Showing posts with label (Sofosbuvir) now Sovaldi. Show all posts
Showing posts with label (Sofosbuvir) now Sovaldi. Show all posts

Tuesday, April 10, 2018

Sweden-Introduction of second-generation direct-acting antivirals in HCV:Register-based Study

Introduction of the second-generation direct-acting antivirals (DAAs) in chronic hepatitis C: a register-based study in Sweden
P. Frisk, K. Aggefors T. Cars N. Feltelius S. A. LoovB. Wettermark O. Weiland

First Online: 09 April 2018

The conditions for introducing the first six of the second-generation direct-acting antivirals for chronic hepatitis C infection in Sweden were outlined in a national introduction protocol. The overall cure rate was estimated to 96%, with some variation between genotypes. Despite regional variation in other cost containment strategies, the high level of adherence to recommendations among prescribers and similar introduction rates in the regions indicate that the protocol contributed considerably to a rapid uptake and equal distribution of DAAs in Sweden.

Full-Text

Abstract
Purpose Introduction of the direct-acting antivirals (DAAs) for treatment of chronic hepatitis C (CHC) infection has been challenging in all health systems. In Sweden, a national protocol for managed introduction was developed. It was optional, but all county councils agreed to implement and follow it. The purpose of this study was to study (a) cure rates among all patients initiated on treatment in 2014–2015, (b) prescribers’ adherence to the drug recommendations and treatment eligibility criteria in the protocol, and (c) introduction rate in the six Swedish healthcare regions.

Method
A cross-sectional study where national data from the Prescribed Drug Register and the quality register InfCare Hepatitis defined the study population, and clinical data from the Patient Register and InfCare Hepatitis were used to monitor outcomes. Descriptive statistics were used.

Results
A total of 3447 patients were initiated on treatment during 2014–2015. The overall cure rate, based on data from 85% of the cohort, was 96%, with variation between genotypes. Adherence to drug recommendations increased over time and varied between 43.2 and 94.2%. Adherence to the treatment eligibility criteria was initially 80% and increased to 87% when treatment restrictions were widened. The introduction rate differed initially between the regions and reached stable levels 15–18 months after the launch of the first DAA.

Conclusion
The estimated overall cure rate was 96%, with some variations between genotypes. A high level of adherence to the introduction protocol as well as similar introduction rates in the health care regions indicate that the introduction protocol, alongside with other measures taken, contributed considerably to a rapid uptake and equal distribution of DAAs in Sweden.

Continuer reading online: https://link.springer.com/article/10.1007%2Fs00228-018-2456-y

Wednesday, February 28, 2018

Ontario Expands Patient Access to Chronic Hepatitis C Therapies On Public Drug Plan

Ontario Expands Patient Access to Chronic Hepatitis C Therapies On Public Drug Plan


  • Gilead applauds Ontario's Ministry of Health for expanding access to curative hepatitis C therapies to all diagnosed patients, regardless of severity of illness
  • Ontario's expanded access includes EPCLUSA®, a 12 week treatment for patients with chronic hepatitis C across all six genotypes
  • Gilead's new product, VOSEVI™ is now available under the Ontario Drug Benefit Program
  • The removal of the fibrosis level criterion for access furthers Canada's commitment to the World Health Organization's Global Hepatitis C elimination efforts
MISSISSAUGA, ON, Feb. 28, 2018 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today recognizes the Ontario Ministry of Health and Long-Term Care for its leadership in the expansion of access to therapies that treat chronic hepatitis C virus infection under the Ontario Drug Benefit (ODB) Program. Today, all eligible ODB recipients will have greater access to treatment, regardless of the severity of disease (fibrosis level), to achieve a cure and improve their quality of life. Patients with chronic hepatitis C will no longer have to wait for their disease to progress before starting treatment.

"Expanded access is an important milestone to achieve Canada's commitment to eliminating hepatitis C by 2030," said Kennet Brysting, General Manager of Gilead Canada. "Increasing hepatitis C treatment rates among patients and high-risk populations will help to reduce the burden of illness, the risk of transmission and the significant associated costs to the healthcare system."

Today's announcement will allow more patients to access a broad selection of therapies, including all those developed by Gilead Canada – EPCLUSA (velpatasvir/sofosbuvir), VOSEVI (voxilaprevir/velpatasvir/sofosbuvir), HARVONI® (ledipasvir/sofosbuvir) and SOVALDI® (sofosbuvir). EPCLUSA is a publicly accessible treatment that can be used for patients with hepatitis C infection across all six genotypes, and VOSEVI is approved for use in patients who have failed on a previous direct-acting antiviral (DAA) treatment regimen.

"Canada has committed to eliminating hepatitis C by 2030, and to accomplish this goal we need to significantly increase treatment rates," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and hepatologist at Toronto General Hospital. "Treatment regimens are getting shorter, simpler and more widely effective across genotypes meaning that treatment is now easier for both patients and physicians to manage.

"Currently, an estimated 44 per cent still remain undiagnosed, so increasing treatment rates also requires improving screening and diagnosis, which is why the Canadian Liver Foundation recommends that everyone in Canada born between 1945 and 1975 receive a one-time test for hepatitis C," added Dr. Sherman. "Treatment should be an option for everyone, regardless of disease severity, where they live in the province or their ability to pay. We're glad to see that the Ontario government is taking steps to make treatments accessible for more Ontarians with chronic hepatitis C."

https://www.newswire.ca/news-releases/ontario-expands-patient-access-to-chronic-hepatitis-c-therapies-on-public-drug-plan-675380743.html

For more information on the expanded access for hepatitis C therapies and VOSEVI listing: http://www.health.gov.on.ca/en/pro/programs/drugs/formulary43/summary_edition43_20180221.pdf

Thursday, October 5, 2017

Real-life results of sofosbuvir based therapy in chronic hepatitis C -naïve and -experienced patients in Egypt

Real-life results of sofosbuvir based therapy in chronic hepatitis C -naïve and -experienced patients in Egypt
Ahmed Nagaty, Ekram W. Abd El-Wahab Published: October 5, 2017

https://doi.org/10.1371/journal.pone.0184654

Full Text Article

Abstract
Background
More than ten million Egyptians are infected with HCV. Every one of them is going to infect about three to four persons every year. Treating those patients is a matter of national security. A dramatic improvement in hepatitis C virus (HCV) infection treatment was achieved in the last five years. A new era of direct-acting antivirals is now dawning in Egypt.

