CDC Underestimates Number of Acute HCV Infections

CDC Underestimates Number of Acute HCV Infections
Lara C. Pullen, PhD
July 07, 2015

Source - Medscape

Formal surveillance by the Centers for Disease Control and Prevention (CDC) does a poor job of measuring the clinical diagnosis of acute hepatitis C virus (HCV) infection, according to a new report. Case ascertainment is negatively affected by incomplete clinician reporting, limitations of diagnostic testing, problematic case definitions, and imperfect data capture, and these problems persist despite automated electronic laboratory reporting.

Shauna Onofrey, MPH, from the Massachusetts Department of Public Health in Jamaica Plain, and colleagues published the results of their case series and chart review online June 30 in the Annals of Internal Medicine. The investigators reviewed medical records from two hospitals as well as a state correctional healthcare system in an effort to validate estimates of the incidence of acute HCV infection in their state.

Theirs was not a population-based survey of acute HCV infection, and thus they did not have an overall denominator with which to calculate incidence of disease.

The investigators identified 183 patients who were clinically diagnosed with acute HCV infection from 2001 to 2011. The majority (81.4%) of these patients were reported to the Massachusetts Department of Public Health for surveillance classification.

During that time, less than 1% of these cases were reported to the CDC, and the majority of the cases did not match the national case definition of acute infection. Reporting was also incomplete because of the requirements for negative hepatitis A and B laboratory results.

The authors had some suggestions to improve surveillance: "we agree with the decision to add seroconversion to the CDC's surveillance case definition of acute HCV infection in late 2012 to account for incident cases without need for an illness compatible with HCV infection, a criterion that is often absent, and to remove the requirement for negative test results for hepatitis A and B virus. Successful application of seroconversion as a criterion requires regular interval testing of high-risk patients. More detailed risk behavior history about specific injection practices and history of onset was extremely useful in a systematic screening for HCV infection in the Massachusetts state prison system, tripling the rate of identification."

In 2010, 850 acute HCV cases were reported to the CDC by local health authorities, and the CDC used this number to estimate a total of 17,000 cases annually. The current study suggests this is an underestimate.

Moreover, the lack of reported surveillance cases in Massachusetts stands in stark contrast to a growing HCV infection epidemic among adolescents and young adults in the state.

One coauthor reports receiving personal fees from AbbVie Pharmaceuticals outside the submitted work. Another coauthor reports receiving grants from the CDC during the conduct of the study. Dr. Kim reports receiving grants from the National Institutes of Health, personal fees from Bristol-Myers Squibb, and grants and personal fees from AbbVie Pharmaceuticals and Gilead Sciences during the conduct of the study. The other authors have disclosed no relevant financial relationships.

Ann Intern Med. Published online June 30, 2015. Abstract

Related-
Hepatitis C - Rise in heroin use drives needle exchange programs

Hepatitis C - Rise in heroin use drives needle exchange programs

Hepatitis C - Rise in heroin use drives needle exchange program

Happy Monday folks, hope your work week is off to a fabulous start. It's always a good day when hepatitis C is in the news, although today the news is tragic, truly disturbing as we focus on the soaring rates of HCV fueled in part by intravenous drug abuse.

The powerful stigma attached to having a disease associated with drug use is difficult to overcome, however, only when we rise above the intolerance and short comings of others can the stigma slowly be eradicated. 

Hepatitis C is highly transmissible by a shared needle, it only takes one time to transmit the virus. With the rise in IV drug use many states are now attempting to implement needle exchange programs to prevent the transmission of hepatitis C, and other blood-borne disease.

This isn't recent news, in May the CDC reported new cases (acute) of hepatitis C were up nationally. The report linked the increase to IV drug use, in particular in four Appalachian states; Kentucky, Tennessee, Virginia and West Virginia.  Recently, Ohio, Maine, Indiana and Florida, reported on the increase use of heroin, and what needs to be done to combat the rise in acute hepatitis C cases.

Before you read the following articles jump over to ABC 57 News to watch a brave Michiana man speak out about his own drug addiction.

Quote;

“People that shoot up and use needles think that they can take bleach and can rinse the needle out or heat up some water and run the needle through some bleach, well you can’t do that. The blood borne pathogens stay in the needle.”

Watch the video, here. 

Side note, the article stated; He lives everyday with incurable diseases but wants to use his story to help other people who want to kick the high.

Click here to learn more about treating HCV, and here for HIV treatment.

In The News

Ohio

Hepatitis C surge in central Ohio may spur needle-exchange program

The boom in heroin use paired with a surge in hepatitis C infections in Franklin County and across Ohio have heightened worries about the spread of other diseases, particularly HIV, and sparked conversations about a local needle exchange.

