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Alan Franciscus

Editor-in-Chief

HCV Advocate



Showing posts with label Harvoni. Show all posts
Showing posts with label Harvoni. Show all posts

Wednesday, October 28, 2015

The Dark Side of Letting Insurance Payers Dictate Hepatitis C Treatment

Imagine that you have a disease and you have two choices of treatment. Both treatments are highly effective at treating your condition. Medication A has mild side effects. Medication B has lots of side effects including, fatigue, nausea, itching, insomnia, and weakness. Pretty much everyone who takes medication B has side effects. Medication A is a pill a day; medication B uses two pills in the morning and one at night, and sometimes additional pills are prescribed that must be taken twice daily. Medication B has the potential to interact with more drugs than medication A does. Which would you pick? I assume you'd pick medication A.

Your doctor would likely recommend medication A. Drug regimens with many side effects means that you are more likely to need assistance from your health care team, perhaps needing additional laboratory tests to monitor your safety. If your doctor has more patients on medication B, then your doctor's schedule will use appointment slots for side effect management, rather than for seeing other patients who also need to be treated.

So, it seems like medication A is the obvious choice. Unfortunately, for many people with hepatitis C, it isn't. In this case, medication A represents Gilead Sciences' Harvoni; medication B represents AbbVie's Viekira Pak or Technivie. Harvoni is not covered under all insurance plans, such as those using Express Scripts. In short, your doctor may want to treat you with Harvoni, but your insurance may not carry it on its drug formulary. Your hep C treatment may be limited to medication B.

Read more....

Friday, October 16, 2015

How insurance providers deny hepatitis C patients lifesaving drugs - Doctors say up to 80 percent of patients are denied expensive but effective drugs like Harvoni

Amber Rojas was almost eight months pregnant when she learned she had hepatitis C. After her daughter was born on Dec. 23, 2014, Rojas had hoped to start treatment with a newly approved, highly effective drug called Harvoni.
After filing for prior authorization and waiting for months, the 34-year old mother received an unwelcome letter on August 27, 2015 — her treatment request had been denied because her liver was still too healthy. Rojas said that even though she felt very sick with flu-like symptoms, her insurance provider deemed her “not sick enough to qualify.”
Rojas is one of an estimated 3.2 million Americans with hepatitis C, an infection that attacks the liver. In the United States, hepatitis C kills more people every year than HIV. Drugs like Harvoni promise to cure more than 90 percent of patients, yet many insurance providers authorize treatment only if a patient has extensive liver damage, or a fibrosis score of 3 or 4.

Tuesday, September 29, 2015

The True Cost of an Expensive Medication

It was supposed to be a miracle, but now it’s what keeps Laura Bush, a nurse-practitioner near Albuquerque, awake at night.

There’s a drug called Sovaldi that works astonishingly well to cure people with the liver disease Hepatitis C. The rub? It costs $1,000 per day for all 12 weeks of treatment.

Bush’s clinic, First Choice Community Healthcare, is a federally qualified health center in the rural town of Los Lunas, New Mexico, which means she sees a disproportionate number of patients who are uninsured, underinsured, and on Medicaid, the government insurance program for the poor. In other words, they can’t afford Sovaldi.

Read more....

Monday, September 28, 2015

September 2015 Mid-Month Edition - SNAPSHOTS —Alan Franciscus, Editor-in-Chief




This month’s Snapshots is about recently published studies on all-oral therapies to treat hepatitis C in people coinfected with HIV.  We have really come a long way in such a short period of time with medications to treat a population in high need of effective therapies.    
______

Article: Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1—S Naggie et al.

Source:  New England Journal of Medicine DOI: 10.1056/NEJMoa1501315

Results and Conclusions
The study included 335 patients coinfected with HIV-1 and hepatitis C genotype 1 or 4.  The median age was 52 yo (48-58 yo).  The majority of patients were White 61% (203 pts) and Black 34% (115 pts), male 82% (276), genotype 1a 75%, genotype 4 two percent, cirrhosis 20%, median CD 4+ cell count 628 (469-823), treatment naïve 45%, previously treated 55%. The treatment period was 12 weeks.  Note: I am not including the genotype 4 patients since there were only 8 patients.  

The Bottom Line
The cure rates were 96% for genotype 1a, and 96% for genotype 1b. The cure rates were similar regardless of prior response or degree of liver damage.  The most common side effects were headache, fatigue and diarrhea.  No patients discontinued treatment due to side effects.

