This is unbelievable in this day and age......Alan
Santa Barbara, CA. The Santa Barbara County Public Health Department has released a report into the investigation of Allen Thomashefsky, the Santa Barbara doctor accused of malpractice that lead to several patients contracting Hepatitis C
The report found that during an unannounced visit to Thomashefsky's medical practice by health officials, the physician did not wash his hands prior to a procedure. "When questioned, the physician stated that the sink was in the kitchen, he didn't want to walk back and forth, and believed his hands were clean," the report says.
According to the report, the physician did not wear gloves during the procedure either and when asked to wear gloves, he replied, "He has been practicing the same way for over 30 years and has never had a patient report any problems...The physician declined to wear gloves and used bare hands during the procedure."
Read more....
Tuesday, September 29, 2015
THE FIVE: Cirrhosis —Alan Franciscus, Editor-in-Chief
This month’s column is about cirrhosis—the causes, how it develops, the symptoms and
consequences and issues about HCV treatment related to cirrhosis.
1. What are the Causes of Cirrhosis?
Cirrhosis is caused by many substances (alcohol), viruses (hepatitis B, C and D), and even by metabolic disorders (diabetes). Currently, the most common reason for liver transplantation in the United States is from complications from the hepatitis C virus. Cirrhosis caused by hepatitis C is responsible for more than 19,000 deaths every year. Prior to the emergence of hepatitis C, the most common cause of cirrhosis was alcohol consumption. Fatty liver is also a common cause of cirrhosis, and it is expected to surpass the hepatitis C virus as the most common cause of cirrhosis and liver transplantation in the next two decades.
2. How Does Cirrhosis Develop?
In the case of hepatitis C, the development of cirrhosis is a complex process of liver cells becoming damaged or destroyed by the hepatitis C virus. Furthermore, the body’s immune system seeks out and identifies the hepatitis C virus (and the destroyed liver cell) as a foreign pathogen—attacks it and kills it. As a result, scar tissue develops. Usually, the liver can repair itself, but as the hepatitis C virus causes more and more damage, it overwhelms the body and the damage builds and builds. As more scar tissue develops the damaged cells start to connect, and fibrosis develops. Over time, the scar tissue can be so extensive that it can interfere with the functioning of the liver. This is called cirrhosis. Cirrhosis is classified into two types: compensated and decompensated. Compensated means that the liver is extensively scarred but can still perform most of its functions; decompensated means that the liver is extensively scarred and unable to perform many of the functions that keep the body healthy.
3. What are the Tests to Identify Cirrhosis?
There are many types of tests to find out if someone has cirrhosis. In the past, the most common test was a liver biopsy. The procedure requires a medical person to insert a needle through the skin to extract a piece of liver tissue and examine it under a microscope. The liver biopsy is still being used, but it is also being replaced by other procedures such as a Fibroscan (an imaging test), Fibrometer (combination of blood tests), and other blood tests to gauge the degree of liver damage.
There are many models used to grade and stage the degree of liver damage. The most common is the Metavir. The Metavir has an inflammation and fibrosis scoring stage—in this article I am just listing the fibrosis stages:
Note: This is important to know because many insurance companies are using this system to approve or deny insurance for HCV treatment claims.
4. What are the Symptoms and Consequences of Cirrhosis?
In the early stages of extensive scarring—called compensated cirrhosis—the symptoms may be similar to hepatitis C—fatigue, loss of appetite, muscle and joint pain, flu-like symptoms, nausea, indigestion, headaches and many other symptoms. As cirrhosis develops and reaches the later stages—called decompensated cirrhosis—the symptoms become more pronounced and can become life-threatening. In addition to the symptoms described above I have listed some of the more common serious conditions below:
Most of these conditions can be managed effectively with lifestyle changes, medications and medical procedures—at least in the short term. The most important step is to be medically monitored and managed on a regular basis. At this point, a person should be evaluated for a liver transplant. The problem is that there are only an estimated 6,000 available livers for the estimated 15,000 livers needed every year for transplantation in the U.S.
