Wednesday, May 18, 2016

"Pay For Performance" Drug Plans Could Impact Biopharma's R&D Priorities

"Pay For Performance" Drug Plans Could Impact Biopharma's R&D Priorities
John LaMattina , Contributor

As healthcare costs continue to rise, payers are seeking ways to get prices under control. One method gaining more and more favor when it comes to paying for new, expensive medicines is pay-for-performance – an arrangement where a payer agrees to allow access to a new drug with the proviso that it gets reimbursed for those patients for whom the drug was not effective.

Pay-for performance works well when you can directly measure the outcome. When a patient with hepatitis C is treated with Harvoni (Gilead), you expect to rid this virus in almost all of the patients within 12 weeks. That’s easy to measure and....

HCV Next - Chipping Away at Medicaid Restrictions to DAA Coverage

HCV NEXT May Issue

Chipping Away at Medicaid Restrictions to DAA Coverage

"HCV Next" offers information on a range of topics, which include diagnosis, new combination therapies, side effects, drug/drug interaction, guidelines, practice management issues, to name a few.

The following articles appeared in the May print edition of HCV NEXT, provided online at Healio.

Table of Contents

5 Questions
A Conversation with Anthony Martinez, MD
Cover Story
In this issue, HCV Next asks five questions of Anthony Martinez, MD, clinical associate professor at Jacobs School of Medicine and Biomedical Sciences at University at Buffalo.

Cover Story
A recent Notice from the Centers for Medicare and Medicaid Services outlined policies surrounding coverage and access to hepatitis C drugs for Medicaid beneficiaries. The authors were sympathetic to ongoing concerns about the high cost of direct-acting antiviral therapies and expressed cautious optimism that market forces will ultimately drive those costs down.

With more than 10,000 attendees and a record-breaking number of presentation submissions, 2016’s International Liver Congress offered much support of our current knowledge of hepatitis C virus along with small, ground breaking studies in areas of need.

Meeting News Coverage
Liver Societies Pledge Solidarity in the Elimination of Viral Hepatitis
“The joint statement I have just received is groundbreaking and constitutes a pivotal movement. This conference will be remembered for when elimination of viral hepatitis was embraced,” Gottfried Hirnschall, MD, MPH, director of the HIV/AIDS department and global hepatitis program at the World Health Organization, said during the general session. “This means that the thousands of hepatologists, clinicians and experts who are members of the four organizations will be ambassadors of eliminating hepatitis in your own countries.”
The recommended guidelines are geared toward policy-makers in low- and middle-income countries who formulate country-specific treatment guidelines and who plan infectious disease treatment programs and services, as well as clinicians responsible for providing treatment, according to the guidelines. They are intended to promote the “scale-up of HCV treatment”, more specifically among people in low- and middle-income countries, where very few have access to these new treatments.

The Big Picture
Non-alcoholic fatty liver disease is one of the most common causes of liver disease in developed countries with an estimated prevalence of 30% and 33% in the United States and European populations, respectively. After excluding significant alcohol consumption and other secondary causes of steatosis (ie, medications), NAFLD can be defined by the presence of hepatic steatosis identified by either imaging or histology.

HCV Next board members and experts in attendance offered varying viewpoints on the data presented. Co-Chief Medical Editor, Ira M. Jacobson, MD, chair of the department of medicine at Mount Sinai Beth Israel Medical Center in New York City; Zobair Younossi, MD, MPH, chairman of the department of medicine, Inova Fairfax Hospital, and vice president for research of Inova Health System; Eric J. Lawitz, MD, vice president of scientific and research development at The Texas Liver Institute and clinical professor of medicine at the University of Texas Health Science Center; and Jordan J. Feld, MD, MPH, associated professor of medicine and research director of gastroenterology at the Toronto Centre for Liver Disease and HCV Next Editorial Board member shared their insights into the most compelling data and topics discussed at this year’s meeting.

Tuesday, May 17, 2016

Watch - New (and Cheaper) HCV Therapy: Option for HIV Coinfection?


New (and Cheaper) HCV Therapy: Option for HIV Coinfection?
Paul E. Sax, MD

Hi. This is Dr Paul Sax, from Brigham and Women's Hospital and Harvard Medical School. Today I'd like to discuss the January approval in the area of hepatitis C virus (HCV) treatment—the single-tablet regimen containing elbasvir and grazoprevir—and in particular, how it relates to our patients coinfected with HIV..

