The Hepatitis C virus (HCV) infection is a chronic blood-borne viral infection that affects an estimated 160 million people, or 2-3% of the population world-wide. Alarmingly, chronic HCV infection accounts for one-quarter of the cases of cirrhosis and hepatocellular carcinoma (HCC). If HCV is left untreated, chronic liver disease will occur in 60-70% of the cases, cirrhosis in 5-20% of the cases, and 1-5% will die from decompensated cirrhosis or HCC.
In most high-income countries, such as the United States, where drug injection is the primary route of HCV transmission, the disease is concentrated among people who inject drugs (PWID). While it is estimated that 50-80% of PWID are chronically infected, fewer than 5% of PWID have received treatment.
In a new study, "Hepatitis C virus (HCV) disease progression in people who inject drugs (PWID): A systematic review and meta-analysis," published in the International Journal of Drug Policy, a team of researchers from New York University's Center for Drug Use and HIV Research (CDUHR) assessed existing data on the natural history of HCV among PWID. A total of twenty-one studies examined over 8500 PWID, who contributed nearly 120,000 person-years at risk, for the study of four major HCV-related outcomes included in the synthesis.
Read more....
Thursday, October 8, 2015
Surge in Youth HCV Presents Hepatologists With Tough Choices
Recently Mark S. Sulkowski, MD, of the John Hopkins University School of Medicine, in Baltimore, saw a teenage patient who had contracted hepatitis C after starting to shoot up as a 12-year-old.
The case is but one in a spike of new infections with the hepatitis C virus (HCV) being driven largely by an epidemic of injection drug use, particularly among adolescents and young adults, according to the Centers for Disease Control and Prevention.
“Sadly, with the heroin epidemic, I’m increasingly seeing teenagers in my practice,” Dr. Sulkowski said earlier this year at the inaugural midyear meeting of the American Association for the Study of Liver Diseases.
See more at:
The case is but one in a spike of new infections with the hepatitis C virus (HCV) being driven largely by an epidemic of injection drug use, particularly among adolescents and young adults, according to the Centers for Disease Control and Prevention.
“Sadly, with the heroin epidemic, I’m increasingly seeing teenagers in my practice,” Dr. Sulkowski said earlier this year at the inaugural midyear meeting of the American Association for the Study of Liver Diseases.
See more at:
Wednesday, October 7, 2015
HCV Drugs - Alan Franciscus
OCTOBER 2015
Vol. 18, Issue 10
HCV DRUGS
—Alan Franciscus, Editor-in-Chief
In this month’s column, I will discuss the recently released data from Achillion, and I will touch on various issues related to current treatment—drug-drug interactions, medical providers and insurance companies, and those who are still the most difficult to treat.
Achillion1
On September 17, 2015, Achillion announced the second part of their Phase 2 study (the PROXY study) of odalasvir (ACH-3102) and sofosbuvir to treat genotype 1. The cure rates were 100% (6 of 6 patients). Earlier, Achillion had announced a 100% cure rate for 12 patients treated for eight weeks, and a 100% cure rate for 12 patients treated for six weeks. Although there was a small number of patients in the PROXY study, this is encouraging data.
The study used Gilead’s drug—sofosbuvir—as the proxy drug. A proxy drug is used as a placeholder while another drug is being developed and tested by a pharmaceutical company—in this case Achillion. Also noteworthy, Achillion and Janssen are collaborating to develop and commercialize HCV drugs worldwide. Janssen has many drugs in development to treat hepatitis C. As well, Gilead, AbbVie, and Merck have drugs in the pipeline. Merck’s new combination of two drugs is expected to be approved by the Food and Drug Administration (FDA) in early 2017.
Medical Providers
Patients are not the only ones who are having a difficult time with the insurance restrictions. Medical providers who have to tell their patients are also upset. Many providers have to spend a lot of time submitting paperwork over and over trying to get their patients’ medications approved. It takes up an inordinate amount of the medical provider and office staff’s time—many times only to be told that the insurance claim was denied. As you can imagine it breaks their hearts to tell a patient “there is a cure, but I cannot give you it because insurance will not cover it.”