5. HCV Treatment
Hepatitis C treatment can now cure most people, the treatment duration is shorter, and treatment side effects are lower than ever. However, once people develop cirrhosis, it becomes more difficult especially for those who are infected with genotype 3 and who have cirrhosis—the second most prevalent genotype in the United States. Unfortunately, we also know that many insurance companies are denying coverage of hepatitis C medications to only those who are in the early stages of HCV infections (F0, F1, F2). Many insurance companies are only covering F3 and F4 unless there are other severe complications. Here’s the problem—if you wait until stage F3 or F4 and are cured you will have to be medically followed for the rest of your life since there is a possibility that you could still have liver disease progression. However, if you are treated early (F0, F1, F2), and cured you are free of future complications. Does this scenario make any sense to you? It does not make any sense to me either!
consequences and issues about HCV treatment related to cirrhosis.
1. What are the Causes of Cirrhosis?
Cirrhosis is caused by many substances (alcohol), viruses (hepatitis B, C and D), and even by metabolic disorders (diabetes). Currently, the most common reason for liver transplantation in the United States is from complications from the hepatitis C virus. Cirrhosis caused by hepatitis C is responsible for more than 19,000 deaths every year. Prior to the emergence of hepatitis C, the most common cause of cirrhosis was alcohol consumption. Fatty liver is also a common cause of cirrhosis, and it is expected to surpass the hepatitis C virus as the most common cause of cirrhosis and liver transplantation in the next two decades.
2. How Does Cirrhosis Develop?
In the case of hepatitis C, the development of cirrhosis is a complex process of liver cells becoming damaged or destroyed by the hepatitis C virus. Furthermore, the body’s immune system seeks out and identifies the hepatitis C virus (and the destroyed liver cell) as a foreign pathogen—attacks it and kills it. As a result, scar tissue develops. Usually, the liver can repair itself, but as the hepatitis C virus causes more and more damage, it overwhelms the body and the damage builds and builds. As more scar tissue develops the damaged cells start to connect, and fibrosis develops. Over time, the scar tissue can be so extensive that it can interfere with the functioning of the liver. This is called cirrhosis. Cirrhosis is classified into two types: compensated and decompensated. Compensated means that the liver is extensively scarred but can still perform most of its functions; decompensated means that the liver is extensively scarred and unable to perform many of the functions that keep the body healthy.
3. What are the Tests to Identify Cirrhosis?
There are many types of tests to find out if someone has cirrhosis. In the past, the most common test was a liver biopsy. The procedure requires a medical person to insert a needle through the skin to extract a piece of liver tissue and examine it under a microscope. The liver biopsy is still being used, but it is also being replaced by other procedures such as a Fibroscan (an imaging test), Fibrometer (combination of blood tests), and other blood tests to gauge the degree of liver damage.
There are many models used to grade and stage the degree of liver damage. The most common is the Metavir. The Metavir has an inflammation and fibrosis scoring stage—in this article I am just listing the fibrosis stages:
- Stage F0 = no fibrosis
- Stage F1 = mild fibrosis
- Stage 2 = moderate fibrosis
- Stage 3 = bridging fibrosis
- Stage 4 = cirrhosis
Note: This is important to know because many insurance companies are using this system to approve or deny insurance for HCV treatment claims.
4. What are the Symptoms and Consequences of Cirrhosis?
In the early stages of extensive scarring—called compensated cirrhosis—the symptoms may be similar to hepatitis C—fatigue, loss of appetite, muscle and joint pain, flu-like symptoms, nausea, indigestion, headaches and many other symptoms. As cirrhosis develops and reaches the later stages—called decompensated cirrhosis—the symptoms become more pronounced and can become life-threatening. In addition to the symptoms described above I have listed some of the more common serious conditions below:
- Portal Hypertension: blood cannot flow through the liver because of the extensive scarring.
