatment for their chronic condition.”

The approval is based upon primary data from two Phase III trials, SWORD-1 and SWORD-2, which together demonstrated that the regimen achieved non-inferior viral suppression at 48 weeks compared with known three- or four-drug regimens. Not only were virological suppression rates similar between the treatment arms, drug-related adverse events were also similar, occurring in low frequency in both arms of the study, although marginally more frequently in the investigational arm.

These results have led to the FDA approving Juluca as a complete regimen for the treatment of HIV-1 infection in adults who are virologically supressed and have been on antiretroviral therapy for at least 6 months with no history of treatment failure.

The drug is expected in US pharmacies from December 11th, and Viiv healthcare have stated that, as the first two-drug regimen, they hope this will help to lessen the lifetime burden of treatment in individuals living with HIV. The company have has also submitted for regulatory approval in Europe Canada, Australia and Switzerland.

John C Pottage, Chief Scientific and Medical Officer at ViiV Healthcare, concluded: “Based on the fundamental principle that no one should have to take more medicines than necessary, ViiV Healthcare has put in place a comprehensive two-drug regimen research and development programme built around the characteristics of dolutegravir.

“Juluca, our new two-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen.”

Source: https://www.viivhealthcare.com/media/press-releases/2017/november/viiv-healthcare-announces-us-fda-approval-for-juluca.aspx


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