HCV New Drugs

Thursday, October 2, 2014

Hepatitis C: New Agents -Abstracts for The Liver Meeting® Now Available

Update Oct 8

AASLD - Late-breaking abstracts now available

Oct 1
Abstracts for The Liver Meeting® Now Available
View abstracts online or download the supplement. [PDF]

A Few HCV Related Abstracts

Parallel 6: Hepatitis C: Currently Approved Drugs (pages 218A–221A)

Article first published online: 1 OCT 2014 | DOI: 10.1002/hep.27455
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Poster Session 2: Hepatitis C: Approved Therapeutic Agents (pages 659A–709A)
Article first published online: 1 OCT 2014 | DOI: 10.1002/hep.27516
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Parallel 12: Hepatitis C: New Agents -Part 1 (pages 236A–241A)
Article first published online: 1 OCT 2014 | DOI: 10.1002/hep.27461
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Parallel 35: Hepatitis C: New Agents - Part 2 (pages 317A–321A)
Article first published online: 1 OCT 2014 | DOI: 10.1002/hep.27487
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Poster Session 4: Hepatitis C: New Agents (Not Approved) (pages 1128A–1161A)
Article first published online: 1 OCT 2014 | DOI: 10.1002/hep.27533
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Poster Session 4: Hepatitis C: Preclinical Development (pages 1161A–1173A)
Article first published online: 1 OCT 2014 | DOI: 10.1002/hep.27534
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Parallel 25: Hepatitis C: Diagnosis, Epidemiology and Natural History (pages 283A–285A)
Article first published online: 1 OCT 2014 | DOI: 10.1002/hep.27476
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Predicting patients with chronic hepatitis C in need of early treatment

Predicting patients with chronic hepatitis C in need of early treatment
Alimentary Pharmacology & Therapeutics
Volume 40, Issue 8, pages 863–879, October 2014

October's issue of the Alimentary Pharmacology & Therapeutics reviewed predictive models that identify patients with chronic hepatitis C in need of early treatment and intensive monitoring

Advances in hepatitis C therapies have led to increasing numbers of patients seeking treatment.

As a result, logistical and financial concerns regarding how treatment can be provided to all patients with chronic hepatitis C have emerged.

Dr Konerman and colleagues from Michigan, USA evaluated predictors and predictive models of histological progression and clinical outcomes for patients with CHC.

MEDLINE via PubMed, EMBASE, Web of Science and Scopus were searched for studies published between January 2003 and June 2014.

There were 2 authors that independently reviewed articles to select eligible studies and performed data abstraction

The researchers identified 29 studies representing 5817 patients from 20 unique cohorts.

The outcome incidence rates were widely variable, including 16–61% during median follow-up of 3 to 10 years for fibrosis progression, 13–40% over 2 to 14 years for hepatic decompensation, and 8–47% over 4 to 14 years for overall mortality.

The researchers showed that baseline steatosis and baseline fibrosis score were the most consistent predictors of fibrosis progression, while baseline platelet count, aspartate and alanine aminotransferase ratio, albumin, bilirubin and age were the most consistent predictors of clinical outcomes.

The team found 5 studies that developed predictive models but none were externally validated.
Dr Konerman's team concludes, "Our review identified the variables that most consistently predict outcomes of patients with chronic hepatitis C allowing the application of risk based approaches to identify patients in need of early treatment and intensive monitoring."

"This approach maximises effective use of resources and costly new direct-acting anti-viral agents."

Aliment Pharmacol Ther 2014: 40(8): 863–879

Sovaldi pricing raises debate over drug costs

Sovaldi pricing raises debate over drug costs
By JaniActman of Medill News Service

WASHINGTON (MarketWatch) — With the California-based drug manufacturer Gilead Sciences planning to roll out another hepatitis C medication, academics said Wednesday that policy changes are needed in the costly drug market so the interests of patients, health insurers and pharmaceutical companies align.

At a Brookings Institution and the University of Southern California’s Schaeffer Center for Health Policy & Economics forum, USC’s Darius Lakdawalla argued that the cost and benefits of some drugs don’t match up.

“I think we have a health policy regime in the U.S. that has been pretty successful, if not very successful, at generating scientific innovation,” said Lakdawalla, Quintiles chairman in Pharmaceutical Development and Regulatory Innovation. “But I think that historically, we have not done such a good job in encouraging innovation of pricing. In fact, in many ways the regulations we have in place stifle creativity and make it very hard to innovate.”

Controversy surrounding high-cost drugs has existed for years, but gained traction last year after the Food and Drug Administration approved the medication Sovaldi, which can cure hepatitis C, but costs about $1,000 a pill. The disease, which can cause cancer or cirrhosis of the liver, affects 3.2 million Americans and kills 15,000 a year, according to the Centers for Disease Control.

At the Washington event, Gilead GILD, +0.12% President John Milligan said the cost of other available hepatitis C drugs was the main consideration in determining the price of Sovaldi. The company has developed another medication that will be two-thirds the price for an eight-week regimen, and offers higher cure rates. It is expected to be approved by the FDA on Oct. 10, Milligan said.

Lakdawalla and others at the forum pointed out that though other drugs are expensive, Sovaldi is unique because it targets a large population and many insurers could take a hit on the coverage because the health benefits can take years to kick in.

“The [insurers] who are paying upfront for the treatment may not reap the benefit of payment reduced at some later time,” said panelist Tom Gustafson, health care policy advisor at law firm Arnold & Porter LLP.

Allowing insurers to open lines of credit and recoup a “hand off” fee when their clients become Medicaid-eligible could help to alleviate problems associated with high-cost medications, suggested Lakdawalla.

Dana Goldman, health policy professor at Southern Cal, argued that policymakers need to focus on a model that would prioritize rewarding innovators for valuable advancements while cutting wasteful spending. Investing in treating all hepatitis C patients in the near term would save in the long run, he said.

“The bottom line from this is that new treatments have great value, but you have to think of the treatment strategy and the long-term versus short-term benefits,” Goldman said.

He added that treating those with only advanced disease may lessen health-care fees upfront, but taking care of all patients would reduce future costs.

“I would argue that if you treat advanced disease, while it may make sense to individual payers, it doesn’t take advantage of the breakthrough innovation that we’ve seen.”

http://www.marketwatch.com/story/sovaldi-pricing-raises-debate-over-drug-costs-2014-10-01?link=MW_home_latest_news

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The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Latest Update Feb 12, 2019

Lancet Study:

Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C

These findings firmly counter those of a Cochrane review of direct-acting antiviral treatment trials that could neither confirm nor reject if direct-acting antivirals had an effect on long-term HCV-related morbidity and mortality. They also provide the best evidence to date to support guidance documents that recommend direct-acting antiviral treatment for all patients with chronic HCV infection.

The Controversy
Rebuttal over Cochrane Review of DAAs
A systematic review published by the Cochrane Collaboration suggested achieving SVR (cure) for patients using hepatitis C direct-acting antivirals (DAAs) doesn't correlate with any long term benefits. View each rebuttal and all ongoing media coverage.

Risk Of Developing Liver Cancer After HCV Treatment

Thursday, October 2, 2014

Hepatitis C: New Agents -Abstracts for The Liver Meeting® Now Available

Predicting patients with chronic hepatitis C in need of early treatment

Sovaldi pricing raises debate over drug costs