Hepatitis C Treatments in Current Clinical Development

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Hepatitis C Treatments in Current Clinical Development

Updated: July 24, 2010

There are many compounds being studied to treat hepatitis C. A number of compounds for these targets are in early “test-tube†development or pre-clinical “animal†development phases. Most of these compounds, however, will never make it to trials in humans (clinical studies). In fact, only one in 1,000 compounds makes it to human testing. Of those drugs that make it to human testing only 1 in 5 will receive FDA marketing approval. Therefore, every effort has been made to focus this list only on treatments that are known to be in current or very near to active clinical development in human subjects.

When a company is ready to proceed to clinical trials, it files an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA). Most clinical trials are designated as phases I, II, or III, and sometimes IV based on the type of questions that the study is seeking to answer.

Study Phases

In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to evaluate safety, optimal dose, and may include some information on the drug’s effectiveness. Most drugs that enter phase II studies do not progress on to phase III studies. This is because the drug is being tested in more people for a generally longer period of time so lack of effectiveness and a better picture of the effectiveness emerges. In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. In Phase IV studies, the drug is already on the market for a particular indication, but is now being tested to answer questions about sub-populations of the same condition it is approved to treat, or for a different indication, use, or disease.

The testing of new drugs is a long process that typically takes about 12 years from pre-clinical testing to FDA approval and marketing to the general public.

Fast Track Status:

A drug can be granted fast track status by the Food and Drug Administration to help facilitate the development and to expedite the review process of new drugs that have the potential to address an unmet medical need for serious or life-threatening conditions such as hepatitis C.

Orphan Drug Status:

A status given to a certain drug by the Food and Drug Administration to encourage the development of drugs that are necessary, but are too expensive or unprofitable to develop under regular circumstances. Drugs being developed to treat orphan diseases (low prevalence in the population) offer tax reductions and marketing exclusivity for the drug manufacturer (up to 20 years).

For more information about clinical trials for the treatment of hepatitis C go to www.clincaltrials.gov.

STAT-C Combinations HCV Inhibitors

Drugs ( General)

Interferons

Vaccines in Development

Anti Cancer Drugs

Adjunct Therapies

Clinical trials on Hold

Clinical Trials that Have Been Cancelled

Clinical Trials – Timeline for new drug development

Preclinical Testing

Phase I

Phase II

Phase III

FDA

Total

Years

Phase IV

Years

3.5

1

2

3

2.5

12

Post-marketing

Test Population

Laboratory & animal studies

20 to 80 healthy volunteers

100 to 300 patient volunteers

1000 to 3000 patient volunteers

Review process/ Approval

Purpose

Assess safety and biological activity

Determine safety and dosage

Evaluate effectiveness, look for side effects

Verify effectiveness, monitor adverse reactions from long-term use

Success Rate

5,000 compounds evaluated

5 enter trials

1 Drug approved

Source: www.allp.com

The following tables will be updated as clinical developments move forward:

Drugs in Current Clinical Development

Specifically targeted antiviral therapy for HCV (STAT-C) Combinations

Drug Name / Category

Drug Name / Category

Pharmaceutical Company

Clinical Phase

RG7128

(Polymerase Inhibitor)

RG7227 (ITMN-191)(Danoprevir)

Protease Inhibitor

Genentech in collaboration with Pharmasset & InterMune

Phase I

Comments: AASLD 2009: Results from 13 days of treatment with RG7128 & RG7227: 63% (5 out of 8) genotype 1 treatment-naive patients were HCV RNA negative (<15 IU/mL) and 25% (2 out of 8) of null responders were HCV RNA negative (<15 IU/mL). The drugs were well-tolerated; no treatment discontinuations due to side effects. Special Presentation Click Here.

On November 17 2009, InterMune announced that an independent data monitoring committee recommended the company stop testing the therapy in the RG7227 900 milligram dosage given once every 12 hours after three patients had elevated levels of ALT, a liver enzyme. EASL 2010: A small study using ritonavir (100 mg) to boost danoprevir (200 mg) both given twice a day achieved 100% undetectable HCV RNA after 15 days and was generally well-tolerated. Based on these findings an additional two study arms of prior complete non-responders will be retreated with danoprevir, ritronavir, PEG/RBV for 12 weeks. A larger study titled INFORM-3 is being planned that will include ritonavir. (June 30, 2010)

Telaprevir

Protease Inhibitor

VX-222

Polymerase Inhibitor

Vertex

Phase II

Comments: On March 2, 2010 Vertex announced the initiation of a phase II trial of telaprevir/VX-222 (2 arms with and 2 arms without pegylated interferon/ribavirin). There will be 4 treatment arms with 25 patients in each arm. The treatment duration (12 weeks, 36 weeks) will be guided by response at certain time points during the trial. (March 2, 2010)

HCV Inhibitors

Drug Name

Drug Category

Pharmaceutical Company

Clinical Phase

PPI-461

NS5A Inhibitor

Presidio Pharmaceuticals

Phase I

Comment: On July 14, Presidio Pharmaceuticals, Inc. announced completion of their phase Ia trial to test the safety, tolerability, and pharmacokinetic properties of PPI 461 in 40 healthy subjects. The study evaluated four single doses followed by a 5-day, once-a-day dose with PP-461 at the highest doses. PPI-461 was found to be safe and well-tolerated with a steady-state pharmacokinetic (drug exposure) profile. A phase Ib study in people with HCV is expected to begin in the fourth quarter of 2010. (July 19, 2010)

IDX320

Protease Inhibitor

Idenix

Phase I

Comments: On June 10, Idenix announced a 3-day proof of concept study of IDX320 in treatment naïve HCV genotype 1. (June 30, 2010)

IDX375

Polymerase Inhibitor

Idenix

Phase I

Comments: Six healthy subjects received 5 doses 25 mg once daily (QD), 50 mg QD, 100 mg QD, 200 mg QD AND 200 mg twice a day or placebo; IDX375 was generally safe and well-tolerated. The trial is on-going and Idenix is planning additional studies. (January 12, 2009)

ABT-072

Polymerase Inhibitor

Abbott

Phase I

Comments: Studies were announced that will assess multiple doses of ABT-072 for a 3-day period. This study will be followed by a triple combination study of ABT-072 in combination with pegylated interferon plus ribavirin for 12 weeks and an additional 36 weeks of pegylated interferon plus ribavirin. All participants are HCV genotype 1 treatment-naïve patients. (March 2, 2010)