Continue reading....

 

Maine

Hepatitis C cases soar with Maine heroin epidemic

BY JOE LAWLOR STAFF WRITER

While no-cost screenings are available, the state lacks treatment options, especially for low-income addicts.

Maine is undergoing its worst acute hepatitis C outbreak since it began recording cases in the 1990s. Reported cases of the disease have soared since 2013, corresponding with skyrocketing heroin use, and are more than triple the national average.

The heroin epidemic is causing many undesirable ripple effects in Maine, public health advocates say, including the spread of infectious diseases such as hepatitis C.

Continue Reading...

Another side note:

The article also reported that hepatitis C can be contracted through; intravenous drug users sharing needles. It also can be contracted through unprotected sex or other contact with infected blood.

Although this is accurate, hepatitis C is rarely transmitted through sexual contact, review links following this post for additional information. 

Indiana 

Health officer may declare HIV, hepatitis C epidemic in Clark County

By ELIZABETH BEILMAN
JEFFERSONVILLE — Clark County Public Health Officer Dr. Kevin Burke is considering declaring an HIV and hepatitis C epidemic in the county, the first step required in implementing a year-long needle exchange program.

“There is at least indirect evidence that there is a problem,” he said.

Burke told a group of residents who meet to discuss drug addiction in Clark County that recent data shows local elevated rates for the diseases. In 2014, Clark County’s rate of new HIV cases was about 37.5 percent higher than Indiana’s average. Clark County had 11 people per 100,000 with HIV, whereas Indiana had 8.

And Clark County’s new cases of hepatitis C were 40.5 percent higher than the state’s average in 2014 — 97 in Clark per 100,000 compared to 69 for Indiana.

Continue reading...

State on alert after HIV outbreak in Indiana
DES MOINES | An outbreak of HIV cases in rural Indiana delivers a dire warning to states with similar rural pockets such as Iowa, even as the number of newly diagnosed Iowans fell sharply last year.

Roughly 170 people in one Indiana county have tested positive for HIV this year. It is the largest outbreak in the state’s history.

The outbreak is believed to have been spread by drug users in rural southern Indiana who were sharing needles.

Continue reading..

Florida

Video:Hepatitis C on the Rise in South Florida; But a Cure is Available For Some

A potentially deadly disease is seeing an alarming increase of cases being reported in South Florida. In fact, cases of hepatitis C have gone up more than 50-percent in Broward County in the past two years alone.
Read more here...

West Virginia
Cabell needle exchange program could guide other communities
by Tyler Bell, Police Reporter

TYLER BELL/ DAILY MAIL
Dr. Rahul Gupta, director of the state Department of Health and Human Services Bureau for Public Health, speaks Thursday at Huntington City Hall during the announcement of Cabell County’s new syringe exchange program.

“It’s important for us to follow evidence-based approaches,” said Dr. Rahul Gupta, director of the state Department of Health and Human Services Bureau of Public Health, at a press conference Thursday. The conference, held at the Huntington City Hall and attended by law enforcement, medical professionals and media outlets from across the state, brought together state and local officials to announce the state’s first-ever syringe exchange program.  

The state’s heroin epidemic creates a host of secondary problems for West Virginia, not least of which is a steadily increasing rate of hepatitis and HIV infections.

Continue reading...

CDC Underestimates Number of Acute HCV Infections
Lara C. Pullen, PhD
July 07, 2015

Source - Medscape
Formal surveillance by the Centers for Disease Control and Prevention (CDC) does a poor job of measuring the clinical diagnosis of acute hepatitis C virus (HCV) infection, according to a new report. Case ascertainment is negatively affected by incomplete clinician reporting, limitations of diagnostic testing, problematic case definitions, and imperfect data capture, and these problems persist despite automated electronic laboratory reporting.

Continue reading...

Annals of Internal Medicine
Provided by NATAP

Underascertainment of Acute Hepatitis C Virus Infections in the U.S. Surveillance System: A Case Series and Chart Review - Opinion

Worried about the transmission of hepatitis C through IV drug use?

The Facts
When you share contaminated syringes or equipment HCV can be transmitted the - first time - or - only time - you use.

Injection Drug Use: 

Injection drug use remains the most common risk factor for acquiring HCV in the United States, accounting for more than 50% of all cases of HCV. A recent study identified injection drug use as the risk factor for 84% of individuals diagnosed with acute HCV. Approximately 20 to 30% of persons who inject drugs are infected with HCV within the first 2 years of starting to inject drugs and 75 to 90% of persons who inject drugs are anti-HCV positive. 