View Video @ Medscape 

Gilead Sciences' patent on hepatitis C drug sofosbuvir challenged in Delhi High Court Our Bureau, Mumbai

Gilead Sciences' patent on hepatitis C drug sofosbuvir challenged in Delhi High Court Our Bureau, Mumbai
Tuesday, May 17, 2016, 08:00 Hrs [IST]

The US-based Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) have filed an appeal with the Delhi High Court challenging the Delhi Patent Office's decision to accord patent to US pharma company Gilead Sciences' blockbuster hepatitis C (HCV) drug sofosbuvir.

In their appeal, these health groups have pleaded that the Indian patent office's latest decision is contrary to the public interest, fails to assess the full scientific and legal evidence presented and ignores key Indian patent law and judicial precedents. Gilead has claimed existing public knowledge as its own and its patent on sofosbuvir, the base compound in its Hep C drug Sovaldi, is 'unmerited', these groups said.

Continue reading...

Monday, May 16, 2016

Increased physical activity associated with lower risk of 13 types of cancer

Increased physical activity associated with lower risk of 13 types of cancer

The investigators confirmed that leisure-time physical activity, as assessed by self-reported surveys, was associated with a lower risk of colon, breast, and endometrial cancers. They also determined that leisure-time physical activity was associated with a lower risk of 10 additional cancers, with the greatest risk reductions for esophageal adenocarcinoma, liver cancer, cancer of the gastric cardia, kidney cancer, and myeloid leukemia.

A new study of the relationship between physical activity and cancer has shown that greater levels of leisure-time physical activity were associated with a lower risk of developing 13 different types of cancer. The risk of developing seven cancer types was 20 percent (or more) lower among the most active participants (90th percentile of activity) as compared with the least active participants (10th percentile of activity). These findings, from researchers at the National Cancer Institute (NCI), part of the National Institutes of Health, and the American Cancer Society, confirm and extend the evidence for a benefit of physical activity on cancer risk and support its role as a key component of population-wide cancer prevention and control efforts. The study, by Steven C. Moore, Ph.D., NCI, and colleagues, appeared May 16, 2016, in JAMA Internal Medicine.

Hundreds of previous studies have examined associations between physical activity and cancer risk and shown reduced risks for colon, breast, and endometrial cancers; however, results have been inconclusive for most cancer types due to small numbers of participants in the studies. This new study pooled data on 1.44 million people, ages 19 to 98, from the United States and Europe, and was able to examine a broad range of cancers, including rare malignancies. Participants were followed for a median of 11 years during which 187,000 new cases of cancer occurred.

The investigators confirmed that leisure-time physical activity, as assessed by self-reported surveys, was associated with a lower risk of colon, breast, and endometrial cancers. They also determined that leisure-time physical activity was associated with a lower risk of 10 additional cancers, with the greatest risk reductions for esophageal adenocarcinoma, liver cancer, cancer of the gastric cardia, kidney cancer, and myeloid leukemia. Myeloma and cancers of the head and neck, rectum, and bladder also showed reduced risks that were significant, but not as strong. Risk was reduced for lung cancer, but only for current and former smokers; the reasons for this are still being studied.

“Leisure-time physical activity is known to reduce risks of heart disease and risk of death from all causes, and our study demonstrates that it is also associated with lower risks of many types of cancer,” said Moore. “Furthermore, our results support that these associations are broadly generalizable to different populations, including people who are overweight or obese, or those with a history of smoking. Health care professionals counseling inactive adults should promote physical activity as a component of a healthy lifestyle and cancer prevention.”

Leisure-time physical activity is defined as exercise done at one’s own discretion, often to improve or maintain fitness or health. Examples include walking, running, swimming, and other moderate to vigorous intensity activities. The median level of activity in the study was about 150 minutes of moderate-intensity activity per week, which is comparable to the current recommended minimum level of physical activity for the U.S. population.

There are a number of mechanisms through which physical activity could affect cancer risk. It has been hypothesized that cancer growth could be initiated or abetted by three metabolic pathways that are also affected by exercise: sex steroids (estrogens and androgens); insulin and insulin-like growth factors; and proteins involved with both insulin metabolism and inflammation. Additionally, several non-hormonal mechanisms have been hypothesized to link physical activity to cancer risk, including inflammation, immune function, oxidative stress, and, for colon cancer, a reduction in time that it takes for waste to pass through the gastrointestinal tract.

Most associations between physical activity and lower cancer risk changed little when adjusted for body mass index, suggesting that physical activity acts through mechanisms other than lowering body weight to reduce cancer risk. Associations between physical activity and cancer were also similar in subgroups of normal weight and overweight participants, and in current smokers or people who never smoked.

The study was a large-scale effort of the Physical Activity Collaboration of NCI’s Cohort Consortium, which was formed to estimate physical activity and disease associations using pooled prospective data and a standardized analytical approach.

