Fw: NATAP: Valeant Starts Infergen Phase 4 Study
- NATAP http://natap.org/
Valeant Pharmaceuticals Initiates Infergen Phase 4 Study
Study Will Evaluate Patients Who Have Partially Responded to Therapy at Week 12
COSTA MESA, Calif., December 12, 2006 -- Valeant Pharmaceuticals International (NYSE:VRX) today announced its plans to initiate a phase 4 study of InfergenÂ® (Consensus Interferon), which is in development for daily use in combination with ribavirin in the treatment of hepatitis C in patients who were non-responsive to previous pegylated interferon and ribavirin therapy. The study will evaluate the use of Infergen 15 Âµg/day plus ribavirin (1.0-1.2 g/day) in patients who did not have an optimal response at week 12 of treatment with pegylated interferon and ribavirin.
â?oApproximately 50 percent of patients do not respond to initial pegylated interferon and ribavirin therapy. Week 12 has been shown to be a pivotal time point in determining the likelihood of responding to therapy. Patients who still have detectable virus at week 12 have less chance of sustaining an SVR than those who are undetectable at week 12. These patients are in need of a new treatment regimen to improve their chance at achieving a sustained response,â? commented Mitchell L. Shiffman, the study's principal investigator and Chief of Hepatology at Virginia Commonwealth University Medical Center.
The multi-center, randomized U.S. study will enroll patients who received initial treatment with pegylated interferon and ribavirin and achieve a >2log10 decline in HCV RNA at week 12 but still have detectable virus. The patients will be immediately randomized to receive Infergen 15 Âµg/day plus ribavirin (1.0-1.2 g/day) for 36 or 48 weeks or continue on their pegylated interferon and ribavirin regimen for an additional 36 weeks of therapy. All treatment groups will have a 24 week follow up period to measure sustained virologic response.
â?oBased on interim results from the DIRECT trial, a shorter washout period from previous pegylated interferon and ribavirin therapy and the degree of fibrosis, may affect response to daily Infergen and ribavirin. This study is the next step in the development of Infergen in patients who exhibit a poor response to initial treatment with pegylated interferon and ribavirin,â? said Wesley P. Wheeler, Valeant's President of North America and Global Product Development.
Infergen, or consensus interferon, is a bio-optimized, selective and highly potent type 1 interferon alpha originally developed by Amgen and launched in the United States in 1997. It is currently indicated for the treatment of adult patients suffering from chronic hepatitis C viral infections with compensated liver disease and is dosed three times per week. Infergen is the only interferon with data in the label regarding use in patients following relapse or non-response to non-pegylated interferons.
Infergen is being studied in ongoing clinical trials to evaluate its potential for daily use with ribavirin. Enrollment in the Phase 3 IHRC-001 (DIRECT) trial was completed in mid-2005 with 513 patients at 45 sites in the United States. The DIRECT trial, which should be completed in 2007, is evaluating the safety and efficacy of both 9 Âµg and 15 Âµg doses of daily Infergen in combination with ribavirin in pegylated interferon and ribavirin non-responders.
About Hepatitis C
According to the Centers for Disease Control and Prevention, an estimated 3.9 million Americans (1.8 percent) have been infected with the hepatitis C virus (HCV). HCV causes an estimated 10,000 to 12,000 deaths annually in the United States and is the leading cause of the need for liver transplants. The prevalence of HCV is increasing and approximately half of all patients with compensated liver disease do not respond to first-line treatment. The treated non-responder patient population is expected to grow from 15,000 patients in 2003 to 161,000 patients in 2013.
Important Safety Information
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.
INFERGENÂ® is contraindicated in patients with known hypersensitivity to alpha interferons or to any component of the product, in patients with decompensated hepatic disease and autoimmune hepatitis. Development of or exacerbation of autoimmune disorders (e.g. autoimmune thrombocytopenia, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis) have been reported in patients receiving alpha interferon therapies, including INFERGEN.
