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Alan Franciscus
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated February 6, 2015

Wednesday, March 4, 2015

Hepatitis C study for District residents

Unity Health Care announced a study to show how health care providers can treat Hepatitis C. 

WASHINGTON (WUSA9) -- Hepatitis C is a contagious liver disease, complications can lead to death. Affecting over 3 million people in the US, the disease is particularly dangerous because there are few noticeable symptoms early on.

Wednesday evening, Unity Health Care announced a study to show how health care providers can treat Hepatitis C.

Called the ASCEND study, 600 DC patients will be treated with Harvoni, a newly FDA approved medication. Unity Health Care is partnering with the National Institutes of Health, the University of Maryland, and Family and Medical Counseling Services Inc. to conduct the research.

Source:  http://www.wusa9.com/story/news/2015/03/04/hepatitis-c-unity-heath/24395001/

Nursing Times-NHS-NICE gives backing to hepatitis C drug in latest draft guidance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

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”.


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".

Patients First: Price Wars, Treatment Outcomes, Longevity Alan Franciscus, Editor-in-Chief

This month’s Patients First is full of good news (for a change) for patients.  The HCV price war between Gilead and AbbVie is lowering drug prices, which will hopefully equal more treatment access for patients.  Curing hepatitis C improves emotional well-being and improves long-term survival in people with cirrhosis.

Price Cuts/Value
Since AbbVie’s approval  of Viekira Pak to treat HCV genotype 1 there have been many negotiations between the various insurance companies and pharmacies for price reductions.  This has led to steep price cuts.  The California Technology Assessment Forum (CTAF) met earlier this year and voted that Harvoni represented a “LOW” health system value based on the price of $95,000 for the 12 week price.  CTAF reasoned that this would increase Medicaid costs by over 5% in a single year if all patients with HCV were treated.  Now, that the price is in the $34,000 to $42,000 range for the average course of therapy, CTAF has changed its assessment to “HIGH” health system value.  This is good news for the state Medicaid budgets and patients.  Hopefully, this will translate  into treatment for more patients.
Treatment: Mental and Physical Health Outcomes
The Chronic Hepatitis Cohort Study (CheCS) is a large ongoing national study.  Electronic health records from four sites for the period between 1/1/2006 and 12/31/2010 were provided for this study.   Overall 4,781 surveys were completed.  Of these, the average age was 57 yo, 71% were white, 57% male, 51% had past injection drug use, 34% were current smokers, and 18% abused alcohol in the past year.  In regards to treatment, 47% had been treated previously and 15% had achieved SVR12.

Overall, about 30% met the criteria for depression—this compared to 9% of the general population who have depression.  About 25% of those with hepatitis C had poor physical health—this is a very large number for any disease condition.

The article discussed how having depression and being on interferon-based therapy affected many areas of life more than interferon-free therapies, “However, achieving SVR was associated with improved emotional well-being—at least the absence of depression—in these patients.  Conversely, there appeared to be little physical or mental health benefit for those who did not achieve SVR, for whatever reason, after starting antiviral therapy.”
Curing HCV = Living Longer
A recent study from the Netherlands sheds some very positive light on how being cured affects long-term survival. The researchers analyzed data between 1990 and 2003 from 5 hepatology centers in Europe and Canada.  The patients were treated, and were followed beginning 24 weeks after treatment ended.  Follow-up was competed in 454 patients—median age was 48, most were male (70%) and 36% patients were cured.  The median follow-up period was 8.4 years (6.4 to 11.4 years).  Importantly, all of the patients had advanced fibrosis.

The 10-year survival of the people who were cured was 91%, which did not differ from the age- and sex-match of the general population – in other words being cured of hepatitis C and advanced fibrosis meant that people would live as long as someone without hepatitis C—that’s pretty important and impressive.


Seattle-HIV testing in ED serves as link to care

"SEATTLE — An HIV testing program in an ED, which was originally implemented to describe the local epidemic, played a significant role in linking individuals to care, according to data presented at CROI 2015".

“Over a 25-year period, the program evolved, and this change is partially evidenced by declining undiagnosed HIV infection, increased use of antiretroviral therapy, increased viral suppression and decline in HIV incidence,” Thomas C. Quinn, MD, of the National Institute of Allergy and Infectious Diseases, said during his presentation".
"Quinn and colleagues examined local trends in HIV and hepatitis C in the Johns Hopkins Hospital ED population for a 25-year period. They conducted 6- to 8-week identity-unlinked serosurveys in the ED in 1987, 1988, 1992, 2001, 2007 and 2013. The study included 18,144 eligible patients who required a blood draw for a medical reason. Excess sera were collected, and specimens underwent ELISA testing followed by Western blot (from 1992-2013). The specimens also were tested for HCV in 1988 and from 2001 to 2013".

Montreal-Hepatitis C cure rate of 97 per cent announced in study of patients co-infected with HIV given 12-week combination

MONTREAL, March 3, 2015 /CNW/ - A combination of two once-daily medications for chronic hepatitis C infection has been shown in newly released study results to cure almost all the patients who participated, despite the patients also being co-infected with human immunodeficiency virus (HIV). This patient population historically has been challenging to treat for hepatitis C, in large part due to potential drug-drug interactions between the antiviral therapy regimens used to treat each infection.

Results of ALLY-2, a Phase 3 clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of chronic hepatitis C in patients co-infected with HIV were announced last week and showed that those treated for 12 weeks (HCV treatment-na├»ve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment, or SVR12). 
"The data showed results that are very promising in patients that are well known as being both difficult to treat and at higher risk for developing serious liver disease, making the results all the more significant," said Dr. Stephen Shafran, Professor of Medicine (Infectious Diseases) at the University of Alberta. "It's also important to note that we are seeing high cure rates with the daclatasvir and sofosbuvir combination regardless of the genotype of the hepatitis C infection."