Monday, February 29, 2016

His Job Is to Sell a $1,000 Pill for $10 Without Losing Money

His Job Is to Sell a $1,000 Pill for $10 Without Losing Money


Gregg Alton has what seems like a disorienting job at Gilead Sciences Inc. He’s paid to figure out how to sell the drug Sovaldi, which infamously retails in the U.S. at $1,000 a pill, for relatively next to nothing.

The instructions for pricing the cure, which wipes out hepatitis C in just 12 weeks, basically go like this: “Get to as many patients as possible in low-income nations --and not lose money,” Alton says. “It’s very simple.”

Actually, it’s not so simple, but it is controversial. Decisions about what to charge around the world for life-saving remedies have spurred debate ever since Big Pharma began offering some discounts after a backlash in the ’90s, when groundbreaking HIV treatments reduced deaths in wealthy countries and not poor ones. Criticism has been harsh with Sovaldi, one of the most expensive and best-selling drugs in history.





Australia - Hep C cures now as cheap as $6.20

Hep C cures now as cheap as $6.20

BY MARGARET SCHEIKOWSKI
MARCH 1, 2016 12:07AM

Breakthrough cheap hepatitis cures are now available to Australians, but many don't even know they have the deadly disease.

Some who do know are unaware of the four different medicines, subsidised by the federal government from March 1, which can cure without the terrible side-effects of previous therapies.

"The drugs themselves are fantastic but they are just a tool," Hepatitis Australia CEO Helen Tyrrell told AAP.

Hepatitis C 'cure' now affordable, but lack of awareness an obstacle

Hepatitis C 'cure' now affordable, but lack of awareness an obstacle

Simon Lauder reported this story on Monday, February 29, 2016 12:30:00

ELEANOR HALL: A new addition to the pharmaceutical benefits scheme is raising hopes of eradication for a deadly disease which affects 230,000 Australians.

A new generation of antiviral drugs has been found to cure Hepatitis C.

But until now, the drugs have been too expensive for most people to afford.

As Simon Lauder reports.

So we are talking about elimination within say a generation we hope to eliminate Hepatitis C.

SIMON LAUDER: But there's one major obstacle to that. Melanie Eagle says at the moment only about 2 per cent of Hepatitis C carriers seek treatment.

MELANIE EAGLE: We are talking deaths at the same rate as we are talking fatalities in cars.



Friday, February 26, 2016

ABBVIE RECEIVES CHMP POSITIVE OPINION FOR VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets)

ABBVIE RECEIVES CHMP POSITIVE OPINION FOR VIEKIRAX® (OMBITASVIR/PARITAPREVIR/RITONAVIR TABLETS) + EXVIERA® (DASABUVIR TABLETS) WITHOUT RIBAVIRIN FOR THE TREATMENT OF CHRONIC HEPATITIS C IN GENOTYPE 1B PATIENTS WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A) IN

- EU LABEL EXPANSION SUPPORTED BY HIGH CURE RATES SHOWN IN TURQUOISE-III STUDY, A DEDICATED PHASE 3B STUDY OF VIEKIRAX + EXVIERA WITHOUT RIBAVIRIN FOR 12 WEEKS

- 100 PERCENT SVR(12) (N=60/60) ACHIEVED IN GENOTYPE 1B PATIENTS WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); NO PATIENTS DISCONTINUED TREATMENT DUE TO ADVERSE EVENTS

Feb 26, 2016
NORTH CHICAGO, Ill., Feb. 26, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).

"This positive CHMP opinion brings us one step closer to delivering a ribavirin-free treatment option for GT1b patients with compensated cirrhosis that has demonstrated high cure rates with no treatment discontinuations in our clinical trial," saidMichael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This milestone reinforces our continued commitment to provide additional treatment options for the HCV community, and we look forward to the final decision by the European Commission."

Approximately 160 million people worldwide are infected with HCV.1 Genotype 1 is the most common type of HCV genotype, accounting for 60 percent of cases worldwide.2 In Europe, the most prevalent genotype is 1b, accounting for 47 percent of the nine million people infected with chronic HCV.3,4

The CHMP opinion of the Type-II variation application for VIEKIRAX + EXVIERA is supported by data from the Phase 3b TURQUOISE-III study, which is part of AbbVie's larger clinical program investigating efficacy and safety in a broad range of GT1 patients. TURQUOISE-III is a dedicated Phase 3 study of VIEKIRAX + EXVIERA without RBV for 12 weeks in GT1b patients with compensated cirrhosis. Results from the TURQUOISE-III study showed 100 percent (n=60/60) of GT1b chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) achieved sustained virologic response at 12 weeks post-treatment (SVR12) with VIEKIRAX + EXVIERA without RBV for 12 weeks.5 No patients discontinued treatment due to adverse events. The most commonly reported adverse events (>10 percent) were fatigue (22 percent), diarrhea (20 percent) and headache (18 percent).5

On January 7, AbbVie announced that its supplemental New Drug Application (sNDA) for VIEKIRA PAK® was accepted and granted priority review by the U.S. Food and Drug Administration (FDA).

About VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.

VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a and GT4 patients with compensated cirrhosis, who should take it for 24 weeks with RBV.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.

Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.



Access: Patent challenge hearing on Gilead hepatitis C drug sofosbuvir starts in India

Access: Patent challenge hearing on Gilead hepatitis C drug sofosbuvir starts in India

‘Patent opposition’ seeks to ensure millions of people left out of Gilead licensing deals can access affordable generics
26 February 2016

New Delhi/New York – In proceedings that could have major implications for millions of people waiting for affordable access to a life-saving hepatitis C drug, the Indian Patent office this week will begin hearings to determine whether US pharmaceutical company Gilead Sciences deserves a patent for sofosbuvir, a hepatitis C drug for which the company currently charges US$1,000 per pill in the US.



Benitec (BLT.AX) to Wind Down and Terminate Hep C Program

Benitec (BLT.AX) to Wind Down and Terminate Hep C Program

Update on TT-034 Hepatitis C Clinical Trial

- A conference call and webcast on this announcement and the Interim Report will be held on Tuesday March 1 at 8:30am AEDT (Australian Eastern Daylight time) and simultaneously on Monday February 29 at 4.30pm EST (US Eastern Standard time)

SYDNEY, Feb. 26, 2016 /PRNewswire/ -- Benitec Biopharma (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) announced today that it will wind-down its hepatitis C program and terminate it upon completion of patients in Cohort 4 in its Phase I/IIa clinical trial for TT-034.

Benitec's Board made the decision to discontinue the hepatitis C program following a review of the commercial opportunities for TT-034. A number of effective therapies have become available for the treatment of hepatitis C since Benitec commenced its clinical trial in January 2014. In recent months, several competitors have made improvements in the efficacy, delivery and success rates of their product treatments while continuing to reduce pricing and treatment duration.