Objective(s)
We share in this report our clinical experience in treating chronic HCV Egyptian patients with Sofosbuvir based regimens to evaluate its safety and efficacy on real life practical ground.

Methods
A total of 205 chronic HCV patients (195 naive and 15 experienced) were enrolled in the study. Patient were treated with Sofosbuvir+Ribavirin 24 weeks as standard of care. Two interferon eligible patients were treated with PEG-INF+ Sofosbuvir+Ribavirin for 12 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response at 24 weeks after cessation of therapy.

Results
The overall response rate was 97.1%. Sustained virological response rate did not differ among treatment-naive patients and patients with previous history of IFN-based therapy. Portal hypertension, prediabetes, and lack of early virologic response were predictors of non response. No clinically significant treatment-emergent adverse effects were noted. No treatment discontinuation was encountered.

Conclusion
In the real-life setting, Sofosbuvir based regimens for 24 weeks has established an efficacious and well tolerated treatment in naïve and experienced patients with chronic HCV genotype 4 infection; although shorter treatment durations may be possible. However, patient follow up should extent to at least 6 months post-treatment and verifying viral load on yearly basis is warranted to track any late relapse.

Monday, September 25, 2017

Gilead's Sovaldi® (Sofosbuvir) Approved In China for Treatment of Chronic Hepatitis C

China Food and Drug Administration Approves Gilead's Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection

- Sovaldi-based Regimens Demonstrated High Rates of Sustained Virologic Response or Cure for Chinese Hepatitis C Infected Patients -

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 25, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
  
The approval of Sovaldi is supported by a Phase 3 study conducted in China, presented earlier this year at the Asian Pacific Association for the Study of the Liver (APASL) meeting. SVR12 (HCV RNA undetectable 12 weeks after completing therapy) rates for Chinese HCV patients with genotype 1, 2, 3 or 6 ranged from 92-100 percent. The study evaluated Sovaldi in combination with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV) across a range of difficult-to-cure patient populations, including treatment-experienced patients and those with compensated cirrhosis. In this study, the safety profiles of the regimens were consistent with the known side effects of pegylated interferon and/or ribavirin. The most common adverse events were hematological abnormalities and pyrexia.
  
Professor Lai Wei, the principal investigator of Sovaldi’s Phase 3 study and former Chairman of the Chinese Society of Hepatology of the Chinese Medical Association said, “The approval of sofosbuvir in China provides more treatment options for Chinese HCV patients. The clinical trials in China and around the world provide evidence that the treatment is effective for multiple genotypes, which offers HCV patients in China a better chance at curing their disease.”
  
HCV is the fourth-most commonly reported infectious disease in China, with approximately 10 million people infected. HCV genotypes 1, 2, 3 and 6 account for more than 96 percent of all cases. Less than one percent of HCV patients are currently treated, using interferon-based regimens that have lower efficacy, longer treatment duration and less favorable safety profiles than more recent regimens that contain direct-acting antiviral medicines.
  
“With the approval of Sovaldi, there is now the potential opportunity to transform treatment for HCV patients in China,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “Medicines are one part of the solution but, as we have seen in other countries around the world, there are many other challenges that impact diagnosis, linkage to care and treatment. Gilead is committed to working with the government and other stakeholders with the goal to help reduce the significant burden of HCV disease in China.”
  
Sovaldi received marketing approval from the U.S. Food and Drug Administration (FDA) in 2013 and the European Commission in 2014. It is also approved for use in 79 countries including Australia, India, Indonesia, the Philippines, New Zealand, Canada, Egypt, Switzerland and Turkey.

Sunday, September 24, 2017

Sofosbuvir plus ribavirin treatment of HCV genotype 2: results of the real-world, clinical practice HCV-TARGET study

Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study
Tania M Welzel1, David R Nelson2, Giuseppe Morelli2, Adrian Di Bisceglie3, Rajender K Reddy4, Alexander Kuo5, Joseph K Lim6, Jama Darling7, Paul Pockros8, Joseph S Galati9, Lynn M Frazier10, Saleh Alqahtani11, Mark S Sulkowski11, Monika Vainorius7, Lucy Akushevich7, Michael W Fried7, Stefan Zeuzem1 for the HCV-TARGET Study Group

Full Text

In summary, in this large, international cohort study, the all-oral combination of SOF and RBV was safe and effective for treatment of HCV GT2. While response rates in patients without cirrhosis were high and comparable with those reported in clinical trials, the presence of lower albumin levels and liver cirrhosis was associated with lower SVR12 rates. Larger, randomised trials in patients with cirrhosis are required to determine the benefit of extended treatment durations of SOF and RBV in this patient group. Recent studies showed that combined SOF and valpatasvir (ASTRAL-1, ASTRAL-2) yielded SVR12 rates of up to 100% in patients with GT2 and cirrhosis, so that the combination of SOF and a GT2-active NS5A inhibitor for 12 weeks may be preferable to SOF and RBV for more than 12 weeks in patients with GT2 and liver cirrhosis.

Abstract
Objective Due to a high efficacy in clinical trials, sofosbuvir (SOF) and ribavirin (RBV) for 12 or 16 weeks is recommended for treatment of patients with HCV genotype (GT) 2 infection. We investigated safety and effectiveness of these regimens for GT2 in HCV-TARGET participants.

