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.

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Be sure to check out our other blogs: The HBV Advocate Blog and Hepatitis & Tattoos.

Alan Franciscus


HCV Advocate

Tuesday, March 31, 2015

Pakistan: Thousands of Pakistan made anti Hepatitis C injections expire

Islamabad- About 10000 injections developed by Punjab University (PU) for treatment of Hepatitis-C have gone redundant, due to negligence of provincial and federal governments.

The government has shifted all the burden of this scam to the shoulders of former PPP led government. PU medical experts had developed 100000 injections for cure of Hepatitis-C at the cost of Rs 7 million, but these have gone time barred while lying in stores, due to non-granting of permission by ministry of health and regulation for conducting laboratory test.

PU Molecular Biology department worked out plan to develop cheap Interferon injection for treatment of Hepatitis C and funds were also provided to the experts of the respective department. The said injection was developed within the span of 5 years time. The permission was sought from federal ministry for health and regulation for laboratory test of these injections. This application was kept unattended in Islamabad secretariat, for two years. These 100000 injections which were prepared for poor patients were wasted, for want of permission by the then minister of health Ejaz Jakhrani and secretary health Khushnood Lashari.


Tazo tea luminary Steven Smith died of liver cancer caused by hepatitis C, a hidden epidemic

After Tazo co-founder Steven Smith died at 65 on March 23, an article on his exceptional life as a serial entrepreneur and whimsical tea visionary attracted more than 100,000 clicks on oregonlive.com -- a lot for a news obituary.

But some readers wrote to The Oregonian with questions. They wanted to know the cause of death. They asked why Smith, still bubbling with energy and ideas, died so relatively young.

On Monday, Smith's widow, Kim DeMent -- a remarkable woman in her own right, who runs Steven Smith Teamaker, dances with BodyVox and writes lyrically -- explained why. The answer should concern baby boomers and others, because it involves a little-known epidemic that could take many more lives at any age without simple precautions.

Smith died from complications of liver cancer.


Canada: Ontario decision to cover costly hepatitis C drug a lifesaver, doctor says

Ottawa liver specialist Dr. Curtis Cooper is calling Ontario’s decision to pay for new treatments that can cure hepatitis C a “landmark event” that will change the lives of thousands of people with the disease.

Cooper, director of The Ottawa Hospital and Regional Hepatitis Program, sees thousands of hepatitis C patients, many of whom will benefit from the new drug therapy now that it is covered by the province.

“This is going to mean the difference between health or illness and death,” for many patients, he said.


Ireland: UP to 80 seriously ill Hepatitis C patients have cleared virus from their blood

New treatment was given to the patients after doctors warned they were not responding to other drugs.

The treatment, which costs around €45,000 to €55,000 per patient was given to the patients after doctors warned they were not responding to other drugs.

Dr Suzanne Norris, a gastroenterologist at St James's Hospital in Dublin, said the patients will continue to be monitored over the coming months to determine their response.

Earlier this year Health Minister Leo Varadkar said a programme was being put in place to provide early access to the powerful new direct-acting anti-viral drugs for Hepatitis C patients with the greatest clinical need, due to the advanced nature of their condition.


Monday, March 30, 2015

Jackson County, IN: ‘There is a significant increase in hepatitis C’

As a result of increased HIV testing in southeastern Indiana due to the large outbreak of the viral disease linked to injectable drug use, health officials in Jackson County say there is a significant increase in hepatitis C being reported in the county.  In fact, more than 50 cases of the disease are currently being investigated, approximately 10 times the number of cases reported in a month.

The Seymour Tribune reports: The increase is being attributed to the ongoing HIV outbreak in southeast Indiana, centered in nearby Scott County. That health emergency has caused many people to seek free HIV testing which has led to more Hepatitis C being diagnosed too, said Lin Montgomery, public health coordinator with the Jackson County Health Department.

On Thursday, Indiana Governor Mike Pence declared a public health disaster emergency for Scott County.