Transmission risk is greatest with “direct sharing” of needles and syringes, but may also occur indirectly via sharing of injection paraphernalia, such as syringes, cookers, and cotton filters. The incidence of HCV in persons who inject drugs has markedly declined in the past 20 years, likely secondary to use of needle exchange programs that arose in response to the HIV epidemic and saturation of HCV infection in the population of persons who inject drugs. 

Recent reports have identified a new cohort of HCV-infected injection-drug users with the following characteristics: age 24 or younger, white race, residence in non-urban areas, and use of oral prescription opiates prior to using heroin. The prototypical new heroin user initiates some type of substance abuse, such as alcohol or marijuana at about age 13, transitions to using oral opiates, most often oxycodone, around age 17, then eventually starts using cheaper and widely available heroin by about age 18. 

Read more here...

Recap

You Can Get HCV If You.........

Share, or reuse equipment and syringes

Examples
Filters - Reusing filters can spread Hep C and also cause health problems such as cotton fever.

Tourniquets - Ties
Straws
Spoons
Acidifiers

Cookers - Reusing HCV contaminated cookers could lead to infection even if using sterile syringes

Water cups - If a person draws up water with a used syringe both the water and the cup have been contaminated

Swabs - Used to clean skin before injecting

Pads - To stop bleeding after needle withdrawal

Re-capping a needle may lead to an accidental needle-stick and HCV

I Don't See Any Blood
The amount of blood needed to pass on HCV is small and blood does not have to be visible for it to be infectious. Microscopic amounts of blood could be on the surface where the drugs and equipment are set up or on any one of the pieces of equipment. Used equipment can also cause more abscesses than new sterile equipment.

Crack Pipes
Smoking drugs can lead to open sores, burns or cuts on the lips and in the mouth, which can transfer blood to a pipe. If the pipe is shared, even a speck of blood carrying hepatitis C can transmit the virus. Sharing includes borrowing, lending, passing on, buying, selling, reusing, receiving or taking any equipment that was used by someone else. Some people do not identify risk with the word “sharing” or when reusing involves a close sexual partner (like a boyfriend or girlfriend). Risk exists, even under these circumstances.
Read More Here

Hepatitis C Sexual Transmission

We begin with sexual transmission among monogamous heterosexual couples;

The HCV partners study 

Listen here:
Sexual Transmission of Hepatitis C
Drs. Stephen A. Harrison and Norah A. Terrault discuss the article: Sexual transmission of hepatitis C virus among monogamous heterosexual couples: The HCV partners study.

CROI2015: HCV transmission risk factors in HIV-infected MSM

The authors conclude that sexual transmission and non-injection drug use are risk factors for HCV infections. This further supports the recommendations that sexually active MSM and those who do not use injection drugs should be routinely screened for HCV as a component of their sexual health and wellness.

Sexual Transmission of Hepatitis C Virus Between HIV Infected Subjects and Their Main Heterosexual Partners

The present study aimed to identify and quantitatively investigate HIV-infected individuals and their main heterosexual partners regarding the risk factors of HCV transmission.

CDC - Sexually Transmitted Diseases Treatment Guidelines, 2015

MMWR Recommendations and Reports
June 5, 2015 / Vol. 64 / No. RR–3
Sexually Transmitted Diseases Treatment Guidelines, 2015
This report presents guidelines for the treatment of persons who have or are at risk for sexually transmitted diseases (STDs). The guidelines update those from 2010. Physicians and other health-care providers can use these guidelines to assist in the prevention and treatment of STDs.

This country has been slow to fund needle exchange programs, the US government forbade funding for such services until 2009 when the federal funding ban was lifted. Let's hope we move forward quickly this time, lives are at risk, people, often young, desperately need access to these programs.

Tina

TGIF- July Weekly Rewind of Hepatitis C News And Updates Around The Web

TGIF- Weekly Rewind of Hepatitis C News and Updates 

It's Friday folks, the end of another week of work and the start of the holiday weekend.

Happy Forth of July!

Here is a look back at this weeks headlines with updates around the web and a bit of today's news.

Today Gilead announced Harvoni ® was approved by Japan's Mininstry of Health, read the press release here.

Japan's Ministry of Health, Labour and Welfare Approves Gilead's Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved by the MHLW under the trade name Sovaldi® in March 2015. Harvoni is indicated for the suppression of viremia in patients with genotype 1 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis, with a treatment duration of 12 weeks.
Continue reading...

Speaking of fireworks, a study published in the July edition of Hepatology reported adding ribavirin to ledipasvir and sofosbuvir did not significantly increase SVR:

Adding the antiviral drug ribavirin to the fixed-dose combination of viral inhibtor ledipasvir and nucleotide inhibitor sofosbuvir offered no better result than ledipasvir/sofosbuvir alone, says a study led by Saleh Alqahtani, M.D., and Mark Sulkowski, M.D., of the Johns Hopkins University School of Medicine. In fact, say the study’s authors, the ribavirin combination was associated with a higher rate of adverse events.

