Enrollment Open for Phase III Trial of Daily Consensus Interferon (Infergen) Plus Ribavirin for HCV Treatment Nonresponders

Sep 2004

Consensus Interferon Study for Peginterferon Nonresponders: 41 study sites

Combination Interferon Therapy: Infergen plus Actimmune
 

INFERGEN® (interferon alfacon-1), also known as consensus interferon, is marketed for the treatment of adults with chronic hepatitis C virus (HCV) infections. It is currently the only FDA approved, bio-optimized interferon developed through rational drug design and the only interferon with data in the label specifically for non-responding or refractory patients. InterMune's sales force re-launched Infergen in January 2002 with an active campaign to educate U.S. hepatologists about the safe and appropriate use of Infergen, which represents new hope for the more than 50 percent of HCV patients who fail other currently available therapies.

All alpha interferons, including interferon alfacon-1, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy. In many but not all cases, these disorders resolve after stopping interferon alfacon-1 therapy. See WARNINGS, and ADVERSE REACTIONS in full prescribing information (Adobe Acrobat required).

Consensus Interferon Study for Peginterferon Nonresponders: 41 study sites
	Enrollment Open for Phase III Trial of Daily Consensus Interferon (Infergen) Plus Ribavirin for HCV Treatment Nonresponders   SEE MORE ABOUT STUDY INCLUDING STUDY SITES & STUDY DESIGN AT END OF THIS INTERMUNE PRESS RELEASE   InterMune Inc. has initiated the DIRECT Trial, a Phase III clinical trial designed to evaluate the safety and efficacy of daily Infergen (consensus interferon) in combination with ribavirin for the treatment of patients chronically infected with hepatitis C virus (HCV) who have failed to respond to a previous course of therapy with pegylated interferon alfa (Pegasys or PEG-Intron) plus ribavirin. These patients are referred to as HCV nonresponders.   INFORMATION ABOUT HEPATITIS C   Nearly 4 million Americans are estimated to be infected with the hepatitis C virus (HCV). That is more than 3 times those with HIV/AIDS, more than 5 times those with Parkinson's disease, and more than 10 times those with multiple sclerosis.   Many people with HCV do not know that they have the virus. This is unfortunate, because HCV can seriously and silently damage the liver. Often, there are no symptoms until the late stages of the disease.   These days, many people are diagnosed after a routine blood test reveals that their liver enzymes are elevated, and further tests show that the virus is in their blood. If you know you have HCV, you can get the treatment you need that may help you overcome the virus and reduce the damage to your liver.   Hepatitis C is not an easy disease to treat. A single course of interferon, or interferon plus ribavirin, may not work in getting rid of the virus. Sometimes, another course of a different interferon may be necessary to help eliminate the virus and reduce the damage to your liver.   STUDY DESIGN   Study Design Chart
	PegIFN alfa-2a or 2b + RBV   If after 12 weeks <2 log drop in HCV RNA* If after 24 weeks still HCV RNA+   *patients with <2 log drop in HCV RNA between week 12 & 24   Randomized to --15 ug QD Interferon alfacon-1 + RBV(n=170) or --9 ug QD Interferon alfacon-1 + RBV (N=170) or --no treatment control arm (n=170); after week 24 may be eligible for roll-over study   PRIMARY OBJECTIVE   * Evaluate the SVR rate of a therapy of daily interferon alfacon-1 (CIFN) at either 15 µg or 9 µg plus RBV compared to no treatment in HCV-infected patients who are nonresponders to previous PegIFN-alfa plus RBV therapy   SECONDARY OBJECTIVES   * Evaluate the safety and tolerability of combination therapy of daily interferon alfacon-1 at either 15 µg or 9 µg plus RBV compared to no treatment in HCV-infected patients who are nonresponders to previous PegIFN-alfa plus RBV therapy   * Evaluate the proportion of patients with abnormal baseline serum alanine aminotransferase (ALT) levels that are normal at: --Week 24 --Week 48 --Weeks 48 and 72   EFFICACY AND SAFETY ENDPOINTS:   -PRIMARY EFFICACY ENDPOINT   * Proportion of patients with SVR rate defined as the absence of detectable HCV RNA