As a result of this increasing competitive landscape and the time required to get TT-034 to market, TT-034 has generated limited and diminishing partnering interest from pharmaceutical companies. The Board has today concluded that the hepatitis C program does not offer the commercial value necessary to attract a worthwhile partnership deal and, as a result, does not warrant additional expenditure or focus of company resources beyond completion of patients in Cohort 4.

Completing the work with patients in Cohort 4 can provide Benitec with valuable data that supports and validates the company's ddRNAi technology platform and other pipeline programs. Benitec is committed to completing the collection of trial data and monitoring patients through the required long-term safety follow-up period. Final data supporting the primary and secondary endpoints of the study will be reported in CYQ4 2016 when the study is completed.

No significant financial obligation will arise from the discontinuance of the hepatitis C program.

Although the hepatitis C program is being discontinued, it is important to note that TT-034 has been shown to be safe and well tolerated, meeting the primary endpoint of the study and, as such, will assist in other programs.

Benitec's Chief Scientific Officer Dr. David Suhy said, "The TT-034 hepatitis C program is a First-in-Man trial. The data presented to date shows that TT-034 transduces hepatic tissues, expresses the anti-HCV shRNA and has a favorable safety profile with no significant adverse events reported relating to the administration of the study drug. Considering the novel characteristics of the drug, administered in a manner that cannot be withdrawn, we are pleased with the validity that TT-034 has shown in this trial. It has provided solid proof of concept for our ddRNAi platform and our other pipeline programs, particularly our hepatitis B program."

Benitec remains focused on advancing its other pipeline programs, including hepatitis B, age-related macular degeneration (AMD) and oculopharyngeal muscular dystrophy (OPMD). The company believes that each of these programs presents attractive commercial opportunities. In particular, the hepatitis B program is attracting considerable interest from pharmaceutical companies. Based on this interest and anticipated in vivo data, combined with a significant potential market opportunity, Benitec will now prioritise the hepatitis B program as its next candidate for clinical development.

Webcast Information and Conference Call:

The Company will host a live audio webcast and conference call on Tuesday, 1 March at 8:30am AEDT/ Monday, 29 February at 4.30pm EST, to provide an operational and financial update.

To access the live webcast please enter at http://services.choruscall.com/links/bntc160229 into your internet browser. Investors will be able to submit questions in writing via the webcast, to be addressed by Benitec's management during the call. To access the conference call please use the dial in details below.

Conference ID: 418337

US dial in: +1 855 624 0077

Australia dial in: 1800 908 299 or 1800 455 963

All other locations dial: +61 2 9007 8048

Shareholders are encouraged to use the webcast link, as conference call lines are limited.

An archive of the webcast will remain available on Benitec's website for 90 days beginning at approximately 5:30pm EST on 1 March 2016. For further information regarding Benitec and its activities, please contact the persons below, or visit the Benitec website at www.benitec.com

Thursday, February 25, 2016

Elbasvir/Grazoprevir - HCV Guidance Website Updated to Reflect Latest Drug Developments

What’s New and Updates/Changes:

This version of the Guidance has been updated to reflect several important developments, including the recent approval of elbasvir/grazoprevir, together with new information regarding the use of testing for HCV resistance associated variants.

Updated recommendations reflecting this approval are provided in these sections:
Initial Treatment of HCV Infection
Retreatment of Persons in Whom Prior Therapy has Failed
Unique Patient Populations: Patients with Renal Impairment

Other updates reflecting recent data are provided in:
Unique Patient Populations: Patients with Decompensated Cirrhosis
Unique Patient Populations: Patients who Develop Recurrent HCV Infection Post-Liver Transplantation
HCV Testing and Linkage to Care

Updated recommendations regarding the monitoring of cirrhotic patients are also provided in:
Monitoring Patients who are Starting Hepatitis C Treatment, are on Treatment, or have Completed Therapy section.

Drug-drug interaction updates are also provided, particularly as they relate to antiretroviral agents and calcineurin inhibitors in:
Unique Patient Populations: Patients with HIV/HCV Coinfection
Unique Patient Populations: Patients who Develop Recurrent HCV Infection Post-Liver Transplantation

Updated references have been provided throughout the Guidance.

Begin here....

Related:
Evidence Review of Zepatier vs. Harvoni and Sovaldi for Hepatitis C

Why America pays so much more for drugs

Why America pays so much more for drugs
By Carolyn Y. Johnson

In a subterranean ballroom Wednesday morning, a panel representing three corners of the health care system took on one of the most perplexing questions about drug prices: Why does the U.S. pay so much more for brand name drugs than other wealthy nations?
The U.S. drug price premium has been shown again and again. It depends on the drug and the country, but a Reuters analysis found that the U.S. pays as much as seven times more than the United Kingdom for some top-selling drugs.

Continue reading...

European Medicines Agency Validates Gilead's Marketing Application for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B

European Medicines Agency Validates Gilead's Marketing Application for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B