New Hepatitis C treatments cost-effective, but only for selected patients, study shows

A study led by Boston Medical Center (BMC) researchers demonstrates that while new therapies to treat Hepatitis C Virus (HCV) are highly effective, they are cost-effective and provide the greatest value in specific groups of HCV-infected patients. The findings of the study, led by Benjamin P. Linas, MD, MPH, from BMC's section of infectious diseases and the Boston University School of Medicine (BUSM), are published in the Annals of Internal Medicine.

The study focused on the combination of sofosbuvir and ribavirin for treatment of HCV genotypes 2 and 3, which account for approximately one quarter of all HCV cases in the United States. These medications were the first all oral combination therapy approved for the treatment of HCV. While this medication regimen is effective in curing more than 90 percent of patients, the wholesale cost of sofosbuvir is approximately $85,000 per treatment course, which has strained insurance budgets and led to treatment restrictions.

Using a simulation model, Linas and colleagues projected outcomes, costs, and cost-effectiveness of sofosbuvir-based treatments for HCV genotype 2 or 3 infection in the US. They found that at these costs, sofosbuvir-based HCV therapy provides excellent economic value in genotype 2 or 3 infected patients who already have advanced liver disease. It also is cost-effective for patients who have already previously failed treatment with other drugs.

Explore further: Cost-effectiveness of immediate HCV Rx in early disease analyzed
Journal reference: Annals of Internal Medicine
Provided by Boston University Medical Center


New hepatitis C drugs are costing Medicare billions

Medicare spent $4.5 billion last year on new, pricey medications that cure the liver disease hepatitis C — more than 15 times what it spent the year before on older treatments for the disease, previously undisclosed federal data shows.

The extraordinary outlays for these breakthrough drugs, which can cost $1,000 a day or more, will be borne largely by federal taxpayers, who pay for most of Medicare’s prescription drug program. But the expenditures will also mean higher deductibles and maximum out-of-pocket costs for many of the program’s 39 million seniors and disabled enrollees, who pay a smaller share of its cost, experts and federal officials said.

The spending dwarfs the approximately $286 million that the program, known as Part D, spent on earlier-generation hepatitis C drugs in 2013, said Sean Cavanaugh, director of Medicare and deputy administrator at the Centers for Medicare and Medicaid Services (CMS).


Editorial | Needle exchanges

The alarming epidemic of HIV in Southern Indiana tied to intravenous drug abuse underscores the wisdom of Kentucky lawmakers who included an option for sterile needle exchanges in the comprehensive heroin bill they passed this session.

In Indiana, the surge of HIV cases among 80 people linked to tiny Scott County — population 24,000 — has attracted national headlines and caused Gov. Mike Pence, who has opposed needle exchanges, to reverse course.

Kentucky’s heroin bill was signed into law Wednesday by Gov. Steve Beshear and could result in many saved lives if communities take advantage of the option to offer needle exchanges through local health departments.

Australia: World first trials for hepatitis C wonder drug in Sydney's maximum security jails

Two of NSW's maximum security jails are the location for a world-first trial of a new wonder drug that could stop the spread of the blood-borne disease hepatitis C through the prison populations.

Prisoners at the Lithgow and Goulburn jails are being recruited to take part in the treatment program, which it is hoped will eventually rid the institutions of the disease and potentially save the lives of thousands suffering chronic infections.

About a third of all prisoners in NSW jails are infected with chronic hepatitis C, which spreads rapidly through prisons by blood-to-blood contact including sharing of needles, syringes and other drug paraphernalia, tattoo equipment and from fights.


UK: Amends must be made to the victims of the contaminated blood scandal now

AFTER decades of campaigning, the decision to hold a public inquiry into what has been dubbed the biggest treatment disaster in the history of the NHS was welcomed by the victims who were infected with HIV and hepatitis C through contaminated blood.

Last week it was a very different story as the publication of the final report was met with anger and accusations of a "whitewash".