in serum by bDNA/TMA assay at weeks 68 and 72   -SAFETY ENDPOINTS   * Proportion of patients with --Adverse events --Abnormal laboratory safety tests --BDI-II score >= 29 --Dose reductions, interruptions, and discontinuations * Proportion of patients randomized to the treatment arms who develop anti-interferon alfacon-1 (anti-CIFN) and neutralizing antibodies     PRESS RELEASE FROM INTERMUNE CONTINUED   "HCV nonresponders represent a growing unmet medical need because retreatment options are limited and generally provide very poor response rates," said Robert L. Carithers Jr., M.D., University of Washington Medical Center and Lead Principal Investigator of the study. "Pilot studies of daily Infergen plus ribavirin in the U.S. and in Europe have shown promising response rates in the treatment of nonresponders. We hope to confirm these preliminary findings in this large, well-controlled Phase III study."   The DIRECT Trial is a randomized, open-label pivotal phase III trial enrolling 510 HCV nonresponders at approximately 40 centers in the United States. There will be three arms to the study.   Patients in the first two arms will receive combination therapy of daily Infergen at one of two dose levels (9 or 15 micrograms) plus 1000-1200 milligrams ribavirin (based on body weight) daily for up to 48 weeks.   The third arm will be a no-treatment control arm and will serve as the comparison for response rates for patients in each of the two treatment arms. Patients in the control arm who have less than a 2 log decrease in HCV RNA at 24 weeks may be eligible to rollover to an additional treatment protocol at the same two dosing levels.   The primary endpoint of the DIRECT Trial is the proportion of patients with sustained viral response (SVR), which is defined as the absence of detectable HCV RNA in serum 68 and 72 weeks after the initiation of treatment.   The secondary endpoints of the study are: the proportion of patients with quantitative measurement of serum HCV RNA levels below the level of detection at weeks 24 and 48; and the proportion of patients with abnormal serum alanine transaminase (ALT) levels at baseline, a marker of liver function, that have normal ALT levels at various time points during the study.   "The launch of this trial comes on the heels of promising data presented at the Digestive Disease Week 2004 conference (May 15 - 20, 2004, New Orleans, LA) from two investigator-sponsored studies of daily Infergen plus ribavirin combination therapy in nonresponders," said Dan Welch, Chief Executive Officer and President of InterMune.   "The results of those studies provide strong scientific rationale for a Phase III study of daily Infergen plus ribavirin. In addition to this Phase III trial, we are simultaneously conducting a Phase II study to assess the use of daily Infergen in combination with our other marketed interferon, Actimmune(R) (Interferon gamma-1b), in the treatment of HCV nonresponders."   About Chronic Hepatitis C   According to the Centers for Disease Control an estimated 3.9 million (1.8%) Americans have been infected with HCV, of whom 2.7 million are chronically infected. Hepatitis C causes an estimated 10,000 to 12,000 deaths annually in the United States.   The prevalence of chronic hepatitis C is increasing. Standard treatment for patients chronically infected with hepatitis C virus is pegylated interferon alfa-2 plus ribavirin. Approximately half of all patients treated do not respond. There are approximately 150,000 nonresponders in the United States and the number is growing by an estimated 50,000 each year.   About Infergen   Infergen is a bio-optimized type 1 interferon alpha indicated for treatment of adult patients with chronic HCV infections with compensated liver disease and is dosed three times a week. Infergen is the only interferon alpha with data in the label regarding use in patients following relapse or non-response to treatment with certain previous treatments.   The most common side effects are flu-like symptoms (i.e., headache, fatigue, fever, myalgia, and rigors). Physicians and patients can obtain additional prescribing information regarding Infergen, including the product's safety profile, by visiting http://www.infergen.com, including the black box warning for all interferon alphas regarding neuropsychiatric, autoimmune, ischemic and infectious disorders.   