- Encephalopathy: the liver is not able to remove toxins such as ammonia, and the result is that these toxins invade the brain. Symptoms include personality changes, and changes in sleep patterns (sleep reversal—awake all night, sleep all day).
- Ascites: accumulation of fluids in the abdominal cavity.
- Edema: accumulation of fluid in the extremities—usually in the feet and legs.
- Coagulopathy: the liver is not able to produce clotting factors that stop the blood from bleeding.
- Male and Female Hormone Regulation: the liver may not be able to regulate female and male hormones.
- Severe Itching: the impairment of bile flow that can cause severe and at times debilitating itching.
- Wasting Syndrome: the liver is not able to process nutrients so people can have severe muscle wasting and weight loss.
Most of these conditions can be managed effectively with lifestyle changes, medications and medical procedures—at least in the short term. The most important step is to be medically monitored and managed on a regular basis. At this point, a person should be evaluated for a liver transplant. The problem is that there are only an estimated 6,000 available livers for the estimated 15,000 livers needed every year for transplantation in the U.S.
5. HCV Treatment
Hepatitis C treatment can now cure most people, the treatment duration is shorter, and treatment side effects are lower than ever. However, once people develop cirrhosis, it becomes more difficult especially for those who are infected with genotype 3 and who have cirrhosis—the second most prevalent genotype in the United States. Unfortunately, we also know that many insurance companies are denying coverage of hepatitis C medications to only those who are in the early stages of HCV infections (F0, F1, F2). Many insurance companies are only covering F3 and F4 unless there are other severe complications. Here’s the problem—if you wait until stage F3 or F4 and are cured you will have to be medically followed for the rest of your life since there is a possibility that you could still have liver disease progression. However, if you are treated early (F0, F1, F2), and cured you are free of future complications. Does this scenario make any sense to you? It does not make any sense to me either!
The True Cost of an Expensive Medication
It was supposed to be a miracle, but now it’s what keeps Laura Bush, a nurse-practitioner near Albuquerque, awake at night.
There’s a drug called Sovaldi that works astonishingly well to cure people with the liver disease Hepatitis C. The rub? It costs $1,000 per day for all 12 weeks of treatment.
Bush’s clinic, First Choice Community Healthcare, is a federally qualified health center in the rural town of Los Lunas, New Mexico, which means she sees a disproportionate number of patients who are uninsured, underinsured, and on Medicaid, the government insurance program for the poor. In other words, they can’t afford Sovaldi.
Read more....
There’s a drug called Sovaldi that works astonishingly well to cure people with the liver disease Hepatitis C. The rub? It costs $1,000 per day for all 12 weeks of treatment.
Bush’s clinic, First Choice Community Healthcare, is a federally qualified health center in the rural town of Los Lunas, New Mexico, which means she sees a disproportionate number of patients who are uninsured, underinsured, and on Medicaid, the government insurance program for the poor. In other words, they can’t afford Sovaldi.
Read more....
PCORI approves $83m for hepatitis C and other studies
The Patient-Centered Outcomes Research Institute (PCORI) has approved $83m to fund 26 patient-centered, comparative clinical effectiveness research (CER) studies on a range of conditions and patient populations.
About $29.5m will support studies on caring for people affected with hepatitis C virus (HCV). Awards totaling around $7.4m will fund research on rare conditions in response to PCORI's offer of a special pool of funding for supportingt rare disease research.
The HCV studies will include national advocacy organizations, professional associations, and stakeholder groups in their research design and implementation.
Read more....
About $29.5m will support studies on caring for people affected with hepatitis C virus (HCV). Awards totaling around $7.4m will fund research on rare conditions in response to PCORI's offer of a special pool of funding for supportingt rare disease research.
The HCV studies will include national advocacy organizations, professional associations, and stakeholder groups in their research design and implementation.
Read more....
HCV Current Initiative: Addressing the National Epidemics of Prescription Opioid misuse and Hepatitis C through Unique Partnerships
By Dominique Saunders, Viral Hepatitis Prevention Coordinator, Kansas Department of Health and Environment and Sarah Knopf-Amelung, Project Manager, Mid-America ATTC, University of Missouri-Kansas City School of Nursing and Health Studies - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.
