Thursday, August 21, 2014

Patients First: Cost–Benefit Considerations in HCV Therapy

Mark S. Sulkowski, MD
Patients First: Cost–Benefit Considerations in HCV Therapy

Hello folks, with all this controversy over the high price of Gilead's Sovaldi, it was refreshing, and informative to watch a video presentation where the focus is on the HCV patient, and not only on drug cost.

This month Clinical Care Options launched a new 35 minute video module addressing the cost issue of new hepatitis C drugs. Interestingly enough, in comparison to the high cost of overall care needed to manage HCV patients, it appears these new drugs are more cost effective. But we all knew that, didn't we.


The program is hosted by Nancy Reau, MD, and Mark S. Sulkowski, MD,. from Johns Hopkins.

Topics include
  • Benefits of achieving SVR with HCV therapy
  • Impact of HCV on the healthcare system
  • Considering immediate cost vs deferred savings
  • Using cost per SVR to determine value of therapy
  • Importance of selecting the best therapy first 
*Free registration is required to view the program.

Clinical Focus: Clinical Outcomes and Cost–Benefit Considerations in HCV Therapy
Nancy Reau, MD, and Mark S. Sulkowski, MD, provide a clinical perspective on the debate over economic aspects of HCV therapy and explore whether new therapies increase or decrease overall HCV patient care costs.

Stay well, and safe.

Tina

Instead of complaining about how much Sovaldi costs why not use the drug to stage a war on hepatitis C?

All over the country, state governments are grappling with the same question: “What do we do about Sovaldi?” The drug seems to be far more effective than alternatives at treating hepatitis C, a disease that, left untreated, frequently progresses to liver disease and then death. It also costs $84,000 for a course of treatment.
State governments, horrified by the cost, are reacting by slapping restrictions on how -- and in one case whether -- it can be prescribed. Many are limiting it to only the worst cases, those who already have cirrhosis. But this strategy may not work, as Governing magazine points out: Patients can sue, and they probably will.
Continue reading.... 

Wednesday, August 20, 2014

Paritaprevir (ABT-450)/ombitasvir/dasabuvir- List Of Upcoming and Recruiting Clinical Trials

Paritaprevir (ABT-450)/ombitasvir/dasabuvir- List Of Upcoming and Recruiting Clinical Trials

Provided below is a list of verified clinical trials using AbbVie's three direct-acting antiviral oral free regimen or "3-DAA combination" consisting of boosted protease inhibitor paritaprevir (also known as ABT-450/r ), NS5A inhibitor ombitasvir (ABT-267), non-nucleoside polymerase inhibitor dasabuvir (ABT-333) with and without ribavirin for the treatment of hepatitis C, and Type 1 (HIV-1) co-infection. Trial participants will represent different stages of disease and genotype. A bit of background information on AbbVie's 3-DAA combination is included as well.

Clinical trials on this page are not a complete list; to learn more about HCV trials or to find out if a study is enrolling patients in your area, please click here. View additional hepatitis trials updated in the last 30 days @ ClinicalTrials.gov

Updates
In June 2014, the U.S. FDA Granted Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C.

NORTH CHICAGO, Ill., June 13, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the New Drug Application (NDA) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted priority review. 
The NDA was submitted on April 21, 2014 and is supported by data from a large clinical program including six Phase III studies of more than 2,300 GT1 patients in over 25 countries. The regimen was granted a Breakthrough Therapy designation by the FDA in May 2013, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint compared to available therapy.