Clemizole

NS4B Inhibitor

Eiger BioPharmaceuticals

Phase I

Comments: On August 11, 2009 it was announced that a proof of concept study will be launched to test clemizole in HCV treatment-naive genotype 1 & 2 patients. (August 13, 2009)

ACH-1625

Protease Inhibitor

Achillion

Phase I

Comments: Results from two small studies (9 pts and 8 pts) treated with 200 or 600 mg for 5 days had a 3.86 and 3.81 log10 viral load decline respectively. Adverse events were classified as mild to moderate. (June 2, 2010)

MK-3281

Polymerase Inhibitor

Merck

Phase I

Comments: AASLD 2009: Results from a small study of 22 HCV treatment-naive and treatment-experienced patients. In the genotype 1b group there was found to be a 3.75 log10 decrease in HCV RNA. No serious side effects were reported. (November 06, 2009)

PSI-7851

Polymerase Inhibitor

Pharmasset

Phase I

Comments: AASLD 2009: In a multiple dose (50mg, 100mg, 200mg or 400mg) study of treatment-naive HCV genotype 1 patients (40 patients) treated for 3 days PSI-7851was well-tolerated. The dose-dependent HCV RNA decline was up to 1.95 log10 IU/mL. Additional studies of PSI-7851 in combination with pegylated interferon plus ribavirin are being planned. (November 6, 2009)

ABT-450 HCV

Protease Inhibitor

Abbott / Enanta

Phase 1

Comments: Studies were announced that will assess multiple doses of ABT-450 for a 3-day period. This study will be followed by a triple combination study of ABT-450 in combination with pegylated interferon plus ribavirin for 12 weeks and an additional 36 weeks of pegylated interferon plus ribavirin. All participants are HCV genotype 1 treatment-naïve patients. (March 2, 2010)

VX-813

Protease Inhibitor

Vertex

Phase I

Comments: Vertex has announced that they have initiated a Phase I study. (October 28, 2008)

PHX1766

Protease Inhibitor

Phenomix

Phase I

Comments: AASLD 2009: In a study of healthy volunteers and HCV genotype 1 patients given PHX1766 the average maximal HCV-RNA decline observed in 6 days was 1.2 log10 in the 400mg BID group and 1.8 log10 in the 800mg BID group. PHX1766 was generally well-tolerated. One serious adverse event was reported but the authors stated that it was unrelated to the study drug. (November 6, 2009)

ABT-333

Polymerase Inhibitor

Abbott

Phase I

Comments: AASLD 2009: In all the groups who were treated with ABT-333 plus pegylated interferon/ribavirin—at Day 28 41.7% (10 out of 24 patients) had less than 25 IU/mL HCV RNA compared to 0% (0 out of 6 patients) in the placebo group (without ABT-333). The side effects were reported to be mild in severity (85%) with 63% believed to be from pegylated interferon /ribavirin. There were no serious AEs or discontinuations due to AEs.

Studies were announced that will assess multiple doses of ABT-333 for a 3-day period followed by an additional 26 days with ABT-333, pegylated interferon/ribavirin. This study will be followed by a triple combination study of ABT-333 in combination with pegylated interferon plus ribavirin for 12 weeks followed by an additional 36 weeks of pegylated interferon plus ribavirin. All participants are HCV genotype 1 treatment-naïve patients. (June 30, 2010)

VX-916

HCV Polymerase Inhibitor

Vertex

Phase I

Comments: In a small study of healthy volunteers, VX-916 was found to be generally safe and well-tolerated and achieved plasma concentrations proportional to the dose given. Based on these results a 14-day study of HCV genotype 1 treatment-naïve subjects is being planned. On March 12, 2009, Vertex announced that it had completed acquisition of Virochem and will be developing Virochem’s HCV polymerase inhibitors in combination with their drug and will study Virochem’s drugs in combination with pegylated interferon plus ribavirin. (March 13, 2009)

Filibuvir

(PF-00868554)

HCV Polymerase Inhibitor

Pfizer

Phase I

Comments: EASL 2010: Week 4 data from a study of 35 patients treated with 200, 300, 500 mg (plus placebo) BID (twice a day) plus pegylated interferon/ribavirin found that up to 75% were viral load negative at week 4. SVR 12 rates were similar between the filibuvir groups vs the placebo group, which is believed to be the result of the short treatment period—longer duration studies have been initiated. (June 30, 2010)

VX-500

HCV Protease Inhibitor

Vertex

Phase I

Comments: VX-500 recently began a phase Ib study. Data is expected in the first quarter of 2009. (February 10, 2009)

RG7128

Polymerase Inhibitor

Pharmasset/Genentech

Phase I

Comments: Pharmasset announced the FDA approval of a phase 2b study of RG7128 in combination with Pegasys/ribavirin. 400 HCV genotype 1 or 4 treatment-naïve patients were enrolled into 4 arms – RG7128 (500 or 100mg bid) plus Pegasys/ribavirin for a treatment durations of 24 or 48 weeks and one control arm – Pegasys/ribavirin – for a treatment duration of 48 weeks. In 2/2010 it was announced that enrollment of participants in the study had been completed. EASL 2010: Results from a small study of 20 genotype 2 and 3 patients who did not achieve an SVR in a previous course of interferon therapy and who were retreated with RG7128 and Pegasys/ribavirin found that 90% of the patients treated for 48 weeks achieved an SVR compared to 67% for the group who were treated for 24 weeks.