Recently, there has been a spotlight on America’s prescription opioid misuse and overdose epidemics. However, too often, people remain unaware of the related hepatitis C virus (HCV) epidemic. The Centers for Disease Control and Prevention (CDC) reported an estimated 150% increase in new HCV infections from 2010 to 2013 and, further, that most of the new infections were associated with injection drug use. An analysis of state and national data indicate that a large proportion of new HCV infections are occurring in young people (<30 years of age) in rural and suburban areas who use oral prescription opioid analgesics before transitioning to injecting. - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.
At the same time, recent years have seen advances that have revolutionized the field of hepatitis C. Groundbreaking treatments with cure rates as high as 90-100% are now available. Preventive screenings without cost-sharing under the Affordable Care Act make HCV screening more accessible for many people. And the national Viral Hepatitis Action Plan increases coordination across federal programs and includes among its priorities the urgent need to reduce viral hepatitis associated with drug use behaviors. - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.
Read more....
Recently, there has been a spotlight on America’s prescription opioid misuse and overdose epidemics. However, too often, people remain unaware of the related hepatitis C virus (HCV) epidemic. The Centers for Disease Control and Prevention (CDC) reported an estimated 150% increase in new HCV infections from 2010 to 2013 and, further, that most of the new infections were associated with injection drug use. An analysis of state and national data indicate that a large proportion of new HCV infections are occurring in young people (<30 years of age) in rural and suburban areas who use oral prescription opioid analgesics before transitioning to injecting. - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.
At the same time, recent years have seen advances that have revolutionized the field of hepatitis C. Groundbreaking treatments with cure rates as high as 90-100% are now available. Preventive screenings without cost-sharing under the Affordable Care Act make HCV screening more accessible for many people. And the national Viral Hepatitis Action Plan increases coordination across federal programs and includes among its priorities the urgent need to reduce viral hepatitis associated with drug use behaviors. - See more at: https://blog.aids.gov/2015/09/hcv-current-initiative-addressing-the-national-epidemics-of-prescription-opioid-misuse-and-hepatitis-c-through-unique-partnerships.
Read more....
Monday, September 28, 2015
Hepatitis and the Sustainable Development Goals: time for an end run - Here, Jeffrey Lazarus talks about the need for a global goal of eliminating viral hepatitis.
This is unfortuante especially with a 'cureable' disease.....AF
Well it’s official. The governments of the world have committed to ending HIV, tuberculosis and malaria, but merely ‘combatting’ viral hepatitis.
When the United Nations General Assembly voted to adopt the Sustainable Development Goals (SDGs) on 25 September, I don’t doubt that advocates of many stripes were left feeling that this highly influential agreement did not sufficiently recognize the urgency of their claims.
It is not my intention to argue that viral hepatitis advocates have been short-changed any more than those who care deeply about other issues. I do, however, think it is important for everyone committed to ending viral hepatitis to think about what this aspect of the SDGs means to us.
Read more....
Well it’s official. The governments of the world have committed to ending HIV, tuberculosis and malaria, but merely ‘combatting’ viral hepatitis.
When the United Nations General Assembly voted to adopt the Sustainable Development Goals (SDGs) on 25 September, I don’t doubt that advocates of many stripes were left feeling that this highly influential agreement did not sufficiently recognize the urgency of their claims.
It is not my intention to argue that viral hepatitis advocates have been short-changed any more than those who care deeply about other issues. I do, however, think it is important for everyone committed to ending viral hepatitis to think about what this aspect of the SDGs means to us.
Read more....
September 2015 Mid-Month Edition - SNAPSHOTS —Alan Franciscus, Editor-in-Chief
This month’s Snapshots is about recently published studies on all-oral therapies to treat hepatitis C in people coinfected with HIV. We have really come a long way in such a short period of time with medications to treat a population in high need of effective therapies.
______
Article: Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1—S Naggie et al.