Design HCV-TARGET, an international, prospective observational study evaluates clinical practice data on novel antiviral therapies at 44 academic and 17 community medical centres in North America and Europe. Clinical data were centrally abstracted from medical records. Selection of treatment regimen and duration was the investigator's choice. The primary efficacy outcome was sustained virological response 12 weeks after therapy (SVR12).

Results Between December 2013 and April 2015, 321 patients completed 12 weeks (n=283) or 16 weeks (n=38) of treatment with SOF and RBV. Prior treatment experience and cirrhosis was more frequent among patients in the 16-week regimen compared with 12 weeks (52.6% vs 27.6% and 63.2% vs 21.9%, respectively). Overall, SVR12 was 88.2%. The SVR12 in patients without cirrhosis was 91.0% and 92.9% for 12 or 16 weeks of therapy, respectively. In patients with cirrhosis treated for 12 or 16 weeks, SVR12 was 79.0% and 83%. In the multivariate analysis, liver cirrhosis, lower serum albumin and RBV dose at baseline were significantly associated with SVR12. Common adverse events (AEs) included fatigue, anaemia, nausea, headache, insomnia, rash and flu-like symptoms. Discontinuation due to AEs occurred in 2.8%.

Conclusions In this clinical practice setting, SOF and RBV was safe and effective for treatment of patients with HCV GT2 infection

Tuesday, August 29, 2017

Treatment Of HCV Infection with New Drugs: Real World Experience in Southern Brazil

2017 Sep-Oct;16(5):727-733. doi: 10.5604/01.3001.0010.2717.

Treatment of Chronic HCV Infection with the New Direct Acting Antivirals (DAA): First Report of a Real World Experience in Southern Brazil.
Cheinquer H1, Sette-Jr H2, Wolff FH1, de Araujo A1, Coelho-Borges S1, Soares SRP2, Barros MFA2.

Full Text 

Abstract
INTRODUCTION AND AIM:
There is almost no data regarding the efficacy of direct acting antivirals (DAAs) therapy in Brazil. The aim of this historical cohort study is to describe the sustained virologic response (SVR) rate among real-world compensated chronic hepatitis C patients in three hepatology centers from Southern Brazil.

MATERIALS AND METHODS:
Patients were included if they had at least 12 weeks follow-up after the end of therapy. Patients that were lost to follow-up or had treatment prematurely interrupted for any reason were considered treatment failure in this intention to treat analysis.

RESULTS:
219 patients were analyzed. Mean age was 57.4 ± 10.9 years and 142/219 (64.8%) were male. Genotype 1 was present in 166 patients (75.8%; 1a 29.2%, 1b 46.6%); Genotypes 2, 3 and 4 in 8 (3.7%), 43 (19.6%) and 2 (0.9%), respectively. 96 (43.8%) were cirrhotic. 134 (59.5%) were treatment experienced. DAA therapies were: sofosbuvir (SOF) + ribavirin (RBV) in 10 patients; SOF + simeprevir (SMV) ± RBV in 73; SOF + pegylated interferon (PEG-IFN) + RBV in 6; SOF + daclatasvir (DCV) ± RBV in 51, SOF + ledipasvir (LDV) ± RBV in 61, and paritaprevir/ ritonavir + ombitasvir + dasabuvir (PTVr/OBV/DSV) ± RBV in 18 patients. SVR-12 was achieved in 208/219 (95%). Ten patients had virologic failure: 6 cirrhotic, 7 treatment experienced, and 6 either genotype 3 or 1a. No adverse event was attributed to the DAA therapy.

CONCLUSIONS:
Real world experience with DAA therapy in Southern Brazil showed a high rate of SVR and excellent tolerability. Failure to achieve SVR was mainly observed among patients with at least one negative predictor of response: cirrhosis and/or genotypes 1a or 3.

Full text

Saturday, July 15, 2017

Hepatitis C Genotype 3 - FDA Approved And Soon To Be Approved Therapies

September: Updated AASLD IDSA HCV Guidance
This page was updated on Aug 3, 2017 to include AbbVie's FDA approval of MAVYRET™ (glecaprevir/pibrentasvir). On July 18, 2017  Gilead announced the FDA approved VoseviTM (Sofosbuvir/Velpatasvir/Voxilaprevir  - EMA granted marketing authorization for both Vosevi, and AbbVie's MAVIRET® on July 28, 2017.

Hepatitis C genotype 3 isn't a death sentence
Published on Jul 14, 2017
By onewhoknows7
We begin with a family who struggle to access HCV therapy. A video with only one picture and a bit of text for us to read, for me - a powerful video. A story that almost anyone who has treated HCV can relate to; falling through the cracks, not receiving quality care, insurance companies deciding when or if to treat patients, is this your story too? In many ways this video hits home for me also, if not for HCV Advocate, I most certainty would have never treated successfully in 1999.  




An estimated 130-150 million people worldwide are living with chronic HCV infection, within the six major HCV genotypes, genotype 3 represents 22-30% of all infection, 10% in the United States.

Research has shown people infected with genotype 3 have significantly increased rates of steatosis (fatty liver), fibrosis, and hepatocellular carcinoma (liver cancer), thus making this genotype both difficult and urgent to treat. Here is a quick review of key HCV genotype 3 research articles,  with an update from the HCV Guidance .

FDA approved drugs to treat HCV genotype 3
September 2017
AASLD IDSA
HCV Guidance: Updated - Geno 1 & 3 Treatment-Naïve & Treatment-Experienced
Recommendations Reflecting Vosevi and Mavyret .
Stay current with all guideline updates, "click here."
Read more click here.....