The chair of the inquiry Lord Penrose, apportioned no blame for the tragedy and did not conclude that the infection of nearly 3,000 people in Scotland with HIV and hepatitis C from blood transfusions and products used to treat bleeding disorders could have been prevented.

But what the final report of the inquiry - which runs to five volumes - does document is a series of shocking revelations about the events which led to the disaster. The scale of the suffering is also laid bare with the harrowing stories detailed in the report - such as a mother who unwittingly infected her young son with HIV believing she was giving him the best treatment for haemophilia.


Friday, March 27, 2015

India: Strides Arcolab Launches Generic Version of Hepatitis C Drug

New Delhi: Strides Arcolab on announced launch of the generic version of Hepatitis C drug 'Sofosbuvir' under the brand name 'Virso'.

The product will be available to Indian patients shortly, the Bangalore-based company said in a statement.

"In September 2014, Strides entered into a licensing agreement with Gilead Sciences Inc to bring Hepatitis C cure to 91 developing countries," Strides Arcolab said in a statement.


Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Sovaldi® (sofosbuvir) for the Treatment of Genotype 2 Chronic Hepatitis C

-- Sovaldi Part of First All-Oral Treatment Regimen for Genotype 2 Patients in Japan --
-- 96 Percent Cure Rates and Shortened, 12-Week Course of Therapy --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 26, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Sovaldi® (sofosbuvir), a once-daily nucleotide analog polymerase inhibitor, for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis. Sovaldi is indicated for use in combination with ribavirin (RBV) for 12 weeks. Sovaldi (in combination with RBV) is the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection. Sovaldi is also the first product to be marketed by Gilead in Japan.

“Today’s approval represents an important step forward in the management of hepatitis C in Japan, enabling genotype 2 infected patients the opportunity of a cure in 12 weeks with an all-oral regimen that eliminates the need for interferon,” said Masao Omata, MD, Yamanashi Prefectural Hospital Organization.

Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people chronically infected with HCV, 20-30 percent have the genotype 2 strain of the virus. Currently approved therapies in Japan for genotype 2 HCV infection involve 24-48 weeks of injections with pegylated interferon, which may not be suitable for many patients.

Sovaldi’s approval is supported by data from a Phase 3 clinical trial conducted in Japan (Study GS-US-334-0118) among treatment-naïve and treatment-experienced genotype 2 patients. Approval was based on 96 percent (n=135/140) of genotype 2 HCV-infected patients who received 12 weeks of an all-oral regimen of Sovaldi plus RBV 600–1,000 mg/day achieving a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. The approval is also supported by SVR12 results from four international Phase 3 studies (FISSION, FUSION, POSITRON and VALENCE), which included genotype 2 HCV patients.

“There is a need in Japan for new HCV treatment options that are more effective and better tolerated and we have been pleased to partner with the medical community here in Japan to demonstrate the efficacy and safety of Sovaldi,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We look forward to making Sovaldi available in Japan as quickly as possible, while simultaneously continuing to work with the agency on its review of our second application for an all-oral sofosbuvir-based regimen for the treatment of genotype 1 HCV infection.”

Gilead filed a New Drug Application (NDA) in Japan for a single-tablet regimen of sofosbuvir and the NS5A inhibitor ledipasvir for the treatment of genotype 1 HCV infected patients on September 24, 2014. The ledipasvir/sofosbuvir single tablet regimen is an investigational product in Japan and its safety and efficacy have not yet been established.

- See more at: http://gilead.com/news/press-releases/2015/3/japans-ministry-of-health-labour-and-welfare-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-genotype-2-chronic-hepatitis-c#sthash.tfSV7EEB.dpuf

Wednesday, March 25, 2015

Kentucky to Allow Local Needle Exchanges

In a last-minute compromise, Kentucky lawmakers took a strong, collective step toward combating the heroin epidemic that kills hundreds each year and puts countless others in danger.  The Kentucky House of Representatives voted 100-0 in favor of Senate Bill 216, while the Senate voted 34-4 in favor.

