Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

For more information on how to use this blog, the HCV drug pipeline, and for more information on HCV clinical trials
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Be sure to check out our other blogs: The HBV Advocate Blog and Hepatitis & Tattoos.

Alan Franciscus


HCV Advocate

Thursday, July 30, 2015

Eradicate hepatitis

By Sen. Mazie Hirono (D-Hawaii) and Rep. Mike Honda (D-Calif.)

Across our country and around the world, hepatitis B and C have taken countless lives and the numbers continue to explode. Regrettably, this rise is partially tied to the heroin epidemic in our country—since the 1990s the medical use and subsequent abuse of highly addictive opioids like Oxycontin has risen tremendously

The overuse of medication has caused too many Americans to succumb to addiction, and many turn to heroin. The rise in heroin use means that individuals are sharing needles as their need for the drug outweighs safety concerns.

The Center for Disease Control (CDC) estimates there were nearly 30,000 new hepatitis C infections in 2013, a 150 percent increase since 2010. The CDC also found an alarming rise in new infections among people under the age of 30, especially in rural areas.

Tragically, hepatitis infection, driven by drug abuse, threatens an alarming portion of an entire generation of Americans. We must do everything we can to help address heroin and opioid addiction.

Hepatitis C and hepatitis B are life threatening yet preventable diseases. Look at the story of Rob, of Hawaii. He met his wife Mei over 30 years ago when they were students at the University of Hawaii.

She is Chinese from Hong Kong, and he is Caucasian. In the over 30 years since they first met they’ve built a life in Hawaii. They have two kids in their 20s—both college educated and looking to build families and lives of their own.

Their life was great—until Mei suddenly became ill. Only weeks after first taking ill, Mei passed away from liver failure.

To add to this incredible tragedy, shortly before Mei’s passing they learned that not only Mei - but both of their children - had been infected by hepatitis B since birth.

For over 30 years, they’d never known that they were infected by hepatitis.

Hepatitis is 100 times more infectious than the HIV virus, and in the U.S. perinatal transmission, or being passed from mother to child immediately before or after birth, is one of the primary ways that people contract the disease. It’s a silent killer that slowly destroys the liver, often displaying no symptoms in those infected with the virus until it is too late – the liver is diseased, riddled with cancer, cirrhosis, or end-stage failure.

Around the world, four hundred million people are living with hepatitis B or C. 1.4 million people die annually from complications due to viral hepatitis. In the United States, approximately 6 million individuals have hepatitis B or C, likely an underestimate. Both hepatitis B and C are the leading causes of liver cancer, and 65-75 percent of infected individuals do not know that they have either virus.

The difficulty with identifying the disease means that we do not have accurate data on infections. Without accurate data, we do not have a strong grasp of the scope of the problem. If we don’t take decisive action soon, our health care system will face a significant burden in decades to come.

We simply cannot handle the costs of the rampant spread of a disease whose complications are entirely preventable.

Stopping hepatitis has to be a three-step process.
First, people need to get tested, especially those in the Asian American and Pacific Islander communities, of which one in 10 will get hepatitis B.

Second, we need to make treatment options available to everyone regardless of income level.

And third, we must continue to invest in research on hepatitis to rid the world of the viruses once and for all.

This week, we recognized World Hepatitis Day, a day that President Obama declared by proclamation for the first time in the United States. This day was an opportunity to make a new commitment to educating people about the silent killers, helping prevent further infection rate spikes, identifying infected individuals, and providing them with proper medical care.

Working together, we can eradicate this preventable, treatable virus and save millions of lives.
Hirono is Hawaii’s junior senator, serving since 2013. She sits on the Armed Services; the Energy and Natural Resources; the Small Business and Entrepreneurship; and the Veterans’ Affairs committees. Honda represents California’s 17th Congressional District and has served in the House since 2001. He sits on the Appropriations Committee.

Source: The Hill

Following Spike in Hepatitis C Cases, Kentucky Considers Expanding Screenings for Virus

Officials at the state and local levels are in discussions about offering hepatitis C testing at all Kentucky county health departments.

Some local offices offered the tests last year as part of a pilot project, when Kentucky began to see a spike in hepatitis C cases related to intravenous drug use. The Centers for Disease Control and Prevention said in May that Kentucky’s rate of hepatitis C is seven times higher than the national average.

Deputy Commissioner Kraig Humbaugh, with the Kentucky Department of Public Health, says increased screening opportunities would be a way for health and addiction experts to reach out to those who need help.


Canada: Hepatitis C treatments skyrocket after pill-based drugs covered by B.C. plan

About 1,400 British Columbians have been treated for hepatitis C in the first four months since new anti-viral medications were covered by the province’s public drug plan — far above predictions.

The Ministry of Health expected 1,500 patients in the first full year for the pill-based medication.
Dr. Mel Krajden, medical head of hepatitis at the B.C. Centre for Disease Control, says the numbers reflect pent-up demand from patients seeking the latest treatments.

“A lot of people who are infected follow the literature on these drugs and they were waiting for the newer ones. It’s a whole group of people who realized these medications are more effective, better tolerated with fewer side effects and work over a shorter period of time,” Krajden said at a World Hepatitis Day event Tuesday in Vancouver.

- See more at: http://www.vancouversun.com/health/Hepatitis+treatments+skyrocket+after+pill+based+drugs+covered+plan/11249876/story.html#sthash.MT3sDoLJ.dpuf

Canada: Warning to all baby boomers: get tested for Hep C

A Saskatoon nurse predicts a surge of liver disease among baby boomers due to undiagnosed Hepatitis C.

“We’re going to see this huge wave of patients with end stage liver disease that are going to be dying from, potentially, liver cancer, kidney failure due to issues with their liver, and this is now the beginning,” said Lesley Gallagher, a Hepatitis C treatment support nurse with the Saskatoon Infectious Disease Care Network in Riversdale.

“We’re seeing it now, and we’re going to keep on seeing it.”

The number of Canadians with advanced liver disease is increasing, according to a 2014 study published in the Canadian Journal of Gastroenterology and Hepatology. More than 20 per cent of those who are infected with Hepatitis C will have significant complications from their disease by 2035, the study found.


25th Anniversary of the Americans with Disabilities Act — July 2015

Morbidity and Mortality Weekly Report (MMWR)


July 31, 2015 / 64(29);777

July 2015 marks the 25th anniversary of the passage of the Americans with Disabilities Act (ADA), signed into law on July 26, 1990, by President George H.W. Bush. ADA prohibits discrimination against persons with disabilities in all areas of their everyday lives, such as work, school, transportation, communication, recreation, and access to state and local government services. When first enacted, ADA defined a disability as a "physical or mental impairment that substantially limits one or more of the major life activities."(1)

During the last 2 decades, multiple national surveys measured disability in various ways because of substantial differences in the conceptualization and definition of disability. More recently, several national health surveys incorporated a recommended standard set of questions assessing functional types of disability.

In recognition of ADA's milestone anniversary, this issue of MMWR includes a report using the first data available on functional types of disability in a state-based health survey. It includes prevalence of functional disability using a standard set of disability questions rather than measuring disability in a nonspecific manner. This report presents the percentage of adults with any disability and with specific types of disabilities by state and key demographic characteristics (e.g., sex, age, race/ethnicity).