Source: New England Journal of Medicine DOI: 10.1056/NEJMoa1501315
Results and Conclusions
The study included 335 patients coinfected with HIV-1 and hepatitis C genotype 1 or 4. The median age was 52 yo (48-58 yo). The majority of patients were White 61% (203 pts) and Black 34% (115 pts), male 82% (276), genotype 1a 75%, genotype 4 two percent, cirrhosis 20%, median CD 4+ cell count 628 (469-823), treatment naïve 45%, previously treated 55%. The treatment period was 12 weeks. Note: I am not including the genotype 4 patients since there were only 8 patients.
The Bottom Line
The cure rates were 96% for genotype 1a, and 96% for genotype 1b. The cure rates were similar regardless of prior response or degree of liver damage. The most common side effects were headache, fatigue and diarrhea. No patients discontinued treatment due to side effects.
Editorial Comment
These results are excellent across subtypes (1a/1b), races, and prior treatment responses. Gilead has filed for marketing approval with the Food and Drug Administration. The American Association for the Study of Liver Disease (AASLD) and the Infectious Disease Society of America (IDSA) recommend Harvoni as a treatment for HCV for people coinfected with HIV and hepatitis C.
_____
Article: Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial—J K Rockstroh, et al
Source: The Lancet HIV Volume 2, No. 8, e319–e327, August 2015
Results and Conclusions
The study was conducted in people with HIV/HCV coinfection to evaluate grazoprevir/elbasvir (one pill, once-a-day) to treat HCV genotype 1, 4, and 6. The treatment period was 12 weeks. There were 218 patients in the phase 3 trial. The trial was conducted in Europe, the United States and Australia.
The Bottom Line
The overall cure rate was 96% (210 of 218 patients). All patients who had cirrhosis were cured. The most common side effects were fatigue, headache and nausea. No patients discontinued treatment due to side effects.
Editorial Comment
The high cure rates and fewer side effects plus no treatment discontinuation due to treatment-related side effects equals very good news for patients.
The once-a-day combination of grazoprevir/elbasvir when approved is going to be a welcome addition to the other therapies to treat hepatitis C in people who are HIV and HCV coinfected.
______
Article: Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1—D L Wyles et al.
Source: New England Journal of Medicine DOI: 10.1056/NEJMoa1503153
Results and Conclusions
There were 3 different treatment groups. All the groups received daclatasvir plus sofosbuvir. Note: Since there was a small number of genotype 2, 3, and 4 patients—I omitted these results. For this article I am just listing the genotype 1 results.
The Bottom Line
The patient characteristics, treatment durations and cure rates are included below:
- Naïve (untreated patients): 101 patients; median age 52 yo; male sex 91%; race: White 65%, Black 30%; genotype 1a: 70%, genotype 1b: 12%; cirrhosis 9%; median CD4+ count 520 (122-1147). Treatment duration = 12 weeks. Cure rate = 96%
- Naïve (untreated patients): 50 patients; median age 51 yo; male 84%; race White 56%, Black 38%; Genotype 1a 70%, Genotype 1b 12%; cirrhosis 10%; treatment duration = 8 weeks. Cure rate = 76%
- Treatment Experienced: 52 patients; median age 57 yo; male 83%; race White 60%, Black 38%; genotype 1a 63%, genotype 1b 21%; cirrhosis 29%; treatment duration =12 weeks. Cure rate = 98%
The most common side effects were fatigue, nausea, and headache. No patient discontinued due to side effects.
Editorial Comment
The 12-week treatment groups had good cure rates as opposed to the 8-week treatment response group. The treatment-experienced group #3 with a 38% Black population and a relatively high cirrhotic population achieved nearly perfect cure rates. The drawback of this combination is going to be the high price tag of the combination of these two drugs.
Note: Another issue with treating hepatitis C in people with HIV is the potential drug-drug interactions with HIV medications. For more information visit the AASLD/IDSA HCV Guidelines http://www.hcvguidelines.org/full-report-view.
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