October 2017
Over at NEJM Journal Watch, a small study for HCV genotype 3 patients is reviewed by Atif Zaman, MD, MPH, published last week in Hepatology. The study; Glecaprevir/pibrentasvir for HCV genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase III clinical trial, is available for download over at NATAP

Watch
June 2017
HCV genotype 3: Work through virtual case study with Dr Doug Dieterich
The HCV Virtual Patient program is an interactive, case-based program featuring real-world case scenarios discussed by HCV thought leaders.

Recommended Reading
July 13, 2017
Sofosbuvir based treatment of chronic hepatitis C genotype 3 infections—A Scandinavian real-life study
We found that sofosbuvir based treatment in a real-life setting could offer SVR rates exceeding 90% in patients with HCV genotype 3 infection and advanced liver disease.

Commentary On This Study
Aug 1, 2017
Hepatitis C Cure Rate Tops 90% in Hard-to-Treat Genotype 3 Patients
Hepatitis C patients with hard-to-treat genotype 3 showed sustained virologic response (SVR) of greater than 90% in a real-life study of a therapy based on the direct-acting antiviral (DAA) drug sofosbuvir (Sovaldi, Gilead Sciences Inc.)

New Drugs FDA Approved 

FDA Approved - Gilead's VoseviTM (Sofosbuvir/Velpatasvir/Voxilaprevir 
On July 18, 2017 Gilead's VoseviTM (Sofosbuvir/Velpatasvir/Voxilaprevir) was FDA Approved, a few weeks later on July 28, the European Commission Granted Marketing Authorization for Vosevi.

Research Articles

Sofosbuvir, Velpatasvir and Voxilaprevir
Patients with prior DAA treatment failure, genotype 3, cirrhosis and/or unfavorable resistance profiles all achieved cure rates of 96% or greater.
This is a review of the preclinical and clinical development of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX), an interferon-free, oral, once daily, pangenotypic treatment for chronic HCV infection.  All relevant literature from 2015 through June of 2017 is included..
FDA Approved AbbVie's MAVIRET (Glecaprevir/Pibrentasvir)
Aug 3, 2017 AbbVie Received U.S. FDA Approval of MAVYRET™ (glecaprevir/pibrentasvir). 
In patients with challenging-to-treat genotype 3 chronic HCV infection with cirrhosis, 95% achieved SVR12 after 8 weeks of therapy.
April 21, 2017 - AbbVie combination cures 97% of genotype 3 hepatitis C
AbbVie's pangenotypic direct-acting antiviral combination of two drugs cured 95% of people with early-stage genotype 3 hepatitis C virus (HCV), the hardest genotype to treat, according to results of the ENDURANCE-3 trial presented at the  International Liver Congress in Amsterdam on Friday. The AbbVie second-generation direct-acting antiviral combination consists of a protease inhibitor and an NS5A inhibitor. Glecaprevir is an HCV NS3/4A protease inhibitor active against all genotypes of hepatitis C. Pibrentasvir is an NS5A inhibitor also active against all genotypes of hepatitis C.

July 26, 2017
Glecaprevir/pibrentasvir is effective for people with HIV/HCV co-infection
Liz Highleyman
Produced in collaboration with hivandhepatitis.com
Published: 26 July 2017
AbbVie's new pangenotypic regimen combining glecaprevir and pibrentasvir cured almost all HIV-positive people with hepatitis C co-infection in the EXPEDITION-2 study, according to a presentation on Monday at the 9th International AIDS Society Conference on HIV Science (IAS 2017) in Paris.

Karine Lacombe of Saint-Antoine Hospital in Paris presented findings from AbbVie's phase 3 EXPEDITION-2 trial, which evaluated an 8-week regimen of glecaprevir/pibrentasvir for people with both HIV and hepatitis C.

Glecaprevir is an HCV NS3/4A protease inhibitor and pibrentasvir is an NS5A inhibitor. Both are pangenotypic, or active against all HCV genotypes. The two drugs have been co-formulated in a once-daily combination pill, to be marketed under the brand name Maviret.

Studies presented at this year's International Liver Congress showed that glecaprevir/pibrentasvir cured 99% of people with hepatitis C with multiple HCV genotypes, as well as 95% of people with hard-to-treat genotype 3.

Recommended Reading
July 14, 2017
The relationship between hepatitis C infection and hepatic steatosis.

Lawrence Serfaty
Key Points
Out of excessive alcohol consumption, steatosis should be classified into 2 types according to hepatitis C virus (HCV) genotypes: metabolic steatosis, which is associated with features of metabolic syndrome and insulin resistance in patients infected with nongenotype 3, and viral steatosis, which is correlated with viral load and hyperlipemia in patients infected with genotype 3.

HCV interacts with host lipid metabolism by several mechanisms, such as promotion of lipogenesis, reduction of fatty acid oxidation, and decreases of lipids export, leading to hepatic steatosis and hypolipidemia.

A strong link between HCV infection and diabetes mellitus has been found in subject based studies and, to a lesser degree, in population-based studies.

The above link was provided by @HenryEChang via Twitter, view an index of all HCV extrahepatic manifestations.

Video - March 2017
Genotype 3 Infection - Identification of the Best Direct-Acting Antiviral Regimen for Patients With Hepatitis C Virus
Drs. Drenth and Berden discuss their manuscript "Identification of the Best Direct-Acting Antiviral Regimen for Patients With Hepatitis C Virus Genotype 3 Infection: A Systematic Review and Network Meta-analysis."

HCV Advocate
Clinical Trials Reference Guide
Users can search for a hepatitis C clinical trial by category (genotype), or learn how to evaluate a clinical trial and become familiar with commonly used terms. HCV Advocate offers an easy to navigate HCV Medications Blog as well, organized by HCV genotype

Stay Updated
Sift through a collection of research articles related to treating HCV according to genotype.