About Actimmune(R) (interferon gamma-1b)   Interferon gamma is a naturally occurring protein that stimulates the immune system. InterMune markets Actimmune for the treatment of two life-threatening congenital diseases: chronic granulomatous disease and severe, malignant osteopetrosis. The most common side effects are flu-like symptoms, including fever, headache and chills.   InterMune is conducting the INSPIRE Trial, a Phase III study of interferon gamma-1b in idiopathic pulmonary fibrosis, the GRACES Trial, a Phase III study of interferon gamma-1b in ovarian cancer and a Phase II trial in HCV nonresponders of interferon alfacon-1 plus interferon gamma-1b. Physicians and patients can obtain additional prescribing information regarding Actimmune, including the product's safety profile, by visiting http://www.actimmune.com.   About InterMune   InterMune is a biopharmaceutical company focused on developing and commercializing innovative therapies in pulmonology and hepatology. For additional information about InterMune, visit http://www.intermune.com.   STUDY RATIONALE   BACKGROUND   * Fewer than 15% of patients respond to retreatment with pegylated interferons (PegIFNs)1 * Preliminary studies suggest that daily dosing of interferon alfacon-1 (CIFN) plus ribavirin (RBV) can achieve improved outcomes2   PURPOSE   * The DIRECT (IRHC-001) trial is designed to study the efficacy and safety of daily interferon alfacon-1 plus RBV in nonresponder patients   TRIAL SUMMARY   * DIRECT is a Phase III, randomized (1:1:1), open-label research study to determine the sustained virological response (SVR) rate of combination therapy of daily interferon alfacon-1 at either 15 µg or 9 µg plus RBV (1000 mg/ patient weight < 75 kg; 1200 mg/patient weight >= 75 kg) compared to no treatment in HCV-infected patients who are nonresponders to previous PegIFN-alfa plus RBV therapy   SAMPLE SIZE   * 510 patients * Approximately 41 sites in the United States * Patients randomized (1:1:1) to receive: --15 µg interferon alfacon-I plus RBV daily for 48 weeks or --9 µg interferon alfacon-1 plus RBV daily for 48 weeks or --No treatment for 24 weeks (may be eligible to be randomized to a roll-over study, 15 µg daily interferon alfacon-1 or 9 µg daily interferon alfacon-1 plus RBV for 48 weeks)   REFERENCES   1. NIH Consensus Conference, 2002. 2. Kaiser S, et al. High dose induction therapy with consensus interferon and ribavirin for treatment naïve patients with hepatitis C. Hepatology. 2002A;36(4 pt. 2):362.A.   InterMune Hepatology   STUDY SITES   InterMune has selected trial sites in North America and the Caribbean for participation in the DIRECT Trial. Please call InterMune Medical Information at 1-888-ITMN-411 (1-888-486-6411) or email medinfo@intermune.com if you cannot find a trial site near you. Not all trial sites are listed below. Trial sites have been activated in the following locations:   California   Cedars-Sinai Medical Center Los Angeles, CA Investigator: Tram Tran, MD Contact Number: (310) 423-2641   Stanford University Medical Center Palo Alto, CA Investigator: Gabriel Garcia, MD Site Contact: Dana Supan, RN Contact Number: (650) 724-3051   UCLA Los Angeles, CA Investigator: Steven Han, MD Site Contact: Val Peacock, RN Contact Number: (310) 794-6067   UCSD Medical Center San Diego, CA Investigator: Tarek Hassanein, MD Site Contact: Fatma Barakat Contact Number: (619) 543-5459   UCSF San Francisco, CA Investigator: Norah Terrault, MD, MPH Site Contact: Wendy May Real Contact Number: (415) 514-2861   Colorado   Arapahoe Gastroenterology Littleton, CO Investigator: Andrzej Triebling, MD, PhD Site Contact: Guy Kennedy, PAC Contact Number: (303) 722-8987 Website: www.arapahoegi.com   Florida   University of Florida, Shands Hospital/MSB, Hepatology Office/MSB Gainesville, FL Investigator: Giuseppe Morelli, MD Site Contact: Angie Martin   Illinois   University of Illinois at Chicago, Section of Hepatology Chicago, IL Investigator: Scott Cotler, MD Site Contact: Lani Krauz, BSN, RN Contact Number: (312) 355-3782   Indiana   Indiana University School of Medicine Indianapolis, IN