Date(s): 25-Feb-2016 10:37 AM

For a complete listing of our news releases, please click here

- High Rates of Viral Suppression and Improved Renal and Bone Safety Parameters Compared to Viread in Phase 3 Studies -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 25, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company's Marketing Authorization Application (MAA) for tenofovir alafenamide (as fumarate) (TAF) 25 mg - an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection - has been fully validated and is now under assessment by the European Medicines Agency (EMA).
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 Europe, with 14 million people living with the disease and more than 1 million Europeans newly infected with the virus each year," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "The validation of this application represents the latest step in our continued efforts to advance the care of people living with progressive liver diseases like HBV."
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 < 29 IU/mL at week 48) 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 American Association for the Study of Liver Disease criteria. Changes in renal and bone laboratory safety parameters favored the TAF treatment regimen. Overall, patients receiving TAF experienced a significantly smaller mean percentage decrease from baseline in hip and spine bone mineral density at week 48 compared to patients receiving TDF. Additionally, the overall median change in serum creatinine from baseline to week 48 favored TAF. Rates of discontinuations due to adverse events and the most commonly reported adverse events were similar in patients receiving TAF or TDF.
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 European Union, Norway and Iceland. Gilead also submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for TAF on January 11, 2016.
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 < 18 years of age with compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis.
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 < 18 years and weighing = 35 kg, recommended dose is one tablet (245 mg) once daily taken with food. The safety and efficacy of Viread in children with CHB aged 2 to < 12 years or weighing < 35 kg have not been established. Viread is also available as 33 mg/g granules for the treatment of CHB in adolescents aged 12 to < 18 years for whom a solid dosage form is not appropriate. Not recommended in paediatric patients with renal impairment. No dose adjustment is required in patients with hepatic impairment. Elderly: Insufficient data are available on which to make dose recommendations for patients over the age of 65 years - caution should be exercised.
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 < 30-49 ml/min) or severe (CrCl < 30 ml/min) renal impairment including haemodialysis patients, daily dose adjustment using Viread 33 mg/g granules is recommended. For adult patients with moderate and severe renal impairment who are unable to use the granules formulation, and with no alternative treatments available, prolonged dose intervals using Viread 245 mg film-coated tablets may be used. Viread is not recommended in paediatric patients with renal impairment. Viread should be discontinued in paediatric patients who develop renal impairment during therapy.
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 CYP450 mediated interactions with other medicinal products. Viread should not be administered concomitantly with other medicinal products containing tenofovir disoproxil fumarate or adefovir dipivoxil, nephrotoxic agents or medicinal products that reduce renal function or compete for active tubular secretion. Monitor renal function if Viread administered with tacrolimus. Co-administration with didanosine is not recommended as it may result in a 40-60% increase in systemic exposure to didanosine which may increase the risk of didanosine-related adverse events. Co-administration with 400 mg daily didanosine has been associated with significant decreases in CD4 cell counts. A reduced dose of 250 mg didanosine administered with Viread has been associated with reports of high rates of virological failure. Co-administration with lopinavir/ritonavir; 30% increase in tenofovir AUC. Co-administration with atazanavir/ritonavir decreased atazanavir concentrations, but increased exposure to tenofovir. Higher tenofovir concentrations could potentiate tenofovir associated adverse events including renal disorders. Food has been shown to enhance the bioavailability of Viread.
Adverse Reactions:
Very commonly reported adverse events (= 1/10): hypophosphataemia*, dizziness, diarrhoea, vomiting, nausea, rash, asthenia. Common (= 1/100 to < 1/10): flatulence, headache, abdominal pain, abdominal distension, fatigue, increased transaminases. Uncommon (= 1/1,000 to < 1/100): hypokalaemia*, pancreatitis, rhabdomyolysis*, muscular weakness, increased creatinine. Rare (= 1/10,000, < 1/1,000): lactic acidosis, hepatic steatosis, hepatitis, angioedema, osteomalacia*, myopathy*, renal failure, acute renal failure, proximal renal tubulopathy including Fanconi syndrome, acute tubular necrosis, nephritis, nephrogenic diabetes insipidus. The side effects marked * may occur as a consequence of proximal renal tubulopathy. In patients with CHB, exacerbations of hepatitis during treatment may arise. Refer to SmPC for full information on adverse events.
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. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
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 European Commission or other regulatory agencies, including the FDA, may not approve TAF for the treatment of chronic hepatitis B and that any marketing approvals, if granted, may have significant limitations on its use. As a result, Gilead may not be able to successfully commercialize TAF for chronic hepatitis B. 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 Annual Report on Form 10-K for the year ended December 31, 2015, 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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O'Brien, +1 650-522-1936
Investors
or
Arran Attridge, +44 (208) 587-2477
Media (Europe)
or
Cara Miller, +1 650-522-1616
Media (U.S.)

Wednesday, February 24, 2016

Predicting the Development of Liver Cirrhosis by Simple Modelling in Patients With Chronic Hepatitis C

Alimentary Pharmacology & Therapeutics

Predicting the Development of Liver Cirrhosis by Simple Modelling in Patients With Chronic Hepatitis C

S. Lens; F. Torres; M. Puigvehi; Z. Mariño; M.-C. Londoño; S. M. Martinez; I. García-Juárez; Á. García-Criado; R. Gilabert; C. Bru; R. Solà; J. M. Sanchez-Tapias; J. A. Carrión; X. FornsDisclosures

Aliment Pharmacol Ther. 2016;43(3):364-374.

Abstract
Summary

Background Data are scarce on the natural history of chronic hepatitis C (CHC) in patients with mild hepatitis C who did not respond to anti-viral therapy.

Aim To predict the risk of progression to cirrhosis, identifying patients with the more urgent need for therapy with effective anti-virals.

Methods A cohort of 1289 noncirrhotic CHC patients treated with interferon-based therapy between 1990 and 2004 in two referral hospitals were followed up for a median of 12 years.

Results Overall, SVR was achieved in 46.6% of patients. Data from a randomly split sample (n = 832) was used to estimate a model to predict outcomes. Among nonresponders (n = 444), cirrhosis developed in 123 (28%) patients. In this group, the 3, 5 and 10-year cumulative probabilities of cirrhosis were 4%, 7% and 22%, respectively, compared to <1% in the SVR-group (P < 0.05). Baseline factors independently associated with progression to cirrhosis in nonresponders were: fibrosis ≥F2, age >40 years, AST >100 IU/L, GGT >40 IU/L. Three logistic regression models that combined these simple variables were highly accurate in predicting the individual risk of developing cirrhosis with areas under the receiving operating characteristic curves (AUC) at 5, 7 and 10 years of ~0.80. The reproducibility of the models in the validation cohort (n = 457, nonresponders = 244), was consistently high.

Conclusions Modelling based on simple laboratory and clinical data can accurately identify the individual risk of progression to cirrhosis in nonresponder patients with chronic hepatitis C, becoming a very helpful tool to prioritise the start of oral anti-viral therapy in clinical practice.

Discussion Only
Full Text Available At Medscape

IFN-based therapies are being replaced by all-oral combinations, at least in those areas of the world in which these molecules are approved and affordable. In this setting, the correct identification of patients at risk of progression to cirrhosis, as well as those with a very low likelihood of progression, is very relevant. However, data on the natural history of patients with mild CHC are scarce, since large cohorts and long follow-up periods are required to assess clinical outcomes.

Evaluation of liver fibrosis is crucial in the assessment of chronic liver disease. However, liver biopsy is an invasive procedure and its accuracy may be limited by sampling error and inter and intra-observer validation.[15] Besides, liver biopsy cannot be repeated during follow-up to assess disease progression, as it may be associated with higher morbidity. In recent years, efforts have been made to develop non-invasive methods for fibrosis staging. Some of the surrogate markers of liver fibrosis have shown a good accuracy; however, data on the usefulness of such methods to predict clinical outcomes are scarce as most studies are transversal and others aim to predict liver-related events in patients who already present advanced liver disease.[16]

The main aim of our study was to develop and validate a simple model to accurately predict individual probabilities to develop liver cirrhosis. We retrospectively assessed a large number of patients mainly with mild stages of fibrosis at baseline, who underwent anti-viral therapy and were prospectively followed up for a median of 12 years. As expected, patients who achieved an SVR had excellent outcomes, with a very low incidence of cirrhosis (<1% at 10 years) and no cases of clinical decompensation. In accordance to previous data,[17, 18]the risk of HCC remained very low after SVR [two patients (0.33%), both with baseline bridging fibrosis]. On the contrary, the cumulative probability of developing cirrhosis during follow-up was remarkably high in nonresponders (7% at 5 years and 22% at 10 years), reinforcing the need of tools to accurately predict the risk of fibrosis progression. The clinical variables associated with the development of liver cirrhosis were the presence of significant fibrosis at baseline, older age, and high AST and GGT levels, which have been previously shown to be related to fibrosis progression in patients with CHC.[19–21]

According to the more recent international guidelines, all patients with chronic hepatitis C infection should be referred and considered for anti-viral therapy. The appropriate drug combination should be chosen depending on HCV genotype and subtype, the severity of liver disease and the availability of the different therapies in each country. IFN-containing regimens have globally been replaced by all-oral, IFN-free therapies with DAAs, at least in those areas of the world where these regimens are approved and their cost is covered.[22]Nevertheless, the huge economical differences between countries make IFN-free therapies not affordable for all Health Care systems. In countries where the indication of DAAs may be restricted because of budget constraints, a careful selection of candidates at risk of disease progression is crucial.