Editorial Comment
These results are excellent across subtypes (1a/1b), races, and prior treatment responses.  Gilead has filed for marketing approval with the Food and Drug Administration.  The American Association for the Study of Liver Disease (AASLD) and the Infectious Disease Society of America (IDSA) recommend Harvoni as a treatment for HCV for people coinfected with HIV and hepatitis C.

_____

Article: Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial—J K Rockstroh, et al

Source:  The Lancet HIV Volume 2, No. 8, e319–e327, August 2015

Results and Conclusions
The study was conducted in people with HIV/HCV coinfection to evaluate grazoprevir/elbasvir (one pill, once-a-day) to treat HCV genotype 1, 4, and 6. The treatment period was 12 weeks. There were 218 patients in the phase 3 trial.  The trial was conducted in Europe, the United States and Australia.

The Bottom Line
The overall cure rate was 96% (210 of 218 patients).  All patients who had cirrhosis were cured.  The most common side effects were fatigue, headache and nausea. No patients discontinued treatment due to side effects.

Editorial Comment
The high cure rates and fewer side effects plus no treatment discontinuation due to treatment-related side effects equals very good news for patients.

The once-a-day combination of grazoprevir/elbasvir when approved is going to be a welcome addition to the other therapies to treat hepatitis C in people who are HIV and HCV coinfected.  

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Article: Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1—D L Wyles et al.  
Source:  New England Journal of Medicine DOI: 10.1056/NEJMoa1503153

Results and Conclusions
There were 3 different treatment groups. All the groups received daclatasvir plus sofosbuvir. Note: Since there was a small number of genotype 2, 3, and 4 patients—I omitted these results.  For this article I am just listing the genotype 1 results.    

The Bottom Line
The patient characteristics, treatment durations and cure rates are included below:


  1. Naïve (untreated patients): 101 patients; median age 52 yo; male sex 91%; race: White 65%, Black 30%; genotype 1a: 70%, genotype 1b: 12%; cirrhosis 9%; median CD4+ count 520 (122-1147). Treatment duration = 12 weeks. Cure rate = 96%
  2. Naïve (untreated patients): 50 patients; median age 51 yo; male 84%; race White 56%, Black 38%; Genotype 1a 70%, Genotype 1b 12%; cirrhosis 10%; treatment duration = 8 weeks.  Cure rate = 76%
  3. Treatment Experienced:  52 patients; median age 57 yo; male 83%; race White 60%, Black 38%; genotype 1a 63%, genotype 1b 21%; cirrhosis 29%; treatment duration =12 weeks.  Cure rate = 98%

The most common side effects were fatigue, nausea, and headache.  No patient discontinued due to side effects.

Editorial Comment
The 12-week treatment groups had good cure rates as opposed to the 8-week treatment response group.  The treatment-experienced group #3 with a 38% Black population and a relatively high cirrhotic population achieved nearly perfect cure rates. The drawback of this combination is going to be the high price tag of the combination of these two drugs.

Note:  Another issue with treating hepatitis C in people with HIV is the potential drug-drug interactions with HIV medications.  For more information visit the AASLD/IDSA  HCV Guidelines http://www.hcvguidelines.org/full-report-view.

Hepatitis C drug costs challenges DOC budget

Covering the cost of a new treatment for hepatitis C treatment for a growing number of patients is a challenge for the Department of Corrections.

Oregon faces budget-busting costs for expensive new treatments for hepatitis C, and the issue is not limited to the state’s Medicaid program.

The prison system also faces higher costs from a new drug that cures many people of the potentially deadly disease, but costs the Department of Corrections roughly $70,000 per inmate for the 12-week treatment. The Legislature already approved an additional $3.2 million in a supplemental budget bill earlier this year to cover the drug Harvoni for inmates, after the number of inmates treated rose sharply in December. The increase was also part of the reason the Legislature boosted the Department of Corrections’ latest two-year budget for medical supplies by nearly 32 percent.

Read more.....


Thursday, September 17, 2015

What We Talk About When We Talk About Hepatitis C

Since 2007, more people have died every year from hepatitis C than from HIV. Fortunately, the latest hepatitis C medications can cure nearly everyone in a relatively quick, easy fashion. So, if it is so easy to cure hepatitis C, why haven't we?