Investigator: Paul Kwo, MD Site Contact: Rhonda Hughes, RN Contact Number: (317) 278-3628   Louisiana   Tulane University Health Sciences Center New Orleans, LA Investigator: Shobha Joshi, MD Site Contact: Delainna Bartholomen Contact Number: (504) 585-6902 Website: www2.tulane.edu/hsc   Missouri   Saint Louis University, GI/Hepatology Clinical Research Unit St. Louis, MO Investigator: Bruce Bacon, MD Site Contact: Cherryl Korte, RN, BSN Website: internalmed.slu.edu/gi   New Jersey   Atlantic Gastroenterology Egg Harbor Township, NJ Investigator: John Santoro, DO, DACG, FACOI Site Contact: Theresa Stevens, APN-C Contact Number: (609) 407-1220 ext. 1108 Fax: (609) 407-1340 Website: www.atlanticgastro.com   Gastroenterology Group of South Jersey Vineland, NJ Investigator: Gary Matusow, DO Site Contact: Kelly Chirico, MSN, NP-C, CCRP Contact Number: (856) 691-1400 Fax: (856) 691-3294   The New Jersey Medical School Liver Center and Sammy Davis, Jr. National Liver Institute Newark, NJ Investigator: Carroll Leevy, MD Site Contact: Andrew Moroianu, MD Contact Number: (973) 972-7292   New Mexico   University of New Mexico Health Sciences Center Albuquerque, NM Investigator: Sanjeev Arora, MD Site Contact: Claudia Scherer Contact Number: (505) 272-4550   New York   Beth Israel Medical Center New York, NY Investigator: Douglas Meyer, MD Site Contact: Ivanka Zinc, RN, MSN, CCRC Contact Number: (212) 420-4245 Fax: (212) 844-1967   New York Medical College, Division of Gastroenterology and Hepatocellular Diseases Valhalla, NY Investigator: Edward Lebovics, MD Site Contact: Jody Hirsh, RPA Contact Number: (914) 594-3448   NYU Medical Center, VA New York- Harbor Healthcare System, GI Section (111D) New York, NY Investigator: Edmund J. Bini, MD, MPH, FACP, FACG Site Contact: Stanley John, CCRC Contact Number: (212) 686-7500 x4477   North Shore University Hospital Manhasset, NY Investigator: David Bernstein, MD Site Contact: Maly Tiev, RN Contact Number: (516) 562-4281   Weill Cornell University Medical College New York, NY Investigator: Gerond Lake-Bakaar, MD Site Contact: Jamie L. Zagorski, NP Contact Number: (212) 746-2115 Fax: (212) 746-8152   North Carolina   Carolinas Center for Liver Disease Charlotte, NC Investigator: Robert Reindollar, MD Site Contact: Martha Hudson Contact Number: (704) 378-4371 ext. 109   Ohio   The Cleveland Clinic Foundation, Department of Gastroenterology Cleveland, OH Investigator: Nizar Zein, MD Site Contact: Marcia R. Grealis, RN, BSN Contact Number: (216) 444-6464   Consultants for Clinical Research, Inc. Cincinnati, OH Investigator: Mark Jonas, MD Site Contact: Eujenia Darakchieva Contact Number: (513) 872-4549   Oklahoma   Baptist Medical Center, Zuhdi Transplantation Institute Oklahoma City, OK Investigator: Ted Bader, MD Site Contact: Jacqui Wood, RN Contact Number: (405) 949-6615   Oregon   The Oregon Clinic Portland, OR Investigator: Kenneth Flora, MD Site Contact: Timothy W. Miller, CRC Contact Number: (503) 963-2756 Fax: (503) 254-1723      Puerto Rico   Fundacion de Investigacion de Diego Santurce, Puerto Rico Investigator: Maribel Rodriguez-Torres, MD Site Contact: Elsa Gonzalez Contact Number: (787) 722-1248   South Carolina   Medical University of South Carolina Charleston, SC Investigator: Adrian Reuben, MBBS, FRCP Site Contact: Nancy Huntley, RN Contact Number: (843) 792-5120   Tennessee   Regional Research Institute Jackson, TN Investigator: Mark Swaim, MD, PhD Site Contact: Vickie Grigsby, RN, CCRP Contact Number: (731) 661-9559   Texas   The Liver Institute at Methodist Dallas Dallas, TX Investigator: Reem Ghalib, MD Site Contact: Artise Shannon Contact Number: (214) 947-4463   Virginia   Metropolitan Research Fairfax, VA Investigator: Vinod Rustgi, MD Site Contact: Phuong Lee Contact Number: (703) 698-9254 ext. 20 Website: www.metrohepgi.com     University of Virginia Dig. Health Center of Excellence Charlottesville, VA Investigator: Carl Berg, MD Contact Number: (434) 924-2626   VCU Health System at MCV Hospital Richmond, VA Investigator: Mitchell Shiffman, MD   Washington   University of Washington Seattle, WA Investigator: Anne Larson, MD Site Contact: Judy Kaiser, RN Contact Number: (206) 598-3568 InterMune Hepatology   http://www.directtrial.com