Insurance
There are other issues that are difficult for patients, medical and service providers. Access to the new medications can be very difficult depending on your insurance carrier. Many people are being denied access to these life-saving HCV medications unless they have more serious disease progression. Shame on the insurance companies that are not covering HCV medications! It doesn’t help that the price of the drugs are so expensive.
The Current State of HCV Therapy
We have certainly come a long way compared to the interferon days. Additionally, many populations—HIV/HCV coinfection, Latinos, compensated cirrhosis, healthy liver-transplanted—and other groups had very low cure rates.
The current state of HCV treatment is nothing short of amazing. Current therapy cures up to 90% to 100% of people with HCV genotype 1, 2, and 4. The medications also have lower side effects and shorter treatment duration.
The improvements in cure rates are impressive especially in certain populations with hepatitis C. In the September 2015 “Mid-Month Edition” of the HCV Advocate newsletter I wrote about 3 different clinical trials using 3 different combinations of direct-acting antivirals to treat HCV in people coinfected with HIV. The patient populations in these studies included many of the patient characteristics previously considered the most difficult to treat—people with HIV, genotype 1a, cirrhosis, Black patients, previously treated patients—all who had not achieved a cure. The cure rate in the three trials ranged from 96% to 98%. Another population that has had dramatic improvements is liver transplanted patients (with moderate liver function and compensated cirrhosis). The cure rates were 96% - 98%.
Drug-Drug Interactions
A very important issue with the new direct antiviral medications is the potential for drug-drug interactions (DDIs). This is more of an issue for people of the Baby Boomer generation who may take additional medications for blood pressure, diabetes, cholesterol, etc. People who are infected with HIV/HCV are also at risk for DDIs. There is also a risk of DDIs with common over-the-counter medications and herbs. This is why it is so important to tell your medical provider(s) about anything you are taking.
Still Difficult to Treat2
A caveat: Even though we need better therapies and strategies to treat the most difficult to treat patients listed here, the DAA therapies are still vast improvements from the older therapies in the people and groups below.
People with genotype 3 with cirrhosis and who have not been cured with a previous course of treatment are an unmet medical need. Current treatments only yield cure rates in the 60 percentile. There is an option of adding pegylated interferon. I wrote about this before and advised people to think about this but I did not get a very positive reaction.
People with decompensated cirrhosis are at risk for severe disease progression, but unfortunately, current treatment does not work as well. Similarly, people with end-stage kidney disease or people who are on dialysis also have a large unmet medical need. Note: Merck’s new combination looks very promising for this group of patients. People who do not respond to a previous course of therapy are another difficult group to treat, but treatment strategies are slowly evolving.
Re-Treatment
For someone who has relapsed, coming up with a plan to prescribe the right combination of drugs to optimize the chances of re-treatment success is more difficult with the development of RAVs (see a brief overview of RAVs in this issue).
There have been many advances in hepatitis C treatment in a short period of time. Hopefully, many of the treatment issues listed above will be quickly resolved. In the meantime, we all have to advocate for ourselves and others with hepatitis C and remember to thank those medical providers who are providing such wonderful care.
References:
1 Company Press Release
2 Difficult-to-cure populations with chronic hepatitis c: Vanishing in the direct-acting antiviral era?
Norah Terrault M.D. Hepatology Volume 62, Issue 1, pages 4–7, July 2015
Vol. 18, Issue 10
HCV DRUGS
—Alan Franciscus, Editor-in-Chief
In this month’s column, I will discuss the recently released data from Achillion, and I will touch on various issues related to current treatment—drug-drug interactions, medical providers and insurance companies, and those who are still the most difficult to treat.
Achillion1
On September 17, 2015, Achillion announced the second part of their Phase 2 study (the PROXY study) of odalasvir (ACH-3102) and sofosbuvir to treat genotype 1. The cure rates were 100% (6 of 6 patients). Earlier, Achillion had announced a 100% cure rate for 12 patients treated for eight weeks, and a 100% cure rate for 12 patients treated for six weeks. Although there was a small number of patients in the PROXY study, this is encouraging data.
