Five former patients of a dentist at the centre of the biggest recall in NHS history have tested positive for hepatitis C, it emerged.
Health chiefs wrote to 22,000 people treated by Desmond D’Mello urging them to undergo tests after he breached hygiene regulations.
The 60-year-old dentist was secretly filmed failing to wash his hands or change equipment between appointments at his practice.
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Tuesday, March 17, 2015
Snapshots —Alan Franciscus, Editor-in-Chief
Read about fast rate of fibrosis progression after seroconversion, compassionate use of sofosbuvir for post-transplant, and transplant delisting after being cured of HCV.
Abstract: Liver Fibrosis Progression in Hepatitis C Virus Infection After Seroconversion—A Butt et al.
Source: JAMA Intern Med.2015;175(2):178-185. doi:10.1001/jamainternmed.2014.6502
Source: JAMA Intern Med.2015;175(2):178-185. doi:10.1001/jamainternmed.2014.6502
The current study analyzed electronic records from the Veterans Administration between 2002 and 2012. Among the 610,514 records 1,840 patients were found to be HCV positive, and the HCV negative patients were matched for age, race and sex. People with HIV, HBV, with less than 24 months of follow-up, liver cancer or cirrhosis were excluded from the analysis. The HCV patients in the study had an initial HCV negative antibody test, but later tested positive for an HCV antibody test and a positive HCV viral load indicating active HCV infections. The control group had 2 HCV negative antibody tests indicating HCV negative status.
Fibrosis scarring was found to start early after initial infection—452 patients developed cirrhosis, and 85 patients developed decompensated cirrhosis (end-stage liver disease).
After 10 years of follow-up—18.4% of the HCV patients developed cirrhosis vs. 6.1% of the patients without hepatitis C. Nine years after diagnosis of hepatitis C, 1.79% developed decompensated cirrhosis vs. 0.33% in the group without hepatitis C.
One very interesting finding was that white race was associated with a 51% increased risk of developing cirrhosis.
Editorial Comments: This is the first study (to my knowledge) that has shown a fibrosis progression after initial infection. It should also wake us up to the need for treatment soon after exposure or immediately after the onset of chronic infection to prevent any damage to the liver.
Abstract: Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C following liver transplantation—X. Forns et al.
Source: Hepatology. 2014 Dec 29. doi: 10.1002/hep.27681. [Epub ahead of print]
Source: Hepatology. 2014 Dec 29. doi: 10.1002/hep.27681. [Epub ahead of print]
Hepatitis C resides in the liver and blood. As a consequence, if someone receives a transplant the new liver is always re-infected with the hepatitis C virus. Due to many factors including the use of immunosuppressant drugs (to prevent rejection of the organ by the body) the virus multiplies out of control. Many times (but not always) there is severe and quick disease progression. Unless there is another donated liver available, the person may face death.
Compassionate use is a program that allows the use of drugs untested in a particular population, i.e., post-transplant patients, which may help save lives when there are no other available options. In this case sofosbuvir and ribavirin was given for 24 to 48 weeks to people who had severe recurrent HCV disease after a liver transplant. The patients in the study were expected to live less than a year. The decision to add pegylated interferon was left up to the judgment of the treating physician.
At the time of the analysis (January 1, 2014) there were 92 patients assessed, 54 (59%) patients achieved SVR12 (virologic cure). Those with early recurrent hepatitis C were more likely to achieve SVR12 (73%) than those with cirrhosis (43%). More than half of the patients who achieved a cure had clinical improvement, more than a fifth were unchanged and only 3% of the patients were worse. Eighteen percent of patients had serious adverse events (side effects).
Editorial comments: These results are excellent for patients who are very difficult to treat. The 73% cure rate of those who were treated early on after recurrent hepatitis C means that everyone with hepatitis C at the time of transplant should be treated as soon as it is safe. However, we should not have to wait—treat well before the need for a transplant, and no one with hepatitis C should ever have to face this potentially life-threatening (and expensive) transplant procedure again.
Article: Letter from the Frontline: Patient with decompensated hepatitis C virus–related cirrhosis delisted for liver transplantation after successful sofosbuvir-based treatment—I Ruiz et al.
Source: Liver Transplantation Volume 21, Issue 3, pages 408–409, March 2015
Source: Liver Transplantation Volume 21, Issue 3, pages 408–409, March 2015
This was a case study of one patient who was listed for a liver transplant in October 2013. The patient was a 67-year-old woman with HCV genotype 4 and decompensated cirrhosis. She was treatment experienced (null responder) to pegylated interferon plus ribavirin and had weekly paracentesis (she had to have fluid drained from her abdominal cavity due to ascites), and moderate encephalopathy (brain disorder caused by the build-up of ammonia and toxins in the brain) that required several hospitalizations.