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By Mark Nelson, MD

Infergen Plus Actimmune Shows Promise in Nonresponders

Results of treatment with a combination of Infergen-interferon alphacon 1- which is 10 to 100 times more potent than natural alfa interferon, and Actimmune- interferon gamma 1b-was reported in individuals failing to respond with at least a 2 log reduction in HCV viral load by week 12 to standard therapy. 

32 individuals were re-treated with Infergen 15micrograms daily and Actimmune 50micrograms three times a week for 48 weeks. 

At the end of 12 weeks of therapy, 38% of treated individuals had undetectable  HCV RNA and a total of 65% either a 2 log or greater decline in viral load, or were HCV negative. 

All individuals had a reduction from baseline of serum ALT. 

Only One patient discontinued therapy because of constitutional symptoms.  5 individuals needed support for neutropenia with GCSF.

01/16/04

Source
HEP DART 2003. December 14-18, 2003. Kauai, Hawaii.

www.hivandhepatitis.com

Potential HCV Therapy Shows Positive Results In Ongoing Pilot Study by John C. Martin Article Date: 12-24-03   An interferon approved as a treatment for hepatitis C is demonstrating its merit in an ongoing pilot study. The study's initial findings were presented at a recent medical conference.1 Infergen, manufactured by Intermune of Brisbane, California, is known as consensus interferon. It is designed specifically for patients who have not responded to interferon therapy for HCV. Continuous Infusion Therapy Researchers at Huntington Memorial Hospital in Pasadena, California; the University of California at San Diego; Medtronic MiniMed, makers of a special pump designed to continuously deliver medication; and Intermune have enrolled 17 patients who were either non-responders to interferon treatment, or hadn’t been treated previously for HCV with interferon. In the open-label study, a group of 6 patients who had previously not responded to interferon therapy began a treatment schedule using a pump that continuously delivered medication at a dosage of 12 micrograms per day. As opposed to a blinded study, an open-label trial is one in which both patients and medical staff are aware of the medication being tested, and there may or may not be a comparative treatment used. After determining that the patients were able to tolerate the medicine during a month of continuous delivery, they enrolled a second group of 6 previously non-responding patients, as well as a group of 5 patients who had not been treated with interferon previously. As part of the trial's protocol, previously untreated patients who failed to respond to Infergen (defined as less than a 100-fold drop in virus levels) after 12 weeks, and previous non-responders who failed to respond to the medication after 24 weeks would be discontinued from therapy. That's because it would be unlikely that they would achieve a sustained virologic response (SVR) by the end of treatment. However, those patients who showed at least a 100-fold drop in virus levels at week 12 or 24 would be continued on therapy for a total of 48 weeks, with the theory that they might achieve an SVR at the end of the study. Hopeful Findings While the study is ongoing, the early results have been positive, the researchers reported. In the group of previously untreated patients, three achieved undetectable levels of the virus after only a month using continuous delivery of Infergen.  One patient had to have the dosage reduced, and another discontinued therapy within 2 weeks because of "inability to acclimate". In the group of previous non-responders, outcomes were just as positive. Seven of the 12 patients receiving 12 to 24 weeks of therapy showed a greater than 100-fold drop in virus levels, one of them to non-detectable levels after 24 weeks. (More than a 7.2 log 10 drop). Three of those patients discontinued therapy due to intolerability. Based on these findings, the researchers concluded that "patients who were previously non-responders to combination therapy show a greater viral load reduction upon retreatment with consensus interferon by continuous infusion." In addition, those previously non-responders "show a greater viral load reduction" using continuously delivered Infergen, the researchers wrote. Infergen Put To The Test A review of other studies testing the effectiveness of Interferon alfacon-1 found similar results.2 Researchers at Yamanouchi Pharmaceuticals in Japan evaluated the results of a randomized, controlled trial, and two, separate open-label investigations, and found Infergen was both "effective and tolerable" in patients with chronic HCV who had relapsed, or with various viral levels. Another study also found merit in the drug, but only initially.3 Doctors at the University of Toronto evaluated the efficacy of consensus interferon in a group of 18 patients for up to 36 weeks. Patients who didn't respond by week 12 were taken off treatment. Nine patients had undetectable viral levels by week 12, and seven completed therapy for 48 weeks (two dropped out due to side effects). But at week 48, only three patients still had no detectable levels of virus in their blood, and this decreased to two patients after 6-months following treatment. In the end, up to 50% of the patients in the study had undetectable viral levels due to Infergen therapy, "but this response was only sustained in 8% of patients on completion of therapy," the researchers wrote. 1. Delivery of Consensus Interferon (Infergen) by continuous infusion for the treatment of chronic hepatitis C: A pilot viral kinetic study. 54th Annual Meeting of the American Association for the Study of Liver Diseases. 2003 Oct 24-28. Boston, MA. 2. Yasuda S, Miyata K. Interferon alfacon-1 (Advaferon): A novel synthetic interferon for the treatment of hepatitis C, its pharmacological and clinical profile. Nippon Yakurigaku Zasshi 2002 Dec;120(6):421-6. 3. Moskovitz DN et al. High dose consensus interferon in nonresponders to interferon alfa-2b and ribavirin with chronic hepatitis C. Can J Gastroenterol 2003 Aug;17(8):479-82. John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.