Click here to read a quick overview of the study...

Elsewhere: 
Bangladesh's Beximco launches copy of Sovaldi
One tablet will cost Tk 600 in Bangladesh, and the total cost of the therapy would be Tk 50,400 for a 12-week course compared to the whooping Tk 67 lakh in developed countries

China rejected patent linked to Gilead hepatitis C drug
China has rejected a Gilead Sciences Inc patent application related to its costly hepatitis C drug, a U.S. advocacy group said, adding the move may lead to other countries to consider rejecting patents for the controversial treatment.

AbbVie's HOLKIRA™ PAK Now Reimbursed in Ontario

Following the positive CDR recommendation announcement, Ontario is the second province to reimburse HOLKIRA PAK on its public formulary through its Exceptional Access Program (EAP) as of June 29, 20152. In Ontario, HOLKIRA PAK will be covered under the following EAP criteria: for treatment-naïve and treatment-experienced adult patients with GT1 chronic HCV infection, with compensated cirrhosis.

Holkira Pak is a combination of dasabuvir, ombitasvir and paritaprevir boosted with ritonavir. Ombitasvir, paritaprevir and ritonavir are co-formulated into one tablet that is taken once per day. Dasabuvir is a separate tablet that is taken twice per day. Holkira Pak may be prescribed with ribavirin. Holkira Pak appears to have few side effects. Common side effects are generally mild and include fatigue, headache, weakness and nausea. Hep C treatment can cure a person from Hep C. However, a person could become infected again, read more @ Catie 

Of Interest
Updates @ NATAP

Sofosbuvir-Based Regimens Are Associated With High SVR Rates Across Genotypes and Among Patients With Multiple Negative Predictive Factors 

Viekira Pak - AbbVie hepatitis C cocktail succeeds in late-stage study
- 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis

- 100 percent SVR(12) rate achieved with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin(1)

Updates Around The Web

We begin with "HCV Virtual Patient" an easy to follow case by case video CME over at "ViralEd." Cases 1-4 include a look at HCV re-treatment, current treatment options for various HCV genotypes, HCV recurrence after liver transplantation, and treatment in HCV/HIV co-infection. Follow "ViralEd on Twitter "or visit "ViralEd" for future launch dates. I am patiently waiting for ViralEd to release Case 5; HCV Genotype 3, Previous Failure. 

"HCV Advocate" has just published their "July Newsletter." Check out an overview of liver toxic herbs, part 2 of a two-part series discussing pain associated with hepatitis C, and long term treatment outcomes and the benefits of achieving an SVR. 

As always "hepmag.com" has a group of talented bloggers who share their personal story about living with HCV, view all updates, here and news updates, here. 

Gilead Controversy

The controversy over Gilead Sciences hepatitis C treatments was in the media again this week when it was announced that; Public Health Groups Sued The FDA For Disclosure of Clinical Trial Data for Costly Hep C Drugs. Read a great commentary over at the WSJ. 

Medicaid

Medicaid has come under much scrutiny in recent months because of Medicaid reimbursement restrictions for newer hepatitis C medications. A study in "Annals Of Internal Medicine." offers insight into how the program works.

July 1

States Vary Widely on Who Gets Hep C Drugs Under Medicaid

Two studies published online June 29 in the Annals of Internal Medicine examine how states are deciding which Medicaid patients will get sofosbuvir, the $1000-per-pill treatment for hepatitis C that has a 90% cure rate.

The authors of both studies find restrictions vary tremendously across states' Medicaid fee-for-service programs and often differ with guidelines set out by professional associations. One study says the restrictions violate the federal Medicaid law.

June 29

State restrictions for hepatitis C drug may go too far

(Reuters Health) - State-run insurance programs for the poor may be putting up illegal barriers that prevent people with hepatitis C from getting a new treatment, a new study suggests.

California Caps What Patients Pay For Pricey Drugs. Will Other States Follow?

Links
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.

Veterans Waiting for HCV Therapy
One year after VA scandal, veterans wait to be treated for everything from Hepatitis C to post-traumatic stress
VA’s leadership attributed the growing wait times to soaring demand from veterans for medical services, brought on by the opening of new centers and a combination of aging Vietnam veterans seeking care, the return of younger veterans from Iraq and Afghanistan and the exploding demand for new and costly treatments for Hepatitis C.
Continue reading......