For more information on disability research and surveillance and state and national disability programs and resources, access the CDC's Disability and Health Branch, available at http://www.cdc.gov/ncbddd/disabilityandhealth/.


  1. Americans with Disabilities Act of 1990, Pub. L. 101-336, 104 Stat. 328 (July 26, 1990) [amended January 1, 2009]. Available at http://www.ada.gov/pubs/adastatute08.htmExternal Web Site Icon.

Wednesday, July 29, 2015

Merck Targets Toughest Cases to Gain Hepatitis C Foothold

Merck & Co. plans to target hard-to-treat hepatitis C patients with its cure for the liver ailment rather than compete for market share by drastically undercutting the price of Gilead Sciences Inc.’s $1,000-a-day treatment.

Merck said Tuesday that the U.S. Food and Drug Administration accepted its application for approval of the single pill, which combines the medications grazoprevir and elbasvir, and granted the medicine a priority review. That means Merck is on course to introduce the treatment to the market early next year.

The field for hepatitis C patients is currently divided between AbbVie Inc. and Gilead, which have locked up arrangements with the leading managers of drug coverage in U.S. health insurance plans, ensuring their medications are the first choice. Still, Merck doesn’t foresee trouble attracting patients.


Tuesday, July 28, 2015

Canada: 'Get informed, get tested': getting the word out about hepatitis C

Steve Pollard came close to death, underwent two liver transplants, and received treatment with experimental drugs before he was clear of hepatitis C and began to get his life back. When he recovered, he vowed he would devote his life to raising awareness about the viral disease — known as the “silent killer” — with the hope of preventing others from going through what he did.

Pollard, 48, was one of the speakers at an event outside Ottawa City Hall on Tuesday to mark World Hepatitis Day.

His message: “Get informed, get tested and tell a friend or loved one to do the same. If you are not doing it for yourself, do it for them.”


La FDA aprueba Technivie para el tratamiento de la hepatitis crónica de genotipo 4

La Administración de Alimentos y Medicamentos (FDA) de los Estados Unidos aprobó el día de hoy Technivie (ombitasvir, paritaprevir y ritonavir) para su uso en combinación con ribavirina para el tratamiento de las infecciones del virus de la hepatitis C (VHC) de genotipo 4 en pacientes sin cicatrización y funcionamiento deficiente del hígado (cirrosis).
Technivie en combinación con ribavirina es el primer medicamento que ha demostrado seguridad y eficacia para tratar infecciones con el VHC de genotipo 4 sin la necesidad de la coadministración de interferón, un medicamento aprobado por la FDA también utilizado para tratar la infección del VHC.
“La aprobación del día de hoy proporciona la primera opción de tratamiento para los pacientes con infecciones del VHC de genotipo 4 que no requiere el uso de interferón”, señaló el Dr. Edward Cox, director de la Oficina de Productos Antimicrobianos del Centro de Evaluación e Investigación de Medicamentos de la FDA.
La hepatitis C es una enfermedad viral que causa inflamación del hígado que puede dar lugar a una disminución de la función hepática o insufic
iencia hepática. La mayoría de las personas infectadas con el VHC no presentan síntomas de la enfermedad hasta que los daños en el hígado son evidentes, lo cual puede tardar varios años. Algunas personas con infección crónica del VHC desarrollan cirrosis a lo largo de varios años, que puede dar lugar a complicaciones como sangramiento, ictericia (coloración amarillenta de la piel), acumulación de líquido abdominal, infecciones o cáncer hepático. Según los Centros para el Control y la Prevención de Enfermedades (CDC), alrededor de 2.7 millones de estadounidenses están infectados con el VHC, de los cuales el genotipo 4 es uno de los menos comunes.
La seguridad y la eficacia de Technivie con ribavirina se evaluaron en estudios clínicos de 135 participantes con infecciones con el VHC de genotipo 4 sin cirrosis. Noventa y un participantes recibieron Technivie con ribavirina una vez al día por 12 semanas. Cuarenta y cuatro participantes recibieron Technivie sin ribavirina por 12 semanas. Los estudios se diseñaron para medir si el virus de la hepatitis C de un participante ya no se detectaba en la sangre luego de 12 semanas de finalizar el tratamiento (respuesta virológica sostenida), lo que indica que la infección por el VHC del participante se ha curado.
Los resultados demostraron que el 100 por ciento de  los participantes que recibieron Technivie con ribavirina lograron una respuesta virológica sostenida. De aquellos que recibieron Technivie sin ribavirina, el 91 por ciento lograron una respuesta virológica sostenida. 
La información de seguridad estuvo disponible para los 316 participantes con VHC tratados con la dosis recomendada de Technivie en combinación con otros medicamentos anti VHC en los estudios clínicos. Los tres medicamentos incluidos en Technivie también están incluidos en Viekira Pak, aprobado previamente para el tratamiento de la infección del VHC de genotipo 1. La información de seguridad adicional para estos medicamentos estuvo disponible en los estudios clínicos de Viekira Pak. Los efectos secundarios más frecuentes de Technivie con ribavirin fueron: fatiga, debilidad (astenia), náuseas, insomnio, picazón (prurito) y otras reacciones de la piel.
Technivie se acompaña de una advertencia que alerta a los pacientes y proveedores de salud que elevaciones de las enzimas hepáticas por encima de cinco veces el límite superior de la normalidad ocurrieron en aproximadamente el 1 por ciento de los participantes de los estudios clínicos. Las elevaciones ocurrieron más frecuentemente en mujeres que tomaban anticonceptivos que contienen etinilestradiol. Los anticonceptivos que contienen etinilestradiol deben suspenderse antes de iniciar Technivie. Deben realizarse pruebas de laboratorio de la función hepática durante las primeras cuatro semanas de iniciar el tratamiento y posteriormente cuando estén indicadas clínicamente.
Technivie y Viekira Park están comercializados por AbbVie Inc. con sede en North Chicago, Illinois.
Para obtener más información:
La FDA, una agencia del Departamento de Salud y Servicios Sociales de los EE. UU. protege la salud pública asegurando la protección, eficacia y seguridad de los medicamentos tanto veterinarios como para los seres humanos, las vacunas y otros productos biológicos destinados al uso en seres humanos, así como de los dispositivos médicos. La agencia también es responsable de la protección y seguridad de nuestro suministro nacional de alimentos, los cosméticos, los suplementos dietéticos, los productos que emiten radiación electrónica, así como de la regulación de los productos de tabaco.

Organizations in California Launch Campaign to Encourage Primary Care Clinicians to Screen Patients for Hepatitis C


Media Contacts:
Ryan Clary
National Viral Hepatitis Roundtable
Shelly Rodrigues, CAE, FACEHP
California Academy of Family Physicians
415-345-8667, ext 228

In Honor of World Hepatitis Day Organizations in California Launch Campaign to Encourage Primary Care Clinicians to Screen Patients for Hepatitis C

(San Francisco, CA, July 28, 2015) – Today the California Academy of Family Physicians, California Hepatitis Alliance (a program of Project Inform) and the National Viral Hepatitis Roundtable launch the “California Hepatitis C Clinicians’ Honor Roll” campaign. The Honor Roll recognizes clinicians who sign a pledge to screen their adult patients for hepatitis C in accordance with the United States Preventive Services Task Force (USPSTF) guidelines. To view the USPSTF hepatitis C screening guidelines, visit: http://www.uspreventiveservicestaskforce.org/uspstf/uspshepc.htm

According to the California Department of Public Health, 750,000 Californians are living with hepatitis C. Because this contagious liver disease often remains asymptomatic for years and many providers and patients commonly overlook testing, the vast majority of individuals are unaware that they are infected.