Interim results from the PROPEL study were released—in the study HCV genotype 1 and 4 patients were treated with RG7128 (with pegylated interferon/ribavirin) or pegylated interferon/ribavirin (without RG7128). More than 80% of the patients in the RG7128 arm had undetectable viral load compared to less than 50% in the group that did not receive RG7128 after twelve weeks of treatment. (June 30, 2010)

GS-9256

Protease Inhibitor

Gilead

Phase II

Comments: EASL 2010: Results from a three day 6-arm safety and dose-ranging study of 54 HCV genotype 1 treatment-naïve patients was released. It was found that GS-9256 was safe and generally well-tolerated and showed dose dependant antiviral activity. Phase II studies of GS-9256 with or without ribavirin are underway. (April 29, 2010)

BI 201335

Protease Inhibitor

Boehringer Ingelheim Pharma

Phase II

Comments: EASL 2010: results from the SILEN-C2 study of 280 HCV genotype 1 patients who were prior non-responders treated for 24 weeks with either 240mg BI 201335 (once-a-day), 240 mg BI 201335 (once-a-day) after a 3-day lead-in of PEG/RBV or 240 BI 201335 (twice-a-day) after a 3-day lead-in period of PEB/RBV. After 24 weeks of treatment the participants were continued on PEG/RBV for an additional 24 weeks. Interim results found at week 12 reported that 54 to 59% were HCV RNA undetectable (less than 10 IU/mL). The majority of people who discontinued treatment were in the BI twice- a-day group (24%) compared to 4% in the once-a-day groups. (April 29, 2010)

VX-222

Polymerase Inhibitor

Vertex

Phase II

Comments: EASL 2010: results from a small study of 32 HCV genotype 1 treatment-naïve patients treated with various doses of VX-222 (250, 500 and 750 twice-a-day; 1500 mg once-a-day) found a viral load reduction of -3.1 to 3.4 log10 IU/mL) by day 4 of treatment. VX-222 was generally safe and well-tolerated. (April 29, 2010)

IDX184

Polymerase Inhibitor

Idenix

Phase II

Comments: AASLD 2009: Data from a three-day, phase I proof-of-concept study evaluating the safety and antiviral activity of IDX184 (monotherapy) enrolled 41 treatment-naive HCV genotype 1-infected patients into four dosing cohorts (25 mg, 50 mg, 75 mg and 100 mg). Mean viral load declines ranged from 0.47 log10 in the 25 mg group to 0.74 log10 in the 100 mg group after three days of treatment. IDX184 was well-tolerated in this study with no serious adverse events reported and no discontinuations from the study. Idenix announced that it has begun a phase II study of IDX184 in combination with pegylated interferon and ribavirin. On January 11, 2010 Idenix announced that in the 50 mg group (in combination with pegylated interferon/ribavirin) there was a median change in HCV RNA of -3.66 log10 compared to a -1.70 log10 in the group that received the placebo (plus pegylated interferon/ribavirin). (January 12, 2010)

RG7227

(Danoprevir)

Protease Inhibitor

InterMune/Genentech

Phase II

Comments: On September 2, it was announced that InterMune, according to the agreement with Genentech, had met certain milestones and that further clinical development would be transitioned over to Genentech. Genentech announced on August 19, 2009 the initiation of a Phase II clinical trial of RG7227 (ITMN-191) in combination with Pegasys and ribavirin to study safety, tolerability and effectiveness. The study will enroll about 300 patients in 45 global sites. On September 29th it was also announced that a separate study would evaluate the boosting properties of ritonavir when used with the combination of RG7227 (ITMN-191), Pegasys plus ribavirin. Results from a study of 30 HCV genotype 1 treatment-naïve patients treated with ritonavir boosted danoprevir, pegylated interferon/ribavirin for 15 days achieved undetectable viral load of 50% to 100% in the ritonavir boosted danoprevir groups compared to 20% in the placebo group. Treatment of prior non-responders using ritonavir boosted triple therapy is underway. (June 30, 2010)

ANA598

Polymerase Inhibitor

Anadys Pharmaceuticals

Phase II

Comments: On December 1, 2008 ANA598 received fast-track designation from the FDA

It was announced on July 31, 2009 that Anadys received FDA clearance to start a phase II study in 90 HCV genotype 1 treatment-naive patients for a dose finding study – First day 800 mg bid followed by 200 or 400 mg, twice daily or placebo in combination with pegylated interferon plus ribavirin for 12 weeks followed by pegylated interferon plus ribavirin for a total treatment duration of 24 or 48 weeks. According to a company press release stated that 75% of patients taking a twice-daily dose of 400 mg (plus pegylated interferon/ribavirin) had undetectable HCV RNA after 12 weeks. (June 2, 2010)

Vaniprevir

(MK-7009)

HCV Protease Inhibitor

Merck

Phase II

Comments: EASL 2009: The results of a study of 95 treatment-naïve patients with HCV genotype 1 who were randomized into 5 groups (300 & 600 twice a day; 300 & 600 once-a-day; and one placebo group pegylated interferon /ribavirin only) were presented. All dosages of MK-7009 were found to have potent antiviral effects and were generally well-tolerated with no serious adverse events or discontinuations.

AASLD 2009: Updated information about the on-going trial (above) was presented. The proportion of subjects who achieved RVR in the MK-7009-containing arms ranged from 69% to 82%, vs. 6% in the placebo group and the percentage of patients who achieved an EVR ranged from 76 to 89% compared to 60% in the placebo group. No serious adverse events resulted in treatment discontinuation. (November 6, 2009)

A-832

NS5A Inhibitor

ArrowTherapeutics

Phase II

Comments: A-832 is a NS5A inhibitor that was found (in a test tube) to prevent the HCV IRES-dependent translation process. A phase I study of A-831 has been initiated in healthy volunteers. In 2007, AstraZeneca acquired Arrow Therapeutics, Ltd. There has been no further news about the development of A-831. (February 10,2009)

GS 9190

Polymerase Inhibitor

Gilead

Phase II

Comments: Gilead has begun recruitment for a clinical trial to study the safety, tolerability and effectiveness of GS-9190 in combination with Pegasys plus ribavirin for a treatment duration of 24 or 48 weeks. (February 10, 2009)

BMS-790052

NS5A Inhibitor

Bristol-Myers Squibb

Phase II

Comments: The results from a study of 48 HCV genotype 1 treatment-naïve patients who received doses of BMS-790052 (3, 10, & 60 mg once a day) combined with pegylated interferon/ribavirin (or just pegylated interferon plus ribavirin – control arm) were released. In the 10 mg & 60 mg groups the rapid virological response (undetectable at week 4) was 83 to 92% and the complete early virological response (undetectable at week 12) was ~83%. There were no safety concerns noted. (July 14, 2010)

SCH900518 (Narlaprevir)

Protease Inhibitor

Schering / Merck

Phase II

Comments: EASL 2009: A study of 40 genotype 1 patients (treatment- naïve; treatment-experienced) who received ritonavir-boosted narlaprevir, pegylated interferon/ ribavirin or placebo (with pegylated interferon/ribavirin) found an 81% SVR in the treatment- naïve group; the SVR results in the treatment-experienced were similar between the narlaprevir and placebo groups. (June 29, 2010)

VX-759

Polymerase Inhibitor

Vertex

Phase II

Comments: AASLD 2007: In a 10 day phase I study in which 32 treatment naïve HCV patients received different doses of VX-759 (400 mg TID, 800 mg BID, and 800 mg TID) all patients achieved a 1 log10 decrease in HCV RNA but the higher dose arm of 800 mg TID achieved 2.5 log10 decrease. The drug was generally well-tolerated. A Phase 2, Multicenter, Randomized, Double-Blinded, and Placebo-Controlled Study of the Antiviral Activity, Safety and Pharmacokinetics of VX-759 is underway.

