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CDC/NYS HCV: Screen Baby Boomers/IDUs-New HCV Treatments
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- CDC Recommends Baby Boomers Tested for Hepatitis C (born between 1945-1965),
- All persons who use or inject drugs illicitly should routinely be offered screening and counseling for HCV infection,
- NYS/Gov Cuomo Pass Law requiring hospitals and health service providers to offer testing for the virus to all patients born between 1945 and 1965
http://www.youtube.com/watch?v=S_bDKPMsNNY
Hepatitis C: Did You Know? by Centers for Disease Control and Prevention (CDC)
CDC HIV & Hepatitis C Screening & Services Guidelines / Recommendations - IDUs Highlighted
http://www.natap.org/2012/HCV/113012_01.htm
"All persons who use or inject drugs illicitly should routinely be offered screening and counseling for HCV infection. Persons with a history of risk, even those who have injected illicitly once or many years ago, should be offered screening and counseling for HCV infection. Facilities that provide counseling and testing should include services or referrals for medical evaluation and management of persons identified as infected with HCV."
USPSTF Recommends Screening Baby Boomers for HCV with a "B", Upgraded from the "C" in the Draft Recommendations from November 2012
http://www.natap.org/2013/HCV/062513_06.htm
The USPSTF recommends screening for hepatitis C virus (HCV) infection in persons at high risk for infection. The most important risk factor for HCV infection is past or current injection drug use, with most studies reporting a prevalence of 50% or more. Task Force strengthened its recommendation for individuals born between 1945 and 1965 from a C grade to a B grade, reflecting increased certainty of the overall benefit of screening
The USPSTF also recommends offering 1-time screening for HCV infection to adults born between 1945 and 1965. (B recommendation)......Persons with continued risk for HCV infection (injection drug users) should be screened periodically. ......study showed a decrease in the risk for all-cause mortality compared with no SVR across patient groups stratified by genotype......positive association between SVR and reduced risk for all-cause mortality (HR, 0.26
(USPSTF) Expanded Hepatitis C Virus Screening Recommendations Promote Opportunities for Care and Cure - Editorial - (06/25/13)
NY State Senate Passes HCV Screening Bill for "Baby Boomers" - NY Baby Boomers Could Avoid Serious Disease With New Hep C Test Requirement - (06/25/13)
Governor Cuomo Signs Bill to Require Hospitals to Offer Hepatitis C Testing - (10/25/13)
Governor Andrew M. Cuomo today signed a new law that will better protect baby boomer New Yorkers from Hepatitis C by requiring hospitals and health service providers to offer testing for the virus to all patients born between 1945 and 1965
NEW TREATMENTS for HCV
In December 2013 the FDA approved 2 new HCV orally administered HCV drugs (DAAs: direct acting antivirals), the protease inhibitor Simeprevir from Janssen & the nucleoside polymerase inhibitor Sofosbuvir from Gilead. At this moment these are newly approved HCV regimens: New HCV Treatments - (11/25/13). In early 2014 it is expected Boehringer Ingelheim's HCV protease inhibitor Faldaprevir will be approved by the FDA; and also in 2014 it is expected that in the first 3 months or perhaps it might take as long as 6 months, the FDA will approve 2 new interferon-free therapies from Abbvie & Gilead; press releases announced in the past 2 weeks provided early results showing 96-99% SVR "cure" rates with 12 weeks therapy, perhaps 8 weeks for some patients with the Gilead regimen. Also in development are additional interferon-free therapies (DAAs) with 12 weeks duration of therapy showing similar results, SVR rates, from BMS, Merck, and Boehringer Ingelheim.
Here are links to the recent press releases from Abbvie & Gilead, and links to recently reported study results of these additional regimens showing similar SVR "cure" rates. These results were reported at the major US annual liver meeting AASLD, held November 1 in Washington DC, 2013, AND if you want more study results at the end below are links to recent HCV updates, news, full AASLD conference reports of all the study results reported, and an AASLD comprehensive Summary Report written for NATAP by Jurgen Rockstroh, MD. Gilead has said: "Gilead will help U.S. patients pay for sofosbuvir if they can't afford it..... or the company will help them look for drug coverage. And Gilead will charge far less for a course of the drug in places such as India, Pakistan, Egypt and China, where most people with hepatitis C live.....Gilead is committed to helping ensure access to Sovaldi in resource-limited settings. The company is developing a hepatitis C treatment access program, focusing on those countries with the greatest HCV burden. Full program details will be announced in the coming months" and I expect the same from Abbvie and others in this market.
OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C - (11/25/13)
Olysio (Simeprevir): FDA (preliminary prescribing information; summary of the basis of approval and highlights from the prescribing information - (11/26/13)
U.S. Food and Drug Administration Approves Gilead's Sovaldi(TM) (Sofosbuvir) for the Treatment of Chronic Hepatitis C (FDA Label, prescribing information)- (12/06/13)
Simeprevir (Olysio) J & J Patient Access Programs
Sofosbuvir (Sovaldi) - Gilead U.S. Patient Assistance Program
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 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)
ABBVIE DEMONSTRATES 96 PERCENT SVR(12) IN ITS PHASE III STUDY OF TREATMENT-EXPERIENCED PATIENTS WITH GENOTYPE 1 HEPATITIS C - (12/18/13)
AASLD: SVR results of a once-daily regimen of simeprevir (SMV, TMC435) plus sofosbuvir (SOF, GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study - (11/05/13)
EASL: Sustained Virologic Response With Daclatasvir Plus Sofosbuvir ± Ribavirin (RBV) in Chronic HCV Genotype (GT) 1-Infected Patients Who Previously Failed Telaprevir (TVR) or Boceprevir (BOC) - (04/27/13)
EASL/2012: Potent Viral Suppression With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) and GS-7977 (Nucleotide NS5B Inhibitor), +/- Ribavirin, in Treatment-Naive Patients With Chronic HCV GT1, 2, or 3 (100% SVR gt1, 91% gt2) - (04/19/12)
AASLD: Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection - (11/04/13)
AASLD: Phase 2b Study of the Interferon-Free and Ribavirin-Free Combination of Daclatasvir, Asunaprevir, and BMS-791325 for 12 Weeks in Treatment-Naive Patients With Chronic HCV Genotype 1 Infection - (11/05/13)
AASLD: High Efficacy and Safety of the All-Oral Combination Regimen, MK-5172 / MK-8742 ± RBV for 12 Weeks in HCV Genotype 1 Infected Patients: The C-WORTHY Study - (11/05/13)
An all-oral phase IIa study combining Simeprevir, TMC647055 and JNJ56914845 in hepatitis C patients to be initiated - (12/16/13)
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AASLD: Summary from AASLD 2013 for Hepatitis C Washington 1-5 November 2013 - Written by Jurgen K. Rockstroh M.D., Professor of Medicine University of Bonn, Germany
HCV News, Updates: Hep C Articles...
64rd Annual Meeting of the American Association for the Study of Liver Diseases
Washington, DC Nov 1-5 2013
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)
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