Ostensibly, it is because of the cost. At $1125 a pill for Gilead Sciences' drug Harvoni, a 12-week course of hepatitis C treatment would amount to $94,500. Trying to manage these costs, many state Medicaid programs and insurance companies have severely restricted access to treatment. You save money if you deny treatment to people, and dead people cost nothing.

This means that although we can cure hepatitis C, we aren't. Under many insurance plans, patients have to prove that they have cirrhosis. In short, treatment is approved when liver damage has progressed to its worst stage. It is like refusing to pay for diabetes drugs until the patient is blind or minus a few toes.

Read more....

Thursday, August 27, 2015

Health ministry approves new hepatitis C drug under insurance scheme

A health ministry panel has added a new highly effective, but expensive, hepatitis C virus drug to the national health insurance scheme, giving high hopes for patients who have had to endure painful interferon injections.

The tablet drug Harvoni, developed by U.S.-based Gilead Sciences Inc., is expected to revolutionize the treatment of patients with hepatitis C genotype 1, which accounts for about 70 percent of all hepatitis C patients in Japan.

A daily dose of one pill set at ¥80,171 will starting Monday be covered by the insurance, limiting the patient cost to about ¥20,000 a month. Read more.... Read our Hepatitis C Around the World on Japan: go here....

Wednesday, August 5, 2015

Snapshots, by Alan Franciscus, Editor-in-Chief

Article:  Treatment with ledipasvir and sofosbuvir improves patient-reported outcomes: Results from the ION-1, -2, and -3 clinical trials—ZM Younossi—et. al
   Source: Hepatology 2015 Jun;61(6):1798-808. doi: 10.1002/hep.27724. Epub 2015 Mar 18.

Results and Conclusions:  In the phase 3 clinical trials of ledipasvir and sofosbuvir with and without ribavirin patient report outcomes were measured.  There was a total of 1,952 patients in the study.  Patients were treated for 8, 12 or 24 weeks. In the groups that received ledipasvir and sofosbuvir (without ribavirin) who had early viral load suppression there was improved quality of life that was maximized by the end of treatment.  In the group that received ledipasvir/sofosbuvir and ribavirin their quality of life decreased regardless of treatment duration until the end of treatment. 

The Bottom Line:  Ribavirin during treatment reduced quality of life, but achieving a cure improved quality of life for all of the groups including the groups who received ribavirin.
 
Editorial Comments:  This is a no-brainer, but we need more of these studies to show that being cured improved quality of life and improved overall survival.  I hope that insurance companies are hearing this and loosen up the restrictions.

Article:  Antigenic cooperation among intrahost HCV variants organized into a complex network of cross-immunoreactivity—P Skums
  Source: Proc Natl Acad Sci USA. 2015 May 26;112(21):6653-8.doi:10.1073/pnas.1422942112. Epub 2015 May 4.
 
Results and Conclusions:
Most people who become acutely infected with hepatitis C become chronically infected – up to 85%.  The reason there is such a high rate of chronic infection is not completely understood, but there are many theories.  The current paper presented a mathematical model to show how the virus contributes to hepatitis C chronicity. 

What is interesting is that various proteins of the hepatitis C virus seem to act together to escape the human host—that is certain proteins of the virus work together to draw off parts of the immune system cells so that other parts of the hepatitis C virus can survive and persist in the body and infect liver cells. This enables the hepatitis C virus to act as a network of parts to establish a chronic infection.   

The Bottom Line:  As with any discovery in science these findings need to be replicated.  If the exact mechanism can be understood an effective protective vaccine could be developed. 

Editorial Comment:  Isn’t science interesting?  The hepatitis C virus is a wily little bugger and endlessly fascinating.  The key would be to understand why this strategy works for some and not others.   This could lead to the development of an effective vaccine.
 
Article: Differentiation of acute from chronic hepatitis C virus infection by nonstructural 5B deep sequencing: A population-level tool for incidence estimation—V. Montoya et. al
   Source:  Hepatology Volume 61, Issue 6, pages 1842–1850, June 2015
 
Results and Conclusions:  In the current study the authors examined the viral proteins from 13 acute and 54 chronic individuals by sequencing the NS5B region of the virus.  They were able to differentiate the viral diversity between the acute and chronic infection.  The viral diversity was significantly different between acute vs. chronic infection. 
 
Editorial Comment:  This and the last issue of the HCV Advocate have discussed the difficult task of trying to diagnose an acute infection of HCV.  If this study is replicated and IF the tool is made available at a reasonable cost it could be a game changer in the way we understand how many people are acutely infected with hepatitis C.