Treatment consisted of sofosbuvir plus ribavirin for 24 weeks. After 8 weeks, of treatment the woman’s viral load was undetectable. The treatment was well tolerated. The patient achieved a cure and her encephalopathy, ascites and liver disease improved to the point that she was taken off the transplant list.
The authors commented that (to their knowledge) this is a first—a patient with hepatitis C related decompensated cirrhosis was delisted from the transplant list.
Editorial comment: In the past interferon and ribavirin was given but was poorly tolerated for people with end-stage liver disease. In fact, treatment with interferon and ribavirin could lead to more severe disease progression and death.
The two studies above provide proof that all-oral therapy provides safe and effective treatment. Now, we just need to provide treatment to everyone with hepatitis C so that no one has to suffer from end-stage liver disease and the need for a liver transplant.
http://hcvadvocate.org/news/newsLetter/2015/advocate0315_mid.html#2
Hepatitis C Drugs Will 'Strain Budgets' at Current Prices: Study
The new therapies have remarkably high cure rates
MONDAY, March 16, 2015 (HealthDay News) -- New hepatitis C drugs promise cure rates above 90 percent, but could prove to be budget-busters for public and private health insurers, a new analysis finds.
Recently approved drugs for chronic hepatitis C have been heralded as a breakthrough that could make the liver disease "rare" in the United States. But with prices topping $1,000 per pill, government and private insurers are balking -- often putting limits on which patients qualify for coverage.
Now two new studies in the March 16 Annals of Internal Medicine conclude that for individual patients, treatment with the pricey pills is "cost-effective." That's a calculation that takes into account the years of better health and quality of life people will likely enjoy.
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Monday, March 16, 2015
HCV in Japan, by Alan Franciscus, Editor-in-Chief
Of all the industrialized countries of the world, Japan has the highest rate of hepatitis C (HCV). It also has one of the oldest and most varied histories of hepatitis C in the world among the industrialized modern nations. Approximately 1.5 to 2 million Japanese are infected with hepatitis C. Approximately 70% of the Japanese population infected with hepatitis C has HCV genotype 1b, and 30% are infected with genotype 2a/b.
The History of HCV in Japan
Modern medicine and public health came early to Japan in the late 1800’s. In the early 1900’s, the discovery of the hypodermic needle and a drug to treat schistosomiasis would transmit hepatitis C throughout Japan.
Modern medicine and public health came early to Japan in the late 1800’s. In the early 1900’s, the discovery of the hypodermic needle and a drug to treat schistosomiasis would transmit hepatitis C throughout Japan.
Schistosomiasis
Schistosomiasis is a disease caused by a worm that lives in water snails. When people wade in water to work on agriculture the worm enters the human body and lays eggs. The eggs hatch and travel to the liver. Schistosomiasis causes damage to the liver, the gastrointestinal system, kidneys, and genitals. It can, over time, cause death. In some parts of the world, it is considered as deadly as malaria. The first treatment developed to treat schistosomiasis consisted of multiple intravenous injections of antimony sodium tartrate. By the 1970’s there were approximately 10 million intravenous injections given to people in Japan. The same type of eradication program was conducted in Egypt, and a similar epidemic of HCV is seen in Egypt. As in Egypt, treatment of schistosomiasis was the beginning of the HCV epidemic in Japan. The injections were given with used or unsterile hypodermic needles.
Schistosomiasis is a disease caused by a worm that lives in water snails. When people wade in water to work on agriculture the worm enters the human body and lays eggs. The eggs hatch and travel to the liver. Schistosomiasis causes damage to the liver, the gastrointestinal system, kidneys, and genitals. It can, over time, cause death. In some parts of the world, it is considered as deadly as malaria. The first treatment developed to treat schistosomiasis consisted of multiple intravenous injections of antimony sodium tartrate. By the 1970’s there were approximately 10 million intravenous injections given to people in Japan. The same type of eradication program was conducted in Egypt, and a similar epidemic of HCV is seen in Egypt. As in Egypt, treatment of schistosomiasis was the beginning of the HCV epidemic in Japan. The injections were given with used or unsterile hypodermic needles.
Methamphetamine
Nagai Nagyoshi discovered methamphetamine in 1893. Dr. Akira was able to synthesize it into crystalline meth in 1919. Widespread use of methamphetamine use did not begin until World War l when it was used as an injectable treatment for asthma. The large scale use came later during World War II when it was prescribed as an oral and injectable stimulant for tired soldiers, pilots, and ammunition workers during the war. After the war methamphetamine was prescribed for general post-war trauma. In 1949, Japan banned the manufacture of methamphetamine, but illegal methamphetamine use continued as did the hepatitis C epidemic.
