NICE PROVISIONALLY RECOMMENDS GILEAD'S NEW HEPATITIS C TREATMENT SOVALDI® (SOFOSBUVIR) FOR USE IN ENGLAND & WALES

NICE PROVISIONALLY RECOMMENDS GILEAD'S NEW HEPATITIS C TREATMENT SOVALDI® (SOFOSBUVIR) FOR USE IN ENGLAND & WALES

Cambridge, UK, August 15, 2014 – Gilead Sciences welcomes provisional guidance published today from the National Institute for Health and Care Excellence (NICE) recommending that Sovaldi®▼ (sofosbuvir) should be made available, as part of a combination treatment regimen, to treat the majority of adult patients with chronic hepatitis C (HCV) in England and Wales.1 The rigorous health technology appraisal process has recommended that sofosbuvir represents good value for money for the NHS in an area of high unmet medical need. Sofosbuvir will be reviewed at a committee meeting in September with final guidance expected later in the year.

Sofosbuvir, a new once-daily oral therapy, has been shown in clinical trials to offer cure rates of ≥90% in treatment-naïve adults patients, with a short 12-week course of combination antiviral therapy (peg-IFN+RBV / RBV for G2).2 The societal, clinical and economic burden of untreated hepatitis C is substantial, with HCV-related healthcare costs directly related to disease severity.3,4 Sofosbuvir is generally well tolerated with a good safety profile and allows many more patients the opportunity of cure.2

Treatment with sofosbuvir has been provisionally recommended by NICE 1 for the following populations:

Sofosbuvir in combination with Peg-IFN+RBV

HCV genotype
Adult patient population
Interferon eligibility
Genotype 1
Treatment-naïve
Interferon eligible

Treatment-experienced
Interferon eligible
Genotype 3
Treatment-naïve with cirrhosis
Interferon eligible

Treatment-experienced
Interferon eligible

Sofosbuvir in combination with RBV

HCV genotype
Adult patient population
Interferon eligibility
Genotype 2

Treatment-naïve

Interferon unsuitable
Treatment-experienced
Interferon eligible
Treatment-experienced
Interferon unsuitable
Genotype 3

Treatment-naïve with cirrhosis
Interferon unsuitable

Treatment-experienced with cirrhosis
Interferon unsuitable


"We are pleased that, following a very complex assessment, NICE have recognised the clinical and economic benefit of treatment with sofosbuvir and have determined it is a valuable use of NHS resources for the majority of hepatitis C patients. Given the high unmet need in this area, we will be working with NICE and other stakeholders to ensure hepatitis C patients are able to benefit from the treatment as quickly as possible," said Stelios Karagiannoglou, General Manager, UK, Gilead Sciences Ltd.

While the draft recommendation will potentially grant access to sofosbuvir for the majority of hepatitis C patients, an unmet need still exists for those with specific sub-types of hepatitis C, who are not recommended for treatment with sofosbuvir under this draft guidance.

The draft recommendation also aligns with Government objectives in this therapy area. As highlighted in the recently published Hepatitis C in the UK 2014 report, Public Health England has identified that there is a substantive need to treat those living with hepatitis C and highlights that both increased uptake and new treatments are needed to prevent hepatitis C-related end-stage liver disease in England.5 Left untreated, the consequences of hepatitis C are serious and can cause irreversible scarring to the liver (cirrhosis), liver disease, transplantation and liver cancer, leading to a significant burden on the individual, their family and the NHS.6

While hepatitis C can be cured, up until now many patients have been ineligible, intolerant or unwilling to endure the side effects of standard treatments.7 Existing standard of care can involve up to 48 weeks of treatment and has been associated with side effects such as flu like symptoms.8 Once a patient is cured of hepatitis C, their risk of developing associated liver disease is substantially reduced. Cure also eliminates the risk of hepatitis C transmission.1

NICE's draft recommendation confirming the cost-effectiveness of sofosbuvir is broadly in line with other health technology appraisal body findings. Patients in Scotland have already been granted access to sofosbuvir following a recommendation by the Scottish Medicines Consortium in June that enables a broad range of hepatitis C patients to receive treatment with sofosbuvir.9