Treatment with INFERGEN should be administered under the guidance of a qualified physician, and may lead to moderate-to-severe adverse experiences requiring dose reduction, temporary dose cessation, or discontinuation of further therapy. Severe psychiatric adverse events may manifest in patients receiving therapy with alpha interferons, including INFERGEN. Depression, suicidal ideation, suicide attempt, and suicide may occur. Other prominent psychiatric adverse events may also occur, including psychosis, aggressive behavior, nervousness, anxiety, emotional lability, abnormal thinking, agitation, apathy and relapse of drug addiction. INFERGEN should be used with extreme caution in patients who report a history of depression. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. In severe cases, therapy should be stopped immediately and psychiatric intervention instituted.
Bone Marrow Toxicity: Alpha interferons suppress bone marrow function and may result in severe cytopenias including very rare events of aplastic anemia. It is advised that complete blood counts be obtained pretreatment and monitored routinely during therapy. Alpha interferon therapy should be discontinued in patients who develop severe decreases in neutrophil (>0.5 x 10(9)/L) or platelet ounts (<50 x 10(9)/L).
Hypertension, tachycardia, palpitation, and tachyarrythmias have been reported in patients treated with INFERGEN. INFERGEN should be administered with caution to patients with preexisting cardiac disease. Supraventricular arrhythmias, chest pain, and myocardial infarction have been associated with alpha interferon therapies.
Pneumonia and interstitial pneumonitis, some resulting in respiratory failure and/or patient deaths, have been induced or aggravated by alpha interferon therapy, including INFERGEN. Patients who develop persistent or unexplained pulmonary infiltrates or pulmonary function impairment should discontinue treatment with INFERGEN.
Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation when treated with alpha interferons, including INFERGEN. During treatment, patients' clinical status and hepatic function should be closely monitored, and INFERGEN treatment should be immediately discontinued if symptoms of hepatic decompensation, such as jaundice, ascites, coagulopathy, or decreased serum albumin, are observed.
Ophthalmologic Disorders: Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots; optic neuritis, and papilledema are induced or aggravated by treatment with INFERGEN or other alpha interferons. All patients should receive an eye examination at baseline. Patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during interferon alpha treatment. INFERGEN therapy should be discontinued in patients who develop new or worsening ophthalmologic disorders.
Ischemic and hemorrhagic cerebrovascular events including hemorrhagic stroke have been observed in patients being treated with INFERGEN. In addition, transient ischemic attack has been reported in young patients being treated with INFERGEN without other reported risk factors.
INFERGEN should be discontinued immediately and appropriate medical treatment instituted if hypersensitivity reactions occur. INFERGEN should be administered with caution to patients with a history of endocrine disorders and should be discontinued mmediately in patients who develop signs and symptoms of colitis. In addition, INFERGEN should be suspended in patients with signs and symptoms suggestive of pancreatitis and discontinued in patients diagnosed with pancreatitis.
The most common adverse events reported for INFERGEN during clinical studies were headache (82%), fatigue (69%), fever (61%), myalgia (58%), rigors (57%), body pain (54%), arthralgia (51%), nausea (40%), insomnia (39%), pharyngitis (34%), nervousness (31%), infection upper respiratory (31%), diarrhea (29%), depression (26%), anorexia (24%), injection site erythema (23%), granulocytopenia (23%), dizziness (22%), cough (22%), dyspepsia (21%), thrombocytopenia (19%), anxiety (19%), sinusitis (17%), influenza-like symptoms (15%) and leucopenia (15%).
Physicians and patients can obtain additional prescribing information regarding Infergen, including the product's safety profile and the box warning for all interferon alphas regarding neuropsychiatric, autoimmune, ischemic and infectious disorders, by visiting www.infergen.com.
Link to NATAP report on DIRECT Study results reported at AASLD 2006:
Infergen (Consensus Interferon) Phase III DIRECT Study End of Treatment Results
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