Source:  http://hcvadvocate.org/news/newsLetter/2015/advocate0815.html#3

Wednesday, July 8, 2015

2 new hepatitis C drugs to be available in November in Egypt

CAIRO: Minister of Health Adel al-Adawy announced that two new hepatitis C drugs, Harvoni and Viekira, are to be available at the hepatitis treatment centers by next November, youm7 reported Wednesday.

There are 2.3 million hepatitis C patients in Egypt, while 996,642 patients applied on the website of the National Committee for the Control of Viral Hepatitis to be treated by Sovaldi until last June, according to Adawy.

He added that 85,536 patients were provided with the treatment until the end of June.

Read more...

Friday, July 3, 2015

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

– 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.--()--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.”

Read complete press release here

Monday, June 1, 2015

EASL 2015: Part 2 —Alan Franciscus, Editor-in-Chief

In part 2 of our European Association for the Study of the Liver (EASL) coverage I will wrap up with a brief overview of some of the remaining data. 

AbbVie:  Ombitasvir/Paritaprevir/Ritonavir for Treatment of HCV Genotype 1b In Japanese Patients with or without Cirrhosis: Results from Gift-I –K Chayama et al
In this current study, Japanese patients were treated with AbbVie’s 2D (paritaprevir/ritonavir plus ombitasvir) given once-a-day for 12 weeks.  This is different from the 3D regime given in the United States and elsewhere because Japanese patients metabolize AbbVie’s drugs differently.  With the 2D combinations Japanese patients reach high enough levels even without ribavirin or dasabuvir.    
In the study there were 215 HCV genotype 1b patients who received the study drugs, 42% were cirrhotic, and 35% were treatment experienced.  The overall cure rate was 95%.  The cure rates among those who had never been treated, as well as those who were treated previously (cirrhotic and non-cirrhotic) were all similar.  The most common side effects were headache, edema and sore throat. 

Comments:  Japan has a long history of hepatitis C.  AbbVie’s 2D combination will be a welcome addition to the drugs in Japan to treat Japanese patients.  For more information about HCV in Japan check out our HCV in Japan—HCV Around the World series.
 
NHANES:  Advanced Fibrosis is Common in Individuals whose Hepatitis C Has Not Been Diagnosed: Results from the National Health and Nutrition Examination Survey 2001-2012—P Udompap et al
This study has been reported at previous conferences, but it is worth discussing again.  The National Health and Nutrition Examination Survey (NHANES) used data from a group of 62,000 American adults of whom 45,000 were tested for hepatitis C antibodies—591 tested antibody positive and of those 420 were HCV RNA or viral load positive. 

Of the 420 who had chronic hepatitis C, 1 in 10 had cirrhosis and 1 in 5 had advanced fibrosis.  Approximately 50% did not know that they had hepatitis C. 

Comments:  This validates the recommendation for “Baby Boomer” testing.  This should WAKE UP the complacency among physicians and associations and start testing baby boomers NOW.  We want to test, monitor, treat, cure and save lives.
 
Gilead:  Ledipasvir/sofosbuvir treatment results in high SVR rates in patients with chronic genotype 4 and 5 HCV infection— A Abergel et al
A total of 44 HCV genotype 4 patients and 41 HCV genotype 5 patients were treated with the combination of sofosbuvir and ledipasvir for 12 weeks.  In both of the groups the patients were evenly divided between treatment experienced (TE) and those who had never been treated (TN) and those with and without cirrhosis (C & w/o C).  The cure rates in the HCV genotype 4 patients was TN =96% (21 of 22 pts); TE = 91% (20 of 22 pts); C= 100% (10 of 10 pts); w/o C = 91% (31 of 34 pts).  The most common side effects were fatigue and headache.
 
Comments:  These are very good cure rates with few side effects.  While the population of genotype 4 and 5 in the United States is very low—genotype 4 is very high in Egypt and other parts of the world (see HCV in Egypt in our HCV Around the World series).  Genotype 5 is primarily seen in South Africa and parts of Europe.  I will be writing an article on Genotype 5 for the June Mid-Monthly edition so stay-tuned.
 