July 1

Vietnam era veteran carries battle cry of hepatitis C

June 30

Veterans Administration Ending Hepatitis C Treatments

Recent articles published on WebMD

Sex and HCV
July 2
How to Be Smart About Sex With Hepatitis C
By Lisa Fields
WebMD Feature
Reviewed by Lisa B. Bernstein, MD

If you’re in a long-term monogamous relationship of at least 5-10 years, though, the risk of getting hep C through vaginal sex is “extremely low,” Wang says.

A recent study in the journal Hepatology shows that the chance someone will spread the virus to a partner this way is 0.07% per year, or 1 in 190,000 sexual contacts.

“The majority of couples in my clinic -- people who are married or partnered for a long time -- do not use condoms,” says hepatologist Andrew J. Muir, MD, an associate professor of medicine at Duke University Medical Center.. “The key is to have a comfortable sex life. You need to have a conversation and make that person feel comfortable.”

Tips to Deal With Hepatitis C Fatigue
By John Donovan
WebMD Feature
Reviewed by Lisa B. Bernstein, MD
When you have hepatitis C, being tired -- really tired -- can be a fact of life. But there are ways you can boost your energy.

Here, three people who have experience with fatigue from the disease share their tips...

That's all folks, check back later for more updates.

Tina

Gilead's Harvoni® Approved By Japan's Ministry of Health

Japan's Ministry of Health, Labour and Welfare Approves Gilead's Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C

Date(s): 3-Jul-2015 2:01 AM

For a complete listing of our news releases, please click here

- Harvoni Achieved Cure Rates (SVR12) of 100 Percent in Japanese Phase 3 Study -

- Eliminates Need for Interferon and Ribavirin for Patients with Genotype 1 Hepatitis C -

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 3, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved by the MHLW under the trade name Sovaldi® in March 2015. Harvoni is indicated for the suppression of viremia in patients with genotype 1 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis, with a treatment duration of 12 weeks.

"Today's approval significantly advances the standard of care for chronic hepatitis C in Japan, as it eliminates the need for interferon and ribavirin, which can be difficult to take and to tolerate, and offers the majority of people with genotype 1 infection to be cured in as little as 12 weeks with a once-daily pill," said Professor Masashi Mizokami, MD, PhD, The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Ichikawa, Japan.

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 in Japan chronically infected with HCV, 70-80 percent are infected with the genotype 1 strain of the virus.

Harvoni's approval in Japan is supported by data from 318 treatment-naïve and treatment-experienced Japanese patients with genotype 1 HCV infection randomized to ledipasvir/sofosbuvir (n=157) or ledipasvir/sofosbuvir plus ribavirin (n=161) in the Phase 3 clinical trial GS-US-337-0113. Of the 318 patients enrolled in this study, 34 percent were ages 65 years or older and 23 percent had cirrhosis.

Among patients receiving 12 weeks of ledipasvir/sofosbuvir without ribavirin, 100 percent (n=78/78) of treatment-naïve and 100 percent (n=79/79) of treatment-experienced patients achieved sustained virologic response 12 weeks after completing therapy (SVR12). Adverse events observed with ledipasvir/sofosbuvir without ribavirin were generally mild and included nasopharyngitis (29 percent), headache (7 percent) and malaise (6 percent).

The approval is also supported by results from three Phase 3 studies (ION-1, ION-2 and ION-3) evaluating eight, 12 or 24 weeks of ledipasvir/sofosbuvir among genotype 1 HCV patients. Trial participants included patients from the United States, Europe and Puerto Rico who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis. Trial participants in the ribavirin-free arms (n=1,080) achieved SVR12 rates of 94 to 99 percent.

"Harvoni is a safe, simple and well-tolerated treatment. With cure rates of up to 100 percent and without the need for interferon or ribavirin, it offers genotype 1-infected patients a high likelihood of cure," said Norbert Bischofberger, PhD, Gilead's Executive Vice President, Research and Development, and Chief Scientific Officer. "We are pleased to have partnered with the medical community in Japan to demonstrate the safety and efficacy of two significant advances in the treatment of chronic hepatitis C - Harvoni for genotype 1 infection and Sovaldi for genotype 2 infection, which was approved just three months ago. We look forward to making Harvoni available in Japan as quickly as possible."

Important Safety Information About Harvoni in Japan

Warnings
Treatment with Harvoni should be initiated by a physician with sufficient knowledge and experience in the management of patients with viral liver diseases who are appropriately diagnosed to receive the treatment.

Contraindications
Harvoni is contraindicated in the following patients: Patients with a history of hypersensitivity to the active substances or to any of the excipients; patients with severe renal function impairment (eGFR<30mL/min/1.73m2) or patients with renal insufficiency requiring dialysis.

Contraindications for Coadministration

Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Carbamazepine, phenytoin, rifampin and St. John's wort should not be administered with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.

Important Precautions

Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with Harvoni due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.

Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir (Sovaldi).