Karen Smith, MD, MPH, Director of the California Department of Public Health notes, “The best tools we have to reduce the human and economic costs of hepatitis C in California are to prevent new infections, screen people at risk, and link those who are infected to care.”

The USPSTF recommends hepatitis C screening for:
  • Adults born between 1945 through 1965
  • Anyone with past or current history of injecting drugs
  • Anyone who received a blood transfusion before 1992
  • Long-term hemodialysis patients
  • Anyone born to a mother infected with hepatitis C
  • Anyone with a history of incarceration
  • Anyone with past or current history of intranasal drug use (snorting drugs)
  • Anyone who has received a tattoo from an unregulated source
  • Anyone with other percutaneous exposures to blood

“Hepatitis C is a devastating disease.  Unfortunately, the majority of people with hepatitis C do not even know they are infected,” states Ron Chapman, MD, MPH, family physician and past director and state health officer for the California Department of Public Health. ”Family doctors, primary care, and other physicians and care team members have a critical role to play to identify these people and save their lives.”

Hepatitis C is the leading cause of catastrophic liver damage, cirrhosis, liver cancer, and liver transplants, and hepatocellular carcinoma is the fastest growing cancer in the United States. While the virus remain undetected, causing potentially life-threatening liver damage, individuals can unknowingly transmit the disease to others. California clinicians can stop this silent epidemic.

This Honor Roll campaign is conducted in partnership with the California Academy of Physician Assistants Foundation, California Department of Public Health, California Medical Association Foundation, Network of Ethnic Physician Organizations and San Francisco Medical Society.

For more information about the Honor Roll campaign, visit http://www.familydocs.org/world-hepatitis-c-day-july-28


The California Academy of Family Physicians (CAFP) is the only organization solely dedicated to advancing the specialty of family medicine in the state. Since 1948, CAFP has championed the cause of family physicians and their patients. CAFP is critically important to primary care. With a strong collective voice of more than 9,200 family physician, family medicine resident and medical student members, the CAFP is the largest primary care medical society in California and the largest chapter of the American Academy of Family Physicians. We focus on family physicians’ professional challenges and health policy concerns through advocacy and education to expand access to high-quality and cost-effective patient care for California. We are committed to helping family physicians improve their everyday practice lives by offering affordable evidence-based continuing medical education, providing cost-saving practice management resources, delivering practical approaches to practice transformation, and fostering opportunities to promote the family medicine specialty and ensure a strong and healthy primary care pipeline. For more information about CAFP, visit www.familydocs.org.

Founded in 2006, the California Hepatitis Alliance (CalHEP), a program of Project Inform (www.projectinform.org), is an alliance of more than 100 organizations dedicated to reducing the scope and consequences of the hepatitis B and C epidemics, which disproportionately affect California’s ethnic communities and the socioeconomically underserved. CalHEP includes among its membership public health organizations, community-based organizations, clinics and health care agencies, county hepatitis task forces, and others committed to viral hepatitis prevention, care, advocacy, and education. Committed to culturally competent public education and awareness, CalHEP’s work focuses on advocating for sound policies; promoting evidence-based education; and broadening access to services.  For more information about CalHEP, visit www.calhep.org.

The National Viral Hepatitis Roundtable (NVHR) is a broad coalition working to fight, and ultimately end, the hepatitis B and hepatitis C epidemics. We seek an aggressive response from policymakers, public health officials, medical and health care providers, the media, and the general public through our advocacy, education, and technical assistance. NVHR believes an end to the hepatitis B and C epidemics is within our reach and can be achieved through addressing stigma and health disparities, removing barriers to prevention, care and treatment, and ensuring respect and compassion for all affected communities. For more information about NVHR, visit www.nvhr.org.

Source: http://us5.campaign-archive1.com/?u=9dd22df1cf3a741391755d010&id=7928f2321c&e=227fe74971

Monday, July 27, 2015

Tennessee Dept. of Health issues public health advisory on hepatitis C epidemic

"The rate of acute Hepatitis C cases in Tennessee has more than tripled in the last seven years, and the steadily increasing number of cases may only represent “the tip of the iceberg” of the state’s Hepatitis-C epidemic, according to TDH Commissioner John Dreyzehner, MD, MPH."

NASHVILLE (WATE) – The Tennessee Department of Health is issuing a public health advisory urging residents to increase their awareness about hepatitis C, a life-threatening disease spread by direct contact with blood from an infected person.

The Knox County Health Department says it’s important to know all the risk factors. Within the last year there’s been an increase of testing for the virus at the health department. Director Dr. Martha Buchanan says her staff will be looking at that data and determining what can be done.

“The best protection you have is knowledge and knowing what behaviors and what things put you at risk,” said Buchanan.


Weekly Special Topic: Advocates & Activists Needed!

Advocates & Activists Needed!

World Hepatitis Day is approaching - What Can YOU do to help raise the level of awareness of viral hepatitis:

World Hepatitis Day: July 28, 2015

July 28, 2015


Worldwide 400 million people are living with hepatitis B or C. Every year 1.4 million people die from viral hepatitis and yet all of these deaths could be prevented. With better awareness and understanding of how we can prevent hepatitis we can eliminate this disease and save 4,000 lives a day.

A New Powerful HCV Health Tool, by Alan Franciscus, Editor-in-Chief

Originally published July 1, 2015

In this age of technology, hepatitis C finally has it is own App!  This technology is brought to you by Help-4-Hep which provides peer-to-peer counselling services for people with hepatitis C.  It is available on the internet and mobile devices.

The application includes everything you need to stay healthy living with hepatitis C and if undergoing treatment: 
  • Appointment Calendar
  • Personal Journal
  • Medication Tracker
  • Symptom tracker
  • Weight Tracker
  • Daily Moods
  • HCV Lab Tracker
  • Meal Tracker
This is another powerful new tool that Help-4-Hep provides nationwide.  Help-4-Hep is a non-profit, peer-to-peer helpline — 877‑HELP‑4‑HEP (877‑435‑7443) — where counselors work with patients to meet the challenges of hepatitis C head-on.  Callers talk one-to-one with a real person, typically someone who’s had hepatitis C touch their own life.  This is a fantastic service.

If you need help or know someone who needs help, please refer them to this service.  Alan

Patients First: Antacid, Pregnancy Categories and Herbs, by Alan Franciscus, Editor-in-Chief

Originally published July 1, 2015

I was recently looking on Facebook and the topic was antacids and Proton Pump Inhibitors.  It was interesting because everyone had a different take on how and when to take them.  As a result I thought I would talk about what they are, when it is safe to take them and a couple of other common topics such as—pregnancy categories and herbal supplements. 