In addition, accelerated assessment was granted a few days later by the European Medicines Agency (EMA) 
Accelerated assessment, which is designated to new medicines of major public health interest, was granted by the EMA for AbbVie's investigational HCV regimen in May. Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. If approved, AbbVie's regimen could be available for marketing in the European Union (EU) in the first quarter of 2015.
August
Paritaprevir (ABT-450/ritonavir)/ombitasvir/dasabuvir with and without ribavirin

Interferon-free regimens yield 96%-100% SVRs
By: MARY ANN MOON
The primary efficacy endpoint – a sustained virologic response (SVR) rate noninferior to the historical rate for interferon-containing regimens in comparable patients – was met and surpassed: 96.6% for ABT-450/ritonavir/ombitasvir/dasabuvir plus ribavirin and 100% for ABT-450/ritonavir/ombitasvir/dasabuvir without ribavirin.


Dr. Pietro Andreone discusses his manuscript "ABT-450, Ritonavir, Ombitasvir, and Dasabuvir Achieves 97% and 100% Sustained Virologic Response With or Without Ribavirin in Treatment-Experienced Patients With HCV Genotype 1b Infection."

 

April - May 2014
VIDEO – ‘Three D’ for hepatitis C called ‘revolutionary’
Dr. Bruce R. Bacon called this oral regimen "revolutionary" Hear his thoughts on treatment with ABT-450 with ritonavir, ombitasvir, and dasabuvir (known as the "three D" regimen) with or without ribavirin. 

New England Journal of Medicine
Retreatment of HCV with ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin
In this phase 3 trial we evaluated the efficacy and safety of the interferon-free combination of ABT-450 with ritonavir (ABT-450/r), ombitasvir (also known as ABT-267), dasabuvir (also known as ABT-333), and ribavirin for the retreatment of HCV in patients who were previously treated with peginterferon–ribavirin.

New England Journal of Medicine: With Cirrhosis
ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis
Interferon-containing regimens for the treatment of hepatitis C virus (HCV) infection are associated with increased toxic effects in patients who also have cirrhosis. We evaluated the interferon-free combination of the protease inhibitor ABT-450 with ritonavir (ABT-450/r), the NS5A inhibitor ombitasvir (ABT-267), the nonnucleoside polymerase inhibitor dasabuvir (ABT-333), and ribavirin in an open-label phase 3 trial involving previously untreated and previously treated adults with HCV genotype 1 infection and compensated cirrhosis.

New England Journal of Medicine: No Cirrhosis
Treatment of HCV with ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin
The interferon-free combination of the protease inhibitor ABT-450 with ritonavir (ABT-450/r) and the NS5A inhibitor ombitasvir (also known as ABT-267) plus the nonnucleoside polymerase inhibitor dasabuvir (also known as ABT-333) and ribavirin has shown efficacy against the hepatitis C virus (HCV) in patients with HCV genotype 1 infection. In this phase 3 trial, we evaluated this regimen in previously untreated patients with HCV genotype 1 infection and no cirrhosis.


Recruiting 

Recruiting
Locations  United States 28 Study Locations 3 in Puerto Rico
ClinicalTrials.gov Identifier: NCT01939197
Conditions: Hepatitis C Virus Infection; Human Immunodeficiency Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis and Non-cirrhotics
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Contact: Melanie Gloria, BS 847-936-0714 melanie.gloria@abbvie.com
Contact: Karmin Robinson-Morgan, BS 847-935-5421 karmin.y.robinson@abbvie.com

Recruiting - Some locations Active and not recruiting
Locations  United States, Australia, France, Germany, Spain, United Kingdom
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Contact: Sundeep K Grewal, BS 847-937-3249 sundeep.grewal@abbvie.com
Contact: George S LIOSSIS 847-937-6450 george.liossis@abbvie.com

Recruiting - Most Study Locations Recruiting 
135 Study Locations United States, Australia, Belgium, Canada, Denmark, Germany, Ireland, Netherlands, New Zealand, Puerto Rico, Spain, United Kingdom
ClinicalTrials.gov Identifier: NCT01773070
Condition: Hepatitis C
Interventions: Drug: ABT-450/ritonavir; Drug: ABT-333; Drug: ABT-267
Contact: Rebecca Craft, BS1-901-854-2643 rebecca.craft@abbvie.com
Contact: Lia Hunter, PhD+44 (0)208 761 7684 lia.hunter@abbvie.com