The most debated part of the bill was approval of local needle exchanges, which would be funded through tax dollars. Opponents in the Senate, who voted after the House unanimously approved the bill, said needle exchanges would further enable heroin users and make the overall problem worse. Supporters said needle exchanges will keep used needles out of public areas, and lessen the risk of infection to those who do not use drugs. They also pointed to studies that claim needle exchanges curb the spread of diseases like Hepatitis C and AIDS.

SB 216 also calls for tougher punishment for convicted large-scale traffickers. They are dealers carrying at least 60 grams of heroin. They would have to serve at least half their sentences before any possibility of parole.

The end of hepatitis C?

2014 will do down as a pivotal year in the fight against hepatitis C virus (HCV), a blood-borne infection that is thought to infect around 2.5% of the world's population - some 170 million people.

The availability of new, more effective therapies for hepatitis C virus have raised the tantalising prospect of being able to eliminate the infection on a global basis,  although there are still significant obstacles to overcome.

Viral hepatitis - which generally means hepatitis B and C - “kills more people every year than HIV, malaria and tuberculosis combined, but has not had the same level of resources committed to it,” according to Charles Gore, who is chief executive of the Hepatitis C Trust in the UK and president of the World Hepatitis Alliance (WHA).

AIDS Specialist Advocates Sweeping Approach to Battle Against Hepatitis C

Could hepatitis C be the next communicable disease to come under a targeted attack in B.C.?

It will be if HIV/AIDS expert Dr. Julio Montaner has his way.

Montaner said Tuesday that even if the virus is eradicated among baby boomers, that won’t stop its continued spread.

USA-Lack of Insurance Bars Some from Hepatitis C Treatment

Survey data from 2001 to 2010 show that lack of insurance kept some people with hepatitis C virus from getting treatment.

Recently, more effective and well-tolerated drugs have been developed to treat hepatitis C, removing many of the discouraging side effects of older drugs. The infection is curable and transmission can be prevented, researchers write in the American Journal of Gastroenterology.

But for the more than three million people in the U.S. who have chronic liver disease from hepatitis C, there are still two important barriers to getting treatment, said lead author Dr. Ivo Ditah from the Mayo Clinic in Rochester, Minnesota.

UK-Prime Minister Apologizes for Tainted Blood Scandal That Infected Thousands in '70s, '80s

LONDON— British Prime Minister David Cameron on Wednesday apologized to thousands of patients who were infected from contaminated blood during the 1970s and 1980s.

Tainted government blood products and transfusions infected an estimated 2,500 people with the hepatitis C virus and HIV from 1970 to 1991. The scandal has been called the worst treatment disaster in the history of Britain's public health care system.

Cameron's apology came after a six-year official inquiry was completed. The probe said more should have been done to screen blood and donors in the early 1990s, and that the collection of blood from prisoners should have stopped earlier.

Cipla launches generic Hepatitis C drug Hepcvir

Cipla, on Wednesday, announced the launch of generic drug Sofosbuvir for treating chronic Hepatitis C under the brand name Hepcvir.

“Following the non-exclusive licensing agreement signed with Gilead Sciences in September last to manufacture and market chronic Hepatitis C medicines, Cipla is now all set to make the drug Sofosbuvir available to Indian patients in a week’s time,” the company said in a statement.

“Cipla has always brought accessible and affordable medicines to fight against diseases like AIDS and Hepatitis B; hence, Cipla has made it a priority to bring Hepcvir to patients in India as well as the other developing nations,” Cipla Managing Director and Global CEO Subhanu Saxena said.

Canada-Ontario decision to cover costly hepatitis C drug a lifesaver, doctor says

Ottawa liver specialist Dr. Curtis Cooper is calling Ontario’s decision to pay for new treatments that can cure hepatitis C a “landmark event” that will change the lives of thousands of people with the disease.

Cooper, director of The Ottawa Hospital and Regional Hepatitis Program, sees thousands of hepatitis C patients, many of whom will benefit from the new drug therapy now that it is covered by the province.