The current standard of care for treating hepatitis C by genotype includes: 
  • Genotype 1:  Harvoni (sofosbuvir/ledipasvir) and Viekira Pak with and without ribavirin
  • Genotype 2 and 3:  Sovaldi (sofosbuvir) plus ribavirin
  • Genotype 4:  Sovaldi (sofosbuvir) plus pegylated interferon and ribavirin
The drugs listed above were approved by the Food and Drug Administration (FDA). The approval process went through vigorous testing that included testing to find out what type of other drugs (drug-drug interactions) affected the absorption of the HCV medicines into the blood stream.  This could change how well these drugs work and affect cure rates. This includes herbs since these can be considered a type of medicine.  It is important to remember that herbs are not regulated. 

Drug-Drug Interactions

• Harvoni/Viekira Pak: 
Proton Pump Inhibitors are drugs that work by reducing the amount of stomach acid made by glands in the lining of your stomach.  The package label specifically lists omeprazole (Priolsec)—talk with your medical provider if you take this type of medication. 

• Harvoni:
  Check with your medical provider if you take any acid reducing agents (antacids).  There are specific times you can and can not take them.  

• Herbal Supplements:
Harvoni/Sovaldi/Viekira Pak:  Do not take St. John’s wort. 

Note:  People who are taking any protease inhibitor (HIV or HCV protease inhibitor) should not take St. John’s wort).  People taking Olysio should not take the herb Milk Thistle.
Note:  Make sure to talk with your medical provider about any herb, supplement or medicine to make sure there is no drug-drug interaction.  For information about liver toxic herbs see this edition of the HCV Advocate newsletter. 

Pregnancy Categories
Harvoni, Sovaldi and Viekira Pak are classified as Pregnancy B drugs.  This means that there have been no studies in humans and that they should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus or if needed. 

Ribavirin is a Pregnancy X drug and as such pregnancy has to be avoided.  Women of child bearing potential and their male partners can not receive ribavirin unless they are using two forms of effective contraception during treatment with ribavirin and for six months after treatment has concluded.  Women should have a pregnancy test before starting treatment, during treatment and the six month period after treatment. 

Women are encouraged to sign up with the ribavirin registry at:  www.ribavirinpregnancyregistry.com

Comment:  If a woman is contemplating pregnancy most medical providers recommend HCV treatment first and starting a family afterwards.  Talk with your medical provider about your options. 

HCV Treatment FDA-Approved Prescribing Information:

Snapshots, by Alan Franciscus, Editor-in-Chief

Originally published July 1, 2015

Article: Long-term treatment outcomes of patients infected with Hepatitis C virus: a systematic review and meta-analysis of the survival benefit of achieving a Sustained Virological Response–B Simmons, et. al
  Source:  Clin Infect Dis. 2015 May 17. pii: civ396. [Epub ahead of print]
Results and Conclusions:  In the current study the authors conducted an electronic search to identify if achieving a cure improved long term outcomes. The records of 33,360 patients from 31 studies were examined with a medium follow-up period of more than five years. The people who were cured were compared to those who were not cured. 

The Bottom Line:  The survival after five years from being cured was significant compared with those who did not achieve a cure.  This included three populations of people—those who were HCV mono-infected, those who had cirrhosis and those who were coinfected with HIV and hepatitis C. 

Editorial Comment:  In science studies are needed for everything, and this is an important one because it proves that successful treatment works to prolong lives.  More of these studies (with larger patient populations) are required to convince insurance companies and other payers that in the long run paying for treatment saves them money and, more importantly, lives.

Article:  Methadone continuation versus forced withdrawal on incarceration in a combined US prison and jail: a randomised, open-label trial—RD Josiah
  Source: The Lancet DOI: http://dx.doi.org/10.1016/S0140-6736(14)62338-2

Results and Conclusions:  Methadone is used for withdrawal/substitute for opioid use.  In this study people who were entering Rhode Island Department of Corrections and who were currently enrolled in a methadone maintenance program at the time of arrest were asked to enroll in a study that would continue them on methadone maintenance while they were in prison.  Participants were only included in the study if they were to be incarcerated for more than 1 week but less than six months.  The participants in the study were randomized by a computer-generated program by sex and race.  The trial took place between June 2011 - April 2013.  
  • The 114 participants in the methadone maintenance group were randomized to receive methadone at their regular dose.
After release from prison the study paid for ten weeks of methadone for the methadone group if financial help was needed.
  • The 109 forced-withdrawal group followed standard guidelines forforced withdrawal. 
The standard withdrawal protocol was to receive methadone for 1 week at the dose at the time of their incarceration, then a tapered withdrawal regimen (for those on a starting dose >100 mg, the dose was reduced by 5 mg per day to 100 mg, then reduced by 3 mg per day to 0 mg; for those on a starting dose >100 mg, the dose was reduced by 3 mg per day to 0 mg).
The Bottom Line: The participants who were given methadone were more than twice as likely than the forced withdrawal group to return to a community methadone clinic in their community within 1 month of release—96% vs. 78%.  There were no serious side effects in either group. 
  • Methadone groups:  one death, one non-fatal overdose, one hospital admission and 11 emergency-room visits
  • Forced-withdrawal groups:  no deaths, two non-fatal overdoses, four admissions to hospitals, 16 emergency-room visits
Editorial Comments:  Providing methadone seems very humane.  It also reduces hospital admission, emergency-room visits and greatly increases the chances that once a prisoner is released they would seek out a methadone clinic.


HealthWise: Hepatitis C and Pain—Part 2, by Lucinda K. Porter, RN

Originally published July 1, 2015

Last month, I talked about hepatitis C and pain, and presented information about over-the-counter and prescription pain medication. Nonsteroidal anti-inflammatory drugs (NSAIDS) and opioids are effective painkillers, but they are associated with the risk of medical complications. This month I focus on pain management techniques that have little or no risk of injuring the liver or other organs in the body. I start with the controversial one—marijuana.  

Marijuana (Cannabis sativa) is slowly emerging from its status as the cause of “reefer madness” to a more reputable one showing potential medical benefits. However, before running out and buying some weed and a bag of Cheese Doodles, let’s explore these questions:
  • Is marijuana effective for reducing pain?
  • What is marijuana’s affect on the liver and hepatitis C?
First, let’s get one big frustrating fact out of the way: Marijuana is classified as a Schedule 1 drug. Drugs with a schedule 1 designation are deemed as having a high potential for abuse and no accepted medical use. Marijuana is tucked in there along with heroin, LSD, peyote, and ecstasy. Politicians determined this, not scientists. Because of this classification, marijuana is nearly impossible to obtain and test in clinical research. The bureaucracy is enormous, and permission is hard to get. In 2010, Time magazine summed it up this way, “Pot is listed as Schedule 1 because science hasn’t found an accepted medical use for it, but science can’t find a medical use for it because it is listed as Schedule 1.”

It is hard to imagine that marijuana is classified as a Schedule 1 drug when there has never been a reported death from marijuana overdose. Compare this to annual deaths from acetaminophen (300) or nonsteroidal anti-inflammatory drugs (7,000-10,000), and opioids (16,000). Compare marijuana’s zero deaths to those from legally obtainable substances, such as alcohol (88,000) or tobacco (480,000 including second-hand), and cannabis seems much safer.