Recruiting - Some locations Active and not recruiting
Locations  United States, Australia, France, Germany, Spain, United Kingdom
ClinicalTrials.gov Identifier: NCT01782495
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: ribavirin (RBV)
Contact: Elizabeth Colon, BA 847-938-4572 elizabeth.colon@abbvie.com
Contact: Melissa Cook, MS 847-937-1399 melissa.cook@abbvie.com

Recruiting
Locations United States
ClinicalTrials.gov Identifier: NCT02068222
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ABT-450/r Drug: ABT-530 Drug: Ribavirin (RBV)
Contact: Charles E Meyer, BS (847) 938-6564 charles.e.meyer@abbvie.com
Contact: Traci Baker, MS (847) 936-6555 traci.baker@abbvie.com

Not yet recruiting 

‎Friday, ‎August ‎15, ‎2014, ‏‎12:00:00 PM 
ClinicalTrials.gov Identifier: NCT02219477
Conditions: Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus
Interventions: Drug: ABT-450/ritonavir/ABT-267; Drug: ABT-333; Drug: Ribavirin
Sponsor: AbbVie
Not yet recruiting - verified August 2014

A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
‎Friday, ‎August ‎15, ‎2014, ‏‎12:00:00 PM
ClinicalTrials.gov Identifier: NCT02219503
Conditions: Chronic Hepatitis C Infection; Compensated Cirrhosis; Hepatitis C Virus
Interventions: Drug: ombitasvir/ABT-450/ritonavir; Drug: dasabuvir
Sponsor: AbbVie
Not yet recruiting - verified August 2014

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
‎Friday, ‎August ‎15, ‎2014, ‏‎12:00:00 PM
ClinicalTrials.gov Identifier: NCT02219490
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Sponsor: AbbVie
Not yet recruiting - verified August 2014

A Study to Evaluate Chronic Hepatitis C Infection in Cirrhotic Adults With Genotype 1b Infection
‎Tuesday, ‎August ‎12, ‎2014, ‏‎12:00:00 PM 
ClinicalTrials.gov Identifier: NCT02216422
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Sponsor: AbbVie
Not yet recruiting - verified August 2014

Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in Treatment-Naïve HCV Genotype 1-Infected Adults With Chronic Kidney Disease
‎Thursday, ‎July ‎31, ‎2014, ‏‎12:00:00 PM 
ClinicalTrials.gov Identifier: NCT02207088
Conditions: Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis; Severe Renal Impairment; End-stage Renal Disease
Interventions: Drug: ombitasvir/ABT-450/ritonavir; Drug: dasabuvir; Drug: Ribavirin
Sponsor: AbbVie
Not yet recruiting - verified July 2014

For additional information visit HCV Advocate News and Pipeline for trial updates;
AbbVie
Bristol-Myers Squibb (BMS)
Gilead
Merck
Tibotec / Janssen
Vertex
**Quick Reference Guide*

Behind the Headlines - Is UK obesity fuelling an increase in 10 cancers?

Obesity is linked
to 12,000 cancer
cases each year
in the UK 
Behind the Headlines - Is UK obesity fuelling an increase in 10 cancers?

“Being overweight and obese puts people at greater risk of developing 10 of the most common cancers,” reports BBC News.

The news is based on research using information in UK GP records for more than 5 million people, to see whether body mass index (BMI) was associated with 22 types of common cancers.

The researchers found that increasing BMI was associated with increased risk of several types of cancer. Some of these associations weren’t linear, meaning that there wasn’t always a steady increase in cancer risk with increased BMI. Additionally, some of the links seemed to be dependent on individual patient characteristics, such as gender and menopausal status.

The researchers estimated that 41% of uterine and 10% or more of gallbladder, kidney, liver and colon cancers could be attributable to excess weight.