On March 12, 2009, Vertex announced that it had completed acquisition of Virochem and will be developing Virochem’s HCV polymerase inhibitors in combination with their drug and will study Virochem’s drugs in combination with pegylated interferon plus ribavirin. (March 13, 2009)

TMC435

Protease Inhibitor

Medivir/Tibotec

Phase IIa

Comments: In July 2010, Medivir announced 24-week end of treatment interim data on their 5 arm (75 to 79 pts. per arm) study in 386 treatment- naïve HCV genotype 1 patients. Based on various stopping rules, 83% of patients were able to stop treatment at week 24. In the arms that received either 12 weeks or 24 weeks of TMC (all received an additional 24 weeks of pegylated interferon/ribavirin) the interim SVR12 results of those who had completed treatment (based on protocol) were 80% to 97%. No unexpected safety concerns were reported. The final study results including more SVR and safety data will be released later this year. (July 14, 2010)

PSI-7977

Polymerase Inhibitor

Pharmasset

Phase IIa

Comments: On May 2, 2010 Pharmasset announced that in their 28-day treatment study (63 HCV genotype 1 treatment naïve pts) of PSI-7977 (100, 200 mg or 400 mg once-a-day) in combination with Pegasys and ribavirin that 88 to 94% were HCV RNA negative (<15 IU/mL) compared to 21% in the group that received placebo with Pegasys plus ribavirin. The drugs were generally well-tolerated and the adverse effects were similar to the adverse effects seen with Pegasys/ribavirin. (June 2, 2010)

Boceprevir

(SCH 503034)

Protease Inhibitor

Schering

Phase III

Comments:

AASLD 2009: Two retrospective analyses of the SPRINT-1 data were conducted:

1. A small study with two arms that included 206 patients: In one arm, patients who were considered null-responders to a PegIntron plus ribavirin 4-week lead-in phase were given boceprevir/PegIntron/ribavirin for an additional 44 weeks and 55% (12 out of 22 patients) achieved SVR. 2. In people who achieved RVR after 4 weeks of triple therapy the SVR rate was 82% in the 28 week treatment arm and 94% in the 48 week treatment arm. (November 13, 2009)

Telaprevir (VX 950)

Protease Inhibitor

Vertex

Phase III

Comments: Phase II Clinical Trials:

PROVE 2: The study results of 323 HCV genotype 1 treatment-naïve patients (never been treated) was released at this year’s (2008) AASLD conference. The results found that the arm that received the 24 weeks of treatment (12 weeks of telaprevir plus pegylated interferon plus ribavirin followed by 12 weeks of pegylated interferon plus ribavirin (without telaprevir) had the highest SVR rate – 69% (56 out of 81 patients) compared to 46% (38 out of 82 patients) in the arm that received 48 weeks of pegylated interferon plus ribavirin (control arm). EASL 2009:

PROVE3 data of 453 patients who did not achieve a sustained virological response (SVR) with a previous course of pegylated interferon plus ribavirin was released. Non-responders by type of non-response were: non-responders (38-39%); relapsers (69-76%); viral breakthroughs (51-52%).

SVR24 results were found to be identical to the SVR12 rates except one person was lost to follow-up.

Study C208 is a new study that is evaluating different doses of telaprevir – 750 mg every 8 hours (q8h or three times a day) compared to 1125 mg dose every 12 hours (q12h or twice a day) in HCV genotype 1 treatment-naïve patients. Week 12 data found that 81-85% of patients who received the every 8 hour dose were HCV undetectable compared to 82.1 to 82.5% in the group that received the every 12 hour dose.

EASL 2010: SVR results from Study 107 of people who failed to achieve an SVR with a previous course of pegylated interferon plus ribavirin therapy were released at EASL which found an SVR of 56% in prior non-responders treated for 48 weeks, and 97% and 55% in prior relapsers at 24 and 48 weeks of treatment respectively.

On April 21, 2010 Vertex announced it has begun the marketing application to the FDA for approval of telaprevir and expects to complete the application mid-2010.

On May 25, 2010, Vertex released top-line results from the phase III study of telaprevir, pegylated interferon plus ribavirin in about 1,095 HCV genotype 1 treatment-naïve patients. SVR was 75% in the group that received telaprevir/pegylated/ribavirin for 12 weeks followed by pegylated/ribavirin for an additional 12 or 36 weeks; and 69% for those who received telaprevir/pegylated/ribavirin for 8 weeks followed by pegylated/ribavirin for 16 or 40 weeks. The control arm (pegylated/ribavirin) which was treated for 48 weeks achieved a 44% SVR. The discontinuation rate due to adverse events was 6.9%, 7.7% and 3.6% respectively. (June 2, 2010)

Drugs in Clinical Development (General)

Drug Name

Drug Category

Pharmaceutical Company

Clinical Phase

SCY-635

Cyclophilin Inhibitor

SCYNEXIS

Phase I

Comments: The top-line results from a Phase Ib trial of SCY-635 demonstrated that it produced a clinically relevant reduction in HCV RNA and that it was well-tolerated with no serious adverse events, no discontinuations and no dose-limiting toxicities. The highest dose tested (900 milligrams/day) showed clinically relevant antiviral activity.