This is not to say that marijuana isn’t without risk. In Colorado, two cannabis-related deaths are under investigation; one a suicide, the other a homicide in which other substances were involved. Also disturbing is the fact that the number of auto accidents have risen in Colorado since the legalization of pot.

These few deaths are hardly worth condemning pot for, especially since marijuana use may be causing a drop in the number of deaths from prescription opioids. States with liberal marijuana laws had a 25 percent reduction in opioid deaths. Cannabis is also associated with lower death rates in patients with traumatic injuries. That is just the beginning. The potential benefits are so many, that U.S. Surgeon General, Vivek Murthy said, “We have some preliminary data showing that for certain medical conditions and symptoms, marijuana can be helpful.”

Is marijuana effective for pain? Yes! I could write pages on this. The bottom line is that cannabinoids (a chemical compound found in a number of plants, including Cannabis sativa) interact with specific receptors in the brain. This appears to reduce pain and inflammation.

Will marijuana cause liver injury? It’s not well researched, but probably not. A Canadian study of 690 participants led by Laurence Brune and colleagues found, “Marijuana smoking does not accelerate progression of liver disease in HIV–Hepatitis C coinfection.” (Clinical Infectious Disease, Sep 2013). Previous studies have had mixed results.

What is marijuana’s effect on hepatitis C? The studies have been mixed. There is some research suggesting that marijuana may lower immune response. However, cannabis is being used in cancer studies with favorable results. In short, we don’t know.

What are the downsides of marijuana use? There are quite a few, such as risks of addiction, cognitive impairment, increased bleeding risks, etc. Frankly, we don’t know all the risks since marijuana has not been rigorously researched. I suspect that a day will come when marijuana will come with a paper insert that will list all the potential drug interactions, side effects, and warnings. Until then, keep this in mind:  We don’t know if cannabis interacts with hepatitis C medications. Marijuana may interfere with drugs that are metabolized via the liver’s cytochrome P450 enzyme system. This may affect the dose of your hepatitis C medications. If you use marijuana, work with a doctor who will prescribe it, and show you how to use it medically and responsibly.
Note: If you are on or are being considered for liver transplantation, marijuana use can be a disqualifier. The state of California recently introduced legislation to prohibit marijuana use as a factor for disqualification for organ transplantation. Other states may follow suit, especially in the light of Congress’s latest legislation banning federal interference on state medical marijuana laws.
Some insurance companies and state Medicaid programs are requiring drug testing prior to approval of hepatitis C treatment. If your medical provider has prescribed treatment and you use pot, find out if there will be drug testing. If so, educate yourself about the washout period, or how to pass the test; it varies depending on how often you use marijuana.

Drug-Free Pain Control
Ideally, relieving pain without drugs is the safest approach. The trick is to work with a specialist who is trained in the art of introducing drug-free pain measures while slowly reducing pain medication. All sorts of drug-free techniques are used, such as acupuncture, massage, hypnosis. Below are three drug-free techniques worth considering.
1. Exercise: I was surprised to learn that exercise topped the list of ways to reduce chronic pain, particularly arthritic and inflammatory pain. Exercise also helps fibromyalgia, migraine headaches and back pain. Aerobic exercise seems to be the best, and the intensity is determined by what you can tolerate. Walking is great exercise because it doesn’t require anything more than a good pair of shoes, sunscreen, and a safe place to walk. Gardening, dancing, bicycling, swimming, yoga, and tai chi are other fun ways to stay fit. If you are new to exercise, be sure to talk to your medical provider before starting. Start slow and only do what feels comfortable. 

2. Meditation: There are countless studies documenting meditation’s profound effect on reducing pain. Personally, I couldn’t imagine sitting still while relaxed, let alone in pain, so I had to experiment with this one myself. It works. It wasn’t as good as a spinal block or sedation, but it was free and without risk. There are many ways to meditate, but probably the most well-known in the U.S. is mindfulness-based stress reduction (MBSR) developed by Jon Kabat-Zinn. MBSR is taught in hospitals, clinics, and communities. 

3. Quitting Smoking:  In “Prevalence and risk factors for patient-reported joint pain among patients with HIV/Hepatitis C coinfection, Hepatitis C monoinfection, and HIV monoinfection,” Alexis Ogdie and colleagues reported that hepatitis C patients who smoked, had higher levels of joint pain. (BMC Musculoskeletal Disorders 2015) (See review of this article by Alan Franciscus here.) Granted, the study did not show that tobacco cessation would reduce pain, but we all know that smoking presents huge health risks. If you do decide to quit, seek professional help. Perhaps MBSR and exercise will help.

Final Words
I have tried to simplify a very complicated subject. Pain management deserves more than I gave it here. In nursing, I learned that pain is the fifth vital sign. In short, pain should be taken seriously. However, the tragic reality is that pain is understudied and poorly misunderstood. Some physicians over-prescribe painkillers; some under-prescribe them. The bottom line is that if your pain is not well controlled, ask to see a pain specialist.

Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com


A Brief Overview of Liver Toxic Herbs —Alan Franciscus, Editor-in-Chief

Originally Published July 1, 2015

A recent article appeared in Gastroenterology that provided an overview of herbal products. This review will focus on the important issues regarding the lack of standardization, possible contamination, some deceptive claims and a list of the herbs that have the most potential to harm the liver.

In the February 2015 edition of the HCV Advocate Mid-Month Newsletter, I wrote “Herbal Supplement Crackdown.”  The article was about four major chains selling herbal supplements in New York State that contained substances not listed on the package label.  Even more disconcerting was that many of the listed herbs when tested, could not be verified as being the actual labeled herbs. 
Some of the important issues raised in the current study included:
There are many factors that affect the potency of herbs such as what season grown, location planted and how much sun the herbs receive, fertilizer (and how much) used and many additional factors. 
For instance, a list of 25 commercial ginseng products from a local health food store was analyzed for ingredients—the ginseng concentrations were different than listed on the label. The difference in the concentrations could be correlated to the standardizations issues listed above.

Contamination and Adulteration:
Herbal products were tested and found to have pesticides and toxins as well as unlabeled drugs in the herbal products.  These types of issues were also found in the herbs analyzed in the New York herbal crackdown. 

Deceptive Marketing:
There have been advertisements that promote the use of herbs stating that some herbal products can help to treat certain conditions and even cure viral infections.  Herbs may provide some relief from particular illnesses and provide supportive care.  However, there never has been a study that has shown that an herb can cure a viral disease such as hepatitis C.  Be careful about these types of claims.