Saturday, May 27, 2017

New drug reduces transplant and mortality rates significantly in patients with hepatitis C

New drug reduces transplant and mortality rates significantly in patients with hepatitis C
Public Release: 
Intermountain Medical Center

Patients with hepatitis C who suffer from advanced stages of liver disease have renewed hope, thanks to findings by researchers who have discovered that a new drug significantly reduces their risk of death and need for transplantation.

The research team, led by clinical researchers at Intermountain Healthcare's Intermountain Medical Center in Salt Lake City, studied nearly 1,900 hep C patients and found that the number of patients needing transplants was reduced by 40 percent after they were given a regimen of the drug, sofosbuvir.

Results of the study will be presented at the 2017 International Joint Congress of ILTS, ELITA & LICAGE in Prague, Czech Republic, on Friday, May 26, 2017.

About 3.3 million people in the United States have chronic hepatitis C infection, which causes inflammation of the liver and eventually leads to serious liver problems like cirrhosis, which is a late stage of scarring (fibrosis) of the liver caused by many forms of liver diseases and conditions, such as hepatitis and chronic alcoholism.

Researchers studied longitudinal data to learn the impact sofosbuvir had in treating patients with advanced stages of cirrhosis. They compared the outcomes of 1,857 patients prior to the United States Food and Drug Administration's approval of sofosbuvir in Dec. 2013 with 623 similar patients who were treated with sofosbuvir after approval of the drug.

"Prior to FDA approval of sofosbuvir, patients with the most advanced stages of cirrhosis either died from their disease or ended up receiving a transplant," said Michael Charlton, MD, lead researcher from Intermountain Healthcare's Intermountain Medical Center Transplant Program, and current president of the International Liver Transplantation Society. "We found that by treating those patients, who were on the verge of needing a transplant, with sofosbuvir-based therapies, we greatly reduced the liver transplant and mortality rates." Only three percent of patients on sofosbuvir ended up needing a transplant, compared to ovder 40% of untreated patients.

Data used in the study included an integrated database of four separate, prospective, multicenter, multinational randomized controlled clinical trials of sofosbuvir-based therapies in patients with advanced stages of cirrhosis, and compared them with patients who were on the United Network for Organ Sharing (UNOS) waitlist for a liver transplant between 2008-2013.

"We found the sicker a patient was, the more benefit they experienced by using sofosbuvir," said Dr. Charlton. "However, many people around the world who might benefit most from this therapy don't have access to it because the regulatory authorities haven't felt it safe for use in patients with advanced stages of liver disease due to hepatitis C. Our research shows the benefits of this drug include significantly improving the health of even the sickest patients, allowing them to return to their normal life sooner."

Study authors conclude the study by recommending that treatment of the hepatitis C virus using sofosbuvir should be considered in all patients with cirrhosis, even those in advanced stages of the liver disease.

Members of the Intermountain Medical Center Liver Transplantation Program involved in the study include Li Dong; Michael Leise; Richard Gilroy, MD; Jake Krong; Anu Osinusi; Michael P. Curry; Michael Manns; Nezam Afdhal; Diana M. Brainard; and Michael Charlton, MD.

Image Credit Intermountain Medical Center.

Tuesday, May 16, 2017

In major shift, Pa. to expand hepatitis C treatment for Medicaid patients

In major shift, Pa. to expand hepatitis C treatment for Medicaid patients
by
The Wolf administration said Tuesday that it would expand Medicaid coverage for treatment of hepatitis C, a major shift that has long been supported by medical organizations but delayed because of potentially high costs to the state.

“Today’s announcement means that thousands of vulnerable Pennsylvanians will soon have easier access to pharmaceuticals that can cure HCV,” Department of Human Services Secretary Ted Dallas said in a statement. “Moving forward, the severity of this disease can no longer prevent all [Medicaid] beneficiaries from getting access to treatment if they need it.”
Continue reading....

Wolf Administration Announces Medicaid Policy Change for Individuals Suffering from Hepatitis C Virus Department of Human Services continues to expand access to high-quality services Harrisburg, PA – Today, the Department of Human Services (DHS) is announcing changes to the state’s Medicaid (MA) policy to expand coverage of life-saving drugs to treat Hepatitis C (HCV) virus. Beginning on July 1, the Department will begin phasing in coverage for individuals who have liver function test scores of “F1” or “F0”.

HCV test scores are categorized by the severity of the disease from F0 through F4, with F0 being the least severe form of the disease and F4 being the most severe. Prior to this announcement, the department provided health care coverage through Medicaid for individuals whose scores ranged from F2 through F4 unless they also had other clinical complications.  

“Today’s announcement means that thousands of vulnerable Pennsylvanians will soon have easier access to pharmaceuticals that can cure HCV,” said DHS Secretary Ted Dallas. “Moving forward, the severity of this disease can no longer prevent all MA beneficiaries from getting access to treatment if they need it.”

The policy change follows the clinical recommendations presented by the department’s Pharmacy & Therapeutics Committee.

Under the new policy, the department will authorize the drugs for beneficiaries with test scores of F1 starting on July 1, 2017 and will authorize treatment for beneficiaries with scores of F0 starting on January 1, 2018. Adding F0 and F1 will ensure that all qualified individuals with HCV will have access to pharmaceuticals that can now cure this disease. 

HCV is a communicable disease that causes chronic inflammation throughout the body and can lead to serious liver damage, cancer, and death. At least 20,000 people in the United States die each year due to liver disease caused by HCV, making it the deadliest communicable disease in the country. Individuals with HCV can suffer from diabetes, lymphoma, fatigue, joint pain, depression, and other diseases even before reaching the advanced state of the disease.

“Pennsylvania’s new approach will directly improve the lives of many of our clients – some of Pennsylvania’s most vulnerable citizens,” said Laval Miller Wilson, Executive Director of the Pennsylvania Health Law Project (PHLP).

