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02-Oct-2018

HIV treatment Symtuza®? (D/C/F/TAF) receives vital NHS England funding

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced that NHS England (NHSE) will provide critical funding for Symtuza®▼ (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), a once-daily darunavir-based single tablet regimen (STR), for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with a body weight of at least 40 kg.[1]

 

This means that across England, clinicians will be able to routinely prescribe
D/C/F/TAF to eligible patients with HIV-1. NHS England will routinely commission cobicistat when:

  • It is part of the Darunavir/cobicistat/emtricitabine/tenofovir-AF fixed dose combination (FDC) utilised under the tenofovir-AF policy
  • It is part of the Darunavir/cobicistat/emtricitabine/tenofovir-AF FDC, used outside the tenofovir-AF policy where there is a multidisciplinary team (MDT)-documented requirement for this regimen and it falls within regional prescribing guidelines

 

Advances in HIV treatment mean that many people living with HIV who are on therapy are living longer, with a near-normal life expectancy.[2] HIV can now be managed as a chronic disease, as such, treatment simplification strategies can help prevent long-term toxicity and improve adherence and quality of life.[3]

 

D/C/F/TAF is the only single tablet regimen indicated for the treatment of this patient group that combines the proven efficacy and durability of darunavir with the potentially improved renal laboratory and bone mineral density profile of F/TAF as compared to F/TDF (emtricitabine/tenofovir disoproxil fumarate).[4] D/C/F/TAF can offer the convenience of an STR alongside the high genetic barrier to resistance provided by darunavir, while being generally well tolerated; genotypic testing should guide use.4,[5]

 

“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 efficacy and safety of switching to D/C/F/TAF from boosted protease-inhibitor (bPI) based regimens regardless of prior treatment regimen in virologically-supressed treatment-experienced adults, was demonstrated in the pivotal Phase 3 EMERALD study.4 Results showed similar virologic response rates at Week 48 (HIV-1 RNA <50 copies/mL) (94.9 percent vs 93.7 percent) and rates of virologic rebound (2.5 percent vs 2.1 percent) with D/C/F/TAF compared to continuing a regimen of boosted PI emtricitabine and TAF.4 Results were consistent across subgroups based on bPI and boosting agent used at baseline.6 No patients developed resistance to study drugs.4 The most common adverse events in EMERALD (occurred in ≥5% of patients in either arm) were nasopharyngitis, upper respiratory tract infection, diarrhoea, headache, back pain, vitamin D deficiency and osteopenia.4

 

About D/C/F/TAF

D/C/F/TAF is a fixed-dose combination of four active substances (800 mg darunavir,
150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide), available as film-coated tablets.5 Darunavir inhibits the HIV protease and prevents the formation of mature infectious virus particles. Emtricitabine and tenofovir alafenamide are substrates and competitive inhibitors of HIV reverse transcriptase.5 After phosphorylation, they are incorporated into the viral DNA chain, resulting in chain termination. Cobicistat enhances the systemic exposure of darunavir and has no direct antiviral effect.5 Cobicistat, emtricitabine and tenofovir alafenamide are from Gilead Sciences, Inc.

 

The most common (≥ 1/10) adverse events for D/C/F/TAF are headache, diarrhoea, nausea and rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalised rash, and allergic dermatitis).5

 

Prescribing and safety information

For complete prescribing and safety information, please visit: https://www.medicines.org.uk/emc/product/8430

 

▼Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Ltd on 01494 567447 or at dsafety@its.jnj.com.

 

About Janssen

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/uk and follow us at @JanssenUK. Janssen-Cilag Ltd is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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Last Updated: 02-Oct-2018