Adverse Reactions
The major adverse reactions were pruritus (3.2 percent), nausea (2.5 percent) and stomatitis (2.5 percent).

Drug Interactions
In addition to carbamazepine, phenytoin, rifampin and St. John's wort, coadministration of Harvoni is also not recommended with antacids, H2-receptor antagonists, proton-pump inhibitors, rifabutin and phenobarbital. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.

Coadministration of Harvoni is not recommended with digoxin because the plasma concentration of digoxin may be increased. Coadministration is also not recommended with rosuvastatin or regimens containing tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.

Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments.

Important Safety Information About Sovaldi in Japan

Warnings
Treatment with Sovaldi should be initiated by a physician with sufficient knowledge and experience in the management of patients with viral liver diseases who are appropriately diagnosed to receive the treatment.

Contraindications
Sovaldi is contraindicated in the following patients: Patients with a history of hypersensitivity to the active substances or to any of the excipients; patients with severe renal function impairment (eGFR<30mL/min/1.73m2) or patients with renal insufficiency requiring dialysis.

Contraindications for Coadministration

Risk of Reduced Therapeutic Effect of Sovaldi Due to P-gp Inducers: Carbamazepine, phenytoin, rifampin and St. John's wort should not be used with Sovaldi as they may significantly decrease sofosbuvir plasma concentration, reducing its therapeutic effect.

Important Precautions
Since Sovaldi is recommended for use in combination with ribavirin, the PRECAUTIONS of the ribavirin package insert, including Warnings, Contraindications, Careful Administration, Important Precautions, and Clinically Significant Adverse Reactions, must be consulted.

Adverse Reactions
The major adverse reactions observed in combination with ribavirin were anemia/hemoglobin decreased (15.0 percent), headache (5.0 percent), malaise (4.3 percent), nausea (4.3 percent) and pruritus (4.3 percent).

Drug Interactions
In addition to carbamazepine, phenytoin, rifampin and St. John's wort, coadministration of Sovaldi is not recommended with phenobarbital and rifabutin. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.

About Gilead
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including that physicians and patients may not see advantages of Harvoni over other therapies and may therefore be reluctant to prescribe the product, and the risk that payers may be reluctant to approve or provide reimbursement for the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full Prescribing Information for Sovaldi and Harvoni is available at www.gilead.com.

Sovaldi and Harvoni are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.


View source version on businesswire.com: http://www.businesswire.com/news/home/20150702005932/en/

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Investors:
Patrick O'Brien, +1 650-522-1936
Media (U.S.):
Cara Miller, +1 650-522-1616
Media (Japan):
Seiko Noma, +81-3-6837-0790

Must Watch: HCV Virtual Patient - Cases 1-4 are now available

HCV Virtual Patient

Hello everyone, summer is here to stay, and its awesome! 

When a new educational resource is released online this blog provides background information and links to the new activity.

If you landed here today to acquire additional knowledge about hepatitis C, jump over to "ViralEd" and review "HCV Virtual Patient" an easy to follow video CME with a look at different case scenarios. This activity is a helpful starting point for people who failed treatment, have cirrhosis or want to learn more about current treatment options for various HCV genotypes. Other cases include HCV recurrence after liver transplantation, HCV/HIV co-infection, in addition an explanation of blood tests used in HCV is also featured. This program is amazing folks, enjoy the follow-up questions.

A brief example of case 1;

64 year old male with cirrhosis, genotype 1, who relapsed after 12weeks of Sofosbuvir with Simeprevir.

After each detailed case is discussed a list of multiple choice questions will appear, in order to move forward the question must be answered correctly, if you don't know the answer click on the "curbside consult" button located in the bottom corner of the presentation.  Instructions will be explained after launching the program. 

Although this learning activity is clinical in nature and directed at physicians, patients will most certainly find the program beneficial, here is a screen shot of each case.

Stay Updated
*Cases 1-4 are now available, follow ViralEd on Twitter or visit ViralEd for future launch dates 

Click here to begin.....

Release Date: June 29, 2015

Disclaimer
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications on dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.