AASLD 2009: According to a company press release data from a phase one study found that SCY-635 demonstrated promising antiviral activity when combined with HCV polymerase and protease inhibitors. A phase 2 study is expected to begin in the second quarter of 2010. (November 6, 2009)

ANA773

TLR Agonist

Anadys Pharmaceuticals

Phase I

Comments: Andays announced that they had begun oral dosing of ANA773 in people with chronic hepatitis C. The study will evaluate the safety and tolerability of ANA773 in doses of 800, 1200, 1600 and 200 mg given to patients every other day for 28 days. AASLD 2009: ANA773 demonstrated a substantial antiviral response in HCV patients at 1600 & 2000 mg. Two out of 6 patients in the 1600 mg group and 5 of 8 in the 2000 mg group had a maximal decline > 1 log10. No serious adverse events or early discontinuations were reported. (November 6, 2009)

CYT107

Immunomodulator

Cytheris

Phase I

Comments: A study to evaluate the safety and tolerability of CYT107 in combination with pegylated interferon and ribavirin has begun enrolment in Taiwan, France, Italy and Switzerland. (October 28, 2008)

SPC3649 (LNA-antimiRTM-122)

microRNA

Santaris Pharma

Phase I

Comments: On May 29, 2008 Santaris announced that it was commencing a study of SPC3649 in up to 48 healthy male volunteers who will receive SPC3659 or placebo. The trial is a placebo-controlled, double-blind, randomized, single dose, dose-escalating safety study. After establishing the safety and tolerability of the drug the next step would be to study the drug in HCV patients. MicroRNA drugs are a new class of drugs and this trial is the first to test a microRNA in humans. It was announced that the phase I trial was completed in May 2009.

According to a company spokesperson, Santaris is planning a phase II study of their miRNA-targeting drug later this year. (June 2, 2010)

CF102

A3AR Agonist

CAN-FITE

Phase I

Comments: Can-Fite announced the completion of a phase I clinical trial in 25 healthy adults. In addition to determining the dosing range for future studies, CF102 was found to be safe and well-tolerated. A phase I/II study is being planned to study antiviral properties; On May 31, 2010 Can-Fite released top line results which found that in one patient there was a 1.4 log10 decline in HCR RNA (viral load). (June 30, 2010)

IMO-2125

TLR9 Agonist

Idera Pharmaceuticals

Phase I

Comments: On September 17, 2007 Idera Pharmaceuticals announced that it started enrollment of patients to study the safety, tolerability and antiviral properties of IMO-2125 in prior null-responder HCV patients. The study is expected to complete enrolment in January 2010. On October 7, 2009 Idera announced that patient treatment has been initiated in a phase 1 clinical trial evaluating IMO-2125 in combination with ribavirin in treatment-naive patients with chronic hepatitis C virus (HCV) infection. IMO-2125 is administered subcutaneously once a week for four weeks in combination with daily oral administration of standard doses of ribavirin. Target enrollment is 15 patients per cohort, with 12 randomized to receive IMO-2125 plus ribavirin and three randomized to receive placebo plus ribavirin treatment. The primary objective of the trial is to assess the safety and tolerability of IMO-2125 over an escalating range of dosages in combination with standard doses of ribavirin. The clinical trial is expected to be conducted at five or more sites in France and Russia. Interim data from the trial above found the drug to be safe and well-tolerated with dose-dependent increases in immune system activation leading to a 40 to 75% (depending on dose) viral load reduction of 1 log10. On January 19, 2010 Can-Fite announced that it had signed a memo of understanding with Morningside Asia Venture Ltd. to develop CF102 treatment for liver cancer and hepatitis in China, Hong Kong, Macau, and Taiwan. (January 24, 2010)

Bavituximab(formerly Tarvacin)

Anti-Phospholipid Therapy

Peregrine

Phase I

Comments: On October 10, 2007, Peregrine announced that it had begun dosing the first patient in a trial of bavituximab for treatment of hepatitis C in people with HIV and hepatitis C coinfection. Peregrine expects to enroll 24 patients in the study.

AASLD 2007: In a study of 24 patients who received bavituximab twice weekly in escalating doses based on body weight for two weeks and where the patients were followed another two weeks, it was found that the HCV RNA viral load reductions were in the moderate range of .5 log10. Bavituximab was found to be generally safe and well-tolerated with no dose limiting toxicities or serious side effects reported. (November 18, 2007)

NOV-205

Immunomodulator

Novelos Therapeutics

Phase I

Comments: A phase I study has begun to evaluate NOV-205 versus placebo as monotherapy in 18 chronic hepatitis C genotype 1 patients who previously failed treatment with pegylated interferon plus ribavirin. Results from the study found that, in the 12 patients treated (6 patients received placebo), there was favorable safety data which has led Novelos to plan a larger study in the second half of 2008 (December 13, 2007)

SD-101

TLR9 Agonist

Dynavax

Phase Ib

Comments: On January 26, 2010, Dynavax announced data from two studies that differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection. The findings of a Phase 1b clinical trial and an in vitro study of SD-101's mechanism of action show that the second-generation TLR9 agonist (1) is well-tolerated and safe and (2) induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity. The data will be presented at EASL April 2010. (February 1, 2010)

CTS-1027

Anti-inflammatory

Conatus

Phase II

Comments: On December 20, 2007, Conatus announced the initiation of a phase II study of CTS-1027 that will enroll 100 HCV patients for 4 weeks in a proof of concept trial. A second study has been initiated to test the optimal dose of CTS-1027 alone and in combination with ribavirin in up to 70 patients who will be treated for up to 24 weeks.

On January 28th Conatus announced the initiation of a Phase II clinical trial evaluating CTS-1027 in combination with pegylated interferon (Pegasys®) and ribavirin (Copegus®) in refractory HCV patients. Antiviral activity, safety and tolerability of the triple combination will be assessed after up to 48 weeks of therapy. (February 1, 2010)

Oglufanide disodium

Immunomodulator

Implicit Bioscience

Phase II

Comments: A drug that works as a regulator of the body’s immune response has begun testing in hepatitis C positive patients. Two studies are currently underway: 1) phase Ib study of Oglufanide by injection, and 2) an intranasal study. (November 20, 2007)

Alinia (nitazoxanide)

Thiazolides

Romark

Phase II

Comments: On May 5, 2010 Romark released results from Stealth C-3 phase II study of 112 HCV genotype 1 treatment-naïve patients (35% had stage 3 or 4 fibrosis). The groups received nitazoxanide (500 mg twice daily) plus Pegasys/ribavirin or placebo plus Pegasys/ribavirin. The group that received nitazoxanide achieved a 44% SVR compared to 32% of patients in the placebo, pegylated/ribavirin arm. Phase III studies are being planned. (June 2, 2010)

