The small molecule multikinase inhibitor sorafenib remains the only molecularly targeted therapy approved by the FDA for the treatment of hepatocellular carcinoma (HCC). Ongoing clinical trials are diligently testing the potential for novel targeted agents or combination therapies to further improve patient outcomes in this setting.
Sorafenib tosylate (Nexavar) was approved by the FDA in late 2007 for the treatment of unresectable HCC, a decision based on the findings of the Sorafenib HCC Assessment Randomized Protocol (SHARP) trial.1According to this multicenter, double-blind, phase III study, a randomized protocol of either sorafenib or placebo in 602 advanced, untreated patients with HCC, sorafenib led to statistically significant improvement in overall survival compared with placebo.
- See more at: http://www.targetedonc.com/publications/hcc-monitor/2015/may-2015/Evolution-of-Treatment-for-HCC-Sorafenib-and-Beyond#sthash.OlPiai0z.dpuf
Friday, May 8, 2015
Snapshots, by Alan Franciscus, Editor-in-Chief
Article: Depression rather than liver impairment reduces quality of life in patients with hepatitis C—LD Silva, et al
Source: Rev Bras Psiquiatr. 2015 Jan-Mar;37(1):21-30. doi: 10.1590/1516-4446-2014-1446
Source: Rev Bras Psiquiatr. 2015 Jan-Mar;37(1):21-30. doi: 10.1590/1516-4446-2014-1446
Results and Conclusion: In the current study there were 124 patients (72 females; 52 males; mean age 53 yo). The patients were given various clinical and psychiatric evaluations. No patients were receiving HCV treatment. Various in-person interviews were given to determine socio-economic information, health-related quality of life, income, smoking, alcohol and drug use.
The study results found that 30.6% had major depressive disorder, which is consistent with other studies. The degree of major depressive disorder and other psychiatric disorders found in people with hepatitis C is associated with health-related quality of life rather than tied to the degree of liver fibrosis. The authors noted that more attention needs to be devoted to “the implementation of integrated medical, psychiatric, and [that] psychological care may be helpful.”
The Bottom Line: Up to 70% of people with chronic hepatitis C have depressive disorders—this is a seven-fold higher rate than the general population.
Editorial Comment: Does HCV cause depression? Many experts believe that the hepatitis C virus causes depression, but the exact mechanism hasn’t been completely understood. There have been some studies that have shown that the hepatitis C virus passes the blood-brain barrier and there have been viral particles found in brain tissue. Another possible reason for depressive disorders could potentially be the results of the immune system cells fighting off the virus in brain tissue.
Regardless of what causes depression in people with hepatitis C, it is clear that curing hepatitis C also can increase the quality of life leading to a wide variety of improvements in health including mental health. It’s time that we recognize that we should treat everyone with hepatitis C regardless of the degree of liver damage—hepatitis C is NOT just a liver disease.
Article: Changes in characteristics of hepatitis C patients seen in a liver center in the United States during the last decade—N Talaat et al.
Source: Journal of Viral Hepatitis Volume 22,Issue 5, pages 481–488, May 2015
Source: Journal of Viral Hepatitis Volume 22,Issue 5, pages 481–488, May 2015
Results and Conclusion: This was a retrospective study of the records of patients seen in liver clinics 1998-1999 (Era-1) compared to the records of patients seen 2011-2012 (Era-2)
The current study sought to describe the characteristics of people with HCV who were newly referred to liver clinics in Era-1 (538 patients). The records from Era-1 patients were compared to those of patients who were seen in Era-2 (810 patients). Advanced liver disease was defined as cirrhosis, decompensated cirrhosis, or liver cancer.
The patients in Era-2 were older (median age 56 vs 45 years), more likely to be Black (17.2% vs 11.6%) and had a longer interval between diagnosis and referral (median 4 years vs 2 years). Genotype 1 was similar in both Era’s, but genotype 1a was 39.9% vs 53.8% in Era-2.
Even though there was a higher percentage of treatment-experienced patients in the Era 2 patient group, the comparison showed that more than three quarters of the patients had never been treated.
Era-2 patients were more likely to have advanced disease at referral (61.6% vs 51.5%)—with an eightfold higher prevalence of HCC or liver cancer (21.6% vs 2.6%).
The Bottom Line: The changes in the Era-2 patients points to important trends in the hepatitis C population. These changes occurred over a relatively short period of time:
- The majority of patients identified had not been treated.
- More patients had HCV genotype 1a – generally a more difficult genotype/subtype to treat. This also reflects a change in the demographics of the HCV population of the United States.