“I would like to thank Laval, Amy Hirsch, Kevin Costello and everyone at PHLP, Community Legal Services, Kairys Rudovsky, Messing & Feinberg, and Center for Health Law & Policy Innovation of Harvard Law School who worked with the department on finding a path forward,” said Secretary Dallas. “Their help has been invaluable throughout the process and been a critical component of being able to make today’s announcement.”

Media Contact: Rachel Kostelac, DHS, 717-425-7606 
http://www.chlpi.org/wp-content/uploads/2017/05/PA_HCV_press-release_05_16_17.pdf

Wednesday, April 19, 2017

FDA Approval Of Hepatitis C Drugs For Kids Is Likely To Speed Treatment

FDA Approval Of Hepatitis C Drugs For Kids Is Likely To Speed Treatment
Michelle Andrews
The two drugs approved for pediatric use by the Food and Drug Administration, Harvoni and Sovaldi, have both been highly effective in treating adults with the disease, though Medicaid programs and private insurers often have balked at paying for the pricey drugs for adults.

"The short answer is that [Medicaid] will likely require coverage for all kids, regardless of whatever the coverage policies for adults may be," said Matt Salo, executive director of the National Association of Medicaid Directors.
Continue reading.....

Friday, April 7, 2017

FDA Approves HCV Sovaldi and Harvoni For Children Ages 12 to 17

Gilead Press Release
(FDA) has approved supplemental indications for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi® (sofosbuvir 400 mg) tablets for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg. Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection. Sovaldi was approved for pediatric patients with genotype 2 or 3 chronic HCV infection, in combination with ribavirin. There are an estimated 23,000-46,000 pediatric HCV patients in the United States, most of whom were infected with the virus at birth.
http://www.businesswire.com/news/home/20170407005379/en/

FDA Update

FDA approves two Hepatitis C drugs for pediatric patients

Today, April 7, 2017 the FDA approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17 or weighing at least 35 kilograms.

These approvals provide pediatric treatment options for six major genotypes, or strains, of the HCV virus. Harvoni is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with HCV genotype 1, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis. Sovaldi in combination with ribavirin is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kilograms with genotype 2 or 3 HCV infection without cirrhosis or with compensated cirrhosis.

The specific changes for each label are summarized below

Sovaldi
Section 1: INDICATIONS AND USAGE
Pediatric Patients:
SOVALDI is indicated for the treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 12 years of age and older or weighing at least 35 kg without cirrhosis or with compensated cirrhosis for use in combination with ribavirin


Section 2: DOSAGE AND ADMINISTRATION
2.3        Recommended Dosage in Pediatric Patients 12 Years of Age and Older or Weighing at Least 35 kg
The recommended dosage of SOVALDI in pediatric patients 12 years of age and older or weighing at least 35 kg is one 400 mg tablet taken orally once daily with or without food in combination with ribavirin [see Clinical Pharmacology (12.3) and Clinical Studies (14.5)].
The recommended treatment regimen and duration for SOVALDI combination therapy is provided in Table 2.  provides the weight-based dosage of ribavirin when used in combination with SOVALDI for pediatric patients. For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 2 and Table 3. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

Table 2  Recommended Treatment Regimen and Duration in Pediatric Patients 12 Years of Age and Older or Weighing at Least 35 kg

Patient Population
Treatment Regimen And Duration
Genotype 2
Treatment-naïve and treatment-experienceda without cirrhosis or with compensated cirrhosis (Child-Pugh A)
SOVALDI + ribavirinb 12 weeks
Genotype 3
Treatment-naïve and treatment-experienceda without cirrhosis or with compensated cirrhosis (Child-Pugh A)
SOVALDI + ribavirinb 24 weeks
a. Treatment-experienced patients have failed an interferon based regimen with or without ribavirin.
b. See Table 3 for weight-based ribavirin dosing recommendations.

             
Table 3 Recommended Dosing for Ribavirin in Combination Therapy with SOVALDI for
Pediatric Patients 12 Years of Age and Older or Weighing at Least 35 kg
Body Weight kg
Ribavirin Daily Dosagea
less than 47
15 mg/kg/day
47–49
600 mg/day
50–65 
800 mg/day
66–80
1000 mg/day
greater than 80
1200 mg/day
a. The daily dosage of ribavirin is weight-based and is administered orally in two divided doses with food

Section 6: ADVERSE REACTIONS
Adverse Reactions in Pediatric Subjects 12 Years of Age and Older
The safety assessment of SOVALDI in pediatric subjects 12 years of age and older is based on data from 50 subjects who were treated with SOVALDI plus ribavirin for 12 weeks (genotype 2 subjects) or 24 weeks (genotype 3 subjects) in a Phase 2, open-label clinical trial. The adverse reactions observed were consistent with those observed in clinical studies of SOVALDI plus ribavirin in adults.
8.4        Pediatric Use
The safety, pharmacokinetics, and efficacy of SOVALDI in pediatric patients 12 years of age and older or weighing at least 35 kg with genotype 2 and 3 infection have been established.  SOVALDI was evaluated in an open-label clinical trial (Study 1112), which included 50 subjects (13 genotype 2; 37 genotype 3) 12 years of age and older. The safety, pharmacokinetics, and efficacy were comparable to that observed in adults.
The safety and efficacy of SOVALDI in pediatric patients 12 years of age and older or weighing at least 35 kg with compensated cirrhosis is supported by comparable sofosbuvir and GS-331007 exposures between: 1) adults and adolescents without cirrhosis and 2) adults without cirrhosis and adults with compensated cirrhosis. Thus, similar efficacy would be expected for adolescent patients with compensated cirrhosis as adults with compensated cirrhosis.
The safety and efficacy of SOVALDI have not been established in pediatric patients less than 12 years of age and weighing less than 35 kg with HCV genotype 2 or 3.  The safety and efficacy of SOVALDI have not been established in pediatric patients with HCV genotype 1 or 4.
Section 12: CLINICAL PHARMACOLOGY
Pediatric Patients
The pharmacokinetics of sofosbuvir and GS-331007 were determined in 50 pediatric subjects 12 years of age and older, infected with HCV genotype 2 or 3, receiving a daily dose of SOVALDI (400 mg sofosbuvir). The pharmacokinetic properties of sofosbuvir and GS‑331007 in pediatric subjects 12 years of age and older are provided in table 4. Exposures in pediatric subjects were similar to those observed in adults.             

