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– High Rates of Viral Suppression and Improved Renal and Bone Safety Parameters Compared to Viread in Phase 3 Studies –
TAF is a novel, targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to Gilead’s Viread® 245 mg of tenofovir disoproxil (as fumarate) (TDF) at one-tenth of the dose. TAF also demonstrated improvements in surrogate laboratory markers of renal and bone safety compared to TDF in clinical trials.
“Chronic hepatitis B infection is a major health concern in
The MAA for TAF is supported by 48-week data from two Phase 3 studies
which met their primary objective of non-inferiority in efficacy (HBV
DNA compared to TDF among
treatment-naïve and treatment-experienced adults with HBeAg-negative and
HBeAg-positive chronic HBV. In both studies, treatment with TAF showed a
statistically significant increase in serum alanine aminotransferase
normalization relative to the TDF arms when using the
TAF for the treatment of HBV will be reviewed by the EMA under the
centralized licensing procedure which, if authorized, provides marketing
authorization in all 28 member states of the
TAF as a single agent treatment for HBV is an investigational product and its safety and efficacy have not been established.
Important Safety Information About Viread
Please refer to the Viread individual Summary of Product Characteristics for full prescribing information
Presentation:
Viread film-coated tablet containing 245 mg of tenofovir disoproxil (as fumarate), equivalent to 300 mg of tenofovir disoproxil fumarate, or 136 mg of tenofovir. Viread is also available as 33 mg/g granules.
Indications:
1) The treatment of chronic hepatitis B (CHB), in adults with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. 2) Evidence of lamivudine-resistant hepatitis B virus. 3) Treatment of CHB in adults with decompensated liver disease. 4) Treatment of CHB in adolescents 12 to
Dosage & Administration:
Adults: One tablet (245 mg) once daily taken with food. Viread is available as 33 mg/g granules for the treatment of CHB in adults for whom a solid dosage form is not appropriate. No dose modification is necessary in patients with mild to moderate liver disease. Optimal duration of treatment is unknown. Children and adolescents: for the treatment of CHB in adolescents aged 12 to
Contraindications:
Known hypersensitivity to tenofovir, tenofovir disoproxil fumarate, or any of the excipients.
Warnings and Precautions:
Renal: If Viread is co-administered with a non-steroidal anti-inflammatory drug (NSAID), renal function should be monitored adequately. A higher risk of renal impairment has been reported in patients receiving Viread in combination with a ritonavir or cobicistat boosted protease inhibitor. A close monitoring of renal function is required in these patients. Renal failure and impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of Viread in clinical practice. It is recommended that creatinine clearance (CrCl) is calculated in all patients prior to therapy initiation and renal function monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors. In patients at risk of renal impairment, a more frequent monitoring of renal function is required. There are limited data on the safety and efficacy of Viread in adult patients with impaired renal function. Viread should only be used in these patients if the potential benefits outweigh the risks. Interrupting treatment with Viread should be considered in case of progressive decline of renal function when no other cause has been identified. For adult patients with moderate (CrCl
Exacerbations of Hepatitis: Flares on treatment: Spontaneous exacerbations in CHB are relatively common. Patients with cirrhosis may be at higher risk for hepatic exacerbations and therefore should be monitored closely. However it also should be noted that increase in ALT can be part of HBV clearance during therapy with Viread. Flares after treatment discontinuation: Acute exacerbations of hepatitis have also been reported in patients who have discontinued hepatitis B therapy. Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of therapy. Treatment discontinuation is not recommended in patients with advanced liver disease or cirrhosis, since post-treatment exacerbations of hepatitis may lead to hepatic decompensation.
Hepatic Decompensation: There are limited data on the safety and efficacy of Viread in HBV-infected patients with decompensated liver disease and who have a Child Pugh Turcotte (CPT) score > 9. These patients may be at higher risk of experiencing serious hepatic or renal adverse reactions. Therefore, hepatobiliary and renal parameters should be closely monitored in this patient population.
Hepatic Disease: Safety and efficacy data are very limited in liver transplant patients.
Bone: Viread may cause a reduction in bone mineral density (BMD). The effects of Viread-associated changes in BMD on long term bone health and future fracture risk are unknown. If bone abnormalities are detected/suspected in paediatric patients, consult an endocrinologist and/or nephrologist. Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy.
HIV Co-infection: HIV antibody testing should be offered to all CHB patients before initiating Viread therapy. Due to the risk of development of HIV resistance, Viread should only be used as part of an appropriate antiretroviral combination regimen in HIV/hepatitis B virus (HBV) co-infected patients. Patients must be advised Viread has not been proven to prevent the risk of transmission of HIV or HBV to others through sexual contact or contamination with blood and appropriate precautions must be used.
Co-infection with Hepatitis C or D: There are no data on the efficacy of Viread in patients co-infected with hepatitis C or D virus.
Use in Pregnancy and Lactation: The use of Viread may be considered during pregnancy. Viread should not be used during breast feeding.
Drug Interactions:
Viread has a low potential for
Adverse Reactions:
Very commonly reported adverse events (≥ 1/10): hypophosphataemia*, dizziness, diarrhoea, vomiting, nausea, rash, asthenia. Common (≥ 1/100 to
About
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 the
The European SmPC for Viread is available from the EMA website at www.ema.europa.eu
Vireadis a registered trademark of
For more information on
View source version on businesswire.com: http://www.businesswire.com/news/home/20160225006065/en/
Source:
Gilead Sciences, Inc.Patrick O’Brien, +1 650-522-1936InvestorsorArran Attridge, +44 (208) 587-2477Media (Europe)orCara Miller, +1 650-522-1616Media (U.S.)
Investors
Jacquie Ross
investors_relations@gilead.com
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Meaghan Smith
public_affairs@gilead.com
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