- The aging of the HCV population is reflective of more advanced disease including an eight-fold increase in liver cancer.
http://hcvadvocate.org/news/newsLetter/2015/advocate0515.html#4
WHO moves to improve access to lifesaving medicines for hepatitis C, drug-resistant TB and cancers
News release
8 MAY 2015 | GENEVA - WHO today published the new edition of its Model List of Essential Medicines which includes ground-breaking new treatments for hepatitis C, a variety of cancers (including breast cancer and leukaemia) and multi-drug resistant tuberculosis (TB), among others. The move opens the way to improve access to innovative medicines that show clear clinical benefits and could have enormous public health impact globally.
“When new effective medicines emerge to safely treat serious and widespread diseases, it is vital to ensure that everyone who needs them can obtain them,” said WHO Director-General, Dr Margaret Chan. “Placing them on the WHO Essential Medicines List is a first step in that direction.”
Increasingly, governments and institutions around the world are using the WHO list to guide the development of their own essential medicines lists, because they know that every medicine listed has been vetted for efficacy, safety and quality, and that there has been a comparative cost-effectiveness evaluation with other alternatives in the same class of medicines.
The list is updated every two years by an Expert Committee, made up of recognized specialists from academia, research and the medical and pharmaceutical professions. This year, the Committee underscored the urgent need to take action to promote equitable access and use of several new highly effective medicines, some of which are currently too costly even for high-income countries.
Until recently, treatment for the disease presented minimal therapeutic benefits and serious side effects. Five new medicines – direct acting oral antivirals – have recently come on the market transforming chronic hepatitis C from a barely manageable to a curable condition, the new medicines have few side effects and high tolerance in patients. All 5 products, including sofosbuvir and daclatasvir, were included in the List. But high prices currently make them unaffordable and thus inaccessible to most people who need them.
“Treatments for hepatitis C are evolving rapidly, with several new, highly effective and safe medicines on the market and many in the development pipeline,” said Dr Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation. “While some efforts have been made to reduce their price for low-income countries, without uniform strategies to make these medicines more affordable globally the potential for public health gains will be reduced considerably.”
Cancers figure among the leading causes of illness and death worldwide, with approximately 14 million new cases and 8.2 million cancer-related deaths in 2012. The number of new cases is expected to rise by about 70% over the next 2 decades. New breakthroughs have been made in cancer treatment in the last years, which prompted WHO to revise the full cancer segment of the Essential Medicines List this year: 52 products were reviewed and 30 treatments confirmed, with 16 new medicines included in the List.
“Some of these medicines produce relevant survival benefits for cancers with high incidence, such as trastuzumab for breast cancer,” explained Dr Kees De Joncheere, WHO Director of Essential Medicines. “Other treatment regimens for rare cancers such as leukemia and lymphoma, which can cure up to 90% of patients, were added to set a global standard.”
TB remains one of the world’s most deadly infectious diseases. In 2013, 9 million people fell ill with TB and 1.5 million died from the disease. Over 95% of TB deaths occur in low- and middle-income countries. After about 45 years of scarce innovation for TB medicines, 5 new products were included in the EML. Four of these, including bedaquiline and delamanid, target multi-drug-resistant TB.
The Committee also recommended supporting off-label uses in cases where there is clear evidence of major health benefits, though no licensed indication, such as for many medicines for children.
“The Essential Medicines List includes medicines on the basis of safety and efficacy evidence, not on the basis of approved indications within national jurisdictions or availability of licensed alternatives,” added Dr De Joncheere. “For example, when it reviewed the application to include ranibizumab, to treat severe eye diseases such as macular degeneration, the Committee looked at the evidence base and the price difference with bevacizumab – the medicine currently listed. The Committee agreed to maintain bevacizumab as the preferred medicine, rejecting the ranibizumab application. ”
“It is important to understand that the Essential Medicines List is the starting block and not the finishing line,” concluded Dr Kieny. “Its purpose is to provide guidance for the prioritization of medicines from a clinical and public health perspective.The hard work begins with efforts to ensure that those medicines are actually available to patients.”
Note to Editors
The meeting of the 20th Expert Committee on the Selection and Use of Essential Medicines was held from 20 to 24 April 2015 at WHO Headquarters. The Expert Committee considered 77 applications for medicines to be added to the 18th WHO Model List of Essential Medicines (EML) and the 4th WHO Model List of Essential Medicines for Children (EMLc). WHO technical departments were involved and consulted with regard to applications relating to their disease areas.
