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Janssen’s single tablet Symtuza gains NHS England funding 

Janssen and Gilead combination first to reach patients

Janssen has gained NHS England funding for its HIV treatment combination Symtuza, which combines a four drug regimen in a single tablet.

Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]).is once-daily darunavir-based single tablet regimen (STR), for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with a body weight of at least 40 kg.

The global HIV market is dominated by Gilead and ViiV (majority controlled by GSK), but NHS England’s decision is a coup for Janssen, as Symtuza becomes the first STR available to patients who need a protease inhibitor treatment.

Symtuza was approved a year ago in Europe, and brings together Janssen’s protease inhibitor darunavir with Gilead’s cobicistat/emtricitabine/tenofovir alafenamide, a licensing deal agreed between the companies in 2014.

“We are delighted that NHSE has provided vital funding for this treatment option; enabling access for individuals who require a darunavir-based STR to effectively control their HIV, with the potential to support adherence to treatment,” says Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen-Cilag Ltd.

“This milestone reflects our efforts to help simplify the way in which HIV is treated, supporting people living with HIV to achieve an undetectable viral load while enjoying an improved quality of life. We are thankful for NHSE’s collaboration throughout this process.”

The company’s phase 3 EMERALD study showed that virologically-supressed treatment-experienced patients who switched to Symtuza from boosted protease-inhibitor (bPI) based regimens maintained similar virologic response rates and virologic rebound compared to continuing a regimen of boosted PI emtricitabine and TAF.

The ruling puts Symtuza ahead of newly EU-approved rivals in the single tablet regimen field.

Gilead gained European approval for its own new single table regimen, Biktarvy in June, hot on the heels of ViiV’s rival Juluca.

Biktarvy is a combination of integrase inhibitor bictegravir with Gilead’s existing blockbuster Descovy, a combination of emtricitabine (FTC) and tenofovir alafenamide (TAF).

Analysts predict big things for Biktarvy, forecasting revenues of around $896mn this year and $3.7bn for 2022, making long-term HIV treatment more convenient for patients, and showing itself to prevent any cases of drug resistance.

ViiV meanwhile has a monthly injection in its late stage pipeline which could also play a big role in the future development of HIV therapy, while Janssen is also advancing a HIV vaccine.

In England, NHS England tightly control spending on HIV drugs, and has looked to drive down costs in recent years by using more generic treatments. A recent court case also saw Gilead's patent on Truvada overturned in the UK - which HIV campaigners hope will see greater use of the drug to prevent HIV infections.

Article by
Andrew McConaghie

2nd October 2018

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