Sustained virological response represents a long-term cure for people with hepatitis C treated with sofosbuvir

Almost all patients with hepatitis C virus (HCV) alone or HIV and HCV co-infection who achieved sustained virological response (SVR) to treatment with sofosbuvir (Sovaldi) plus ribavirin or sofosbuvir/ledipasvir (Harvoni) still had undetectable HCV RNA up to two years later, confirming that SVR represents a cure, according to a poster presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI 2015) in Seattle, USA.

The advent of interferon-free therapy using combinations of direct-acting antiviral drugs has brought about a revolution in hepatitis C treatment. Sustained virological response, or continued undetectable HCV RNA at 12 or 24 weeks post-treatment, is considered a cure, but rare cases of apparent late relapse have been observed after this point. (More often, HCV recurrence is due to reinfection.) 

While some studies have detected residual bits of HCV in the blood or the liver after successful treatment, this does not appear to indicate ongoing active disease. Interferon-based therapy has been shown to have a late relapse rate below 5% – usually occurring within two years after treatment – but this is not yet well defined for interferon-free therapy because it is so new.

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Hepatitis C and the Baby Boomer Generation

As the Centers for Disease Control and Prevention release new guidelines regarding testing baby boomers - St. Luke' s Magic Valley is putting a new initiative in place.

"Three quarters of all patients with Hep. C in fact are baby boomers. Unfortunately more than three quarters of them are unknown to us," explained Dr. Brian Berk, Gastroenterologist, St. Luke’s Magic Valley.

Hepatitis C is a contagious liver disease that ranges in severity. It's spread primarily through contact with the blood of an infected person.

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U.K-Five Patients Test Positive for Hepatitis C in Mass Screening Following Hygiene Alert in Nottingham

Health bosses have confirmed that five patients have tested positively for hepatitis C in a mass screening programme set up after concerns were raised about the hygiene practises of a Nottinghamshire dentist.

Patients who had received treatment  at Daybrook Dental Practice from Mr Desmond D’Mello were contacted by the NHS to encourage them to go for blood tests after it was reported that the dentist did not clean his hands between patients and employ the relevant infection control procedures. Mr D’Mello had been working at the practice for many years and in total, more than 22,000 people were contacted.

In the largest ever NHS recall, 4,526 patients were tested and five were diagnosed with hepatitis C. There were no cases of HIV or hepatitis B.

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Zydus, Gilead Sciences, SoviHep, Sofosbuvir, Ledipasvir, HCV, Liver Gilead Sciences And Zydus Launch SoviHep Hepatitis C Drug

American biotechnology firm Gilead Sciences and Indian pharmaceutical company Zydus launched SoviHep, a drug for treating Hepatitis C.

On Tuesday, March 17, Zydus issued a statement that confirmed it has signed a non-exclusive agreement with Gilead Sciences, which will enable the company to manufacture sofosbuvir, trade name SoviHep, as well as fixed-dose combination of sofosbuvir/ ledipasvir for circulation in more than 90 countries, which includes India. The drug will be marketed by Zydus Heptiza, which is a specialty division in the group.

Hepatitis C may affect the quality of life for patients. Pankaj Patel, Managing Director and Chairman of the Zydus Group, reveals that the launch of SoviHep will provide better treatment for the disease and improve the quality of life for millions of people.

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Hepatitis C Therapeutic Development and Pipeline Review H1 2015 Research Report

RnRMarketResearch.com adds "Hepatitis C - Pipeline Review, H1 2015" therapeutic market research report of 639 pages with latest updates, data and information to its online business intelligence library.

The report "Hepatitis C - Pipeline Review, H1 2015" provides an overview of the Hepatitis C's therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Hepatitis C, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Hepatitis C and special features on late-stage and discontinued projects.

Hepatitis C is a liver disease caused by the hepatitis C virus. The virus can cause both acute and chronic hepatitis infection, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. There are many types of hepatitis C virus. The most common in the U.S. is type 1. No type is more serious than any other, but they respond differently to treatment. Hepatitis C is an increasing public health concern in the United States and throughout the world. Symptoms of Hepatitis C include jaundice, stomach pain, loss of appetite, nausea and fatigue. 3, 50,000 to 5, 00,000 people die each year from hepatitis C-related liver diseases. 

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Re-infection due to ongoing risk probably the cause of HCV recurrence after SVR

Rates of hepatitis C virus (HCV) reoccurrence after successful therapy differ markedly between risk groups, according to the results of a meta-analysis presented at the recent Conference on Retroviruses and Opportunistic Infections. 

At one end of the spectrum, over a fifth of patients with HIV co-infection who cleared HCV infection with treatment experienced a recurrence of the infection. This compared to a rate just 1% in patients with no HCV risk factors. The UK investigators leading the study believe these large differences point to re-infection rather than relapse being the cause of the re-emergence of HCV after treatment response.