“This is going to mean the difference between health or illness and death,” for many patients, he said.

Tuesday, March 24, 2015

FDA MedWatch: Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone

MedWatch logo

AUDIENCE: Cardiology, Infectious Disease, Gastroenterology, Pharmacy

ISSUE: FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. FDA is adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. FDA is recommending that health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as the investigational drug daclatasvir or Olysio (simeprevir), with amiodarone.

FDA review of submitted postmarketing adverse event reports found that patients can develop a serious and life-threatening symptomatic bradycardia when either Harvoni or Sovaldi combined with another direct-acting antiviral is taken together with amiodarone. The reports included the death of one patient due to cardiac arrest and three patients requiring placement of a pacemaker to regulate their heart rhythms. The other patients recovered after discontinuing either the hepatitis C drugs or amiodarone, or both (see Data Summary). The cause of these events could not be determined. FDA will continue to monitor Harvoni and Sovaldi for risks of serious symptomatic bradycardia and further investigate the reason why the use of amiodarone with these hepatitis C drugs led to the heart-related events.

BACKGROUND: For a Data Summary and additional recommendations for health professionals and patients, see the FDA Drug Safety Communication.

RECOMMENDATION: Health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone. However, in cases where alternative treatment options are unavailable, FDA recommends heart monitoring in an inpatient hospital setting for the first 48 hours. Subsequently, monitoring in a doctor’s office or self-monitoring of the heart rate should be done every day through at least the first 2 weeks of treatment.

Due to the long half-life of amiodarone, patients discontinuing amiodarone just prior to starting Harvoni, or Sovaldi in combination with another direct-acting antiviral, should also undergo similar cardiac monitoring as outlined above.

Patients taking either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone should seek medical attention right away if they experience signs or symptoms of symptomatic bradycardia such as:
  • Near-fainting or fainting
  • Dizziness or light-headedness
  • Malaise
  • Weakness
  • Excessive tiredness
  • Shortness of breath
  • Chest pains
  • Confusion or memory problems
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

Cannabis use lowers risk for insulin resistance in patients with HIV/HCV

Among patients coinfected with HIV and hepatitis C, cannabis use reduced the risk for insulin resistance, according to researchers from INSERM in France.

“This is the first longitudinal study documenting the relationship between the reduced risk of insulin resistance and cannabis use in a population particularly concerned by insulin resistance risk,” the researchers wrote in Clinical Infectious Diseases. “The results found were robust as they were confirmed in three sensitivity analyses, one of [these] also including patients with diabetes.”

M. Patrizia Carrieri, PhD, and colleagues evaluated data from the ANRS HEPAVIH CO-13 cohort, which included patients in France coinfected with HIV and HCV. The data included patient information obtained from self-administered questionnaires, such as HIV and HCV testing, HIV-related symptoms, coffee consumption and drug and alcohol use in the previous month. The questionnaires were completed every 12 months for 60 months.


Canada: Multiple Provinces Align to Provide Public Funding for Harvoni™, the First Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C Virus Infection

-- Reimbursement of Harvoni Within Five Months of Health Canada Notice of Compliance Brings Patients Earlier Opportunity for a Cure --

MISSISSAUGA, Ontario, Mar 24, 2015 (BUSINESS WIRE) -- Gilead Sciences Canada, Inc. (Gilead Canada) today announced that multiple provinces will provide public access to Harvoni™ (ledipasvir/sofosbuvir), the first once-daily, single tablet regimen for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults. In Canada, it is estimated that more than 250,000 Canadians are living with chronic HCV infection, with thousands of new cases diagnosed each year.1 Genotype 1 infection represents an estimated 65 per cent of patient cases.2

Public reimbursement comes after a positive recommendation from the Common Drug Review, and as a result of a productive collaboration between Gilead Canada and the Pan-Canadian Pharmaceutical Alliance (pCPA) to ensure participating provinces are able to provide timely access to patients in need of curative treatment. This review, co-led by the BC Ministry of Health and the Ontario Ministry of Health and Long-Term Care, resulted in an agreement with member provinces to fund the innovative therapy for patients.