Gilead Sciences will be working closely with NICE to help ensure a positive final recommendation can be reached without further delay so that sofosbuvir can become available for the majority of hepatitis C patients across England and Wales.
-Ends-

Notes to editors:

The full NICE appraisal consultation document can be found at:

https://www.nice.org.uk/

About sofosbuvir
Sofosbuvir is a once daily oral treatment indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.2

Recommended regimens and treatment duration for sofosbuvir combination therapy in HCV mono-infected or HCV/HIV-1 co- infected patients follow2:

Patient population
Treatment
Duration
Genotype 1, 4, 5 or 6 CHC
Sofosbuvir + RBV + peg-IFN
12 weeksa,b
Sofosbuvir + RBV

Only for use in patients ineligible or intolerant to peg-IFN
24 weeks
Genotype 2 CHC
Sofosbuvir + RBV

12 weeksb
Genotype 3 CHC
Sofosbuvir + RBV + peg-IFN
Sofosbuvir + RBV
12 weeksb
24 weeks
Patients with CHC awaiting liver transplantation
Sofosbuvir + RBV
Until liver transplantationc
For previously-treated patients with HCV genotype 1 infection, no data exist with the combination of sofosbuvir + RBV and peg-IFN
Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those sub-groups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peg-IFN and RBV therapy).
Special patient populations - The duration of administration of sofosbuvir in patients awaiting liver transplantation should be guided by an assessment of the potential benefits and risks for the individual patient.

Monotherapy is not recommended.

Important Safety Information
Contraindications: Hypersensitivity to the active substance or to any of the excipients.2

Special warnings and precautions for use: The summary of product characteristics of co-prescribed medicinal products should be consulted before starting therapy with sofosbuvir. When sofosbuvir is used in combination with RBV or peg-IFN/RBV, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for a period of time after the treatment as recommended in the Summary of Product Characteristics for ribavirin.2 Refer to the Summary of Product Characteristics for ribavirin for additional information.2

Use with potent P gp inducers: Medicinal products that are potent P glycoprotein (P gp) inducers in the intestine (e.g. rifampicin, St. John's wort [Hypericum perforatum], carbamazepine and phenytoin) may significantly decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of sofosbuvir. Such medicinal products should not be used with sofosbuvir.2

For the Summary of Product Characteristics, please visit: www.ema.europa.eu.

About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians and patients may not see advantages of sofosbuvir over other therapies and may therefore be reluctant to prescribe the product, and the risk that public payers may be reluctant to approve or provide reimbursement for the product. In addition, pending marketing applications for sofosbuvir in other territories may not be approved in the currently anticipated timelines or at all, and marketing approval, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward- looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, as filed with the U.S. Securities and Exchange Commission. All forward- looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

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Sovaldi is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at +1 (650) 574-3000.


References
1.         National Institute for Health and Care Excellence (NICE). Appraisal Consultation Document. Sofosbuvir for treating Hepatitis C. 15 August 2014
2.         Sovaldi SmPC. January 2014

3.         El Khoury A et al. J Med Econ 2012; 15(5):887-96
4.         Blachier M et al. Available at www.easl.eu/assets/application/files/54ae845caec619f_file.pdf [Accessed January 2014]
5.         Public Health England (PHE). Hepatitis C in the UK 2014 report. July 2014. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/337115/HCV_in_the_UK_2014_24_July.pdf  [Accessed August 2014]
6.         Van der Meer AJ, et al. JAMA. 2012; 308(24):2584-2593

7.        North CS et al. Gen Hosp Psych 2012; 35:122-128
8.        NHS Choices. Hepatitis C – Treatment. Available at: http://www.nhs.uk/Conditions/Hepatitis-C/Pages/Treatment.aspx [Accessed August 2014]
9.         Scottish Medicines Consortium. Advice for sofosbuvir. 9th June 2014

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