Table 4   Pharmacokinetic Properties of SOVALDI in HCV-infected
Pediatric Subjects 12 Years of Age and Older
a
Geometric Mean
Sofosbuvirb
GS-331007b
AUCtau (ng•hr/mL)
1060
7570
Cmax (ng/mL)
472
572
a. Population PK derived parameters
b. Sofosbuvir N=28; GS-331007 N=50

The pharmacokinetics of sofosbuvir have not been established in pediatric subjects less than 12 years of age.

Section 14: CLINICAL STUDIES
Clinical Trial in Pediatrics
The efficacy of SOVALDI in HCV-infected pediatric subjects 12 years of age and older was evaluated in 50 subjects with HCV genotype 2 (N = 13) or genotype 3 (N = 37) in a Phase 2, open label clinical trial. Subjects with HCV genotype 2 or 3 infection in the trial were treated with SOVALDI and weight-based ribavirin for 12 or 24 weeks, respectively [see Dosage and Administration (2.3)].
Of the 50 treated subjects, the median age was 15 years (range: 12 to 17); 42% of the subjects were female; 90% were White, 4% were Black, and 2% were Asian; 4% were Hispanic/Latino; mean weight was 61 kg (range: 30 to 101 kg); 18% were treatment experienced; 66% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 74% of subjects had non-CC IL28B alleles (CT or TT); and no subjects had known cirrhosis. The majority of subjects (69%) had been infected through vertical transmission.
The SVR12 rate was 100% (13/13) in genotype 2 subjects and 97% (36/37) in genotype 3 subjects. No subject experienced on-treatment virologic failure or relapse.
Harvoni
S
ection 1: INDICATIONS AND USAGE
Pediatric Patients:
HARVONI is indicated for the treatment of pediatric patients 12 years of age and older or weighing at least 35 kg with HCV genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
Section 2: DOSAGE AND ADMINISTRATION

2.3        Recommended Dosage in Pediatric Patients 12 Years of Age and Older or Weighing at Least 35 kg
The recommended dosage of HARVONI in pediatric patients 12 years of age and older or weighing at least 35 kg is one tablet (90 mg ledipasvir and 400 mg sofosbuvir) taken orally once daily with or without food for 12 weeks.
Table 2 shows the recommended HARVONI duration based on pediatric patient population.
For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 2 [.

Table 2 Recommended Regimen and Duration for HARVONI in Pediatric Patients 12 Years of Age or Older or Weighing at Least 35 kg with Genotype 1, 4, 5, or 6 HCV without Cirrhosis or with Compensated Cirrhosis
Patient PopulationTreatment Regimen and Duration
Genotype
1
Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A)HARVONI 12 weeks
Treatment-experienceda without cirrhosisHARVONI 12 weeks
Treatment-experienceda with
compensated cirrhosis (Child-Pugh A)
HARVONI 24 weeks
Genotype
4, 5, or 6
Treatment-naïve and treatment-experienceda
without cirrhosis or with compensated
cirrhosis (Child-Pugh A)
HARVONI 12 weeks
a. Treatment-experienced patients have failed an interferon based regimen with or without ribavirin.

Section 6: ADVERSE REACTIONS
Adverse Reactions in Pediatric Subjects 12 Years of Age and Older
The safety assessment of HARVONI in pediatric subjects 12 years of age and older is based on data from a Phase 2, open-label clinical trial (Study 1116) that enrolled 100 subjects without cirrhosis or with compensated cirrhosis who were treated with HARVONI for 12 weeks. The adverse reactions observed were consistent with those observed in clinical studies of HARVONI in adults. Limited safety data are available in pediatric subjects receiving HARVONI for 24 weeks. No Grade 3 or 4 adverse reactions or discontinuation due to an adverse reaction was observed in those pediatric subjects receiving HARVONI for 24 weeks.

6.2        Postmarketing Experience
Skin and Subcutaneous Tissue Disorders
AngioeAngioedema
8.4        Pediatric Use
The safety, pharmacokinetics, and efficacy of HARVONI for treatment of HCV genotype 1 infection in treatment-naïve and treatment-experienced pediatric patients 12 years of age and older without cirrhosis or with compensated cirrhosis have been established in an open-label, multicenter clinical trial (Study 1116, N=100; 80 treatment-naïve, 20 treatment-experienced) and are comparable to that observed in adults.
The safety and efficacy of HARVONI for treatment of HCV genotypes 4, 5, or 6 infection in pediatric patients 12 years of age and older or weighing at least 35 kg without cirrhosis or with compensated cirrhosis is supported by comparable ledipasvir, sofosbuvir, and GS-331007 exposures between adults and adolescents with HCV genotype 1 and similar efficacy and exposures across HCV genotypes 1, 4, 5, and 6 in adults.
The safety and efficacy of HARVONI have not been established in pediatric patients less than 12 years of age and weighing less than 35 kg, in pediatric patients with decompensated cirrhosis, or in pediatric liver transplant recipients

Section 12: CLINICAL PHARMACOLOGY

Pediatric Patients:  The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 were determined in 100 pediatric subjects 12 years of age and older infected with HCV genotype 1 receiving a daily dose of HARVONI (90 mg ledipasvir and 400 mg sofosbuvir). The pharmacokinetic properties of ledipasvir, sofosbuvir, and GS-331007 in pediatric subjects 12 years of age and older are provided in Table 6. Exposures in pediatric subjects were similar to those observed in adults.



