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New Recommendations for Testing, Managing, and Treating Hepatitis C from AASLD/IDSA Panel. And newer developments in HCV therapy
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Online Expert Advice for Clinicians Treating Hepatitis C Now Available at HCVguidelines.org
Today, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with the International Antiviral Society- USA (IAS-USA), announced the launch of a new website, HCVguidelines.org, that will offer up- to-date guidance for the treatment of hepatitis C virus (HCV) infection.
From Jules: below following this introduction is a discussion of the latest developments in HCV treatments & new therapies & their availabilities not addressed in these new Guidelines. Last week just prior to the announcement of these Guidelines 3 new studies of interferon-free Daclatasvir+Sofosbuvir were announced for patients with HCV/HIV coinfection (treatment-naïve & experienced), patients with cirrhosis, patients with genotype 3, and post-transplant patients, see below for full discussion & links to studies; in both the USA & Europe.
"The next generation of direct-acting antivirals has the potential to treat and cure most patients with hepatitis C,"
"We recommend daily sofosbuvir (Sovaldi, Gilead Sciences) with ribavirin plus weekly pegylated interferon for 12 weeks for eligible patients regardless of subtype," David Thomas said. "For interferon-intolerant patients, daily sofosbuvir with simeprevir (Olysio, Janssen) with or without ribavirin for 12 weeks is recommended."
".....insurance coverage and cost of the drugs, to which Don Jensen replied that the first iteration does not contain such information. "We haven't taken that into full consideration yet," he said. "The guidelines are what we think is best for a patient who needs therapy at this time." Jensen said "issues of coverage and cost are important for payers and from a public health perspective, and they will be dealt with in due time."....."Our committee is composed of panelists on the clinical side," Henry Masur, MD, of the NIH, said. "We made our recommendations based on what we think is best practice for our patients. We would hope that those responsible for providing medications would follow best practices. We looked at the science."
Thomas said the next question the guidelines will address is how to treat new patients, rather than patients clinicians have already decided to treat. He suggested that it was necessary to deal with new indications for current patients first, before attempting to account for the hundreds of thousands of new diagnoses resulting from expanded screening protocols.
"This is the beauty of Web-based guidance," Jensen said. "We can be nimble and address things quickly without waiting 18 months for new guidelines to come out."
Jensen added that this streamlined flow of information benefits not just clinicians, but payers and patients.
New sections will be added, and the recommendations will be updated on a regular basis as new information becomes available. An ongoing summary of "recent changes" will also be available for readers who want to be directed to updates and changes.
HCVguidelines.org is the result of an ongoing collaboration between the two medical professional societies and IAS-USA. A panel of 26 liver disease and infectious diseases specialists and a patient advocate developed evidenced-based, consensus recommendations for the screening, treatment and management of patients with HCV. This guidance will be made available for health care providers who treat the disease and others who need updated information on the best practices. The site will be updated regularly to keep pace with improved diagnostic tools and new drug options as they meet Food and Drug Administration approval.
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Guidelines Homepage: http://www.hcvguidelines.org/
Full Report:
http://www.hcvguidelines.org/full-report-view
Recommendations for Testing, Managing, and Treating Hepatitis C.......http://www.hcvguidelines.org/full-report/hcv-testing-and-linkage-care
from Jules: this year likely at the end of the 1st quarter both Gilead & Abbvie will submit approval for interferon-free regimens which have yielded 95-100% cure rates with as little as 12 weeks duration of therapy, phase 3 studies are ongoing, press releases with data from these studies have been released. It is estimated as much as 75% of HCV-infected remain untested & undiagnosed, so its estimated perhaps as many as 5 or 7-8 million have HCV in the USA although official federal estimates are 3.5 million. Abbvie & Gilead regimens should get approved by the end of 2014 by the FDA. The NS5A inhibitor Daclatasvir submission to the FDA for approval by BMS is expected this year, as well so is review of approval for the HCV protease inhibitor Faldaprevir from Boehringer Ingelheim. Ongoing are interferon-free HCV regimens with similar results in earlier studies in phase 2 & 3 by BMS, Merck, Janssen. Just last week before these guidelines were released new studies were announced using Daclatasvir+Sofosbuvir for treatment-naive & treatment-experienced for HCV/HIV coinfected patients, patients with cirrhosis, patients with genotype 3 and patients after transplant. Earlier phase 2 studies with this regimen for prior telaprevir & boceprevir failures yielded 100% SVR rates, with similar results in genotype 2/3, below are links to this info.