Merck: The Phase 3 C-Edge Treatment-Naive (TN) Study of a 12-Week Oral Regimen of Grazoprevir (GZR, MK-5172)/Elbasvir (EBR, MK-8742) in Patients with Chronic HCV Genotype (Gt) 1, 4, or 6 Infection—S Zeuzem et al
This was a phase 3 study of a one pill, once-a-day grazoprevir and elbasvir pill taken for 12 weeks.  The study included treatment naïve (TN). The trial included a total of 421 infected HCV genotype 1, 4 or 6.  Most of the trial participants were male sex, and White.  Ninety-one percent were genotype 1.   Approximately 22% had cirrhosis. 

The overall cure rate was 95%: 92% for genotype 1a and 99% for genotype 1b; 100% (36 of 36 pts) of the genotype 4 patients were cured; 80% (5 of 6 pts) of genotype 6 patients were cured.  The most common side effects were headache, fatigue, nausea and joint pain.
 
Comments:  These are high cure rates with a low side effect profile and it will make a good addition to the treatment landscape of HCV in 2016.  In people with the genotype 1a NS5A resistance-associated variants (RAVs) it shows greater than a 5-fold loss in sensitivity to elbasvir (a protease inhibitor).  What this means in clinical practice in unknown at this time.

http://hcvadvocate.org/news/newsLetter/2015/advocate0615.html#1

Thursday, May 28, 2015

Harvoni added benefit for patients with HCV/HIV coinfection

In a manufacturer dossier assessment conducted by the Institute for Quality and Efficiency in Health Care in Germany, Harvoni was deemed to have an added benefit for patients with hepatitis C genotype 1a virus infection and HIV without cirrhosis, according to a press release.

The dossier assessment is a procedural part of the Reform of the Market for Medicinal Products Act, overseen by the Federal Joint Committee (G-BA). The G-BA conducts a commenting procedure once the dossier assessment is complete and then determines the extent of the added benefit determined by the Institute for Quality and Efficacy in Health Care (IQWiG).

The assessment was based on additional data from five clinical studies submitted by Gilead Sciences. The information led the IQWiG to conclude that SVR achieved by patients without HIV coinfection was “transferable” to patients with HIV coinfection without cirrhosis. However, the extent of the added benefit in this population of patients is “non-quantifiable” due to the fact it is unclear in how many patients with undetectable viral load prevention of late complications and liver cancer can be achieved, according to the release.

Saturday, March 21, 2015

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



IMPORTANT DRUG WARNING

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.

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

Wednesday, March 11, 2015

Hepatitis Pills Contributed to 13 Percent Spike in Drug Spending

Costly new hepatitis pills helped drove a 13 percent increase in drug spending last year among insurer-managed plans in the United States, a rate not seen in more than a decade, according to a report from the pharmacy benefit manager Express Scripts.
A course of therapy to treat the liver-damaging hepatitis C virus could cost as much as $150,000 with the approvals of medicines such as Gilead Sciences Inc.’s Sovaldi and Harvoni and Johnson & Johnson’s Olysio, Express Scripts said in the report, released Tuesday. Driven as well by higher costs of specialty and compounded medicines, the estimated drug spend in general for each person in commercial-insured plans was $980 in 2014.
The new hepatitis C medicines are particularly challenging for government health plans and programs.

Gilead Sciences (NASDAQ:GILD) and AbbVie (NYSE:ABBV) Trying to Make the Most from Market Share

Gilead Sciences (NASDAQ:GILD) share prices are dropping as a result of the FDA giving the approval to AbbVie (NYSE:ABBV) of its hepatitis C drug, Viekira Pak. Through drastic price cuts, Gilead Sciences (NASDAQ:GILD) is facing a tough time trying to become market leader. Both companies have confirmed that the price reductions are so that they can attract more customers yet investors may not consider this a positive sign.
After Gilead Sciences (NASDAQ: GILD) launched Sovaldi, its drug for oral hepatitis C, it revolutionized the treatment. Before this, patients of hepatitis C had to be treatment with cures that had significant side effects like ribavirin and peg interferon that lasted nearly 48 weeks and had only 50%-80% cure rates.
However, Sovaldi’s treatment doesn’t eliminate ribavirin from the core, but it does put aside peg interferon and gives cure rates of 90%. This is why doctors embraced the drug with open arms and turned it into the quickest drug to achieve such successful levels of treatment. It made nearly $10.3 billion sales in the previous year. However, Gilead Sciences (NASDAQ: GILD) strengthened its drug back in October, when it won the approval by the FDA for its drug Harvoni.