Most Common Liver Toxic Herbs:
The herbs listed below are the most common herbs that have been found to cause liver toxicity, liver injury, possible liver failure and death.  I have listed the common name (bolded), scientific name and the most common ailments the herb is used to treat:
  • Black cohosh (Cimicifuga racemose):  menopausal symptoms
  • Chaparral (Larrea tridentate): weight loss, rheumatic pain, antibiotic
  • Comfrey (Symphyturn officinale): Wound healing
  • Germander (Teucrium chamaedrys):  Weight loss
  • Greater celandine (Chelidonium majus):  Liver and biliary tract disease
  • Green tea extract (Camellia sinensis): General health, weight loss
  • Herbalife product line (Multi-ingredient): Mental health and weight loss
  • Kava kava (Piper methysticum):  mental health and well-being
  • Hydroxycut (multi-ingredient):  Weight loss
  • Oxy-Elite Pro (multi-ingredient):  Performance-enhancement,  weight loss
  • Saw palmetto (Serenoa repens):  Prostate disease
The good news about herbs is that the New York attorney general and 13 other states are petitioning Congress to investigate the herbal supplement industry.  Additionally, the states are requesting the Food and Drug Administration to provide more oversight to the herbal supplements industry.  Until that time, it is up to the consumer to advocate for themselves, dig deep and to stick to the old warning to consumers—buyer beware.


Sunday, July 26, 2015

New Zealand: Cost keeps cure out of reach for those with Hepatitis C

Craig Hopkins, 52, nearly died from liver failure after contracting Hepatitis C virus (HCV) from an amateur tattoo. His new liver developed HCV but was finally cured after treatment with a new unsubsidised drug made available on compassionate grounds.

Now Hepatitis C free, the 52-year-old is calling for Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) to be made available in New Zealand.

"I reckon it's really sad the drugs are not available. If they were, it would free up the operating tables and they wouldn't need to do so many liver transplants."


Street Art Fair Raises Awareness About ‘Silent Killer’ Hepatitis C

DENVER (CBS4) – Local artists spent Sunday creating a mural to raise awareness about Hepatitis C. It’s a disease that patients call a silent killer.

Patients and survivors came out to the event to support World Hepatitis Day, including Rhonda Robineau. Today she is happy and healthy, but it wasn’t always that way.

Read more ...

Ireland: Faithfull promotes Hepatitis C awareness week

Singer songwriter Marianne Faithfull is set to front Ireland’s
first campaign to promote awareness of hepatitis C.

The 68-year-old will front The National Hepatitis C Awareness Week. The campaign takes place from July 27 to 31, and Faithfull will be the guest speaker at the launch of the campaign tomorrow at 6pm in the Smock Alley Theatre in Dublin.

Hepatitis C is a viral infection that affects the liver, causing it to become inflamed and not work as effectively in the body. It can be contracted via blood-to-blood contact with an infected person’s blood.

Speaking to The Sunday Times, Faithfull said she was diagnosed with the virus 23 years ago.


Saturday, July 25, 2015

Canada: Quebec to start reimbursing for 'revolutionary' Hepatitis C treatment

Quebec has decided to reimburse “revolutionary” drugs that can cure Hepatitis C, but only for the sickest patients at first.

According to the rules adopted by the Régie de l’assurance maladie du Québec, some Quebecers with the disease will have to wait three years before getting access to new treatments.

The measures concern two drugs called Harvoni and Holkira Pak that are supposed to cure the condition in 8-12 weeks.


Tuskegee launches hepatitis C virus testing initiative

In honor of the third annual National African American Hepatitis C Action Day today, the City of Tuskegee is taking steps to eradicate the hepatitis C virus (HCV) infection in its community, beginning with testing.

Mayor Johnny Ford of Tuskegee joined with national and local health leaders to discuss starting an initiative to diagnose and treat those infected with HCV in his area Friday morning.

C. Virginia Fields, president and CEO of the National Black Leadership Commission on AIDS, joined Ford in announcing that something must be done to counteract the spread of hepatitis C in the African American community.


Friday, July 24, 2015

Bristol-Myers wins approval for 1st hepatitis C type 3 drug

TRENTON, N.J. (AP) - An experimental drug for one of the hardest-to-treat types of hepatitis C has been approved by the Food and Drug Administration, adding to the surge of new options - all much more effective but extremely costly - for patients with the liver-destroying virus.

Daklinza, developed by New York-based Bristol-Myers Squibb Co., is the first drug approved to treat genotype 3, the second-most-common form. About 10 percent of Americans with hepatitis C have genotype 3.

Because genotype 3 is so hard to cure and damages the liver more quickly than other types, Daklinza is to be taken with Sovaldi, one of two blockbuster hepatitis C drugs sold by market leader Gilead Sciences Inc., along with Harvoni.

Meanwhile, the FDA on Friday also approved Technivie, a combination drug made by AbbVie Inc. for one of the least common forms of hepatitis C, genotype 4. Technivie also must be taken with a second drug, a much-older, generic pill called ribavirin.

Read more..

FDA approves new treatment for chronic hepatitis C genotype 3 infections

The Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which, approximately 10 percent are genotype 3.

“Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

The safety and efficacy of Daklinza in combination with sofosbuvir were evaluated in a clinical trial of 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection. Participants received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks and were monitored for 24 weeks post treatment. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured.

Results showed that 98 percent of the treatment-naive participants with no cirrhosis of the liver and 58 percent of the treatment-naive participants with cirrhosis achieved sustained virologic response. Of the participants who were treatment-experienced, 92 percent with no cirrhosis of the liver and 69 percent with cirrhosis achieved sustained virologic response. Daklinza labeling carries a Limitations of Use statement to inform prescribers that sustained virologic response rates are reduced in HCV genotype 3 infected patients with cirrhosis.

Safety information was available for approximately 1,900 patients with HCV treated with the recommended dose of Daklinza in combination with other anti-HCV drugs in clinical trials. The most common side effects of Daklinza with sofosbuvir were fatigue and headache.

Daklinza carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is co-administered with sofosbuvir in combination with another HCV direct-acting antiviral, including Daklinza. Co-administration of amiodarone with Daklinza in combination with sofosbuvir is not recommended.

Daklinza was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Daklinza is marketed by Bristol-Myers Squibb, based in Princeton, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Press Release Source:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455888.htm

FDA approves Technivie for treatment of chronic hepatitis C genotype 4

For Immediate Release

July 24, 2015

The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).

Technivie in combination with ribavirin is the first drug that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon, an FDA-approved drug also used to treat HCV infection.

“Today’s approval provides the first treatment option for patients with genotype 4 HCV infections without requiring use of interferon,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop cirrhosis over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV, of which genotype 4 is one of the least common.

The safety and efficacy of Technivie with ribavirin were evaluated in a clinical trial of 135 participants with chronic HCV genotype 4 infections without cirrhosis. Ninety-one participants received Technivie with ribavirin once daily for 12 weeks. Forty-four participants received Technivie once daily without ribavirin for 12 weeks. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured.

Results showed that 100 percent of the participants who received Technivie with ribavirin achieved a sustained virologic response. Of those who received Technivie without ribavirin, 91 percent achieved sustained virologic response.

Safety information was available for 316 participants with HCV treated with the recommended dose of Technivie in combination with other anti-HCV drugs in clinical trials. The three drugs included in Technivie are also included in Viekira Pak, previously approved for the treatment of HCV genotype 1 infection. Additional safety information for those drugs was available from the Viekira Pak trials. The most common side effects of Technivie with ribavirin were fatigue, weakness (asthenia), nausea, insomnia, itching (pruritus) and other skin reactions.