However, increasing BMI was also found to decrease the risk of some types of cancer (such as prostate and premenopausal breast cancer).

The researchers suggest that BMI affects cancer risk through a number of different processes. However, the study was not able to demonstrate that being overweight or obese directly increase or decrease risk of these cancers, nor is it able to show the biological reasons for any of the associations found.

It is also not able to account for all possible factors that contribute to cancer risk, such as genetics and lifestyle factors.

Nevertheless, maintaining a healthy weight has proven benefits beyond any reduction in cancer risk. As always, the best way to do this is by eating a balanced diet and exercising regularly.

Where did the story come from?

The study was carried out by researchers from the London School of Hygiene and Tropical Medicine, and the Farr Institute of Health Informatics Research. The study was funded by the National Institute for Health Research, the Wellcome Trust and the Medical Research Council. 

The study was published in the peer-reviewed medical journal The Lancet. This article is open-access and can be accessed for free on the journal’s website.

The story was widely covered by the media.

What kind of research was this?

This was a cohort study that aimed to investigate the link between BMI and the most common site-specific cancers after adjusting for potential confounders.

As this is a cohort study, it cannot prove that obesity causes cancer, as there may be a wide variety of other factors (such as hereditary, sociodemographic and lifestyle factors) that could explain the associations seen.

What did the research involve?

The researchers studied primary care (GP) records from 5.24 million people, using data collected between 1987 and 2012.

They calculated BMI from recorded weight and height, both of which are recorded by GPs when patients are registered, during patient care, or because the GP thinks it’s relevant to the patients’ health.

The researchers then looked to see if people had a cancer diagnosis in their records, in particular:

female breast cancer
prostate cancer
mouth, oesophageal, stomach, colon and rectum cancers
lung cancer
non-Hodgkin lymphoma
leukaemia and multiple myeloma (blood cancers)
ovary, uterus (womb) and cervix cancers
pancreas, brain and central nervous system cancers
liver and gallbladder cancer
kidney and bladder cancer
thyroid cancer
malignant melanoma 

The researchers looked to see whether BMI was linked with increased risk of cancer. They estimated the average effect of a 5kg/m² increase in BMI on cancer risk.

They controlled for age, smoking status, alcohol use, previous diabetes diagnosis, socioeconomic status, time period and gender in their analyses.
 
What were the basic results?

People were followed for 7.5 years on average, and during the study, 166,995 people (3.2%) developed one of the cancers of interest.

The researchers found that a 5kg/m² increase in BMI was associated with an increased risk of the following types of cancer:

uterus (hazard ratio (HR) 1.62, 99% confidence interval (CI) 1.56 to 1.69)
gallbladder (HR 1.31, 99% CI 1.12 to 1.52)
kidney (HR 1.25, 99% CI 1.17 to 1.33)
cervix (HR 1.10, 99% CI 1.03 to 1.17)
leukaemia (HR 1.09, 99% CI 1.05 to 1.13)
liver (HR 1.19, 99% CI 1.12 to 1.27)
colon (HR 1.10, 99% CI 1.07 to 1.13)
ovarian (HR 1.09, 99% CI 1.04 to 1.14)
postmenopausal breast cancers (HR 1.05, 99% CI 1.03 to 1.07) 

There was a borderline statistically significant increase in the risk of thyroid cancer (HR 1.09, 99% CI 1.00 to 1.19), pancreatic cancer (HR 1.05, 95% CI 1.00 to 1.10) and cancer of the rectum (HR 1.04, 95% CI 1.00 to 1.08).

The researchers noted that not all the associations were linear, and that the associations between BMI and both colon and liver cancer were more marked in men than in women. Increases in ovarian cancer risk with BMI were larger in premenopausal than postmenopausal women, and there were differences by menopausal status for breast cancer.

The researchers estimated that 41% of uterine and 10% or more of gallbladder, kidney, liver and colon cancers could be attributable to excess weight. 