1. INITIAL TREATMENT OF HCV INFECTION IN PATIENTS STARTING TREATMENT, for genotypes 1-6 .....http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection-patients-starting-treatment
2. RETREATMENT OF PERSONS IN WHOM PRIOR THERAPY HAS FAILED......http://www.hcvguidelines.org/full-report/retreatment-persons-whom-prior-therapy-has-failed [from Jules: for prior Peg/rbv with a protease inhibitor non responder patients who are eligible to take IFN the guidelines recommend Sofosbuvir+Rbv+Peg-IFN with a rating of Class2b, Level C, just prior to these guidelines being released a series of studies were announced using Daclatasvir+Sofosbuvir for certain proscribed patient populations including HCV/HIV coinfected treatment-naive & experienced patients, patients with cirrhosis, for genotype 3 patients, and post-liver transplant patients; my understanding is in Europe access will be provided to this regimen as well likely just for certain proscribed patient populations......Daclatasvir+Sofosbuvir-new studies, Daclatasvir Phase 3 IFN-free, EMA Compassionate Use, Accelerated EMA Marketing Review Recommendation]
3. UNIQUE PATIENT POPULATIONS: 1. Patients with HIV/HCV Coinfection; 2. Patients with Cirrhosis; 3. Patients Who Develop Recurrent HCV Infection Post-Liver Transplantation; 4. Patients with Renal Impairment, Including Severe Renal Impairment (CrCl <30 mL/min) or ESRD Requiring Hemodialysis or Peritoneal Dialysis.......http://www.hcvguidelines.org/full-report/unique-patient-populations....[from Jules: regarding HIV/HCV connected treatment-naive & experienced, patients with cirrhosis, & patients with genotype 3, again, the announcement just last week prior to the release of these guidelines of studies of Daclatasvir+Sofosbuvir: Daclatasvir+Sofosbuvir-new studies, Daclatasvir Phase 3 IFN-free, EMA Compassionate Use, Accelerated EMA Marketing Review Recommendation]
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Daclatasvir+Sofosbuvir-new studies, Daclatasvir Phase 3 IFN-free, EMA Compassionate Use, Accelerated EMA Marketing Review Recommendation ......Sofosbuvir (Sovaldi) - Gilead U.S. Patient Assistance Program - (12/10/13)......Simeprevir (Olysio) J & J Patient Access Programs
Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection - (01/17/14)
GILEAD ANNOUNCES SVR12 RATES FROM THREE PHASE 3 STUDIES EVALUATING A ONCE-DAILY FIXED-DOSE COMBINATION OF SOFOSBUVIR AND LEDIPASVIR FOR GENOTYPE 1 HEPATITIS C PATIENTS - For Immediate Release - (12/18/13)
ABBVIE DEMONSTRATES 96 PERCENT SVR(12) IN ITS PHASE III STUDY OF TREATMENT-EXPERIENCED PATIENTS WITH GENOTYPE 1 HEPATITIS C - (12/18/13)
AbbVie Releases First of Six Phase III Results from Investigational All-Oral, Interferon-Free, 12-week Regimen, Showing 96 Percent SVR12 in Genotype 1 Hepatitis C Patients New to Therapy - (11/18/13)
Roche at AASLD - (11/26/13)
AASLD: Gilead at AASLD: Sofosbuvir for GT 3, 2 and 1 - (11/18/13)
AASLD: Gilead at AASLD: 2 - (11/18/13)
AASLD: BMS at AASLD - (11/18/13)
AASLD: Boehringer Ingelheim - (11/18/13)
AASLD: Merck at AASLD - (11/18/13)
AASLD: Janssen at AASLD - (11/18/13)
AASLD: Abbvie at AASLD - (11/18/13)
Boehringer Ingelheim HCV Announcement - (01/17/14)
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