Technivie carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1 percent of clinical trial participants. The elevations occurred more frequently in females taking contraceptives containing ethinyl estradiol. Contraceptives containing ethinyl estradiol must be discontinued prior to starting Technivie. Hepatic laboratory testing should be performed during the first four weeks of starting treatment, and as clinically indicated thereafter.

Technivie and Viekira Park are marketed by AbbVie Inc. based in North Chicago, Illinois.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Thursday, July 23, 2015

MSD Announces European Medicines Agency Acceptance of Marketing Authorisation Application for Grazoprevir/Elbasvir, an Investigational Therapy for Treatment of Chronic Hepatitis C Infection

KENILWORTH N.J., Jul 23, 2015 (BUSINESS WIRE) -- MSD, known as Merck MRK, -0.10% in the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a marketing authorisation application (MAA) for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy, for the treatment of adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection.1 The EMA will initiate review of the MAA under accelerated assessment timelines.

“Given the diversity of patient populations affected by chronic hepatitis C, including the estimated 15 million people living with the disease in Europe, it is important to provide patients and physicians with treatment options,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories, a U.S.-based division of Merck & Co., Inc., Kenilworth, N.J., U.S.A. “We are pleased to be working with regulatory authorities as we advance grazoprevir/elbasvir for appropriate patients living with chronic hepatitis C around the world.”

The EMA’s accelerated assessment is available for products that respond to unmet medical needs or represent a significant improvement over current treatment options within a major public health interest, such as the treatment of chronic HCV infection. The Committee for Medicinal Products for Human Use (CHMP) will continue to evaluate the accelerated assessment status throughout the MAA evaluation process.

The MAA for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials programme, as well as the C-SURFER, C-SALVAGE and C-SWIFT clinical trials, evaluating grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in patients with chronic HCV infection. Collectively, these trials evaluated treatment regimens in multiple genotypes (GT1, 3, 4 and 6), including patient populations who were previously treated, and those with cirrhosis or certain co-morbidities (i.e., HIV co-infection, chronic kidney disease stages 4 and 5).

The company submitted a New Drug Application for grazoprevir/elbasvir (100mg/50mg) to the U.S. Food and Drug Administration (FDA) in May 2015 for the treatment of chronic HCV GT 1, 4 or 6 infection, and is submitting additional license applications in other markets by the end of 2015. In April 2015, the U.S. FDA granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
About Grazoprevir/Elbasvir
Grazoprevir/elbasvir is MSD’s investigational, once-daily, single-tablet combination therapy consisting of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor). As part of MSD’s broad clinical trials programme, grazoprevir/elbasvir is being evaluated in multiple HCV genotypes including patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, liver cirrhosis and in those on opiate substitution therapy.
About MSD
Today's MSD is a global health care leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programmes and partnerships.

Read complete press release here..

Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral, Once-Daily OLYSIO® (Simeprevir) in Combination with Sofosbuvir

Filing Supported by Data from the Phase 3 OPTIMIST-1 and -2 Clinical Trials Evaluating OLYSIO® Combination Therapy in Hepatitis C Patients with and without Cirrhosis

TITUSVILLE, N.J., July 23, 2015 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the label for once-daily, all-oral OLYSIO® (simeprevir). OLYSIO® is a hepatitis C virus (HCV) NS3/4A protease inhibitor, currently approved for use with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection as a 12-week treatment for patients without cirrhosis or a 24-week treatment regimen for patients with cirrhosis. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor marketed by Gilead Sciences, Inc.

OLYSIO® was approved in November 2014 in combination with sofosbuvir based on the Phase 2 COSMOS clinical trial. This sNDA is based on results from the Phase 3 OPTIMIST-1 and OPTIMIST-2 trials, which evaluated 12 and eight weeks of therapy for treatment-naive and treatment-experienced genotype 1 CHC adult patients without cirrhosis, and 12 weeks of therapy for treatment-naive and treatment-experienced genotype 1 CHC adult patients with cirrhosis.

"OLYSIO® has contributed significantly to the care of people living with hepatitis C. The availability of multiple treatment options is important to help offer an opportunity for cure, and we believe OLYSIO® will continue to play a meaningful role going forward," said Richard Nettles, M.D., vice president, Medical Affairs, Janssen Therapeutics. "We're pleased to submit the data from the Phase 3 OPTIMIST trials, which adds to the body of clinical information about this combination in patients with and without cirrhosis."

Results from the OPTIMIST trials were presented in April 2015 at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) in Vienna.

About the OPTIMIST TrialsOPTIMIST-1 is a Phase 3, randomized, open-label trial to investigate the efficacy and safety of the all-oral regimen of simeprevir and sofosbuvir (SMV/SOF) among treatment-naive and treatment-experienced genotype 1 CHC patients without cirrhosis. The primary study endpoint is sustained virologic response (SVR) at 12 weeks after treatment (SVR12) with 12 and eight weeks of treatment with SMV/SOF versus a historical control (patients previously treated with approved regimens containing a direct-acting antiviral, pegylated interferon and ribavirin).
  • Ninety-seven (97) percent of patients treated with SMV/SOF for 12 weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate of 87 percent among the historical control.
    • SVR12 rates of 100 percent were seen among patients with IL28B CC genotype (n=43/43) and those with baseline NS5A and NS3 Q80K polymorphisms (n=9/9).
  • Patients treated with eight weeks of SMV/SOF achieved an SVR12 rate of 83 percent (n=128/155), which was not superior to the SVR12 rate of 83 percent in the historical control.
    • High SVR12 rates were seen among patients with baseline HCV RNA < 4 million IU/mL (96 percent; n=46/48), IL28B CC genotype (93 percent; n=38/41), patients with genotype 1b CHC (92 percent; n=36/39) and patients without baseline NS5A and Q80K polymorphisms (89 percent; n=78/88).
  • The most frequently reported adverse events in the 12- and eight-week treatment arms were headache (14 and 17 percent, respectively), fatigue (12 and 15 percent, respectively) and nausea (15 and 9 percent, respectively).
OPTIMIST-2 is a Phase 3, open-label, single-arm trial to investigate the efficacy and safety of SMV/SOF in treatment-naive and treatment-experienced genotype 1 CHC patients with cirrhosis. The primary endpoint is SVR12 with SMV/SOF versus a historical control.
  • Twelve (12) weeks of treatment with SMV/SOF resulted in SVR12 rates of 84 percent (n=86/103), which was superior to the SVR12 rate of 70 percent in the historical control.
  • Higher SVR12 rates were seen in patients with baseline NS5A polymorphisms with or without NS3 Q80K polymorphisms (100 percent; n=13/13), patients with albumin ≥4 g/dL (94 percent; n=47/50) and treatment-naïve patients (88 percent; n=44/50).
  • The most common adverse events were fatigue (20 percent), headache (20 percent) and nausea (11 percent).
Read complete press release here

World Hepatitis Day — July 28, 2015

Morbidity and Mortality Weekly Report (MMWR)


July 24, 2015 / 64(28);753

July 28, 2015, marks the fifth annual World Hepatitis Day, established in 2010 by the World Health Organization to increase awareness and understanding of viral hepatitis. Millions of acute hepatitis infections occur each year, and approximately 400 million persons are living with chronic hepatitis B or hepatitis C (1). An estimated 1.4 million persons die each year from the various forms of viral hepatitis (1). The theme of this year's World Hepatitis Day is "Prevent Hepatitis. Act Now." Key messages will focus on risks, safe injection practices, vaccination, and testing and treatment.

