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Sofosbuvir Approval- Australia/New Zealand
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Sovaldi® (Sofosbuvir) - a new treatment for chronic hepatitis C
[4th July, 2014] Gilead Sciences, Australia New Zealand, today announced that the Therapeutic Goods Administration (TGA) has approved Sovaldi® (sofosbuvir), a new direct acting antiviral treatment, for the treatment of chronic hepatitis C (CHC) infection in adults as a component of a combination antiviral treatment regimen.
Sovaldi is a once-daily treatment that works across all genotypes of hepatitis C.1 It works by stopping part of the process the virus needs to go through in order to replicate itself and is used in combination with other therapies.1 Sovaldi has a treatment duration as short as 12 weeks and is well tolerated with few side effects.1, 2, 3
"Currently, chronic hepatitis C has a high diagnosis rate but a low treatment rate," said Professor Gregory Dore, Head of the Viral Hepatitis Clinical Research Program, Kirby Institute. "Sofosbuvir is a major advance for hepatitis C treatment, enabling shorter treatment duration and less side effects. Its efficacy, lack of resistance, and once daily dosing, should place Sofosbuvir at the forefront of the new era of improved treatments for people living with hepatitis C," he added.
"Sovaldi offers the opportunity to take hepatitis C from a life-threatening chronic disease to one that can be cured in more people," said Rob Hetherington, General Manager Gilead, Australia and New Zealand. "We believe Sovaldi will change the way hepatitis C is treated in Australia and help reverse the growing burden of liver disease and rising death toll from associated diseases."
CHC affects an estimated 230,000 people in Australia.4 CHC is the most common reason for liver transplantation in Australia and a leading cause of liver cancer.5, 6 It is estimated that the number of people with CHC developing advanced liver disease and dying from liver disease-related causes, including liver cancer, will increase dramatically over the coming decades if low treatment levels continue.7, 8, 9
In addition to life-threatening complications, CHC also affects a person's social wellbeing, their ability to work, their relationships and their psychological health.10, 11 Curing them of their CHC infection will lift an enormous social and psychological burden, which will positively impact the individuals living with this disease, their partners and their family members. 7, 12
Sovaldi has been approved for use in chronic hepatitis C infection in adults as a component of a combination antiviral treatment regimen [Sovaldi is indicated for the treatment of adults with chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen].1 Sovaldi is approved in the United States, Canada, Europe and New Zealand.
About Sovaldi
Sovaldi is an oral nucleotide analog inhibitor of the HCV NS5B polymerase enzyme, which plays an essential role in HCV replication. Sovaldi is a direct-acting agent, meaning that it interferes directly with the HCV life cycle by suppressing viral replication. Treatment regimen and duration for Sovaldi are dependent on both viral genotype and patient population. Treatment response varies based on baseline host and viral factors. Monotherapy is not recommended for treatment of CHC.1
About the TGA Submission
The Therapeutic Goods Administration authorisation for Sovaldi is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION in which 12 or 16 weeks of Sovaldi-based therapy was found to be superior or non-inferior compared with the currently available treatment options RBV/peg-IFN or historical controls, based on the proportion of patients who had a sustained virologic response (where HCV becomes undetectable) 12 weeks after completing therapy (SVR12).1 Patients who achieve SVR12 are considered cured of HCV.13 Trial participants taking Sovaldi-based therapy achieved SVR12 rates of up to 90 per cent.1 For full study details, see the Approved Product information provided.
In addition to the above, two Phase 3 studies VALENCE and PHOTON-1 were also evaluated by the TGA. In the VALENCE study, patients with genotype 3 HCV infection were treated with Sovaldi and RBV for 24 weeks. The PHOTON-1 study evaluated Sovaldi and RBV for 12 or 24 weeks in patients with genotype 1, 2 or 3 HCV infection co-infected with HIV-1.1
Sovaldi was well tolerated in clinical studies. Adverse events were generally mild and there were few treatment discontinuations due to adverse events. The most common adverse events occurring in at least 10 per cent of patients were consistent with the safety profiles of peg-IFN and RBV and included fatigue, headache, nausea, insomnia, pruritus (severe itching), anaemia and asthenia.1
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.
Sovaldi is a registered trademark of Gilead Sciences, Inc., or its related companies.
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