Using baseline variables with an independent predictive value, we constructed three models to forecast individual probabilities for developing liver cirrhosis over time. Model I included AST, GGT, age and fibrosis stage, while model II was simplified by excluding the information provided by liver histology. Model III was generated by including well-known and validated non-invasive fibrosis scores. All three models were equally accurate at estimating the individual risk of progression to cirrhosis among nonresponders in the long-term. Moreover, the classification of nonresponder patients according to the associated baseline probability of developing cirrhosis obtained from the multivariate logistic model was discriminative in our sample throughout the follow-up period: the highest risk group had a probability of developing cirrhosis greater than 20% over 10 years, while the lowest risk group was associated with a very low probability of developing cirrhosis (<5%). The latter may be reassuring (both for doctors and patients) if these individuals are advised to defer therapy.

Figures for models I and III are almost identical as both take into account fibrosis stage either by histological assessment or by Forns index value (Figures 2 and 4). Model II, which is based only in three variables, was accurate at identifying those patients with a very lower risk of progression but did not discriminate between individuals with intermediate and high risk of cirrhosis development (Figure 3). Importantly, the assessment of the reproducibility of the models in the validation cohort showed equally good results even in the long-term follow-up, thus strengthening the statistical power of the models.

Our study has several limitations. The first derives from the lack of paired biopsies in order to establish the diagnosis of cirrhosis, which would have provided further validation to our findings. Nevertheless, we believe that the established criteria for diagnosing liver cirrhosis were those used in routine clinical practice[12, 13] and are very accurate. For those patients in whom the diagnosis relied on US, and in order to exclude inter-observation bias, the US images were recovered and blindly re-assessed by expert radiologists to confirm the diagnosis of cirrhosis. Nonetheless, the fact that the same variables of the models were also associated with clinical decompensation or HCC (outcomes not subjected to inconsistencies) strengthens the criteria used to diagnose cirrhosis in this cohort.

A second limitation is the lack of a baseline transient elastography (TE), which is widely used in Europe to assess the fibrosis stage.[23, 24] However, the method was implemented in our Unit in 2005 and thus, the data was not available in most patients. If a baseline TE might improve the predictability of our current models needs to be assessed in future studies. Third, a selection bias cannot be excluded due to the retrospective nature of the study; our models would need further validation in a prospectivelyfollowed cohort.

Finally, in a few years from now and in a decreasing-cost scenario, anti-viral therapy might be offered to the patients even if they have a very low risk of cirrhosis after 10 years.

The strengths of our study are the large cohort of patients with a well-characterised disease and the fact that patients were followed in two large referral centres by an established protocol and the long follow-up period. An additional strength is that besides identifying patients at highest risk of progression of cirrhosis, our models are able to recognise those patients with a remarkably low risk of progression, thus facilitating clinical decisions in routine practice.

In conclusion, sustained virological response to interferon-based therapy in patients with noncirrhotic CHC eliminates liver-related complications in the long term. Among patients with chronic hepatitis C, modelling based on simple laboratory and clinical data is helpful at identifying the individual risks of progression to cirrhosis and could be used in clinical practice to better allocate patients in treatment protocols.





Tuesday, February 23, 2016

New recommendations in the updated WHO guidelines for the screening, care and treatment of persons with chronic hepatitis C infection



New recommendations in the updated WHO guidelines for the screening, care and treatment of persons with chronic hepatitis C infection

Policy brief

Authors: WHO

Publication details
Number of pages: 12
Publication date: February 2016
Languages: English
WHO reference number: WHO/HIV/2016.01

Downloads
Policy brief on new recommendations in the updated hepatitis C guidelines
pdf, 194Kb

Background
The World Health Organization (WHO) issued the first Guidelines for the screening, care and treatment of persons with hepatitis C infection in 2014. Since then, several new medicines for the treatment of HCV infection have been introduced. These medicines are transforming the treatment of HCV, enabling the use of regimens that can be administered orally, are shorter in duration (as short as eight weeks), result in cure rates higher than 90%, and are associated with fewer serious adverse events (SAEs) than the previous interferon-containing regimens.

The objectives of these updated WHO Guidelines are to provide evidence-based recommendations for the treatment of persons with hepatitis C infection using, where possible, all-oral combinations of these new medicines, also called direct-acting antivirals (DAAs).

Thousands recalled for hepatitis C test after NHS worker's diagnosis

Thousands recalled for hepatitis C test after NHS worker's diagnosis

More than 8,000 people advised to have blood test after Lanarkshire health trust finds two former patients probably infected

More than 8,000 patients who may have been treated by a former NHS healthcare worker who tested positive for hepatitis C are being advised to have a blood test, Lanarkshire health trust said.

The trust is contacting patients who may have had a surgical procedure carried out by the NHS employee before the worker tested positive for the virus in 2008 and ceased clinical practice.

At the time the individual tested positive, the UK Advisory Panel advised that a patient notification exercise was not necessary, the trust said. It was being done now because its health protection team had been made aware of two patients who were probably infected with the virus during procedures carried out by the healthcare worker.

Continue reading...

SCOTLAND LEADS HEPATITIS C PATIENT NOTIFICATION EXERCISE
Public Health England (PHE) has been working closely with NHS Lanarkshire, NHS England and other agencies in other parts of the UK to notify patients who may have had a surgical procedure carried out by the former healthcare worker between 1982 and 2008.

Advice from Scottish and UK experts is that the risk of the hepatitis C virus having been transmitted to a patient during surgery involving the healthcare worker is low.

8,443 patients, mainly from Lanarkshire, but also from across Scotland and the rest of the UK, are receiving letters this week informing them of the situation and recommending that they arrange an appointment for a blood test. Only patients who have received a letter need to undergo hepatitis C testing. There are 336 patients in total in England who are being contacted.

Dr James Sedgwick, Consultant Epidemiologist at PHE said:

We would like to reassure people that the likelihood of patients acquiring the virus from a surgical procedure carried out by the healthcare worker is low.

We know that some people receiving the letter will be concerned about what this means for them. Although the risk of infection is low, we are recommending that people take up the offer of a blood test to ensure that anyone who may have the virus can receive the right treatment. The latest treatment for hepatitis C is very effective.