Nagai Nagyoshi discovered methamphetamine in 1893. Dr. Akira was able to synthesize it into crystalline meth in 1919. Widespread use of methamphetamine use did not begin until World War l when it was used as an injectable treatment for asthma. The large scale use came later during World War II when it was prescribed as an oral and injectable stimulant for tired soldiers, pilots, and ammunition workers during the war. After the war methamphetamine was prescribed for general post-war trauma. In 1949, Japan banned the manufacture of methamphetamine, but illegal methamphetamine use continued as did the hepatitis C epidemic.
Modern Japan and Hepatitis C
Hepatitis C and its complications are the leading cause of liver cancer in Japan. Japan has the highest rates of liver cancer in industrialized countries. HCV is the 4th leading cause of death among Japanese men and the 5th leading cause of mortality among Japanese women.
Hepatitis C and its complications are the leading cause of liver cancer in Japan. Japan has the highest rates of liver cancer in industrialized countries. HCV is the 4th leading cause of death among Japanese men and the 5th leading cause of mortality among Japanese women.
Japan has a multi-layered healthcare system. Many people can get healthcare insurance through their employer or the national healthcare system. The government system covers about 70%, and the patient covers the remaining 30%.
Interferon-free Therapies
The first interferon and ribavirin free therapy that was approved to treat hepatitis C is the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir). In a clinical trial of Japanese patients with genotype 1b patients treated with the combination of Daklinza plus Sunvepra the cure rate was 84.7%.
The first interferon and ribavirin free therapy that was approved to treat hepatitis C is the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir). In a clinical trial of Japanese patients with genotype 1b patients treated with the combination of Daklinza plus Sunvepra the cure rate was 84.7%.
Gilead has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for sofosbuvir. Sofosbuvir plus ribavirin for a treatment duration of 12 weeks to treat 153 HCV genotype 2a patients achieved a cure rate of 97%. The study was conducted in Japan
Gilead is conducting a phase 3 study of sofosbuvir plus ledipasvir to treat genotype 1 in Japan.
Gilead is conducting a phase 3 study of sofosbuvir plus ledipasvir to treat genotype 1 in Japan.
Source:
http://japanfocus.org/-Vivian-Blaxell/4112
http://hcvadvocate.org/news/newsLetter/2015/advocate0315_mid.html#1
HCV Advocate Weekly Special Topic: HCV Treatment Page
HCV Treatment Page
Check out our revised hepatitis C treatment page for the latest information about the current standard of care to treat hepatitis C, side effects and how to manage those same side effects.
Why we need a petition to increase access to novel therapies
The Alliance for the Adoption of Innovations in Medicine (Aimed Alliance) believes Americans are better served through policies that define the value of new therapies in patient terms, not upfront costs. This means assessing novel therapies on the basis of improved longevity, productivity, and quality of life where the payoff can be substantial.
Given that restricting access harms patients, 15 states and the District of Columbia are taking action, including Delaware, Maryland, and Louisiana, which passed laws capping co-pays on specialty medicines. Yet, if the real value of novel therapies is to be realized, we need more patient protections at the state and federal levels. Instead of a petition to impose more cost containment policies, now is the time for a petition to increase patient access to novel therapies through legislative and regulatory remedies.
Read more...
Given that restricting access harms patients, 15 states and the District of Columbia are taking action, including Delaware, Maryland, and Louisiana, which passed laws capping co-pays on specialty medicines. Yet, if the real value of novel therapies is to be realized, we need more patient protections at the state and federal levels. Instead of a petition to impose more cost containment policies, now is the time for a petition to increase patient access to novel therapies through legislative and regulatory remedies.
Read more...
Thursday, March 12, 2015
Hepatitis C a focus at CROI
New interferon-free treatment can cure nearly 100 percent of HIV-positive people coinfected with hepatitis C virus, researchers reported at the recent 2015 Conference on Retroviruses and Opportunistic Infections in Seattle. But another study showed that delaying treatment results in a higher risk of liver-related complications and death even after being cured.
Two studies presented at the conference showed that HIV/HCV coinfected people can expect the same high cure rates as HIV-negative people using recently or soon-to-be approved antivirals.
Susanna Naggie from Duke Clinical Research Institute presented results from ION-4, a trial evaluating Gilead Science's HCV polymerase inhibitor sofosbuvir and NS5A inhibitor ledipasvir – the drugs in the Harvoni coformulation approved last October. The study enrolled 335 coinfected participants, mostly with HCV genotype 1 (the most common type in the U.S.).
Read more...
Two studies presented at the conference showed that HIV/HCV coinfected people can expect the same high cure rates as HIV-negative people using recently or soon-to-be approved antivirals.
Susanna Naggie from Duke Clinical Research Institute presented results from ION-4, a trial evaluating Gilead Science's HCV polymerase inhibitor sofosbuvir and NS5A inhibitor ledipasvir – the drugs in the Harvoni coformulation approved last October. The study enrolled 335 coinfected participants, mostly with HCV genotype 1 (the most common type in the U.S.).
Read more...
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