SCV-07

Broad Spectrum Immune Stimulator

SciClone

Phase II

Comments: In July, SciClone announced that the first patient had been enrolled in their study of 20 HCV genotype 1 prior relapsers who will be treated for 4 weeks of SCV-07 (lead-in phase) followed by 4 weeks of SCV-07 plus ribavirin. The study will evaluate the safety and immunomodulatory effects of SCV-07. (July 23, 2010)

MitoQ (mitoquinone)

Inflammation/Fibrosis Inhibitor

Antipodean Pharmaceuticals

Phase II

Comments: EASL 2008: In a study to determine if MitoQ reduced necroinflammation in 30 patients with hepatitis C it was found that there was a 26.4% (40 mg dose group) and 28% (80 mg dose group) reduction in ALT levels. The drug was well-tolerated with no significant safety issues reported. (April 29, 2008)

Debio 025

Cyclophilin Inhibitor

Debio

Phase II

Comments: EASL 2008: Results from a double-blind, placebo-controlled study of Debio 025 in combination with Pegasys in HCV genotype 1 and 4 patients vs. treatment with Pegasys monotherapy were released – total of 90 patients in the study. It was found that in the Debio combination arms that there was a 4.6 log10 decrease in HCV RNA in the 600 mg/day arm and a 4.8 log10 decrease in HCV RNA in 1000 mg/day arm. This compares to 2.49 log10 in the Pegasys plus placebo arm and 2.20 log10 decrease in HCV RNA in the Debio 1000 mg/day monotherapy arm. On January 26, 2009 Debiopharm announced the start of a phase IIb triple therapy study of Debio 025 (60 mg) plus standard doses of Pegasys and ribavirin in 272 HCV treatment-naive genotype 1 patients. On February 9, 2010, Novartis announced that it had signed an agreement with Debiopharm Group to develop and market Debio 025. (February 15, 2010)

PF-03491390(Formerly IDN-6556)

Pancaspase Inhibitor

Pfizer Pharmaceuticals

Phase II

Comments: Pancaspase inhibitors do not have any direct antiviral properties, but are believed to preserve the cell structure and protect the liver from damage caused by HCV. The FDA granted Orphan Drug Designation to PF-03491930 for use with organ transplantation in May 2006.

Study results of doses ranging from 5 mg to 400 mg daily (given 1 to 3 times a day) in 105 patients (with various liver conditions) for 14 days reported in Hepatology (August 2007) found that there was a significant reduction of ALT and AST levels in all doses except in the lowest dose group. The study authors concluded that longer studies are needed to assess the potential effects of the drug on liver inflammation and fibrosis. (August 2, 2007)

Interferons in development

Drug Name

Drug Category

Pharmaceutical Company

Clinical Phase

IL-29 (Type III Interferon)

Long Acting Interferon

ZymoGenetics/BMS

Phase II

Comments: On January 12, 2009, Bristol-Myers announced that it signed an agreement with ZymoGenetics to co-develop IL-29 and will have an option of selling and receiving profits from the sale of IL-29 in the United States as well as royalties from foreign sales. AASLD 2009: In a study of 25 HCV patients who relapsed to a previous course of treatment and who were given IL-29 and ribavirin (1000-2000 mg) for 4 weeks, it was found that the mean maximum decrease from baseline viral load was 1.8 log10 (0.5-3.6) in the .05 ug/kg group to 3.8 log10 (3.2-5.1) in the 2.25 ug/kg group. In 7 HCV treatment-naive patients who were given 1.5 ug/kg plus ribavirin for 4 weeks it was found that the maximum decrease in viral load from baseline viral load was 3.3 (1.2-5.5)

On October 27, ZymoGenetics announced they had dosed the first patient in a Phase 2 clinical trial of PEG-Interferon lambda (IL-29) and ribavirin in treatment-naïve patients with chronic hepatitis C virus (HCV) infection (the “EMERGE†study). Part B of the phase IIa study (600 pts-genotypes 1 through 4) was initiated using 120, 180 and 240 mcg doses plus ribavirin vs. Pegasys plus ribavirin for a treatment duration of 24 or 48 weeks. (June 2, 2010)

Belerofon (oral)

Oral Interferon

Nautilus Biotech

Phase II

Comments: It was announced on May 14, 2007 that the U.S. Food and Drug Administration approved the initiation of a phase I, open-label, ascending study of four doses of oral Belerofon interferon. According to the company the trial is scheduled to begin in late 2007. (May 29, 2007)

BLX-883 (Locteron)

Long Acting Interferon

Biolex Therapeutics / OctoPlus

Phase II

Comments: A form of interferon being tested with a new technology (LEX System â„¢) for controlled-release of Locteron (injection every two weeks instead of the weekly injection for pegylated interferon). EASL 2010: The results from 133 patients in the EMPOWER study (formerly 2 studies--Select-2 & 480) found that 31% of the Locteron group were HCV RNA undetectable compared to 19% in the PEG-Intron arm (SOC arm) after 6 weeks of treatment. (April 29, 2010)

Oral Interferon

Oral Interferon

Amarillo Bisociences

PhaseII

Comments: Amarillo announced that their development partner CytoPharm has been approved to conduct a clinical trial of 165 chronic hepatitis C patients in Taiwan. The aim of the study is to find out if their oral interferon lozenges will help to reduce the relapse rate in patients who will receive a high dose injection of interferon in combination with ribavirin. Results are expected in the 4th quarter of 2010. (July 1, 2009)

Omega Interferon

Interferon

Intarcia Therapeutics

Phase II

Comments: Uses an implantable infusion pump that releases a steady amount of Omega interferon for about 1 month. An ongoing Phase II trial is evaluating daily omega interferon alone and in combination with ribavirin in 102 HCV treatment-naïve patients with genotype 1.

EASL 2007: Final results from this study found that 36% of patients who received daily Omega interferon plus ribavirin achieved an SVR compared to 6% who received Omega interferon monotherapy. The company may study higher doses of Omega interferon. (April 17, 2007)

Albuferon (ZALBIN)

Long Acting Interferon (injections every two weeks)

Human Genome Sciences

Phase III

Comments: Final results of the phase III studies of Zalbin used in combination with ribavirin met its primary endpoint of non-inferiority to Pegasys for treatment of hepatitis C in people with HCV genotypes 1, 2, and 3.