Faculty

Nezam H. Afdhal, MDProfessor of Medicine
Harvard Medical School
Chief of Hepatology, Director of Liver Center
Beth Israel Deaconess Medical Center
Boston, Massachusetts

Douglas T. Dieterich, MD
Professor of Medicine and Director of CME
Department of Medicine
Director of Outpatient Hepatology
Division of Liver Diseases
Mount Sinai School of Medicine
New York, New York

Ian Frank, MD
Professor of Medicine
Director, Clinical Therapeutics Program
Penn Center for AIDS Research
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania

Paul Kwo, MD
Professor of Medicine
Medical Director, Liver Transplantation
Division of Gastroenterology and Hepatology
Indiana University School of Medicine
Indianapolis, Indiana

K. Rajender Reddy, MD
Ruimy Family President's Distinguished Professor of Medicine
Professor of Medicine in Surgery
Director of Hepatology
Director, Viral Hepatitis Center
University of Pennsylvania
Philadelphia, Pennsylvania

Mark Sulkowski, MD
Professor of Medicine and Medical Director
Viral Hepatitis Center
Johns Hopkins University School of Medicine
Baltimore, Maryland

About ViralEd
ViralEd, Inc. is a physician-directed medical education company whose mission is to provide thought-provoking, effective, and evidence-based CME to help improve health care provider knowledge and professional development. For over a decade, ViralEd's team of dedicated professionals have specialized in using a blended learning approach that combines innovative technology with live programming to provide programs and medical education content that is unique and of high quality.

Program Types
Examples of recent and ongoing ViralEd programs include:
The HIV Grand Rounds from Perelman School of Medicine at the University of Pennsylvania. Since 2010, this ongoing, weekly, live program has featured well-known experts in HIV medicine and research presenting at the Perelman School of Medicine. The series has reached more than 22,000 participants in 70 countries with presentations ranging from basic virology and the origins of HIV to conference updates, new treatment options, and case studies.

The Viral Hepatitis Grand Rounds from Perelman School of Medicine at the University of Pennsylvania. Building on the success and reach of the HIV Grand Rounds program, in 2012 we started a regular live and broadcast grand rounds series on viral hepatitis topics. This program continues to provide important information on basic science and treatment issues associated with viral hepatitis and has moved from a monthly to a weekly schedule. 

CME Dinner programs. We regularly run a wide range of national dinner series in major U.S. cities; each 2-hour dinner program is carefully designed to create a unique opportunity for participants to learn from and interact with leading experts in a relaxed, open environment.
Live Internet eSymposia. ViralEd regularly broadcasts live updates from major scientific conferences featuring experts in the field, including many of the researchers involved in major studies that are being discussed. These 2-hour live broadcasts are recorded and can be viewed on-demand on the ViralEd website.

Poster programs: We have prepared several video programs that feature experts reporting from major scientific conferences and discussing the clinical significant of important posters that have been presented at the conference.

Satellite symposia. These consist of large meetings that are presented live during major conferences, then offered in a recorded version on our website.

Newsletters. ViralEd regularly prepares CME newsletter, including updates from major
international conferences and congresses.

Programs in French and Spanish. As we recognize that many of our program participants speak languages other than English, many of the ViralEd CME programs are provided in either French or Spanish translations. In fact, we offer a separate page dedicated to French and Spanish programming.

Ledipasvir/sofosbuvir : New Hepatitis C Treatment Needs No Antiviral Boost

Related:

Adding Ribavirin to Harvoni for Hepatitis C Increases Side Effects But Not Efficacy

Saleh Alqahtani and Mark Sulkowski from Johns Hopkins and colleagues analyzed data from the ION trials to compare the safety and tolerability profiles of sofosbuvir/ledipasvirwith and without ribavirin. They looked at treatment-emergent adverse events and laboratory abnormalities among patients randomly assigned to receive sofosbuvir/ledipasvirfor 8, 12, or 24 weeks, with or without ribavirin....

New Hepatitis C Treatment Needs No Antiviral Boost

Release Date: July 1, 2015

FAST FACTS:
A study of nearly 2,000 patients showed that adding ribavirin to the combination of ledipasvir and sofosbuvir had no benefit in treating hepatitis C.

Patients taking ribavirin along with the combination were more likely to have adverse side effects to the treatment.

The drug approved to treat patients infected with the hepatitis C virus needs no help from other antivirals, according to a study released online this week in the journal Hepatology.

Adding the antiviral drug ribavirin to the fixed-dose combination of viral inhibtor ledipasvir and nucleotide inhibitor sofosbuvir offered no better result than ledipasvir/sofosbuvir alone, says a study led by Saleh Alqahtani, M.D., and Mark Sulkowski, M.D., of the Johns Hopkins University School of Medicine. In fact, say the study’s authors, the ribavirin combination was associated with a higher rate of adverse events.

Analyzing data from nearly 2,000 patients taking ledipasvir/sofosbuvir to clear their systems of hepatitis C, the study’s authors compared patients who were prescribed only the ledipasvir/sofosbuvir fixed-dose tablet with patients whose physicians added ribavirin to the ledipasvir/sofosbuvir treatment regimen.

“We’re in the very early days of prescribing this medication,” says Alqahtani, director of clinical liver research at Johns Hopkins. “We learn more about it all the time. This study should put to rest the notion that ledipasvir and sofosbuvir need a boost from ribavirin.”