www.hepatitisneighborhood.com

  Infergen Plus Ribavirin Produces Higher Sustained Viral Response Rates At

                          72 Weeks Than Rebetron(R)

    BOSTON and BRISBANE, Calif., Nov. 5 /PRNewswire-FirstCall/ --

InterMune, Inc. (Nasdaq: ITMN) today announced that positive preliminary

results of an investigator initiated, prospective randomized Phase IV clinical

trial comparing the use of Infergen(R) (interferon alfacon-1) plus ribavirin

versus interferon alfa-2b plus ribavirin (Rebetron(R)) for the treatment of

chronic hepatitis C infections were presented at the 53rd Annual Meeting of

the American Association for the Study of Liver Diseases (AASLD) in Boston.

Patients treated with Infergen in combination with ribavirin achieved a higher

sustained virologic response (SVR), the study's primary endpoint, compared to

those patients treated with Rebetron.

    "These data suggest that the combination of consensus interferon plus

ribavirin is more efficacious than Rebetron therapy," said Maria H. Sjogren,

M.D., M.P.H., Chief, Department of Clinical Investigations, Walter Reed Army

Medical Center in Washington, D.C. and lead investigator of the Phase IV

trial.  "The sustained response we observed in this trial with the Infergen

combination could set a new treatment threshold for this difficult to treat

U.S. patient population.  As a matter of fact, the SVR is consistent to that

reported for the pegylated interferons plus ribavirin but with less

hematologic toxicity.  These data help to provide clinical confirmation of the

in vitro biologic potency of Infergen.  Infergen in combination with ribavirin

appears to be a viable treatment alternative.  Further study comparing the use

of Infergen to other treatment regimens is warranted."

    In data analyzed and reported by a group at Walter Reed Army Medical

Center and Kaiser Permanente Mid-Atlantic Region, 127 patients with chronic

hepatitis C (128 patients randomized; one patient data point pending) were

randomized to receive Infergen (15 mcg, TIW) plus ribavirin (1 g/day) or

interferon alfa-2b (3MU, equivalent to 15 mcg, TIW) plus ribavirin (1g/ day)

for up to 48 weeks with an additional 24 weeks of observational follow-up.