This issue of MMWR includes a report describing the launch of a nationwide hepatitis C elimination program in Georgia, a country with a high burden of hepatitis C. The initial phase of the program is focused on increasing access to affordable diagnostics, free treatment of persons with severe liver disease who are at highest risk for hepatitis C–related morbidity and mortality with new curative regimens, and building capacity to achieve program goals of prevention of transmission and elimination of disease. Georgia's program might provide information and experience that can inform similar efforts in other parts of the world.

A second report summarizes viral hepatitis surveillance and outbreak data from a national surveillance system in India for epidemic-prone diseases. This report sheds light on the burden and epidemiology of acute viral hepatitis in India, particularly hepatitis A and E, and highlights the important role that routine hepatitis surveillance can play in guiding prevention efforts.
Additional information about World Hepatitis Day is available at http://worldhepatitisday.orgExternal Web Site Icon. Resources for health professionals are available at http://www.cdc.gov/hepatitis.


  1. World Health Organization. Hepatitis. Geneva, Switzerland: World Health Organization; 2015. Available at http://www.who.int/hiv/topics/hepatitis/hepatitisinfo/enExternal Web Site Icon.

Tuesday, July 21, 2015

Rural docs want looser rules for Hepatitis C treatment

INDIANAPOLIS – The only doctor at the center of an HIV outbreak in rural Indiana cannot prescribe the latest treatments for patients also infected with the deadly Hepatitis C virus.

Dr. William Cooke, a family practitioner in Scott County, is treating dozens of people with HIV, the AIDS-causing virus that exploded in numbers among intravenous drug users earlier this year.

But state Medicaid rules forbid him from prescribing new treatments to those same patients with Hepatitis C, the blood-borne disease that causes inflammation in the liver and now claims more lives than HIV in the United States.


Genotype 5, by Alan Franciscus, Editor-in-Chief

Originally Published June 15, 2015

Of all the genotypes identified, Genotype 5 is the least studied, and the least prevalent.  However, it is possibly the most interesting in terms of where it is believed to have originated and where there are pockets of it found around the world. 

In terms of the worldwide prevalence of genotype 5 it is estimated at 1.5 million. The highest incidence of genotype 5 is found in the northern part of the nation of South Africa.  Globally, there are an estimated 436,000 people in Eastern sub-Sahara, 47,000 people in North Africa, the Middle East, 80,000 people in South Asia, 26,000 people in Western Europe, Southern Latin America and 887,000 people Southern sub-Africa.  

The percentage of genotype 5 is found in the following countries:  South Africa-northern (39%); France-central (14%); Syria (10%); Saudi Arabia (1%); Canada-Montreal, Quebec ( 5%); Belgium (4%); Spain-southeast (10%). 

Origins and Spread
The exact origin of genotype 5 is unknown, but there have been studies that have been able to ‘predict’ where it originated and how it spread with a reasonable certainty.  However, like most facts in science, it needs more studies to confirm if it is a fact and until it is confirmed or disproved, it remains a theory.

What is on scientific ground is that the hepatitis C virus originated in Africa and most likely in Western or Central Africa.  Genotype 5 most likely originated in Central Africa possibly what is now the Democratic Republic of Congo more than 120 years ago based on the genetic testing of the viral makeup.  However, why is the highest prevalence of genotype 5 in the northern part of South Africa and only in small pockets in other regions of the world?  That question has been not fully answered, but there are some interesting theories.   There were trade routes from Central Africa to South Africa that could have spread genotype 5 from central Africa to South Africa.  The pockets of genotype 5 in Belgium, France, and the Netherlands can be explained by the European trade and colonization of Africa.    

Genotype 5 only has one subtype – 5a.  This means that the viral diversity remained intact because it was not widely transmitted like the other genotypes.  There have been studies in the other clusters of genotype subtype 5a but most of them have been isolated in ethnic communities in Belgium, the Netherlands, Luxembourg and rural France.   Many of those that have been studied have found that the infections had come from a single source of infection. 

There have been only a handful of studies about treatment of genotype 5.  Pegylated interferon plus ribavirin for a treatment duration of 24 to 48 weeks achieved cure rates from 64% to 71%. 
In a study recently released at the EASL 2015 conference showed great promise with interferon-free and ribavirin-free therapy.  The study included 41 genotype 5 patients—21 treatment naïve/20 treatment experience patients treated with Harvoni (ledipasvir/sofosbuvir) for 12 weeks.  The cure rates were 95% (20 of 21 pts) of treatment naïve patients and 95% (19 of 20 pts) in the treatment experienced patients.  The treatment was safe and well tolerated.

These are very high cure rates.  Very good news for those with genotype 5.


HCV Drugs —Alan Franciscus, Editor-in-Chief

Originally Published June 15, 2015

This month’s column discusses Merck’s New Drug Application (NDA) application to the Food and Drug Administration (FDA), BMS’s Breakthrough Designation, a pharmaceutical collaboration, and good news for patients who need help with co-payments for HCV medications. 

On May 28, 2015, Merck submitted a NDA to the FDA for their combination of one pill (grazoprevir/elbasvir) taken once-a-day to treat HCV genotypes 1, 4 and 6.  Merck’s combination was granted Breakthrough Therapy designation status for the combination by the FDA for people with genotype 1 with end state kidney disease on hemodialysis (to filter the kidneys) and for patients with genotype 4.  Breakthrough Therapy is given to a drug(s) to treat a serious or life-threatening disease or condition when a drug may demonstrate a substantial improvement over existing therapies.    There were many reports on Merck’s HCV medications from EASL 2015 that resulted in cure rates up to 95-99% in people with genotype 1; 100% in genotype 4 and 80% in genotype 6. 

Merck states that they will be notified within 60 days if the FDA will accept their application for review. Furthermore, Merck is expected to file additional licenses in the European Union and other markets by the end of 2015. This will be good news for paients—we may just have another choice of medications in the near future.

Bristol-Myers-Squibb announced that they have been granted Breakthrough Therapy Designation by the FDA for the combination of daclatasvir and sofosbuvir.   The cure rates of Daclatasvir, sofosbuvir and ribavirin performed well in liver transplant patients and in those who had advanced cirrhosis.  I reported on a study from EASL 2015 that in this population there was a cure rate of 76% to 100%. 

Achillion and J&J Deal
It was announced in May that Johnson and Johnson would collaborate with Achillion.  The deal would mean that J & J would invest in and help develop Achillion’s HCV 3 drug pipeline.  The three drugs are all in early development and could work on all HCV genotypes, i.e., be pan-genotypic.  J & J hopes to co-develop their drug pipeline with Achillion and achieve an effective 6-week HCV treatment cure. 
Co-Pay Assistance
The current medications to treat hepatitis C can have high co-payments.  Presented here is another co-pay assistant program for patients—HealthWell Foundation’s New Fund.  For more information visit their website at http://healthwellfoundation.org/ or contact:  Ginny Dunn 240-632-5309, email Ginny.Dunn@HealthWellFoundation.org