“We have been waiting for an innovative therapy like Harvoni since interferon was first used to treat the disease,” said Dr. Alnoor Ramji, Clinical Associate Professor of Medicine (Gastroenterology and Hepatology), University of British Columbia. “This is a transformative, interferon-free therapy, with a combination of high cure rates, good tolerability and simplicity of treatment. Harvoni provides patients with the confidence to commit to therapy and a very high probability to achieve a cure.”

Current treatments include interferon and ribavirin that often exclude patients from treatment or lead to early discontinuation of treatment due to associated side effects. Harvoni represents a significant advance in the treatment of genotype 1 HCV infection, the most prevalent genotype in Canada. Harvoni is the only once-daily, single tablet regimen that offers cure rates between 94 and 99 per cent, eliminates the need for interferon and ribavirin, and shortens the duration of treatment to as little as eight weeks for many patients. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL. Recently, the Canadian Association for the Study of the Liver updated the Canadian consensus guidelines on the management of hepatitis C and recommended Harvoni as first-line therapy for all genotype 1 patients.

“Today’s announcement recognizes the significant health-system and societal benefits associated with curing this disease and preventing its complications,” said Dr. Paul Marotta, Associate Professor, University of Western Ontario and with London Health Sciences Centre. “Access to Harvoni will help us confront this serious public health issue and start formulating longer-term solutions that may prove relevant to the hepatitis C disease elimination efforts across Canada.”

In a recent article, “Burden of disease and cost of chronic hepatitis C virus infection in Canada,” (Canadian Journal of Gastroenterology and Hepatology), leading Canadian hepatitis C specialists highlighted an expected 205 per cent increase in cases of liver cancer, a 160 per cent increase in liver-related deaths, and a 60 per cent increase in total healthcare costs over the next 20 years.2 Recently, the article was recognized with a scientific award for its groundbreaking research in Canada.
In addition to Harvoni, Gilead Canada’s Sovaldi® (sofosbuvir) has also been listed for public reimbursement for chronic HCV genotypes 1, 2 and 3 infection in multiple provinces.

“We live in an era of rapid evolution in the treatment of chronic hepatitis C infection, and Gilead Canada is pleased that our collaboration with the pCPA has allowed multiple provinces to recognize the clinical value of Harvoni as a simple, well tolerated and curative therapy for patients living with genotype 1 HCV,” said Edward Gudaitis, General Manager, Gilead Sciences Canada, Inc. “Gilead Canada will continue to work closely with all provinces and territories to bring this cost-effective, once-daily treatment to patients across Canada.”

Read complete press release here

Monday, March 23, 2015

Canada: B.C Parmacare to cover Sovaldi and Harvoni

Sovaldi and Harvoni now covered by Pharmacare in BC

VICTORIA – British Columbia is providing public drug plan coverage of two new, often curative, hepatitis C drugs effective March 24, 2015, announced Minister of Health Terry Lake today.

People with hepatitis C will be able to apply tomorrow for coverage under B.C.’s PharmaCare program of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir). These new medications cure about 90% or more of people treated; are easier to take; involve a much shorter course of treatment; and have fewer side effects than older drugs.

“These two new drugs can utterly change the lives of people with hepatitis C for the better,” said B.C. Health Minister Terry Lake. “These drugs represent a significant advance in the treatment of chronic hepatitis C, and more British Columbians affected by this virus now have significantly better odds of becoming free of the disease.”


India: Portal to create awareness on Hepatitis C launched

This was formally launched by E S L Narasimhan, Governor, Andhra Pradesh and Telangana, at a function here on Monday.

Speaking on the occasion, D Nageshwar Reddy, Chairman of AIG, said out of an estimated 150 million people affected by Hepatitis C in the world, 15 million were from India.