The study used Gilead’s drug—sofosbuvir—as the proxy drug. A proxy drug is used as a placeholder while another drug is being developed and tested by a pharmaceutical company—in this case Achillion. Also noteworthy, Achillion and Janssen are collaborating to develop and commercialize HCV drugs worldwide. Janssen has many drugs in development to treat hepatitis C. As well, Gilead, AbbVie, and Merck have drugs in the pipeline. Merck’s new combination of two drugs is expected to be approved by the Food and Drug Administration (FDA) in early 2017.
Medical Providers
Patients are not the only ones who are having a difficult time with the insurance restrictions. Medical providers who have to tell their patients are also upset. Many providers have to spend a lot of time submitting paperwork over and over trying to get their patients’ medications approved. It takes up an inordinate amount of the medical provider and office staff’s time—many times only to be told that the insurance claim was denied. As you can imagine it breaks their hearts to tell a patient “there is a cure, but I cannot give you it because insurance will not cover it.”
Insurance
There are other issues that are difficult for patients, medical and service providers. Access to the new medications can be very difficult depending on your insurance carrier. Many people are being denied access to these life-saving HCV medications unless they have more serious disease progression. Shame on the insurance companies that are not covering HCV medications! It doesn’t help that the price of the drugs are so expensive.
The Current State of HCV Therapy
We have certainly come a long way compared to the interferon days. Additionally, many populations—HIV/HCV coinfection, Latinos, compensated cirrhosis, healthy liver-transplanted—and other groups had very low cure rates.
The current state of HCV treatment is nothing short of amazing. Current therapy cures up to 90% to 100% of people with HCV genotype 1, 2, and 4. The medications also have lower side effects and shorter treatment duration.
The improvements in cure rates are impressive especially in certain populations with hepatitis C. In the September 2015 “Mid-Month Edition” of the HCV Advocate newsletter I wrote about 3 different clinical trials using 3 different combinations of direct-acting antivirals to treat HCV in people coinfected with HIV. The patient populations in these studies included many of the patient characteristics previously considered the most difficult to treat—people with HIV, genotype 1a, cirrhosis, Black patients, previously treated patients—all who had not achieved a cure. The cure rate in the three trials ranged from 96% to 98%. Another population that has had dramatic improvements is liver transplanted patients (with moderate liver function and compensated cirrhosis). The cure rates were 96% - 98%.
Drug-Drug Interactions
A very important issue with the new direct antiviral medications is the potential for drug-drug interactions (DDIs). This is more of an issue for people of the Baby Boomer generation who may take additional medications for blood pressure, diabetes, cholesterol, etc. People who are infected with HIV/HCV are also at risk for DDIs. There is also a risk of DDIs with common over-the-counter medications and herbs. This is why it is so important to tell your medical provider(s) about anything you are taking.
Still Difficult to Treat2
A caveat: Even though we need better therapies and strategies to treat the most difficult to treat patients listed here, the DAA therapies are still vast improvements from the older therapies in the people and groups below.
People with genotype 3 with cirrhosis and who have not been cured with a previous course of treatment are an unmet medical need. Current treatments only yield cure rates in the 60 percentile. There is an option of adding pegylated interferon. I wrote about this before and advised people to think about this but I did not get a very positive reaction.
People with decompensated cirrhosis are at risk for severe disease progression, but unfortunately, current treatment does not work as well. Similarly, people with end-stage kidney disease or people who are on dialysis also have a large unmet medical need. Note: Merck’s new combination looks very promising for this group of patients. People who do not respond to a previous course of therapy are another difficult group to treat, but treatment strategies are slowly evolving.
Re-Treatment
For someone who has relapsed, coming up with a plan to prescribe the right combination of drugs to optimize the chances of re-treatment success is more difficult with the development of RAVs (see a brief overview of RAVs in this issue).
There have been many advances in hepatitis C treatment in a short period of time. Hopefully, many of the treatment issues listed above will be quickly resolved. In the meantime, we all have to advocate for ourselves and others with hepatitis C and remember to thank those medical providers who are providing such wonderful care.
References:
1 Company Press Release
2 Difficult-to-cure populations with chronic hepatitis c: Vanishing in the direct-acting antiviral era?
Norah Terrault M.D. Hepatology Volume 62, Issue 1, pages 4–7, July 2015
Treating 5 Percent of Hepatitis C Patients with New Drugs Would Reduce Cost, Infections: Study
Treating 5 percent of all hepatitis C patients with the latest drugs would be more effective at reducing infections and health care costs than the current approach, a new study shows.
