Medivir announces that Janssen has initiated an open-label phase IIb study of the 3DAA combination of simeprevir, odalasvir and AL-335 (JNJ-4178)

A phase IIb open-label study of the combination of simeprevir, odalasvir and AL-335, also known as JNJ-4178, has been initiated by Janssen in treatment-naive and treatment-experienced subjects with chronic hepatitis C virus infection without cirrhosis. This global, multi-center study includes clinical trial sites in North America, Europe and Asia and forms part of Janssen’s global development program for JNJ-4178. The objectives of the phase IIb study are

Updated: HepCBC Patient Group Submissions to CADTH and BC Pharmacare

To view all submissions (2011 to present) HepCBC has made to either CADTH (to determine if drug should be allowed for sale in Canada for a specific purpose) and BC Pharmacare (to determine if drug should be covered/purchase reimbursed by Pharmacare) please see this updated link: http://hepcbc.ca/patient-group-submissions-bc-pharmacare-cadth/

Simeprevir: two nods from Sask. & Health Canada

Simeprevir received two boosts on Nov. 12th: it is now listed on the Sasketchewan formulary (will be reimbursed by their public health insurance Pharmacare) and was also recommended highly by a Canadian Drug Review (CDR, CADTH, Health Canada) "Therapeutic Review" of hepatitis C DAA's (new Direct Acting Antiviral therapies) for HCV genotype 1. Details below: SASKATCHEWAN FORMULARY DETAILS: simeprevir, capsule, 150mg (Galexos-JAN) For the treatment of chroni

In Praise of Stand-Alone HCV Drugs

BMS recently withdrew its US FDA application for the hepatitis C drug, asunaprevir. It is probably a very wise decision on BMS' part, because asunaprevir is close in formulation and results to several other generation 2 NS3 protease inhibitors*. Instead, BMS seems to be focusing on its more unique product, the NS5A replication complex inhibitor, daclatasvir, of which they say in their Oct. 7 press release, is "currently being investigated globally in multi

CADTH simeprevir (GALEXOS) news!

The Canadian Drug Review's CDEC Board approved simeprevir (GALEXOS) on June 18th, 2014, and has sent HepCBC a thank you letter for its simeprevir submission. Simeprevir (GALEXOS) is a new hepatitis C drug for genotype 1 infection which, at this point at least, is to be used in a triple therapy along with interferon alpha and ribavirin. This drug, developed by Janssen Pharmaceuticals and marketed in the USA as OLYSIO, is also being recommended in the US and

US Prisoners get sofosbuvir-simeprevir with new Guidelines

In Canada, we are still awaiting the kind of hepatitis C treatment now recommended for federal prisoners in the USA! New guidelines were just released in May 2014 and are available here: http://www.bop.gov/resources/pdfs/hepatitis_c_current.pdf These are the recommended treatments for federal prisoners with chronic hepatitis C, according to genotype (GT): GT1: PREVIOUS NON-RESPONDER (partial or null) TO INTERFERON TREATMENT or INTERFERON-INTOLERANTcombine

Simeprevir (GALEXOS) now covered in Quebec as well!

Simeprevir (GALEXOS) is also now covered on the Quebec formulary, according to CATIE, the Canadian AIDS Treatment Information Exchange. However, it is only available to those who have already failed conventional treatment with interferon and ribavirin. It is available only to genotype 1 patients who do not have the Q80K mutation and not co-infected with HIV. MUST MEET ALL THESE QUALIFICATIONS TO GET REIMBURSED FOR SIMEPREVIR: -- to be used in association w

PATIENTS, CAREGIVERS: HepCBC NEEDS YOUR INPUT RE: SIMEPREVIR

Simeprevir (trade name GALEXOS™, produced by Janssen, Inc.) was recently approved for use in Canada to treat hepatitis C, but BC PharmaCare doesn't cover it yet. Like similar drugs telaprevir/INCIVEK™ and boceprevir/VICTRELIS™, simeprevir is generally given to genotype 1 patients for several weeks in combination with two other medications (hence the name, "Triple Therapy"). In Triple Therapy with simeprevir, the drug is taken once a day (one pill) along wi

GALEXOS™ (simeprevir) approved by Health Canada

Simeprevir (trade name Galexos) has now been approved for use in Canada. It is a once-daily pill which is taken along with ribavirin and pegylated interferon alfa to treat hepatitis C genotype 1 in a "triple therapy."  There will still be many months before it is approved for coverage by your provincial Pharmacare plan. See details in complete Janssen Inc. Press Release below. ### New Treatment for Hepatitis C Approved by Health Canada Priority Review Give

URGENT REQUEST FOR YOUR INPUT into a new HCV drug, SIMEPREVIR

On August 22nd, 2013 the Canadian Agency for Drugs and Technologies in Health (CADTH) released a call for patient input into Janssen Inc.'s new HCV drug, SIMEPREVIR. In order to prepare our Patient Group submission by the Sept. 13th deadline, HepCBC is ASKING for INPUT from HCV+ people and caregivers from throughout Canada, by Wednesday, Sept. 11th. CLICK HERE to ADD YOUR VOICE to HepCBC's group submission which will help determine whether this new treatme