See also:  Most Hepatitis C affected untreated in India

Local Patients Denied Lifesaving Treatment

ALTOONA - Imagine being diagnosed with a deadly disease that can be cured, but you can't get the treatment. More than 100 patients in our region and millions across the country, with Hepatitis C face that frightening situation. Treatments that can reverse the virus  cost about $1,000 a pill.

A tattoo changed a Bedford County man's life. Mike Miller got it done a few years ago by a friend and  last August he found out he'd also gotten the hepatitis C virus. He's tired, he has abdominal pain and his joints ache. He says, "there are just days that I don't feel like getting out of bed."

Fortunately, tests show Mike is still in the early stages of Hep. C.  His blood doesn't show a high number of infected cells and he doesn't have cirrhosis of the liver. So, he doesn't qualify for treatment that could keep the disease from progressing. 


India: Dr Reddy's to launch Hepatitis C drug in India

NEW DELHI: Dr Reddy's Laboratories today entered into an agreement with Hetero to distribute and market generic version of US-firm Gilead Sciences' Hepatitis C drug under the brand 'Resof' in India.

"The company has entered into an agreement with Hetero, under which Dr Reddy's has been licensed to distribute and market Sofosbuvir 400 mg tablets indicated in treatment of chronic Hepatitis C under the brand 'Resof' in India," the Hyderabad-based drug major said in a BSE filing.

Hepatitis C clinic in Charlotte fights for survival

CHARLOTTE COUNTY, FL - A free Hepatitis C Clinic in Charlotte County is struggling to keep its doors open and asking the county for help. Clinic leaders say the number of cases are growing and they desperately need $50,000 to save lives.

Since 2008, Charlotte County's free Hepatitis C clinic at the Virginia B Anderson Volunteer Community Clinic has been treating patients.

Co- founders Dr. Mark Asperilla and Dr. David Klein started it after treating residents at their HIV clinic. They were surprised by what they found.


Weekly Special Topic: HCV & Women

HCV & Women
Our HCV and Women Series has been updated and condensed to better provide the latest information to help inform our audience.

Saturday, March 21, 2015

FDA Hepatitis Update - Important safety information: Harvoni , and Sovaldi


Subject: Serious and Life-Threatening Cases of Symptomatic Bradycardia as well as One Case of Fatal Cardiac Arrest Reported with Coadministration of Amiodarone With Either Harvoni® (ledipasvir and sofosbuvir fixed-dose combination) or With Sovaldi® (sofosbuvir) in Combination with Another Direct Acting Antiviral.

On March 20, 2015, FDA approved changes to the Harvoni (ledipasvir/sofosbuvir fixed dose combination) and Sovaldi (sofosbuvir) labels to update the WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and DRUG INTERATIONS sections of the labeling and the patient package insert with information on post-marketing cases of symptomatic bradycardia when co-administered with amiodarone. Additionally, Gilead Sciences has issued a Dear Healthcare Provider letter (below):

Dear Health Care Provider,
The purpose of this letter is to inform you of new important safety information for Harvoni and Sovaldi.

·       Harvoni is indicatedfor the treatment of chronic hepatitis C genotype 1 infection in adults.

·       Sovaldi is indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen.
Serious Risk of Symptomatic Bradycardia With Co-Use of Amiodarone with Either Harvoni or With Sovaldi in Combination with Another Direct Acting Antiviral (DAA)
·       Postmarketing casesof symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported in patients taking amiodarone and Harvoni, or amiodarone and Sovaldi in combination with another DAA.
·       Bradycardia was observed within hours to days of starting Harvoni, or Sovaldi in combination with another DAA, but cases have been observed up to 2 weeks after initiating HCV treatment.
·       Risk factors for the development of symptomatic bradycardia in patients receiving amiodarone may include coadministration of a beta blocker, or those with underlying cardiac comorbidities and/or advanced liver disease.
·       Similar cases have not been reported in patients receiving Sovaldi with ribavirin or with pegylated interferon and ribavirin.

Warning and Precaution
Coadministration of amiodarone with either Harvoni or with Sovaldi in combination with another DAA is not recommended.