To ensure a consistent and coordinated approach for all patients, PHE and NHS Lanarkshire have been working with partner organisations and agencies including:
other Scottish health boards
Health Protection Scotland
NHS England
Public Health Agency of Northern Ireland
Public Health Wales
UK Advisory Panel for Healthcare Workers Infected with Blood Borne Viruses (UKAP)

Prior to 1982, the healthcare worker worked in England. Hospital trusts where the healthcare worker was employed are being contacted to determine whether records are available to identify patients who underwent surgical procedures performed by the healthcare worker during this period. Any further patients identified in England will be contacted by letter and invited for testing.

Videos and other information about hepatitis C and the public health exercise are available at www.nhslanarkshire.org.uk. More information about hepatitis C is also available from the Hepatitis C Trust.

Monday, February 22, 2016

Bristol-Myers Squibb (NYSE:BMY) Presents Data on All-Oral Hepatitis C Regimen

Bristol-Myers Squibb (NYSE:BMY) Presents Data on All-Oral Hepatitis C Regimen
By Carol Harper February 22, 2016
Bristol-Myers Squibb Co (NYSE:BMY) presented the first completed all-oral hepatitis C regimen’s late stage trial data at the Asian Pacific Association for the Study of the Liver conference (APASL) in Japan.... 

Primary Endpoint
Bristol-Myers Squibb said that the trial’s primary endpoint was a sustained virologic response post-treatment at 24 weeks, or SVR24. The company indicated that 91% of the patients from China have achieved SVR24 in the trial and that it increased to 98% of patients without any resistant variants at baseline. The company said that SVR24 results were high in all subgroups with genotype 1bHCV. That includes cirrhosis patients, and patients from Korea and Taiwan.....
Continue reading...

Press Release
Data Presented at APASL from First Completed Phase 3 Trial of All-oral Chronic Hepatitis C Regimen in Chinese Patient Population Shows Daclatasvir and Asunaprevir DUAL Therapy Demonstrated High Cure Rates Among HCV Genotype 1b Patients
Monday, February 22, 2016 6:59 am EST

"This is an important finding because the burden of HCV in China is extremely high, and newer direct-acting antivirals have yet to be introduced for any patients."

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced data from the first completed all-oral chronic hepatitis C (HCV) regimen Phase 3 trial that includes a Chinese patient population. The results of the registrational trial, which studied daclatasvir in combination with asunaprevir for 24 weeks in Asian (non-Japanese) patients with genotype 1b HCV, were presented today at the Asian Pacific Association for the Study of the Liver Conference (APASL) in Tokyo. Genotype 1b is particularly prevalent in China, where interferon/ribavirin combination regimens are still the current standard of care.

The primary endpoint of the study was sustained virologic response at post-treatment week 24 (SVR24). In the study, 91% of patients from China achieved SVR24, which rose to 98% of patients without NS5A resistance-associated variants (RAVs) at baseline. SVR24 results were similarly high across all subgroups with genotype 1b HCV, including those with cirrhosis (90%), and patients from Korea (94%) and Taiwan (87%).

SVR24 rates were also higher in all patients without baseline NS5A RAVs (n=137/139 [99%]), regardless of the presence (98%) or absence (99%) of cirrhosis, and lower in patients with baseline NS5A RAVs (n=8/19 [42%]). Baseline NS5A RAVs were present in 12% of patients. HCV NS5A RAVs exist naturally (albeit in lower prevalence vs wildtype) and can emerge after virologic response failure. Screening for the presence of specific NS5A mutations can help physicians determine the best patients for treatment by identifying those most likely to achieve cure with an NS5A-containing regimen.

In the trial presented today, across all patient cohorts, all serious adverse events (SAEs) (n=5/159 [3%]), grade 4 laboratory abnormalities (n=3/159 [1.9%]) and deaths (n=1/159 [1%]) that occurred on treatment were unrelated to the study drugs. Two patients discontinued due to adverse events (AEs). The most common AEs (> 5% of patients) were decrease in platelets (9%), upper respiratory tract infection (8%), ALT increase (7%), ANC decrease (7%), monocyte decrease (6%), white blood cell decrease (6%), thrombocytopenia (6%), and pruritus (6%).

“These results signal that the daclatasvir and asunaprevir regimen could provide a highly effective all-oral, interferon- and ribavirin-free treatment for many Chinese HCV patients with genotype 1b infection,” said Dr. Lai Wei, Professor of Hepatology & Medicine and Director, Peking University Hepatology Institute, Chief, Department of Hepatology, Peking University People’s Hospital. “This is an important finding because the burden of HCV in China is extremely high, and newer direct-acting antivirals have yet to be introduced for any patients.”

The daclatasvir and asunaprevir regimen already is approved by regulatory authorities in several countries across the Asia Pacific region, including Japan, Korea and Taiwan, as well as in some countries in Latin America and Eastern Europe. At APASL, Bristol-Myers Squibb is also presenting other data for the daclatasvir and asunaprevir regimen in Asian populations, including integrated safety, pooled resistance and pooled exposure data.

“So much progress has been made globally in the fight against chronic hepatitis C, but the battle against the disease is not over,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “At Bristol-Myers Squibb, we continue to seek out areas and patient populations that remain in need of new treatment solutions, such as China, where at last count 13 million people are estimated to be living with the disease.”

Study Design

The Phase 3, open-label study evaluated daclatasvir and asunaprevir in interferon- ineligible and/or intolerant non-Japanese Asian patients with chronic HCV genotype 1b infection. Patients received daclatasvir 60 mg (tablet) once daily plus asunaprevir 100 mg (soft capsule) twice daily for 24 weeks. The primary endpoint was sustained virologic response at post-treatment week 24 (SVR24). The study treated 159 patients overall, 80% from mainland China, 11% from Korea and 9% from Taiwan, including patients with cirrhosis (33%), IL28B nonCC genotypes (40%), and aged ≥70 years (4%).

About Hepatitis in China

HCV represents a significant public health burden in China and is now the fourth most commonly reported infectious disease countrywide. An estimated 13 million Chinese are currently living with HCV, and genotype 1b, one of seven major genotypes of the virus, is the most common, representing 57% of the total infected population in China.

About Daclatasvir

In many countries, daclatasvir, marketed as Daklinza, is approved as part of a regimen with sofosbuvir. Daklinza is approved by the U.S. Food and Drug Administration (FDA) for use with sofosbuvir, with or without ribavirin, for the treatment of patients with HCV genotype 1 or genotype 3 infection. SVR rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving Daklinza in combination with sofosbuvir for 12 weeks. When Daklinza is used in combination with other agents, the contraindications applicable to those agents are applicable to the combination regimen. Daklinza is contraindicated in combination with drugs that strongly induce CYP3A and P-glycoprotein transporter, and, thus, may lead to lower exposure and loss of efficacy of Daklinza. Please see full Important Safety Information below for more details.

About Bristol-Myers Squibb in HCV

Bristol-Myers Squibb is focused on helping to eradicate hepatitis C around the world, with a primary emphasis on difficult-to-treat patients, including those millions in countries where population-based HCV solutions remain a high unmet need.