The cost-benefits analysis by researchers from the USC Schaeffer Center for Health Policy and Economics and other institutions compares three treatment options to the current approach, or "baseline" scenario, which treats patients in the most advanced stages of the disease when they may need a costly liver transplant.
"We made a mistake with HIV by limiting access to treatment to just people who had AIDS, and we ended up with a virus that has been with us for decades," said corresponding author Dana Goldman, the Schaeffer Center director and a professor at the USC School of Pharmacy and the USC Price School of Public Policy. "We didn't initially treat HIV aggressively enough in part because the science wasn't there to justify it. With hepatitis C, we have the science. We just need to find a way to finance it."
Nurse used same syringe on 67 people at N.J. flu clinic, state says
A nurse who administered flu vaccines to employees of a West Windsor company has been reported to health officials because she re-used a single syringe for the shots.
At an employer-sponsored flu clinic at Otsuka Pharmaceuticals last week, the unnamed nurse committed an "infection control breach," according to a spokeswoman for the N.J. Department of Health.
"Full infection control practices that prevent transmission of blood-borne diseases were not used by a contracted health care agency, Total Wellness," said Donna Leusner, the spokeswoman.
Tuesday, October 6, 2015
Hepatitis C cases on rise in northeast Indiana, Allen County proposes needle-exchange program
FORT WAYNE, Ind. (October 6, 2015) — Officials in northeastern Indiana’s Allen County have taken a first step toward creating a needle exchange to combat the county’s growing hepatitis C cases.
The Fort Wayne-Allen County Board of Health unanimously approved a resolution Monday calling for a needle-exchange program to slow the spread of the disease among intravenous drug users.
Allen County has had about 270 new hepatitis C cases during the first nine months of 2015. That’s more than in any of the past three years.
Read more....
The Fort Wayne-Allen County Board of Health unanimously approved a resolution Monday calling for a needle-exchange program to slow the spread of the disease among intravenous drug users.
Allen County has had about 270 new hepatitis C cases during the first nine months of 2015. That’s more than in any of the past three years.
Read more....
Health plan tiers raise drug costs for hepatitis patients
This is important information to think about if you have open enrollment. Jacques Chambers article "Open Enrollment" will be featured in the next issue of the October Mid-Monthly HCV Advocate Newsletter - Alan
By Bob Herman | October 5, 2015
A new report says that health insurance companies discriminate against people with hepatitis B and C by charging high out-of-pocket costs for drugs, but the industry lobby has called the analysis “very one-sided” and limited in scope.
The Affordable Care Act prohibits health insurers from discriminating against people on the basis of age, gender or health conditions, and the federal government has already made it clear it will monitor health plans sold on the public exchanges to ensure they meet ACA standards.
The not-for-profit AIDS Institute examined silver-level health plans that were sold on Florida's insurance marketplace in 2015. The group found that eight of the 12 insurers that sold 2015 plans had what it deemed as discriminatory practices for hepatitis B and C drugs. For example, Aetna placed many of its hepatitis drugs on the most expensive tiers with coinsurance rates up to 50%. Humana had a $1,500 prescription drug deductible and also had many of its hepatitis drugs on the highest tiers with large cost-sharing, the report found.
Read more....
By Bob Herman | October 5, 2015
A new report says that health insurance companies discriminate against people with hepatitis B and C by charging high out-of-pocket costs for drugs, but the industry lobby has called the analysis “very one-sided” and limited in scope.
The Affordable Care Act prohibits health insurers from discriminating against people on the basis of age, gender or health conditions, and the federal government has already made it clear it will monitor health plans sold on the public exchanges to ensure they meet ACA standards.
The not-for-profit AIDS Institute examined silver-level health plans that were sold on Florida's insurance marketplace in 2015. The group found that eight of the 12 insurers that sold 2015 plans had what it deemed as discriminatory practices for hepatitis B and C drugs. For example, Aetna placed many of its hepatitis drugs on the most expensive tiers with coinsurance rates up to 50%. Humana had a $1,500 prescription drug deductible and also had many of its hepatitis drugs on the highest tiers with large cost-sharing, the report found.
Read more....
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