A 5kg/m² increase in BMI was associated with a reduced risk of the following types of cancer:

premenopausal breast cancer risk (HR 0.89, 99% CI 0.86 to 0.92)
oral cavity (HR 0.81, 99% CI 0.74 to 0.89)
lung (HR 0.82. 99% CI 0.81 to 0.84) 

There was a borderline statistically significant reduction in the risk of prostate cancer (HR 0.98, 99% CI 0.95 to 1.00).

The researchers noted that when the analysis was restricted to people who had never smoked, a 5kg/m² increase in BMI did not reduce the risk of oral cavity or lung cancer. They suggest that this inverse association seen when all people were considered was due to residual confounding. 

Overall, the researchers estimated that a 1kg/m² population-wide increase in BMI would result in 3,790 additional annual UK patients developing cancer of the uterus, gallbladder, kidney, cervix, thyroid, leukaemia, liver, colon, ovarian or postmenopausal breast cancer.

How did the researchers interpret the results?

The researchers concluded that, “BMI is associated with cancer risk, with substantial population-level effects. The heterogeneity in the effects suggests that different mechanisms are associated with different cancer sites and different patient subgroups.”

Conclusion

This large UK cohort study of more than 5 million people has found that, although there was variation in the effect of BMI on different cancers, a higher BMI was associated with increased risk of several cancers.

Overall, the researchers estimated that a 1kg/m² population-wide increase in BMI would result in 3,790 additional people in the UK each year developing uterus, gallbladder, kidney, cervix, thyroid, leukaemia, liver, colon, ovarian or postmenopausal breast cancer. 

However, not all of the identified links were completely clear, with some showing a clearer linear association between increasing BMI and increasing cancer risk than others. Also, strangely, increased BMI was also found to decrease the risk of some types of cancer, such as lung cancer. Such associations may be explained by other factors: for example, smokers – who are obviously at a much higher risk of lung cancer – tend to have a lower BMI than non-smokers.

However, this study is unable to demonstrate that being overweight or obese definitely directly increase or decrease the risk of these cancers. The researchers suggest that BMI affects cancer risk through a number of different processes. The study is also not able to account for all possible factors that may be entangled in the links (such as various hereditary, sociodemographic and lifestyle factors).

Nevertheless, it is well established that maintaining a healthy weight has many health benefits, including reducing the risk of many common chronic diseases. The best way to do this is by eating a balanced diet and exercising regularly.

Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on Twitter. Join the Healthy Evidence forum.


What is Behind the Headlines?
We give you the facts without the fiction. Professor Sir Muir Gray, founder of Behind the Headlines, explains more...

Experts denounce clinical trials of unscientific, 'alternative' medicines

Experts denounce clinical trials of unscientific, 'alternative' medicines

Experts writing in the Cell Press journal Trends in Molecular Medicine on August 20th call for an end to clinical trials of "highly implausible treatments" such as homeopathy and reiki. Over the last two decades, such complementary and alternative medicine (CAM) treatments have been embraced in medical academia despite budget constraints and the fact that they rest on dubious science, they say.
The writers, David Gorski of Wayne State University School of Medicine and Steven Novella of Yale University, argue that, in these cases, the medical establishment is essentially testing whether magic works. Gorski and Novella are both editors for Science-Based Medicine, an organization and blog dedicated to exploring the complicated relationship between science and medicine.

"We hope this will be the first of many opportunities to discuss in the peer-reviewed literature the perils and pitfalls of doing clinical trials on treatment modalities that have already been refuted by basic science," said Gorski. "The two key examples in the article, homeopathy and reiki, are about as close to impossible from basic science considerations alone as you can imagine. Homeopathy involves diluting substances away to nothing and beyond, while reiki is in essence faith healing that substitutes Eastern mysticism for Christian beliefs, as can be demonstrated by substituting the word 'god' for the 'universal source' that reiki masters claim to be able to tap into to channel their 'healing energy' into patients."

