HepCBC is seeking individual patient input for our submission to the federal government for an INTERFERON-FREE, ONE PILL/DAY drug combo, shown to be effective for genotypes 1, 3, 4, and 6, Merck Pharmaceutical’s elbasvir + grazoprevir (± ribavirin). The treatment’s success (96% – 100% SVR12) has been confirmed in trials including people considered ‘hard to treat’ including those who had failed previous treatment (including simeprevir, boceprevir, and telaprevir), were co-infected with HIV, had advanced liver disease, or had renal issues requiring dialysis.

Most patients will be able to clear the disease in 12 weeks without the use of ribavirin. The use of ribavirin and increasing the treatment time is necessary to get a high rate of success with hard-to-treat patients.

ADD YOUR VOICE! We will be accepting input from anyone affected by hepatitis C between Wednesday, Oct. 14th, 2015 and midnight on Friday, Nov. 6, 2015 through this confidential online form: 
Click here for PATIENT INPUT FORM for Merck’s grazoprevir+elbasvir ± ribavirin 

EVER WONDER WHAT WE DO WITH YOUR INPUT? View all of our Patient Group Submissions since 2011 HERE!

FURTHER INFORMATION about this new treatment: 

Elbasvir is an NS5A “replication complex inhibitor” also known as MK-8742.
Grazoprevir is an NS3/4A “protease inhibitor” also known as MK-5172.

The length of treatment in these research studies varied from 4 to 24 weeks. The results showed that treatment should generally be either 12, or 16 weeks, depending on genotype, degree of liver damage, and treatment history. The value of adding ribavirin to the combo was shown to generally depend on these three factors as well.

Common side effects reported include (in order of frequency): Fatigue, headache, asthenia (weakness, lack of energy), and nausea. These side-effects were generally minor or moderate. Very few cases were reported of severe side effects, or of side-effects so debilitating as to end treatment.

Elbasvir and grazoprevir were granted “Priority Review” status by the US Food and Drug Administration (FDA) on July 28, 2015 for genotypes 1, 4, and 6. Studies referenced included previously treated, those with compensated cirrhosis, HIV/HCV co-infection, chronic kidney disease stages 4 and 5, inherited blood disorders, and those on opiate substitution therapy.

In April, 2015, the FDA had granted “Breakthrough Therapy” status for this combo with two groups: genotype 1 with end-stage renal disease on hemodialysis, and for anyone with genotype 4.

Seven trials using this drug combo are described below, one of which investigated using this combo with a third Direct-Acting Antiviral (DAA), sofosbuvir, which is added in the C-SWIFT study for GT 1 and 3 patients.

** The great links below are from the National AIDS Treatment Advocacy Project ( NATAP) in the USA (Thanks, NATAP!)**

 

GT 1, 4 & 6 Treatment Naive
C-EDGE TN: PHASE 3 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.
http://www.natap.org/2015/EASL/EASL_29.htm

GT 1, 4 & 6, HIV-HCV Co-infection
C-EDGE COINFECTION: PHASE 3 STUDY OF GRAZOPREVIR/ELBASVIR IN PATIENTS WITH HCV/HIV (GT 1, 4, 6)
http://www.natap.org/2015/EASL/EASL_07.htm

GT 1, 4 & 6 Treatment experienced
C-EDGE TE: Phase 3 EFFICACY AND SAFETY OF GRAZOPREVIR/ELBASVIR +/- RBV FOR 12 OR 16 WEEKS IN PATIENTS WITH HCV G1, G4 OR G6 INFECTION WHO PREVIOUSLY FAILED PEGINTERFERON/RBV
http://www.natap.org/2015/EASL/EASL_04.htm

GT 1, Chronic Kidney Disease, stage 4 &5
C-SURFER: Phase 3 GRAZOPREVIR PLUS ELBASVIR IN TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS WITH HEPATITIS C VIRUS GENOTYPE 1 INFECTION AND CHRONIC KIDNEY DISEASE
http://www.natap.org/2015/EASL/EASL_10.htm

GT 1, DAA treatment failure
C-SALVAGE: Phase 2 GRAZOPREVIR (GZR; MK-5172), ELBASVIR (EBR; MK-8742) AND RIBAVIRIN (RBV) FOR CHRONIC HCV-GENOTYPE 1 (GT1) INFECTION AFTER FAILURE OF DIRECT-ACTING ANTIVIRAL (DAA) THERAPY
http://www.natap.org/2015/EASL/EASL_03.htm

GT 1, GT 3, Triple therapy 4-12 weeks naive
C-SWIFT: GRAZOPREVIR/ELBASVIR + SOFOSBUVIR IN CIRRHOTIC AND NONCIRRHOTIC, TREATMENT-NAIVE PATIENTS WITH HEPATITIS C VIRUS GENOTYPE 1 INFECTION, FOR DURATIONS OF 4, 6 OR 8 WEEKS AND GENOTYPE 3 INFECTION FOR DURATIONS OF 8 OR 12 WEEKS
http://www.natap.org/2015/EASL/EASL_11.htm

GT 1b: 8 Week naïve non-cirrhotic
C-WORTHY: Phase 2 EFFICACY OF AN 8-WEEK REGIMEN OF GRAZOPREVIR PLUS ELBASVIR WITH AND WITHOUT RIBAVIRIN IN TREATMENT-NAIVE, NONCIRRHOTIC HCV GENOTYPE 1B INFECTION
http://www.natap.org/2015/EASL/EASL_62.htm

Click here for PATIENT INPUT FORM for Merck’s grazoprevir+elbasvir ± ribavirin