On November 25, 2009 HGS announced that it had submitted an application to the FDA for marketing approval of Zalbin (injection once every 2 weeks & in combination with ribavirin) for the treatment of hepatitis C.

It was announced on June that the FDA had raised some questions about the benefit risk assessment, which means that it is unlikely to have a favorable ruling from the FDA on their application to approve the drug. (June 30, 2010)

Vaccines in Development

Drug Name

Drug Category

Pharmaceutical Company

Clinical Phase

CT-1011

Therapeutic Vaccine

CureTech/Teva

Phase I

Comments: The first dosing of 20 patients is expected to begin toward the end of 2009. (August 7, 2009)

MBL-HCV1

Neutralizing Vaccine

MassBiologics

Phase I

Comments: The first dosing of MBL-HCV1 to test the safety and activity of the drug was announced. 30 healthy subjects are expected to be treated. (August 7, 2009)

ChronVac-C

DNA-based Therapeutic Vaccine

Inovio / Tripep

Phase I

Comments: EASL 2009: The results of a trial of 12 treatment-naïve, HCV genotype patients found that 67% (four out of six patients) in the two highest dose groups had viral load reductions greater than 0.5 log10 lasting for two to greater than 10 weeks. Of the patients in these groups three had activations of the HCV-specific T cell responses at the time of the viral load reductions indicating an immune response.

Samples from 12 patients (HCV genotype 1) found that the vaccine was safe, immunogenic and had transient effects on HCV viral load. (December 09, 2009)

TG4040

Therapeutic Vaccine

Transgene

Phase I

Comments: EASL 2009: Results from a phase I study found that in 6 out of 15 patients there was a decrease in viral load ranging from 0.5 to 1.4 log10 from baseline. All doses were reported to be safe and well-tolerated with no serious adverse events or treatment medication or discontinuation. Transgene reported that a new clinical trial of TG4040 in combination with pegylated interferon plus ribavirin is expected to begin in 2010. (May 5, 2009)

PeviPROTM

Therapeutic Vaccine

Pevion Biotect

Phase I

Comments: On December 18, 2006, Pevion Biotech announced the start of a phase I clinical trial in 30 healthy volunteers to test the safety and tolerability of the synthetic vaccine. The secondary objective is to assess the immunogenicity of the vaccine. The study is scheduled for completion by the end of 2007. (September 4, 2007)

HCV/MF59

Vaccine(s)

Chiron/Novartis

Phase I

Comments: Two vaccines are being tested in collaboration with CSL Ltd. and St. Louis University. Early clinical data from St. Louis University reported that 60 patients received 4 different doses of vaccine, and that all produced HCV antibodies. The study is on-going. (May 2, 2008)

GI-5005 (Tarmogen)

Therapeutic Vaccine

Globe Immune

Phase II

Comments: A form of therapeutic vaccine that is believed to stimulate the immune system to help fight HCV.

On December 19, 2007, GlobeImmune announced the initiation of a phase II study expected to enroll 120 patients who will receive Tarmogen in combination with pegylated interferon plus ribavirin and compare the triple to regular standard of care (pegylated interferon with ribavirin).

AASLD 2009: Report from an ongoing Phase 2b study to compare GI-5005 plus pegylated interferon plus ribavirin versus pegylated interferon/ribavirin alone in 140 HCV genotype 1 patients who were either treatment-naïve or prior non-responders. On a modified intent-to-treat basis (patients having received at least one dose of combination therapy), treatment-naïve patients receiving GI-5005 plus pegylated interferon/ribavirin as a triple therapy had an end-of-treatment complete response rate (HCV RNA < 25 IU/mL by PCR assay at 48 weeks) of 74%, compared with an end-of-treatment response rate of 59% for treatment-naïve patients receiving pegylated interferon/ribavirin (without GI-5005). (November 6, 2009)

Civacir

Vaccine / Immune Globulin

NABI

Phase II

Comments: A drug that is believed to prevent the post-transplant recurrence of HCV. Preliminary results show positive safety and pharmacokinetics results. On Feb 1, 2006 the FDA granted fast track designation. Initiation of a phase II ‘Proof of Concept’ clinical trial has begun - the Mayo Clinics in Arizona, Florida and Minnesota have started enrollment. On September 11, 2007 Nabi sold its Biologic strategic business (which includes Civacir) to Biotest AG. The close of the transaction is expected by the end of 2007. (November 22, 2007)

IC41

Therapeutic Vaccine

Intercell

Phase II

Comments: A combination synthetic therapeutic vaccine (medicines to increase the T-cell response plus peptides identified through studies of people with natural immunity to HCV or successful response to HCV therapy).

IC41 has completed Phase I & Phase II studies and has been shown to have a good safety profile in healthy adults and previously treated HCV patients who failed to achieve a successful treatment outcome. In the HCV patients there was an increase in T-cell response and a temporary reduction of HCV RNA (viral load). AASLD 2009: Final results: The use of IC41 did not conclusively find a viral load reduction except in the group with a high viral load. (November 13, 2009)

Anti Liver Cancer Drugs in Development

Drug Name

Drug Category

Pharmaceutical Company

Clinical Phase

ALN-VSP

RNAi

Alnylam

Phase I

Comments: On April 2, 2009, Alnylam Pharmaceuticals initiated a Phase I trial, conducted in the U.S., is a multi-center, open label, dose escalation study designed to enroll approximately 55 patients with advanced solid tumors with liver involvement, who have failed to respond to or have progressed after standard treatment. The primary objective is to evaluate the safety, tolerability, and pharmacokinetics of intravenous ALN-VSP, including demonstration of the maximum tolerated dose. (November 20, 2009)

PV-10

Anti-Liver Cancer

Provectus

Phase I

Comments: A phase I study of PV-10 for the treatment of cancer metastatic to the liver or recurrent liver cancer. The study will enroll up to six subjects. (October 05, 2009)

CF102

Anti-Liver Cancer

Can-Fite BioPharma

Phase I/II

Comments: On April 21, 2009 Can-Fite BioPharma announced the initiation of a phase I/II clinical trial testing the safety and effectiveness of CF102 in up to 40 patients. (April 21, 2009)

ZIO-101

Anti-Liver Cancer (Arsenic)