"Studying highly implausible treatments is a losing proposition," Novella added. "Such studies are unlikely to demonstrate benefit, and proponents are unlikely to stop using the treatment when the study is negative. Such research only serves to lend legitimacy to otherwise dubious practices."
What is needed, say Gorski and Novella, is science-based medicine rather than evidence-based medicine. Biologically plausible treatments should advance to randomized clinical trials only when there is sufficient preclinical evidence to justify the effort, time, and expense, as well as the use of human subjects.

"Somehow this idea has sprung up that to be a 'holistic' doctor you have to embrace pseudoscience like homeopathy, reiki, traditional Chinese medicine, and the like, but that's a false dichotomy," Gorski said. "If the medical system is currently too impersonal and patients are rushed through office visits because a doctor has to see more and more patients to cover his salary and expenses, then the answer is to find a way to fix those problems, not to embrace quackery. 'Integrating' pseudoscience with science-based medicine isn't going to make science-based medicine better. One of our bloggers, Mark Crislip, has a fantastic saying for this: 'If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.' With CAM or 'integrative medicine,' that's exactly what we're doing, and these clinical trials of magic are just more examples of it."

Gorski and Novella call on patients to exercise their critical thinking skills when it comes to evaluating the evidence for or against any kind of treatment, whether it is deemed "alternative" or not. "Critical thinking will help patients learn to recognize when a course of treatment is not supported by data or to tell when a health claim from any practitioner is just too good to be true," Gorski said.
Source

Trends in Molecular Medicine - Full Text Article
Clinical trials of integrative medicine: testing whether magic works?


A commonly assumed paradigm in evidence-based medicine: Bench to bedside: findings in basic science progress through cell culture and in vitro studies, then to animal models, then to clinical trials. Clinical trials in turn consist of preliminary Phase I/II trials, followed by larger randomized Phase III trials. Although it is true that each stage can ‘cross-pollinate’ other stages, it is generally assumed that treatments do not reach the clinical trial stage without having passed through the first three stages and demonstrated promise, and thus prior plausibility, in preclinical experiments. Clinical trials of complementary and alternative medicine (CAM) upend this paradigm, with treatments that have little or no prior plausibility based on preclinical experimentation being tested prematurely in clinical trials.

Full Text Article

The Risky Business of Limiting Medicaid Access to Sovaldi

The Risky Business of Limiting Medicaid Access to Sovaldi
by Chris Kardish | August 19, 2014
Partially because of its high cost, nearly half the states are restricting Medicaid patients' access to an effective new hepatitis C drug. Experts say there’s no question lawsuits will come....
States typically have to cover drugs from makers that participate in Medicaid’s drug rebate program, which includes Gilead Sciences, the company that sells Sovaldi. According to the company, 47 states are covering the drug for their Medicaid populations. But in order to limit its use, about half are enforcing “prior authorization,” essentially creating lists of criteria that patients must meet before a doctor can prescribe the drug. Most commonly those criteria require a patient to be in the worst stage of hepatitis C, which is cirrhosis, and that they be drug-free for a period of time. The goal is to restrict Sovaldi to people who already have severe liver damage, which opponents argue is too late. Among the states limiting Sovaldi are California, Florida, Louisiana and Oregon, which typically have larger Medicaid populations and more patients with hepatitis C....
Continue reading....

Related @ NATAP

Medicaids/ Feds Deny HCV Treatment to Poor/Disenfranchised, Those Most Affected by HCV-
HCV Restrictions New Meeting Dec 18, 2014 by California Panel (CTAF) That Previously was the 1st to construct absurd restrictions .....the CTAF meeting in March 2014 was the 1st "kangaroo court" to restrict HCV treatment access, it appeared rigged as all these efforts are, they are not in the best interests of patients/marginalized patients and are opposite of the spirit of Medicaid & federally funded healthcare...they say - HCV treatment is too expensive...we can't treat everyone....we will construct restrictions that in affect deny access to drug users & treat only those with advanced disease
Sovaldi represents great pharmaceutical innovation. Results have been exceptional. Unfortunately, the drug's maker — taking advantage of a lack of competition fostered by patent protection — has priced it so high as to be a major threat to health care affordability.