In July 2014, Japan became the first country in the world to approve the use of a daclatasvir-based regimen for the treatment of chronic hepatitis C. Since then, daclatasvir-based regimens have been approved in more than 50 countries across Europe, Central and South America, the Middle East and the Asia-Pacific region.

U.S. Indication and Important Safety Information - DAKLINZA™ (daclatasvir)

INDICATIONS

Daklinza™ (daclatasvir) is indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection.

Limitations of Use:
Sustained virologic response (SVR12) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving Daklinza in combination with sofosbuvir for 12 weeks.

CONTRAINDICATIONS
When used in combination with other agents, the contraindications applicable to those agents are applicable to the combination regimen; refer to the respective prescribing information.
Drugs contraindicated with Daklinza: strong inducers of CYP3A that may lead to loss of efficacy of Daklinza include, but are not limited to:
-Phenytoin, carbamazepine, rifampin, St. John’s wort (Hypericum perforatum).

WARNINGS AND PRECAUTIONS
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Coadministration of Daklinza and other drugs may result in known or potentially significant drug interactions. Interactions may include the loss of therapeutic effect of Daklinza and possible development of resistance, dosage adjustments for other agents or Daklinza, possible clinically significant adverse events from greater exposure for the other agents or Daklinza.
Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone: Post-marketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with sofosbuvir in combination with another direct-acting antiviral, including Daklinza. A fatal cardiac arrest was reported with ledipasvir/sofosbuvir.
-Coadministration of amiodarone with Daklinza in combination with sofosbuvir is not recommended. For patients taking amiodarone who have no alternative treatment options, patients should undergo cardiac monitoring, as outlined in Section 5.2 of the prescribing information.
-Patients also taking beta blockers or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone.
-Bradycardia generally resolved after discontinuation of HCV treatment.
Risks Associated with Ribavirin Combination Treatment: If ribavirin is used as part of the regimen, the warnings and precautions for ribavirin, particularly the pregnancy avoidance warning, apply. See the ribavirin full prescribing information for complete information.

ADVERSE REACTIONS
In clinical trials (Ally 2, 3) with the Daklinza and sofosbuvir regimen, themost common adverse reactions (≥ 5%) were, respectively: headache (8%, 14%), fatigue (15%, 14%), nausea (9%, 8%), diarrhea (7%, 5%).
In clinical trials (Ally 1) with Daklinza, in combination with sofosbuvir and ribavirin, the most common adverse reactions (≥ 5%) were, in the cirrhosis cohort and the post-liver transplantation cohort, respectively: headache (12%, 30%), anemia (20%, 19%), fatigue (15%, 17%), nausea (15%, 6%), rash (8%, 2%), diarrhea (3%, 6%), insomnia (3%, 6%), dizziness (0, 6%), somnolence (5%, 0).

DRUG INTERACTIONS
CYP3A: Daklinza is a substrate. Moderate or strong inducers may decrease plasma levels and effect of Daklinza. Strong inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) may increase plasma levels of Daklinza.
P-gp, OATP 1B1 and 1B3, and BCRP: Daklinza is an inhibitor, and may increase exposure to substrates, potentially increasing or prolonging their adverse effect.
See Sections 4, 7, and 12.3 of the Daklinza Full Prescribing Information for additional established and other potentially significant drug interactions and related dose modification recommendations. Refer to the prescribing information for other agents in the regimen for drug interaction information.

DAKLINZA IN PREGNANCY:
No adequate human data are available to determine whether or not DAKLINZA poses a risk to pregnancy outcomes. Animal studies of Daklinza at exposure above the recommended human dose have shown maternal and embryofetal toxicity.
If Daklinza and sofosbuvir are administered with ribavirin, the information for ribavirin with regard to pregnancy testing, contraception, and infertility also applies to this combination regimen.Refer to the ribavirin prescribing information.

NURSING MOTHERS:
It is not known whether DAKLINZA is present in human milk, affects human milk production, or has effects on the breastfed infant. Daklinza was present in the milk of lactating rats. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for DAKLINZA and any potential adverse effects on the breastfed child from DAKLINZA or from the underlying condition.
When Daklinza is administered with ribavirin, the nursing mothers’ information for ribavirin also applies to this combination regimen. Refer to the nursing mothers’ information in the ribavirin prescribing information.

Please click here for the Daklinza full prescribing information.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us onLinkedIn, Twitter, and YouTube.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that daclatasvir and asunaprevir will be approved for the indication mentioned above. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2015, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.



Listen: Australia Hepatitis C treatment coming to PBS

Listen: Hepatitis C treatment coming to PBS

Monday 22 February 2016 5:50PM

Listen Now
Download

Monday 5.30pm
Repeated: Tuesday 5:30am
Presented by Dr Norman Swan
(view full episode)

Hepatitis C impacts 230,000 Australians.

A direct acting antiviral hepatitis C treatments will be available on the Pharmaceutical Benefits Scheme (PBS) from March 2016.

Australia are 18 months behind the U.S. roll out of this treatment - a result of the Australian government's protracted negotiations.

Hepatitis C is a chronic disease that can be cured – Helen Tyrrell, CEO of Hepatitis Australia, sees a possibility of it being eliminated in the next 15-20 years.

Sunday, February 21, 2016

Evidence Review of Zepatier vs. Harvoni and Sovaldi for Hepatitis C

Evidence Review of Zepatier vs. Harvoni and Sovaldi for Hepatitis C

Summary:
Comparing 3 Direct-Acting Antiviral Agents for HCV: A Review of the Evidence
Jackie Syrop
Published Online: February 21, 2016

According to Advera’s report, as a standalone therapy Harvoni appears more effective in treatment-naïve patients, while Zepatier and Harvoni seem to have similar efficacy in treatment-experienced patients. Zepatier, Harvoni, and Sovaldi are direct-acting antiviral (DAA) agents that treat HCV.  
The analysis noted that Harvoni and Sovaldi are associated with AEs such as cardiac arrest, suicidal ideation, and suicide, while Zepatier’s label does not include these AEs. Initial analysis of Zepatier’s label showed comparatively fewer AEs (29 vs 41 for Sovaldi). Liver cirrhosis, the only Important Medical Event (IME) listed on the label, is largely associated with HCV and not with the drug.
Continue reading... 

Special Report Download
Evidence Review of Zepatier vs. Harvoni and Sovaldi for Hepatitis C

By Downloading this report you will:
Receive an in-depth review of the clinical safety and efficacy evidence for Zepatier (elbasvir, grazoprevir)

Understand how that evidence compares to Harvoni's (sofosbuvir, ledipasvir) and Sovaldi's (sofosbuvir) clinical evidence, including monograph ready tables

Gain access to the latest real world safety evidence on Harvoni and Sovaldi, including new safety signals and updated cost of side effect analysis

Drugs Included in this Report:
Zepatier (elbasvir, grazoprevir), Merck
Sovaldi (sofosbuvir), Gilead
Harvoni (ledipasvir and sofosbuvir), Gilead

For full access to this free report, please complete the form on this page.