Press Release Source: http://www.who.int/mediacentre/news/releases/2015/new-essential-medicines-list/en/
8 MAY 2015 | GENEVA - WHO today published the new edition of its Model List of Essential Medicines which includes ground-breaking new treatments for hepatitis C, a variety of cancers (including breast cancer and leukaemia) and multi-drug resistant tuberculosis (TB), among others. The move opens the way to improve access to innovative medicines that show clear clinical benefits and could have enormous public health impact globally.
“When new effective medicines emerge to safely treat serious and widespread diseases, it is vital to ensure that everyone who needs them can obtain them,” said WHO Director-General, Dr Margaret Chan. “Placing them on the WHO Essential Medicines List is a first step in that direction.”
Increasingly, governments and institutions around the world are using the WHO list to guide the development of their own essential medicines lists, because they know that every medicine listed has been vetted for efficacy, safety and quality, and that there has been a comparative cost-effectiveness evaluation with other alternatives in the same class of medicines.
The list is updated every two years by an Expert Committee, made up of recognized specialists from academia, research and the medical and pharmaceutical professions. This year, the Committee underscored the urgent need to take action to promote equitable access and use of several new highly effective medicines, some of which are currently too costly even for high-income countries.
New medicines to treat Hepatitis C
These included new medicines to treat hepatitis C, which affects about 150 million people globally, killing approximately half a million people each year, when chronic infection develops into liver cirrhosis or liver cancer. The disease is present in high- and lower-income countries alike, with higher concentrations in several middle- and low-income countries.Until recently, treatment for the disease presented minimal therapeutic benefits and serious side effects. Five new medicines – direct acting oral antivirals – have recently come on the market transforming chronic hepatitis C from a barely manageable to a curable condition, the new medicines have few side effects and high tolerance in patients. All 5 products, including sofosbuvir and daclatasvir, were included in the List. But high prices currently make them unaffordable and thus inaccessible to most people who need them.
“Treatments for hepatitis C are evolving rapidly, with several new, highly effective and safe medicines on the market and many in the development pipeline,” said Dr Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation. “While some efforts have been made to reduce their price for low-income countries, without uniform strategies to make these medicines more affordable globally the potential for public health gains will be reduced considerably.”
Cancers figure among the leading causes of illness and death worldwide, with approximately 14 million new cases and 8.2 million cancer-related deaths in 2012. The number of new cases is expected to rise by about 70% over the next 2 decades. New breakthroughs have been made in cancer treatment in the last years, which prompted WHO to revise the full cancer segment of the Essential Medicines List this year: 52 products were reviewed and 30 treatments confirmed, with 16 new medicines included in the List.
“Some of these medicines produce relevant survival benefits for cancers with high incidence, such as trastuzumab for breast cancer,” explained Dr Kees De Joncheere, WHO Director of Essential Medicines. “Other treatment regimens for rare cancers such as leukemia and lymphoma, which can cure up to 90% of patients, were added to set a global standard.”
TB remains one of the world’s most deadly infectious diseases. In 2013, 9 million people fell ill with TB and 1.5 million died from the disease. Over 95% of TB deaths occur in low- and middle-income countries. After about 45 years of scarce innovation for TB medicines, 5 new products were included in the EML. Four of these, including bedaquiline and delamanid, target multi-drug-resistant TB.
The Committee also recommended supporting off-label uses in cases where there is clear evidence of major health benefits, though no licensed indication, such as for many medicines for children.
“The Essential Medicines List includes medicines on the basis of safety and efficacy evidence, not on the basis of approved indications within national jurisdictions or availability of licensed alternatives,” added Dr De Joncheere. “For example, when it reviewed the application to include ranibizumab, to treat severe eye diseases such as macular degeneration, the Committee looked at the evidence base and the price difference with bevacizumab – the medicine currently listed. The Committee agreed to maintain bevacizumab as the preferred medicine, rejecting the ranibizumab application. ”
“It is important to understand that the Essential Medicines List is the starting block and not the finishing line,” concluded Dr Kieny. “Its purpose is to provide guidance for the prioritization of medicines from a clinical and public health perspective.The hard work begins with efforts to ensure that those medicines are actually available to patients.”
Note to Editors
The meeting of the 20th Expert Committee on the Selection and Use of Essential Medicines was held from 20 to 24 April 2015 at WHO Headquarters. The Expert Committee considered 77 applications for medicines to be added to the 18th WHO Model List of Essential Medicines (EML) and the 4th WHO Model List of Essential Medicines for Children (EMLc). WHO technical departments were involved and consulted with regard to applications relating to their disease areas.