Patients who were still HCV RNA positive following 24 weeks of therapy stopped

treatment and were considered treatment failures.  Analysis of the

127 patients who reached week 72 or who discontinued early for any reason,

revealed an overall SVR rate of 57% in the Infergen plus ribavirin-treated

group compared to 39% in the interferon alfa-2b plus ribavirin group

(p = 0.04).

    Dr. Sjogren and colleagues reported that all patients in the study

received the same dose of ribavirin.  However, a retrospective analysis

demonstrated those patients who received the appropriate dose of ribavirin

based on their weight (i.e., greater than 10.6 mg/kg per day) achieved a

higher sustained viral response rate in both treatment arms:  75% SVR for the

Infergen/ribavirin treated patients and an SVR rate of 52% for the Rebetron

arm of the study.  According to Dr. Sjogren, the side effects associated with

Infergen plus ribavirin were similar to those seen with Rebetron and included

flu-like symptoms, fatigue, headache, nausea, cough and mood disorders such as

depressed mood, anxiety, irritability and insomnia.

    "There remains a great medical need for effective therapies for the

treatment of hepatitis C because approximately 50% of patients currently fail

best available therapy," said Scott Harkonen, InterMune's President and CEO.

"This study, which suggests that Infergen plus ribavirin makes a compelling

treatment option for HCV patients, will play an important role in our efforts

to broaden this drug's use in managing chronic hepatitis."

About Infergen for Hepatitis C

    Infergen is a bioengineered type I interferon alfa indicated for treatment

of adult patients with chronic hepatitis C infections, including therapy for

patients who have never been treated with interferons and for patients

following relapse or non-response to treatment with certain previous

treatments.  Physicians and patients can obtain additional information about

Infergen by visiting http://www.infergen.com .

    Hepatitis C is a liver disease caused by the hepatitis C virus that is

found in the blood of people with this disease.  It is the most common form of

hepatitis infection in North America and Europe.  According to the National

Center for Infectious Diseases, there are an estimated 3.9 million (1.8%)

Americans who have been infected with hepatitis C, of whom 2.7 million are

chronically infected.  If not detected and treated, hepatitis C may lead to

chronic liver disease, including liver cancer, and ranks second to alcoholism

as a cause of cirrhosis.  Hepatitis C causes an estimated 8,000 to

10,000 deaths annually in the United States.

    About InterMune

    InterMune is a commercially driven biopharmaceutical company focused on

the marketing, development and applied research of life-saving therapies for

pulmonary disease, infectious disease and cancer.  For additional information

about InterMune, please visit http://www.intermune.com.

    Except for the historical information contained herein, this press release

contains certain forward-looking statements that involve risks and

uncertainties, including without limitation the statement indicating that

combining Infergen plus ribavirin may be promising for the treatment of

chronic hepatitis C.  All forward-looking statements and other information

included in this press release are based on information available to InterMune

as of the date hereof, and InterMune assumes no obligation to update any such

forward-looking statements or information.  InterMune's actual results could

differ materially from those described in InterMune's forward-looking

statements.  Factors that could cause or contribute to such differences

include, but are not limited to those discussed under the heading "Risk

Factors" and the risks and factors discussed in InterMune's 10-K report filed

with the SEC on March 21, 2002, and other periodic reports (i.e., 10-Q and

8-K) filed with the SEC.  The risks and other factors that follow, concerning

the forward-looking statements in this press release, should be considered

only in connection with the fully discussed risks and other factors discussed

in detail in the 10-K report and InterMune's other periodic reports filed with

the SEC.  InterMune's forward-looking statement concerning combining Infergen

and ribavirin for the treatment of hepatitis C is subject to the uncertainties

and risks associated with the uncertain, lengthy and expensive clinical

development and regulatory process; achieving positive Phase IV clinical trial

results; patient enrollment and retention in clinical trials; budget

constraints; third-party manufacturers; whether InterMune is able to obtain,

maintain and enforce patents and other intellectual property; and significant

regulatory, supply, intellectual property and competitive barriers to entry.