Tuesday, March 10, 2015

Sofosbuvir/ledipasvir raises some antiretroviral levels in HIV/HCV coinfected people

HIV/HCV coinfected people who take sofosbuvir/ledipasvir (Harvoni) to treat hepatitis C along with boosted protease inhibitor antiretroviral regimens may experience changes in drugs levels, but these are mostly not considered clinically relevant, according to a drug-drug interaction study presented at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) last month in Seattle. However, data on the safety and efficacy of combining sofosbuvir/ledipasvir with boosted protease inhibitors during treatment are lacking, and increased tenofovir exposure may be a concern.

The advent of interferon-free direct-acting antiviral regimens has brought about a revolution in treatment for chronic hepatitis C virus (HCV) infection, including for patients who have traditionally been considered 'difficult to treat', such as those with HIV/HCV coinfection. Clinical trials have seen cure rates for coinfected people equal to those for patients with HCV alone, and current treatment guidelines and product labels indicate that HIV-positive patients can be treated with the same recommended regimens as HIV-negative ones, taking into account potential interactions with antiretroviral therapy (ART).

Polina German of Gilead Sciences reported findings from a phase 1 study to evaluate interactions between sofosbuvir/ledipasvir and ART regimens containing ritonavir-boosted atazanavir (Reyataz) or darunavir (Prezista) plus tenofovir/emtricitabine (Truvada) in healthy HIV-negative volunteers.

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Monday, March 9, 2015

Scotland: Scots patients first in UK to hepatitis C ‘cure’

HEPATITIS C sufferers in Scotland are the first patients in the UK to be given access to a new treatment that cures up to 99 per cent of cases in eight or 12 weeks.

The Scottish Medicines Consortium (SMC) has accepted for use Harvoni for the treatment of chronic hepatitis C which affects one in every 100 people in Scotland and causes more than 20 per cent of all liver transplants.

Approximately 50,000 people in Scotland are infected with hepatitis C, which can cause liver cancer or liver failure – equivalent to around 1 per cent of the Scottish population.

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Canada: Drug cure for hep C comes with $95,000 price for Windsor man

Thirty-three years after a van-motorcycle crash put Mike North in hospital for multiple surgeries, he is suffering the devastating health effects from the hepatitis C virus that snuck into his body via blood transfusions.

The virus has attacked his liver, which is now in the most advanced stage of cirrhosis, and he needs a transplant. But before the transplant he must take a recently approved drug that should cure him of hep C, so the virus won’t attack the new liver. Harvoni boasts a cure rate higher than 95 per cent. But there’s a catch: it costs $95,000 for a 12-week treatment, and North has almost no coverage.

“If I don’t get a liver, I’m done,” said North, 62, a former manager at several local automotive plants, who has some savings (including his share of the settlement paid out to victims of Canada’s tainted blood scandal), but only enough to fund his retirement. So his family and medical staff are scrambling to find a way to get him these $1,130 pills as quickly as they can.

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Thursday, March 5, 2015

State OKs new Hep C drug for Medicaid patients

Two drugs now available, but cost difference unclear

During the latter portion of 2014, Oregon officials and Hepatitis C patient advocates debated who would be able to receive a new, highly effective yet prohibitively expensive drug under the state’s Medicaid program.

Officials approved criteria that restricted the drug, Sovaldi, to very sick patients, with the caveat that they’d take up the issue again once new, perhaps more affordable drugs hit the market.

That appears to have happened sooner than expected. The director of the Oregon Health Authority, which oversees the state’s Medicaid program, the Oregon Health Plan, approved new criteria this month that permits some OHP beneficiaries with Hepatitis C to access a new drug: Harvoni. Hepatitis C is a disease that causes inflammation of the liver and can lead to liver failure or liver cancer.  


Wednesday, March 4, 2015

Hepatitis C study for District residents

Unity Health Care announced a study to show how health care providers can treat Hepatitis C. 

WASHINGTON (WUSA9) -- Hepatitis C is a contagious liver disease, complications can lead to death. Affecting over 3 million people in the US, the disease is particularly dangerous because there are few noticeable symptoms early on.

Wednesday evening, Unity Health Care announced a study to show how health care providers can treat Hepatitis C.

Called the ASCEND study, 600 DC patients will be treated with Harvoni, a newly FDA approved medication. Unity Health Care is partnering with the National Institutes of Health, the University of Maryland, and Family and Medical Counseling Services Inc. to conduct the research.

Source:  http://www.wusa9.com/story/news/2015/03/04/hepatitis-c-unity-heath/24395001/