Updated August 20, 2014 
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi

Tuesday, August 19, 2014

Hepatitis C - 40% Surveyed Specialists Expect to Prescribe Gilead's Sofosbuvir/Ledipasvir Regimen

Nearly Half of Surveyed Specialists Expect to Prescribe Gilead's Sofosbuvir/Ledipasvir Regimen Near-Term for Hepatitis C Infections

HEADLINE2 Reimbursement and Out-of-Pocket Costs are the Leading Reasons for Treatment Discontinuation, According to Findings from Decision Resources Group

BURLINGTON, Mass., Aug. 19, 2014 /PRNewswire/ -- Decision Resources Group finds that, for the treatment of hepatitis C virus (HCV) infections, 40 percent of surveyed HCV treating specialists expect to prescribe Gilead's investigational fixed-dose combination of sofosbuvir/ledipasvir in the next six months to their genotype 1 patients. Analysis of surveyed specialists' near-term prescribing intent indicates that nearly one in every four actively treated genotype 1 patients will be prescribed the sofosbuvir/ledipasvir regimen in the next six months. However, the on-treatment patient shares for the off-label Olysio (Janssen) and Sovaldi combination regimen are expected to remain stable over this period.

Other key findings from the report entitled LaunchTrends: Sovaldi and Olysio US Wave 3:

  • Current treatment of HCV: Six months after the launch of Sovaldi, the shift in treatment paradigm is evident; Sovaldi-containing regimens lead the pack across key genotypes, accounting for over 70 percent of the patient share. While Olysio still lags behind Sovaldi for genotype 1 infections, the drug's performance thus far cannot be overlooked. Olysio, mainly when used in combination with Sovaldi, captures nearly one-quarter of the patient share, which represents an increase compared with the previous sampling period.
  • Treatment rates: At six months after the launch of Sovaldi, surveyed prescribers of Olysio and Sovaldi are reporting discontinuation rates and proportions of patients achieving sustained virologic response for patients treated with Olysio and/or Sovaldi. Among patients who prematurely discontinued treatment with Olysio- and/or Sovaldi-containing regimens, surveyed physicians cited reimbursement issues and high out-of pocket costs as the main causes.
  • Awareness of emerging HCV therapies: Surveyed physicians are more likely to be aware of the U.S. regulatory filing for sofosbuvir/ledipasvir than the filings for Bristol-Myers Squibb's daclatasvir and asunaprevir and AbbVie's combination regimen. While awareness of sofosbuvir/ledipasvir has risen since the previous sampling period, many physicians remain unaware of emerging therapies on the horizon.
Comments from Decision Resources Group Director Brenda Perez-Cheeks, Ph.D.:

  • "Our findings suggest that in the next six months, HCV treatment will once again undergo a significant transformation, with Gilead's sofosbuvir/ledipasvir regimen expected to rapidly gain market share. However, near-term competitors that offer favorable pricing and cost sensitivity of payers will likely be a constraint on the uptake of this regimen."
  • "High treatment costs and cost control obstacles erected by payers not only continue to be the leading barrier to Olysio and Sovaldi prescribing but are impacting rates of premature treatment discontinuation for these regimens. Indeed, interviewed specialists noted the cumbersome nature of the managed care approval process that impedes patient access and strains resources and staff."  
About Decision Resources Group
Decision Resources Group offers best-in-class, high-value information and insights on critical issues within the healthcare industry. Clients rely on this analysis and data to make informed decisions. Find out more at www.DecisionResourcesGroup.com.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact: Decision Resources Group
Christopher Comfort
781-993-2597
ccomfort@dresourcesgroup.com
Logo - http://photos.prnewswire.com/prnh/20130103/MM36768LOGO
SOURCE Decision Resources Group

Treating HCV- Learning The Basics

HCV- Learning The Basics

Happy Tuesday folks, hope you all had a great weekend. Since a new week is just beginning why not try something new by using an online learning activity to gain additional knowledge about HCV?