Both sets of patients showed 97 percent viral clearance success rates. But 71 percent of patients whose regimens included ribavirin experienced adverse events related to their treatment. While less than 1 percent of the adverse reactions were severe, the 71 percent did experience symptoms like fatigue, insomnia, irritability and a skin rash. Of the patients taking only ledipasvir/sofosbuvir, 45 percent had similar reactions. Patients taking ribavirin were also more likely to need interruptions to their medication regime to resolve their complications.

The combination of ledipasvir and sofosbuvir was approved for treatment of hepatitis C by the Food and Drug Administration only last fall. The medication is a new way to treat a viral disease that causes slow liver damage and has killed millions of people around the world.

Prior to the emergence of ledipasvir and sofosbuvir, the standard of care to treat hepatitis C was the antiviral drug ribavirin, prescribed alongside interferon. Medication regimens were long, serious side effects were nearly universal and the rates of sustained viral response varied.

“Ribavirin had a real place when we fought hepatitis C with interferon,” says Alqahtani. “But as care for patients with hepatitis C evolves, this study shows that it no longer offers a benefit.”

In addition to Alqahtani and Sulkowski, the study’s authors are Nazam Afdal of Beth Israel Deaconess Hospital in Boston; Stefan Zeuzem of Johann Wolfgang Goethe University in Franfurt; Stuart C. Gordon of the Henry Ford Health System in Detroit; Alessandra Mangia of Casa Sollievo della Sofferenza Hospital in Italy; Paul Kwo of Indiana University, Michael Fried of the University of North Carolina; Jenny C. Yang, Xiao Ding, Phillip S. Pang and John G. McHutchinson of Gilead Sciences in California; David Pound of the Indianapolis Gastroenterology Research Foundation; K. Rajender Reddy of the University of Pennsylvania; Patrick Marcellin of the Centre Hospitalier Universitaire Beaujon in France; and Kris V. Kowdley of the Swedish Medical Center in Seattle.

Funding and drugs for the studies described in the Hepatology article were provided by Gilead Sciences. Drs. Sulkowski and Alqahtani were both paid advisory board members for Gilead Sciences. This arrangement has been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies.

http://www.hopkinsmedicine.org/news/media/releases/new_hepatitis_c_treatment_needs_no_antiviral_boost

Vietnam era veteran carries battle cry of hepatitis C

Vietnam era veteran
By SKIP VAUGHN Rocket editor

ATHENS – Mike Blackburn didn’t serve in Vietnam but he was a veteran of that era. He never served in combat. But his war continues to this day. And according to his doctors, his war will end soon.

Blackburn, 62, has hepatitis C virus with stage 4 liver failure. A few weeks ago he was placed on hospice with 3-6 months life expectancy. His diagnosis of hepatitis C didn’t come until Aug. 10, 2014, just six days before his 62nd birthday, when he went to the hospital with severe stomach pain.

Last year’s birthday of course is a blur for Blackburn and his wife, Pam. But he’s a self-proclaimed old country boy from Kentucky and he’s a fighter and he hasn’t given up hope.

Continue reading....

Bangladesh's Beximco launches copy of Sovaldi

Bangladesh's Beximco launches copy of Sovaldi

Updated on 1 July 2015

 One tablet will cost Tk 600 in Bangladesh, and the total cost of the therapy would be Tk 50,400 for a 12-week course compared to the whooping Tk 67 lakh in developed countries. Singapore: Bangladesh drug major Beximco pharmaceuticals recently announced the launch of the generic version of the wonder drug Sofosbuvir for treating hepatitis C under the brand name Sofovir C. 

The drug considered as a boon to hepatitis C patients was initially produced by Gilead Sciences under its brand Sovaldi. Touted as one of the most expensive medicines, the drug costs $1,000 per tablet in the developed market. The medicine was first launched in Bangladesh by local drugmaker, Incepta Pharmaceuticals. 

"We are proud to have played a role in introducing this breakthrough therapy at a price which is currently the lowest in the world. It will be sold as a prescription-only medicine, and will be distributed through our own distribution channel and will not be available in retail outlets, " said, Mr Nazmul Hassan, managing director of Beximco Pharma. 

Globally, it is estimated that 170-185 million people, about 3 percent of the world's population, are chronically infected with hepatitis C virus. In Bangladesh, hepatitis C emerges as a major health problem with nearly two million patients estimated to be infected with this virus, Beximco said in the statement.

Source - http://www.biospectrumasia.com/biospectrum/news/221747/bangladeshs-beximco-launches-copy-sovaldi?WT.rss_f=Home&WT.rss_a=Bangladesh%27s+Beximco+launches+copy+of+Sovaldi