“For years, we’ve had substantial evidence supporting a role for physical activity in three leading cancers: colon, breast, and endometrial cancers, which together account for nearly one in four cancers in the United States,” said Alpa V. Patel, Ph.D., a co-author from the American Cancer Society. “This study linking physical activity to 10 additional cancers shows its impact may be even more relevant, and that physical activity has far reaching value for cancer prevention.”

The National Cancer Institute leads the National Cancer Program and the NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at or call NCI's Cancer Information Service at 1-800-4-CANCER.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit
NIH…Turning Discovery Into Health®
Moore SC, et al. Leisure-time physical activity and risk of 26 types of cancer in 1.44 million adults. JAMA Internal Medicine. May 16, 2016. DOI:10.1001/jamainternmed.2016.1548.

Listen: Is liver cancer more common than we think? on Health Report

Is liver cancer more common than we think? on Health Report
with Norman Swan on RN
Monday 16th May
The number of new cases of Hepatocellular carcinoma (HCC), or liver cancer, is on the rise in developed countries.

Cancer incidence is often calculated from cancer registry data - but a recent study from St Vincent’s Hospital Melbourne instead analysed a variety of other sources, including admissions information from seven major hospitals, outpatient data, and other data from radiology, pathology and pharmacy services.

And, compared to the cancer registry, incidence almost doubled.

Excessive alcohol consumption is one of the primary causes of the disease, and the researchers think more work is needed to examine its impact on this finding.
Listen here......

Image: Liver cancer cells (Getty Images/STEVE GSCHMEISSNER

The curious case of generic Hep C drug sofosbuvir

The curious case of generic Hep C drug sofosbuvir

Flip-flop around its patent in India points to need for developing nations to band for tech
For more than a decade, an academic debate has raged among public health experts, the World Health Organization and governments on the capacity, cost effectiveness and the potential benefits of generic drug production in developing countries other than India and China.
Hepatitis C and the revolution in the generic production and supply of new HCV medicines changed all that.
The first approvals by the European Medicines Agency and the US Food and Drug Administration of a new generation of HCV medicines, called direct-acting antivirals (DAAs), started with sofosbuvir in 2013. The US price tag of $84,000 for sofosbuvir and $47,000 in Europe brought to world attention the spiralling cost of patented medicines.

Sunday, May 15, 2016

A Continued Role for Ribavirin in HCV Genotype 3 Infection with Advanced Liver Disease

A Continued Role for Ribavirin in HCV Genotype 3 Infection with Advanced Liver Disease
Atif Zaman, MD, MPH reviewing Leroy V et al. Hepatology 2016 May.

12-week regimen of sofosbuvir, daclatasvir, and ribavirin achieved sustained response in >85% of patients with cirrhosis regardless of treatment experience.

Although current treatment regimens for hepatitis C virus (HCV) infection are effective in most scenarios, sustained virologic response (SVR) rates tend to be lower among HCV genotype 3 patients with advanced liver disease (e.g., SVR rates are approximately 65% in patients with cirrhosis versus >95% in those without cirrhosis).

In the current industry-funded, open-label, randomized, phase III study, investigators evaluated the efficacy of daclatasvir 60 mg daily and sofosbuvir 400 mg daily plus ribavirin 1000–1200 mg daily for 12 or 16 weeks (randomized in a 1:1 fashion) in patients with treatment-naive or treatment-experienced HCV genotype 3 infection and well-compensated stage 3 fibrosis or cirrhosis. The primary endpoint was SVR at 12 weeks after treatment completion (SVR12).

Among 50 study participants, 37 were treatment-experienced and 36 had cirrhosis. The SVR12 rate was 90% (45 of 50) overall, 88% among those treated for 12 weeks, and 92% among those treated for 16 weeks. SVR12 was 100% among patients with stage 3 fibrosis and 86% among those with cirrhosis (83% in the 12-week arm and 89% in the 16-week arm). SVR12 rates for treatment-experienced patients with cirrhosis were similar and ranged from 86% to 88%. Four patients relapsed after treatment. The most common adverse effects were insomnia, fatigue, and headache.

Adding ribavirin to daclatasvir and sofosbuvir in patients with HCV genotype 3 infection and advanced fibrosis or cirrhosis markedly improved SVR rates, even in those who had failed HCV treatment previously. This was accomplished without extending treatment duration beyond 12 weeks, thus being cost-effective as well. It seems that ribavirin use still has a role in HCV treatment.

Editor Disclosures at Time of Publication
Disclosures for Atif Zaman, MD, MPH at time of publication Nothing to disclose

Leroy V et al. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+).
( Open Url PubMed abstract (Free)