ZIOPHARM Oncology

Phase II

Comments; On May 10, 2007, ZIOPHARM announced the dosing of the first patient in a phase II trial for the treatment of primary liver cancer. This study is not specific to hepatitis C-related liver cancer. (May 29, 2007)

4SC-201 (Resminostat)

HDAC Inhibitor

4SC AG

Phase II

Comments: On August 18, 2009 4SC announced the initiation of a proof of concept study that would test the effectiveness, safety and pharmacokinetics of 4SC-201 used alone or in combination with sorafenib (another anti-cancer drug). The study will include two arms (1) 15 patients in a dose escalation study and (2) patients who discontinued sorafenib to be treated with 4SC-201 as a monotherapy. (September 7, 2009)

PI-88

Anti-Liver Cancer

Progen Industries

Phase II

Comments: A treatment for primary liver cancer following surgical resection of a liver tumor. Final results from the phase II clinical trial found that the 160 mg dose was well-tolerated and increased the disease free state (liver cancer) of 25% of the patients and prolonged the time to tumor recurrence from 27 to 48 weeks (78%). Progen estimates that phase III clinical trials will begin at the end of 2007. The U.S. FDA granted Fast Track status and the commission of the European Communities has granted orphan product designation. (October 1, 2007)

GV1001 (Heptovax)

Anti-Liver Cancer

Pharmexa

Phase II

Comments: Initiation of phase II studies has begun in France, Spain and Germany to treat liver cancer (HCC).The trial will enroll 41 patients with advanced liver cancer using GV1001 in combination with GM-CSF (stimulates the production of neutrophils or white blood cells). On November 19, 2007, Pharmexa released interim data on 21 patients in the trial—all six vaccine doses were well-tolerated and no vaccine-attributable serious adverse events were observed. No tumor responses were observed in any of the 21 patients, but the measurable response data will not be available until the second quarter of 2008. (November 21, 2007)

Doxorubicin (BA-003 Transdrug)

Anti-Liver Cancer

BioAlliance Pharma

Phase II

Comments: On December 10, 2009 BioAlliance Pharma announced positive survival data in its phase II clinical trial with doxorubicin Transdrug® in patients with advanced hepatocellular carcinoma (primary liver cancer). Doxorubicin Transdrug®, a treatment presented in the form of nanoparticles delivered via hepatic intra-arterial route, was granted orphan drug status in Europe and the United States. It is being evaluated in patients with advanced hepatocellular carcinoma.

Phase II results showed a 88.9% survival rate after 18 months of treatment in patients having received three intra-arterial doxorubicin Transdrug® injections, as per protocol. This increased survival rate is relevant compared to the 54.5% rate observed in patients with the current standard of care (usually transarterial chemoembolisation with a cytotoxic drug). Based on these data, BioAlliance Pharma will design new approaches using doxorubicin Transdrug® while reducing pulmonary adverse events that led to the suspension of the trial. (December 10, 2009)

Doxorubicin (ThermoDox)

Anti-Liver Cancer

Celsion

Phase III

FDA Approved

Comments: Phase one interim results found that ThermoDox (doxorubicin) – heat-activated liposome therapy – in combination with Radiofrequency Ablation of primary and metastatic tumors to the liver showed local return of cancer in only 2 of 44 tumors resulting in a 4.5% local recurrence rate. Also, 5 of the 10 evaluable patients demonstrated a complete response along with a single partial response. In June 2008 the company also announced a new phase III trial of Doxorubicin in patients with hepatocellular carcinoma (HEAT study).

On December 3, 2009 Celsion reported that enrollment in this 600 patient study continues to accelerate and Celsion expects to meet its objective of completing enrollment by the middle of 2010. A pre-planned, un-blinded interim efficacy analysis will be performed by an independent Data Management Committee when 50% of the endpoint events, tumor recurrence, are realized in the study population. Based on an historical review of RFA cases, Celsion expects the study could be completed by the middle of 2011, and pending positive data, a NDA would be submitted to the FDA before the end of 2011. On February 11, Celsion announced that the Data Monitoring Committee (DMC) had reviewed the safety data and has recommended that the study continue. (February 15, 2010)

Nexavar (sorafenib)

Anti-Liver Cancer

Onyx Pharmaceuticals

Phase IV

Comments: It was announced that Bayer and Onyx have begun enrolment in a multi-international clinical trial to evaluate the use of Nexavar to prevent the recurrence of hepatocellular carcinoma (HCC) following surgery or local radiation for patients with HCC or primary liver cancer. Nexavar is already FDA approved to treat liver and kidney cancer. On June 1, 2009, Bayer and Onyx announced the initiation of a trial to study the combination of Nexavar and Tarceva (Genentech) in patients with liver cancer. The trial is expected to enroll 700 patients with advanced liver cancer to find out if the combination prolongs survival time. (July 1, 2009)

Adjunct Therapies

Drug Name

Drug Category

Pharmaceutical Company

Clinical Phase

LGD-4665

Thrombopoeitin Receptor Agonist

Ligand Pharmaceuticals Inc.

Phase II

Comments: A phase I study that evaluated LGD-4665 in multiple doses over 14 days found that it was safe and well-tolerated and produced an increase in platelet counts in the single and multiple daily dose regimens.

In April 2008, Ligand initiated a Phase IIa trial evaluating LGD-4665 in ITP patients in a randomized double-blind, placebo-controlled, proof of concept study. (December 8, 2008)

Clinical trials on Hold

Drug Name

Drug Category

Pharmaceutical Company

Clinical Phase

None at present

Clinical trials that have been cancelled:

Drug Name

Drug Category

PharmaceuticalCompany

Clinical Phase

PYN17

Botanical

Phynova

Studies Cancelled

VGX-410C (Mifepristone)

IRES Inhibitor

VGX Pharmaceuticals

Studies Cancelled

JBK-122

Anti inflammatory

Jenken Biosciences

Studies Cancelled

Eltrombopag (Promacta)

Thrombopoeitin Receptor Agonist

GlaxcoKline

Studies Cancelled

MX-3253 (celgosivir)

Glucosidase I Inhibitor

MIGENIX

Studies Cancelled

GS-9450

Caspase Inhibitor

Gilead

Studies Cancelled

ITX5061

HCV Entry Inhibitor

iTherx

Studies Cancelled

(The listing of the pharmaceutical industries are for information only and do not constitute endorsement of the pharmaceutical companies or the drugs in development)

http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html