Further Information
Ninecases of symptomatic bradycardia have been reported during postmarketing in patients receiving amiodarone with either Harvoni, or Sovaldi in combination with another DAA (daclatasvir, an investigational DAA, or Olysio (simeprevir)). Seven patients were also receiving a beta blocker.
·       Sixcases occurred within the first 24 hours and the remaining 3cases occurred within the first 2-12 days following HCV treatment initiation.
·       One case was a fatal cardiac arrest and 3 cases required pacemaker intervention.
·       In 3cases, rechallenge with HCV treatment in the setting of continued amiodarone therapy resulted in recurrence of symptomatic bradycardia.

·       Inone case discontinuation of amiodarone followed by rechallengeof HCV treatment after 8 weeks did not result in recurrent bradycardia.
·       Three of the 9 cases were in patients receiving Harvoni, 5 cases were in patients receiving Sovaldi plus an investigational agent (daclatasvir) and 1 case was in a patient receiving Sovaldi with Olysio (simeprevir).
The mechanism of the potential interaction between amiodarone and Harvoni, or Sovaldi in combination with another DAA is unknown.
Because the number of patients taking amiodarone who have been exposed to Harvoni or Sovaldi in combination with another DAA is unknown, it is not possible to estimate the incidence of occurrence of these events.
Prescriber Action
For patients taking amiodarone who have no other alternative, viable treatment options and who will be co-administered Harvoni, or Sovaldi in combination with another DAA:
·       Counsel patients about the risk of serious symptomatic bradycardia
·       Cardiac monitoring in an in-patient setting for the first 48 hours of coadministration is recommended, after which outpatient or self-monitoring of the heart rate should occur on a daily basis through at least the first 2 weeks of treatment.
Patients who are taking Harvoni or Sovaldi in combination with another DAA who need to start amiodarone therapy due to no other alternative, viable treatment options should undergo similar cardiac monitoring as outlined above.
Due to amiodarone’s long half-life, patients discontinuing amiodarone just prior to starting Harvoni or Sovaldi in combination with a DAA should also undergo similar cardiac monitoring as outlined above.
Tell your patients if they develop signs or symptoms that might suggest symptomatic bradycardia they should seek medical evaluation immediately. Symptoms may include:
·       Near-fainting or fainting
·       Excessive tiredness
·       Dizziness or lightheadedness
·       Shortness of breath
·       Malaise
·       Chest pains
·       Weakness
·       Confusion or memory problems

Patients should not stop taking any of their medicines without talking to their healthcare provider.
This information is based on currently available data and recommendationsmay change. Additionally, the product labeling will be updated.
Reporting Adverse Events
Please report all adverse events, following or coincident with the use of Harvoni or Sovaldi, to Gilead Global Drug Safety at 1-800-GILEAD-5, option 3; or to FDA's MedWatch program by telephone at 1-800-332-1088; by fax at 1-800-332-0178; via www.FDA.gov/medwatch; or by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20857 (use postage-paid FDA Form 3500).
Please refer to the accompanying full prescribing information and approved patient information for a complete description of the risk profile for Harvoni or Sovaldi.
Contact Gilead Medical Information at 1-800-GILEAD-5, option 2 if you have additional questions.

This information is being sent in agreement with the FDA.

John McHutchison, MD
Executive Vice President, Clinical Research
Gilead Sciences, Inc.

Friday, March 20, 2015

HIV, Hepatitis C infections up in Marion Co.

INDIANAPOLIS - New infections of HIV and Hepatitis C increased dramatically from 2013 to 2014 among Marion County's young adult population, RTV6 has learned.

According to Marion County Health Department data, new Hepatitis C infections among people ages 20-24 increased by 120 percent between 2013 and 2014 – the latest year data was available for. Hepatitis C infections increased by 100 percent among people ages 25 to 34.

New HIV infections also increased 51 percent during that time frame in the 20-24 age group, and 32 percent among people 25-34.