HCV infection is an increasingly important cause of liver-related illness and death around the world. Diagnosing and treating HCV is therefore a global health priority, especially as therapy with combinations of new direct-acting anti-HCV drugs can achieve a cure or sustained virological response (SVR) – absence of HCV RNA 24 weeks after the completion of therapy – in up to 90% of patients.    

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Gilead Sciences (NASDAQ:GILD) and AbbVie (NYSE:ABBV) Trying to Make the Most from Market Share

Gilead Sciences (NASDAQ:GILD) share prices are dropping as a result of the FDA giving the approval to AbbVie (NYSE:ABBV) of its hepatitis C drug, Viekira Pak. Through drastic price cuts, Gilead Sciences (NASDAQ:GILD) is facing a tough time trying to become market leader. Both companies have confirmed that the price reductions are so that they can attract more customers yet investors may not consider this a positive sign.

After Gilead Sciences (NASDAQ: GILD) launched Sovaldi, its drug for oral hepatitis C, it revolutionized the treatment. Before this, patients of hepatitis C had to be treatment with cures that had significant side effects like ribavirin and peg interferon that lasted nearly 48 weeks and had only 50%-80% cure rates.

However, Sovaldi’s treatment doesn’t eliminate ribavirin from the core, but it does put aside peg interferon and gives cure rates of 90%. This is why doctors embraced the drug with open arms and turned it into the quickest drug to achieve such successful levels of treatment. It made nearly $10.3 billion sales in the previous year. However, Gilead Sciences (NASDAQ: GILD) strengthened its drug back in October, when it won the approval by the FDA for its drug Harvoni.

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Nursing Times-NHS-NICE gives backing to hepatitis C drug in latest draft guidance

“The marketing authorisation for ledipasvir-sofosbuvir recommends treatment for hepatitis C genotypes 1, 3 – in combination with ribavirin – and 4”.

“Genotypes 1 and 3 hepatitis C account for the majority of chronic hepatitis C cases in England (46% and 43%, respectively). Genotype 4 hepatitis C accounts for around 4% of cases”.

“Ledipasvir-sofosbuvir, manufactured by Gilead, is administered orally as a single tablet – with or without ribavirin – and works by inhibiting the replication of the hepatitis C virus. It prevents hepatitis C virus replication by inhibiting the NS5A and NS5B proteins”.

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U.S.A-Programs Focus on Hepatitis C

“Chronic hepatitis C infection is a commonly silent disease that according to the Center of Disease Control affects an estimated 3.2 million Americans”.

 “For primary care providers looking to address hepatitis, the University of Wisconsin-Superior’s Continuing Education Department holds a program 4-9:30 p.m. March 17 at Barker’s Island Inn and Convention Center in Superior”. “The Wisconsin Department of Health Services estimates 74,000 people in Wisconsin are infected; 50 percent of them baby boomers.

The Institute of Medicine reports that up to 75 percent of those infected are unaware they are infected. Yet, with appropriate care, hepatitis C can be a curable infection”.

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New Cigna, Catamaran Hep C Pacts Put Gilead Drugs to the Test

"Since the December 2014 approval of AbbVie Inc.’s hepatitis C treatment Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets), at least 10 companies have disclosed exclusive or semi-exclusive deals with Gilead Sciences, Inc. that feature the manufacturer’s hepatitis C agents, Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir). But Catamaran Corp. and Cigna Corp. this month unveiled the first outcomes-based arrangements with Gilead that industry observers say could open the door for more value-based deals around hepatitis C and other specialty agents".

"Catamaran on Feb. 3 said it would offer a new hepatitis C patient management program through its specialty pharmacy, BriovaRx, that features Gilead’s Harvoni and Sovaldi as exclusive hepatitis C treatment options (DBN 2/6/15, p. 1). Similarly, Cigna Corp., a long-term Catamaran customer, on Feb. 4 said it would offer Harvoni as the only preferred brand drug treatment for customers with hepatitis C genotype 1 infection as well as develop an outcomes-based incentive program".

"While both companies declined to provide specifics on how the deals are structured, other outcomes-based pharmaceutical arrangements between manufacturers and insurers or PBMs have tied rebate payments to agreed-upon outcomes achieved by the payers’ members. Cigna, for instance, in 2010 embarked on an outcomes-based partnership with Merck & Co. in which the drugmaker provided rebates to Cigna when its members with type 2 diabetes met goals for adherence to prescribed medications and low blood sugar levels (DBN 12/17/10, p. 1). And Prime Therapeutics LLC in 2012 signed an outcomes-based contract with EMD Serono, Inc. for its multiple sclerosis drug Rebif (interferon beta-1a) through which the drugmaker promised to pay rebates to the PBM if its members taking Rebif had a higher total cost of care than people on other MS medications. Adherence levels were also considered. Cigna inked a similar deal with EMD Serono in 2011".

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