Related links
Essential Medicines List 2015Press Release Source: http://www.who.int/mediacentre/news/releases/2015/new-essential-medicines-list/en/
Thursday, May 7, 2015
The SLO Hep C Project wants you to get tested
The month of May is Viral Hepatitis Awareness Month. The SLO Hep C Project wants you to get tested, and is now offering free hepatitis C testing throughout SLO County.
Kris Gottlieb, the finance support and communications coordinator for the SLO County Aids Support Network—which works in conjunction with the SLO Hep C Project—said it’s important to get the word out about the virus, who’s at risk, and what the symptoms are. He said a recently introduced bill could help spread the word.
AR 57, a bill recently introduced by state Sen. Bill Monning (D-Carmel) and Assemblymember Katcho Achadijan (R-SLO) would recognize May 19 as Viral Hepatitis Awareness Day in the county, with the aim of spreading awareness and understanding about the virus. Gottlieb said it’s a big deal on the local level.
Read more...
Kris Gottlieb, the finance support and communications coordinator for the SLO County Aids Support Network—which works in conjunction with the SLO Hep C Project—said it’s important to get the word out about the virus, who’s at risk, and what the symptoms are. He said a recently introduced bill could help spread the word.
AR 57, a bill recently introduced by state Sen. Bill Monning (D-Carmel) and Assemblymember Katcho Achadijan (R-SLO) would recognize May 19 as Viral Hepatitis Awareness Day in the county, with the aim of spreading awareness and understanding about the virus. Gottlieb said it’s a big deal on the local level.
Read more...
Research shows Hepatitis C illness, death increasing in Arkansas
Hepatitis C (Hep C) infection is increasing in Arkansas, according to new research published in the May 2015 issue of the Journal of the Arkansas Medical Society. The research, conducted by physicians and epidemiologists from the Arkansas Department of Health and University of Arkansas for Medical Sciences, showed that Hep C-related hospitalizations increased from 2,837 in 2004, to 4,141 in 2012. In addition, Hep C is now a leading cause or contributing factor in more deaths than HIV; the most recent data available suggests Hep C-related deaths occur at nearly twice the rate of HIV-related deaths.
Dr. Naveen Patil with the Arkansas Department of Health says, "We believe that in Arkansas there may be about 30,000 people who might be chronically infected and a majority of them may not be knowing about it. People who are infected at that time. It usually takes decades for people to manifest the disease of chronic infection, maybe 30-40-50 years. So we are seeing an increased burden of that disease with all it's chronic manifestations right now."
As a result, the Arkansas Department of Health (ADH) is encouraging all individuals born between 1945 and 1965, or anyone who is at risk for infection, get tested for Hepatitis C at least once. Testing is available at all 94 county health units, and individuals may also ask their primary care doctor about getting tested.
Read more...
Dr. Naveen Patil with the Arkansas Department of Health says, "We believe that in Arkansas there may be about 30,000 people who might be chronically infected and a majority of them may not be knowing about it. People who are infected at that time. It usually takes decades for people to manifest the disease of chronic infection, maybe 30-40-50 years. So we are seeing an increased burden of that disease with all it's chronic manifestations right now."
As a result, the Arkansas Department of Health (ADH) is encouraging all individuals born between 1945 and 1965, or anyone who is at risk for infection, get tested for Hepatitis C at least once. Testing is available at all 94 county health units, and individuals may also ask their primary care doctor about getting tested.
Read more...
Treatment Curing Patients with Advanced Hepatitis C Symptoms
A medical breakthrough tested in San Antonio is opening doors for patients diagnosed with hepatitis C.
The virus can be deadly, but now researchers say they've found a cure for those suffering from advanced stages of the disease.
People like Joey Libby.
Libby was just 15 years old when he was diagnosed with liver failure.
Read more...
CDC Warns of Rise in Hepatitis C Cases Linked to Injection-Drug Use
Reported Hep C cases in young people more than tripled from 2006 to 2012 in Kentucky, Tennessee, Virginia and West Virginia, CDC study finds
The Centers for Disease Control and Prevention warned about a sharp increase in hepatitis C infections linked to injection-drug abuse in four Appalachian states, and called for better health services to contain the spread.
Reported cases of acute hepatitis C infection in people ages 30 or under more than tripled from 2006 to 2012 in four states—Kentucky, Tennessee, Virginia and West Virginia—according to a new study published by the CDC Thursday. Among patients for whom associated risk factors were reported, more than 70% reported injection-drug abuse.
During the same period, the number of people under 30 admitted to substance-abuse treatment facilities for opioid drugs grew by 21% in those states. A significant proportion of these people identified injection as their main method of drug use.
Read more...
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