The HCV landscape is quickly changing, with many new investigational agents making their way to FDA approval, and newer treatments now available that require shorter treatment duration, less side effects and higher cure rates. 

In order to gain a better understand of treating HCV, a review of the basics, especially treatment response, is a necessary first step. By doing so, participating in the decision process and communicating with a healthcare provider is made easier, if treatment is needed.

A good  place to start is with this video presentation by The American Association for the Study of Liver Diseases (AASLD) which include eight modules discussing the following topics;

Modules 

Hepatitis C
  • Module 1: HCV: Epidemiology and Screening
  • Module 2: Patient with New Diagnosis of HCV (anti-HCV positive)
  • Module 3. Assessing Severity of Liver Disease in HCV
  • Module 4: Management of the Patient with Chronic HCV
  • Module 5. Management of the Chronic HCV Patient with Co-Morbid and Other Conditions
  • Module 6. Antiviral Treatment of the Patient with HCV Infection
  • Module 7. Management of Patients with HCV who have achieved a Virological "Cure"
  • Module 8. The Pediatric Patient with HCV
** The CME offers information on hepatitis B as well. 

  • Module 1: HBV: Epidemiology and Screening
  • Module 2: Patient with Positive Hepatitis B Serologies
  • Module 3. Natural History of HBV and Identification of Treatment Candidates
  • Module 4. Management of the Chronic HBV Patient with Co-Morbid and Other Conditions
  • Module 5: Antiviral treatment of the Patient with Chronic HBV
  • Module 6: Prevention of HBV Infection
  • Module 7: Hepatitis B in the Pediatric Patient
Although the learning activity is for healthcare professionals, the savvy patient will benefit greatly from reviewing the program.

First time participants should register here, before clicking on the links provided below. After this is achieved, come back and follow the instructions for navigating the activity. The goal is to learn more about managing and treating HCV, since we are not healthcare professionals earning a CME credit, or taking the pretest isn't necessary. Skip these steps by using the following tips.

Navigating The Program

Register here, type in all required fields marked with the red asterisk *
Next, click here
After landing on the CME, click on; First step: Self needs-assessment questions
The user will be prompted to answer two questions, and asked to choose from a drop down menu under "Which Topics" answer as seen below. 

Click Submit

Click on the first module to view the video presentation; Module 1: HCV: Epidemiology and Screening

Click on "Presentation" ignore the pre-test, post-test or the evaluation form. 

After clicking on "Presentation" a pop up will appear asking you; Do you wish to receive credits for this activity? 
Respond with no. 

Another pop up will appear warning no credit will be issued for taking the CME.
Respond with, okay. 

The program will begin.

If you decide to only review one module, check out; Antiviral Treatment of the Patient with HCV Infection narrated by Dr. Michael Fried discussing current and new therapies for HCV. This module is newer, released on April 10, 2014. 


In addition, this month a new section was added to AASLD/IDSA recommendations for testing, managing, and treating Hepatitis C titled; When and in Whom to Initiate HCV Therapy. Recently, Alan Franciscus, Editor-in-Chief at HCV Advocate offered a review with commentary on the update, view the entire report here, on their website.

Finally, a self-study, interactive; Hepatitis C Online Course, covering other conditions related to the virus, disease progression, noninvasive tests for diagnosing liver fibrosis, treatment and so much more, is most certainly a valuable tool worth exploring. The course is provided by the University of Washington and includes a collaboration with the International Antiviral Society-USA (IAS-USA). Funded by a grant from the Centers for Disease Control and Prevention.

Enjoy, see you soon.
Tina