The pharmacokinetics of ledipasvir or sofosbuvir have not been established in pediatric patients less than 12 years of age

Section 14: CLINICAL STUDIES
14.6      Clinical Trial in Pediatric Subjects
The efficacy of HARVONI was evaluated in an open-label trial (Study 1116) that evaluated 12 weeks of treatment with HARVONI once daily in genotype 1 HCV treatment-naïve (N=80) and treatment-experienced (N=20) pediatric subjects 12 years of age and older without cirrhosis or with compensated cirrhosis.
Demographics and baseline characteristics were balanced across treatment-naïve and treatment-experienced subjects (patients had failed an interferon based regimen with or without ribavirin). Of the 100 treated subjects, the median age was 15 years (range: 12 to 17); 63% of the subjects were female; 90% were White, 7% were Black, and 2% were Asian; 13% were Hispanic/Latino; mean body mass index was 23 kg/m2 (range: 13.1 to 36.6 kg/m2); mean weight was 61 kg (range 33 to 126 kg); 55% had baseline HCV RNA levels greater than or equal to 800,000 IU/mL; 81% had genotype 1a HCV infection; 76% had non-CC IL28B alleles (CT or TT).  One subject had known compensated cirrhosis. The majority of subjects (84%) had been infected through vertical transmission.

The SVR12 rate was 98% overall (98% [78/80] in treatment-naïve subjects and 100% [20/20] in treatment-experienced subjects). No subject experienced on-treatment virologic failure or relapse. Two subjects were lost to follow-up.
You will be able to view the updated labels at drugs@fda or dailymed.
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
For more information about the Hepatitis Liaison Program visit the FDA Patient Network

Friday, March 31, 2017

Scale Up of Hepatitis C Treatment Possible as Brazil Rejects Patent on Key Drug

Scale Up of Hepatitis C Treatment Possible as Brazil Rejects Patent on Key Drug

Decision enables price reductions and scale-up of treatment that leads to cure in 95% of cases

Treatment for hepatitis C using the key drug sofosbuvir could be vastly scaled up in Brazil after the decision by the National Agency of Health Surveillance (Anvisa) to reject a key patent application on the drug marketed by pharmaceutical corporation Gilead. The decision could pave the way to enable generic competition in Brazil, which should lead to price reductions, making it more affordable to scale up treatment.

“In Brazil, as in many other countries, the high price charged by Gilead for sofosbuvir has meant treatment rationing. A report by WHO issued in October 2016 shows that out of 80 million people infected with hepatitis C worldwide, only 5.4 million people, including only 1 million people from low- and middle-income countries, had access to new treatment options”, said Felipe de Carvalho, Brazil Coordinator of Médecins Sans Frontières’ Access Campaign. “On the other hand, it is very encouraging to see in the report that countries achieving great results in treatment coverage are the ones where generics are available. We need a coordinated global effort to ensure effective medicines are available to the largest number of people as soon as possible – and this decision in Brazil is a step towards that.”

The exorbitant cost of sofosbuvir has prompted a global debate about inaccessible and unacceptable prices of patented drugs. In the United States, Gilead originally set the price of sofosbuvir at US$1,000 per pill – making the drug more expensive than gold – while studies show it can be produced for less than $1 per pill. This week, in Europe, MSF and partners have challenged the same patent that was rejected in Brazil by Anvisa at the European Patent Office, in order to increase access to the treatment.

In Brazil, sofosbuvir has been used in the Brazilian Public Health System (SUS) since the end of 2015. Prior to that, the Working Group on Intellectual Property (GTPI) – a collective of civil society organisations coordinated by the Brazilian Interdisciplinary Aids Association (ABIA) – had filed a patent opposition on the drug showing the patent is not merited. In the decision, Anvisa took into account GTPI’s argument that the patent application does not meet patentability criteria established in Brazilian law. Patent applications on sofosbuvir have already been rejected in Egypt, China and Ukraine.

“This decision is extremely beneficial for the 1.6 million Brazilians living with hepatitis C, because it allows the government to be more ambitious with its treatment goals. Currently, we see the violation of universal access to medicines in favour of Gilead’s abusive price”, said Pedro Villardi, GTPI coordinator. “It is important now to ensure that this decision will not be appealed and that it is validated by INPI, allowing the government to quickly buy affordable generic versions. There is an agreement under discussion that can eliminate Anvisa’s ability to reject patents based on patentability criteria. This cannot happen. If Anvisa’s decision on sofosbuvir is respected, we could potentially now treat seven times the number of people currently on hepatitis C treatment without spending more money, if Brazil buys generic sofosbuvir at the lowest global prices.”

Gilead currently charges $6,293 for a 12-week treatment course of sofosbuvir in Brazil. The best generic prices are currently available for around $200 per treatment course, but access is restricted by voluntary licences signed by Gilead, which block sales to countries like Brazil. In June 2016, an initiative for local production of a generic version of sofosbuvir was announced by a consortium that announced a price less than half of what Gilead charges. In early 2017, this consortium also filled a patent opposition. Following the patent rejection, generic versions could soon enter the market, reducing the price and expanding access to treatment.

“Brazil is a high-burden country for hepatitis C and so far, around 30,000 people have received new treatments – it’s crucial we scale up treatment with affordable versions of sofosbuvir. In some States, even people in an advanced stage of the disease have had to wait a long time to get treatment”, said Arair Azambuja, president of the Brazilian Movement of Viral Hepatitis (MBHV). “We are talking about a cure that is cheap to produce; it should not be priced out of reach. We hope Brazilian stakeholders make efforts to bring prices to the lowest levels, so we can really tackle the hepatitis C epidemic in Brazil.”