Please note: This is an independent analysis conducted by Advera Health, based upon data and insight generated by the analytical tools of Adverse Events Explorer and other pertinent information gathered at the time of publication. This analysis is not sponsored or influenced by any third party. The inclusion of a particular company, drug, adverse event, class or indication in this report is determined wholly by our quantitative signaling and analytic systems along with our qualitative analysis work.

Begin here....



Friday, February 19, 2016

Second State Sued Over Hepatitis C Medication Access

Second State Sued Over Hepatitis C Medication Access
By KRISTIN GOURLAY

Medicaid patients in Washington state (a similar suit is underway in Indiana) have sued the state's Medicaid agency claiming they were denied treatment for hepatitis C because of the high cost of the drugs. Litigation director Kevin Costello with the Harvard Center for Health Law and Policy Innovation says his organization has joined the lawsuit.

Thursday, February 18, 2016

Watch - The cost of the curing Hepatitis C - BBC Newsnight

The cost of the curing Hepatitis C - BBC Newsnight
Published on Feb 18, 2016
BBC Newsnight 

New drugs are now available to cure Hepatitis C, but why are they so expensive? Filmmaker Kate Brown explores the cost of curing Hepatitis C, and Evan Davis speaks to Virginia Acha, Executive Director of the Association of the British Pharmaceutical Industry.

 


February Updates
Reducing the cost of new hepatitis C drugs
Sovaldi Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000 Hepatitis Drug
Check out an index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.


Wednesday, February 17, 2016

RG-101 Interim Analysis Shows 97% Response at 8 Week Follow-Up- RG-101 Containing Regimen

RG-101 Interim Analysis Shows 97% Response at 8 Week Follow-Up- RG-101 Containing Regimen 

Has Potential to Reduce Harvoni®, Olysio®, or Daklinza™ Rx to 4 Week Duration -

- Regulus to Accelerate Development of RG-101 as Backbone Therapy in HCV -

- Conference Call at 8:30am EST Today -
LA JOLLA, Calif., Feb. 17, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced interim results from one of the company's ongoing Phase II studies of RG-101 for the treatment of Hepatitis C Virus infection (HCV). The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral agents Harvoni®, Olysio®, or Daklinza™. The study enrolled 79 treatment naïve genotype 1 and 4 HCV patients (Harvoni® arm, n=27, Olysio® arm, n=27, Daklinza™ arm, n=25). Thirty-eight patients have been evaluated through 8 weeks of follow up. Ninety-seven percent of those patients (37/38) had HCV RNA viral load measurements below the limit of quantification. To date, RG-101 has been generally well tolerated with the majority of adverse events considered mild or moderate, and with no study discontinuations. For those patients through 12 weeks of follow-up, 100% remained below the limit of quantification (14/14). The primary endpoint analysis (12 week follow up) for all 79 patients in the study are anticipated to be reported in late Q2 2016.

"These sustained virologic responses demonstrate the potential ability of RG-101 to successfully reduce currently marketed oral treatment regimens to just four weeks, a major clinical breakthrough that the HCV field has not been able to achieve until today and I look forward to future results," said Eric Lawitz, M.D., Vice President, Scientific and Research Development, The Texas Liver Institute, and Clinical Professor of Medicine, University of Texas Health Science Center in San Antonio. "In addition, I believe this novel approach might allow treating physicians to overcome compliance issues in a wide variety of patient populations."

"The potent antiviral activity and sustained, durable responses observed from this interim analysis, provide evidence that RG-101 may have clinical utility as a potential backbone agent in combination with oral therapies to treat a wide range of HCV patients," said Paul Grint, M.D., President and CEO of Regulus. "Based on the results announced today, Regulus intends to accelerate development of RG-101 given its promising potential to shorten treatment regimens."

Conference Call & Webcast Information

Today at 8:30 a.m. EST, Regulus will host a conference call and webcast to discuss these interim results. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 54426274. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 54426274. The webcast and telephone replay will be archived on the company's website following the call.

About Hepatitis C Virus Infection (HCV)

Hepatitis C is a result of a hepatocyte specific infection induced by the virus known as HCV. Chronic HCV may lead to significant liver disease, including chronic active hepatitis, cirrhosis, and hepatocellular carcinoma. Up to 185 million people are chronically infected with HCV worldwide, and more than 500,000 people die from HCV annually. The CDC estimates that there are currently approximately 3.5 million persons infected with HCV in the United States. HCV shows significant genetic variation in worldwide populations due to its frequent rates of mutation and rapid evolution. There are six genotypes of HCV, with several subtypes within each genotype, which vary in prevalence across the different regions of the world. The response to treatment varies from individual to individual underscoring the inadequacy of existing therapies and highlights the need for combination therapies that not only target the virus but endogenous host factors as well, such as microRNA-122. Regulus believes that its miR-122 antagonist, RG-101, may be a useful agent in emerging combination regimens to address difficult-to-treat genotypes and to potentially expand upon the current therapies available to clinicians treating HCV patients.

About RG-101 for HCV

RG-101 is Regulus' wholly-owned, GalNAc-conjugated anti-miR targeting miR-122 for the treatment of HCV. In a completed Phase I human proof-of-concept study, Regulus demonstrated that treatment with a single subcutaneous dose of RG-101 as monotherapy resulted in significant and sustained viral load reductions in all treated HCV patients, including patients with difficult to treat genotypes, various liver fibrosis status and those who have experienced viral relapse after a prior IFN-containing regimen.

Recently, Regulus presented favorable interim data from an ongoing Phase II study evaluating the combination of RG-101 with multiple approved DAAs positioning RG-101 for both front-line and second-line commercial opportunities. Patients received a single subcutaneous injection of 2 mg/kg of RG-101, followed by 28 days of once daily DAAs Harvoni®, Olysio®, or Daklinza™, followed by an additional subcutaneous injection of 2 mg/kg of RG-101 on Day 29. Regulus is planning to report primary endpoint analysis at 12 weeks following conclusion of treatment in late Q2 2016.

In the first-quarter of 2016, Regulus, in collaboration with GSK, plans to initiate a Phase II study evaluating the combination of RG-101 and GSK2878175, a non-nucleoside NS5B polymerase inhibitor, in treatment-naïve patients chronically infected with HCV genotypes 1 and 3. Additionally, enrollment is expected to complete in the first half of 2016 in a multi-center, open label, non-randomized Phase I study to compare the safety, tolerability, pharmacokinetics, and pharmacodynamics of 2 mg/kg of RG-101 in subjects with severe renal insufficiency or end-stage renal disease (ESRD) to healthy control subjects, and further explore RG-101 in hepatitis C infected subjects with severe renal insufficiency or ESRD.

