Hepatitis c treatments in current clinical development

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Hepatitis C Treatments in Current Clinical Development
Alan Franciscus
Editor-in-Chief
Updated April 6, 2012
Drugs in Development – Direct Acting Antiviral (DAA) Combinations
Drugs in Development - General
HIV / HCV Coinfection Studies
Interferon Free Trials
Clinical Trial Process: Making Sense of Clinical Trials
How to Read an Abstract
Cancelled Trials
On Hold
To locate clinical trials go towww.clinicaltrials.gov – type in HCV or hepatitis C and drill down
to studies that are listed by this resource.

Terms Used
Dosing:




BID = Taken twice a day
QD = Taken once a day
TID = Taken three times a day (every 7 to 9 hours)

Response:







RVR (Rapid virological response)= No virus detected at week 4
eRVR(Extended rapid virological response) = No virus detected at week 4 and week12
EVR (Early Virological Response) — 2 log drop of HCV RNA after 12 weeks.
cEVR = Complete Early Virological Response — No virus detected after 12 Weeks.
SVR12 (Sustained virological response) = No virus detected at 12 weeks after completion
of treatment.
SVR24 = No virus detected at 24 weeks after completion of treatment.

1

Quick Reference Guide
Phase I
Drug Name

Drug Category

CompanyALS-2158

Polymerase Inhibitor

Alios

ALS-2200

Polymerase Inhibitor

Alios

ABT-072

Polymerase Inhibitor

Abbott

ABT-333

Polymerase Inhibitor

Abbott

ACH-2684

Protease Inhibitor

Achillion

ACH-2928

NS5A Inhibitor

Achillion

AZD-7295

NS5A Inhibitor

AstraZeneca

Clemizole

NS4B Inhibitor

Eiger BioPharmaceuticals

IDX719

NS5A Inhibitor

Idenix

ITX-5061

Entry Inhibitor

iTherX

MK-3281Polymerase Inhibitor

Merck

PPI-461

NS5A Inhibitor

Presidio

PPI-688

NS5A Inhibitor

Presidio

TMC649128

Polymerase Inhibitor

Medivir / Tibotec

Note: Only drugs that have advanced into phase 2 and 3 studies will include comments

DAA Combinations
Drug Name/
Drug Name/
Category
Category
ABT-450 Protease ABT-072 Polymerase Inhibitor
Inhibitor

Company
Abbott / Enanta

ABT-450 ProteaseInhibitor

ABT-267 Cytochrome P450 Inhibitor

Abbott / Enanta

ABT-450 Protease
Inhibitor

ABT-267 Cytochrome P450 Inhibitor
and/or ABT-333 Polymerase Inhibitor

Abbott / Enanta

2

Phase /
Updated
Phase II
Apr 6,
2012
Phase II
Feb 7,
2012
Phase II
Apr 6,
2012

ABT-450 Protease
Inhibitor

ABT-333 Polymerase Inhibitor

Abbott / Enanta

BI 201335
Protease Inhibitor

BI 207127 Polymerase InhibitorBMS-790052
(Daclatasvir)
(NS5a Inhibitor)
BMS-790052
(Daclatasvir)
(NS5a Inhibitor)
Boceprevir
Protease Inhibitor

BMS-650032 (Asunaprevir)
(Protease Inhibitor)

Boehringer
Ingelheim
Pharma
Bristol-Myers
Squibb

GS-7977 (Polymerase Inhibitor)

Bristol-Myers
Squibb / Gilead

Mericitabine Polymerase Inhibitor

Merck /
Genentech

GS-9256

GS-9190 (Tegobuvir)

Gilead

GS-7977
Polymerase
Inhibitor
RG7128(Polymerase
Inhibitor)
Telaprevir
(Protease Inhibitor)

TMC435
NS3/4A Inhibitor

Gilead/ Tibotec

RG7227(Danoprevir) Protease Inhibitor

Genentech

VX-222 (Polymerase Inhibitor)

Vertex

Phase 2
Drug Name
ABT-450
ACH-1625
ANA598
(Setrobuvir)
BI 207127
BIT225
BMS-650032
(Asunaprevir)

Drug Category
Protease Inhibitor
Protease Inhibitor
Polymerase
Inhibitor
Polymerase
Inhibitor
p7 Inhibitor
ProteaseInhibitor

Phase II
Apr 6,
2012
Phase II
Nov 7,
2011
Phase II
Jan 21,
2012
Phase II
Nov 4,
2011
Phase II
Dec 16,
2011
Phase II
Sep 22,
2011
Phase II
July 10,
2011
Phase II
Apr 5,
2011
Phase II
Mar 5,
2012

Company
Abbott / Enanta
Achillion
Anadys / Genentech

Updated
Oct 22, 2011
Jan 9, 2012
Oct 20, 2011

Boehringer Ingelheim
Pharma
Biotron
Bristol-Myers Squibb

Jun 29, 2010

3

Oct 12, 2011
Aug 5,2011

BMS-791325
Filibuvir
GS 9190 (Tegobuvir)
GS-9256
IDX184
INX-189
MK-5172
GS-938
RG7128
(Mericitabine)
RG7227 (Danoprevir)
Vaniprevir (MK-7009)
VX-222
VX-759

Phase 3
Drug Name
BI 201335
BMS-790052
(Daclatasvir)
GS-7977
Telaprevir (Phase IIIb)
TMC435
Phase 4
Drug Name
Boceprevir
Telaprevir

Protease Inhibitor
Polymerase
Inhibitor
Polymerase
Inhibitor
Protease Inhibitor
Polymerase
Inhibitor...
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