About microRNAs

The discovery of microRNAs in humans during the last decade is one of the most exciting scientific breakthroughs in recent history. microRNAs are small RNA molecules, typically 20 to 25 nucleotides in length, that do not encode proteins but instead regulate gene expression. More than 800 microRNAs have been identified in the human genome, and over two-thirds of all human genes are believed to be regulated by microRNAs. A single microRNA can regulate entire networks of genes. As such, these molecules are considered master regulators of the human genome. microRNA expression, or function, has been shown to be significantly altered or dysregulated in many disease states, including oncology, fibrosis, metabolic diseases, immune-inflammatory diseases and HCV. Targeting microRNAs with anti-miRs, chemically modified, single-stranded oligonucleotides, offers a unique approach to treating disease by modulating entire biological pathways and may become a new and major class of drugs with broad therapeutic application.

About Regulus

Regulus Therapeutics Inc. (NASDAQ: RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a maturing microMarkersSM biomarkers platform and a rich intellectual property estate to retain its leadership in the microRNA field. Regulus is developing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection, and RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy. In addition, RG-125, a GalNAc-conjugated anti-miR targeting microRNA-103/107 for the treatment of NASH in patients with type 2 diabetes/pre-diabetes, has entered Phase I clinical development through its strategic alliance with AstraZeneca. Regulus is also advancing several programs toward clinical development in orphan disease indications, oncology and fibrosis. Regulus' commitment to innovation has resulted in multiple peer-reviewed publications in notable scientific journals and has resulted in the formation of strategic alliances with AstraZeneca and Sanofi. Regulus maintains its corporate headquarters in La Jolla, CA. For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to development and other activities related to RG-101), the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus' business plans, technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by Regulus. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Regulus' financial position and programs are described in additional detail in Regulus filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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HCV Next - Women with HCV Postmenopause May Experience Insulin Resistance

HCV Next - A Roadmap to Building a Community HCV Center

"HCV Next" features cutting edge news on the latest HCV research developments. With in-depth articles on a range of topics; diagnosis, hepatitis c treatment regimens, side effects, drug/drug interaction, guidelines, practice management issues, to name a few.

The following articles appeared in the February issue of HCV NEXT, provided online at Healio.

Table of Contents

COVER STORY

GUEST EDITORIAL


SPECIAL SERIES

TREND WATCH


Hepatitis C-Free Europe is Possible by 2030

Hepatitis C-Free Europe is Possible by 2030

BRUSSELS, February 17, 2016 /PRNewswire/ --

Europe's leading experts, medical specialists and patient advocacy groups on hepatitis announced their intention to work towards the elimination of Hepatitis C Virus (HCV) in Europe by 2030.

The 'Hepatitis C Elimination Manifesto' was presented at the first EU HCV Policy Summit, organised by the Hepatitis B and C Public Policy Association, and supported by the main European patient and clinician groups.

Signatories of the 'Hepatitis C Elimination Manifesto' pledge to:
- Make hepatitis C and its elimination in Europe an explicit public health priority
to be pursued at all levels
- Ensure that patients, civil society groups and other relevant stakeholders are
directly involved in developing and implementing hepatitis C elimination strategies
- Pay particular attention to the links between hepatitis C and social marginalisation
- Introduce a European Hepatitis Awareness Week

Vytenis Andriukaitis, Commissioner for Health and Food Safety, delivered a keynote speech at the event, commenting: "Hepatitis C has in the past been referred to as a "silent" epidemic within the European Union. It is high time that we brought this "silent" epidemic out of the shadows and into the light, so I welcome initiatives such as this Summit and the Elimination Manifesto to create momentum for action, for raising awareness and for stimulating discussion".

After twenty five years of research, scientists have delivered the means to effectively cure hepatitis C, paving the way for elimination in Europe within the next decade. "What would have taken a hundred years for us to achieve, is now at hand! This is a unique opportunity, but political action is needed to make this happen", stated Prof Angelos Hatzakis, Co-Chair of the Hepatitis B and C Public Policy Association. "Our 'Elimination Manifesto' is a rallying platform for policymakers and advocates. If we act now, Europe will be hepatitis C free by 2030", continued Prof Hatzakis.

The specific challenges of hepatitis C require holistic, people-centred, health system-wide approaches to disease awareness, prevention and integrated care, with all stakeholders combining their diverse skills and resources in a unified response.
"Succeeding against hepatitis C in Europe is even more important given the current international crises and refugee flows towards our countries", explained Cristian-Silviu Buşoi, Member of the European Parliament and Co-chair of the Parliament's Friends of the Liver group. Buşoi continued: "Elimination strategies need to take into consideration the links between hepatitis C and marginalised groups, such as recent migrants, people who inject drugs and others."

"The Manifesto sets out our vision and commitment to eliminate hepatitis C in Europe", declared Prof Michael P. Manns, Co-Chair of the Hepatitis B and C Public Policy Association, "concrete actions at all levels must follow to achieve our goal". The Manifesto will be presented to national and local governments as well as to the European institutions to encourage action.

Signatories
The Elimination Manifesto is supported by the following organisations:
- European Liver Patients Association (ELPA)
- European Association for the Study of the Liver (EASL)
- Viral Hepatitis Prevention Board (VHPB)
- The Correlation Network
- The International Center for Migration Health and Development (ICMHD)
- The World Hepatitis Alliance (WHA)
- Hepatitis B and C Public Policy Association

About Hepatitis C in Europe
- In the EU more people die each year from HCV than from HIV.
- HCV is 7 times more prevalent than HIV in Europe.
- An estimated 15 million Europeans are chronically infected, including 5.5 million
living in EU; each year there are 27,000-29,000 newly diagnosed HCV cases in the
EU/EEA.
- Existing evidence shows that, for some European countries, annual deaths from HCV have quadrupled over the past 20 years.

About the first EU HCV Summit
The EU HCV Summit was organised by the Hepatitis B & C Public Policy Association in partnership with European Association for the Study of the Liver (EASL), the Eurpean Liver Patient Association (ELPA) and the Correlation Network. It was financially supported by AbbVie, BMS, Gilead and MSD. The Summit, which was attended by 120 policymakers and stakeholders from across Europe and beyond, was officially endorsed by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), the International Centre for Migration, Health and Development (ICMHD), the European Parliament Friends of the Liver Group and the World Hepatitis Alliance (WHA).

About Hepatitis B & C Public Policy Association
The Hepatitis B & C Public Policy Association was founded in 2009 by a group of leading European scientists, public health experts and patient advocates. We aim to urge and facilitate the formulation of public policies at national and international level for the communication, prevention and management of viral Hepatitis B and C. The Association's unique approach in furtherance of this aim is to gather together, and work in partnership with, the major stakeholders in the field of these diseases including regulators, patients, clinicians, public health and civil society communities and the private sector. For more information about the Association's activities please visit http://www.hepbcppa.org

For more information, please contact:
Ann Fox, Hepatitis B & C Public Policy Association
afox@hepbcppa.org
19 rue Eugène Ruppert
L-2453 Luxembourg
Tel: +39-339-65-96-105