NEW DATA FROM GIFT-I STUDY PRESENTED AT THE ANNUAL MEETING OF THE JAPAN SOCIETY OF HEPATOLOGY
- PRIMARY ENDPOINT OF 95 PERCENT AND SECONDARY ENDPOINT OF 91 PERCENT SVR12 ACHIEVED IN GENOTYPE 1B HEPATITIS C VIRUS INFECTED JAPANESE PATIENTS WITHOUT AND WITH COMPENSATED CIRRHOSIS, RESPECTIVELY(1)
- 98 PERCENT SVR12 ACHIEVED IN ADDITIONAL ANALYSIS OF PATIENTS WITHOUT CIRRHOSIS RECEIVING DOUBLE-BLIND PLACEBO FOR 12 WEEKS, FOLLOWED BY OPEN-LABEL THERAPY WITH ABBVIE'S INVESTIGATIONAL TREATMENT(1)
- ABBVIE'S RIBAVIRIN-FREE TREATMENT FOR GENOTYPE 1 HEPATITIS C JAPANESE PATIENTS CONSISTS OF A 12-WEEK, TWO DIRECT-ACTING ANTIVIRAL, FIXED-DOSED COMBINATION OF PARITAPREVIR/RITONAVIR WITH OMBITASVIR, DOSED ONCE DAILY
Might 26, 2015
NORTH CHICAGO, Ill., May 26, 2015/PRNewswire/ - AbbVie (NYSE: ABBV) exhibited new results from the Phase 3 GIFT-I investigation of its investigational, all-oral, interferon (IFN)- and ribavirin (RBV)- free, two immediate acting antiviral treatment with ombitasvir/paritaprevir/ritonavir at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.1 GIFT-I assessed genotype 1b (GT1b) unending hepatitis C infection (HCV) tainted Japanese patients, with and without cirrhosis, who were either treatment-gullible or IFN (with or without RBV) treatment-experienced.1 The essential endpoint was accomplished, showing 95 percent (n=106/112) SVR12 in a sub-gathering of treatment-innocent, non-cirrhotic, grown-up GT1b HCV contaminated Japanese patients who were qualified for treatment with IFN and had a high popular load.1 In study results identified with the auxiliary endpoint, GT1b HCV patients with remunerated cirrhosis accomplished 91 percent (n=38/42) SVR12.1
In an extra aim to-treat (ITT) investigation, SVR12 was accomplished in 98 percent (n=104/106) of the GT1b HCV contaminated patients without cirrhosis (Arm B) who were randomized to at first get twofold visually impaired placebo for 12 weeks, trailed by open-mark treatment with ombitasvir/paritaprevir/ritonavir.1 The ITT populace incorporated each patient that was randomized to placebo and got no less than one dosage of dynamic, open-name study drug.
"It is basic to address the weight of hepatitis C in Japan, with GT1b being the most common sub-kind of the malady in the nation," said Kazuaki Chayama, M.D., Ph.D, teacher and leader of the Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University. "Blessing I demonstrates the capability of this treatment to accomplish high SVR rates for Japanese patients with GT1b hepatitis C, incorporating those with repaid cirrhosis."
Over all study arms, three patients (n=3/363) ceased treatment because of antagonistic events.1 The most usually reported unfriendly occasions (>5 percent in any arm) were nasopharyngitis, cerebral pain, fringe edema, queasiness, pyrexia and diminished platelet count.1
"We are satisfied to present full results from GIFT-I, which give further knowledge into our hepatitis C treatment as of now under need audit by the Japanese wellbeing powers," said Scott Brun, M.D., VP, pharmaceutical advancement, AbbVie. "We know doctors measure the dangers and advantages of HCV medications for their patients as they search for a choice that offers a potential cure. These information will help guide clinicians in their choice making and backing AbbVie's objective of bringing an interferon-and without ribavirin treatment to individuals living with genotype 1 hepatitis C in Japan."
In Japan, roughly 1.5 to 2 million individuals are living with HCV.2 Genotype 1 is the most widely recognized HCV genotype inJapan with 60 to 70 percent of patients tainted and, of those, around 95 percent are contaminated with the GT1b sub-type.3AbbVie concentrated on its two immediate acting antiviral treatment regimen without RBV in Japan because of patient and viral qualities particular to the Japanese populace, including high commonness of GT1b.
AbbVie's investigational, two immediate acting antiviral treatment comprises of ombitasvir/paritaprevir/ritonavir and is at present under need survey by the Japanese Ministry of Health, Labor and Welfare.
About GIFT-I Study
Blessing I embodies 363 patients in two sub-studies. In sub-contemplate 1, 321 genotype 1b (GT1b) patients without cirrhosis, both treatment-credulous and interferon (IFN) [with or without ribavirin (RBV)] treatment-experienced, were randomized to get either ombitasvir/paritaprevir/ritonavir (Arm A) [OBV/PTV/r] or placebo (Arm B) [2:1 randomization proportion, stratified by treatment history, past reaction, viral burden and IFN eligibility]. Patients at first randomized to placebo (Arm B) then got OBV/PTV/r for an extra 12 weeks of open-name treatment. Supported virologic reaction was evaluated 12 weeks post-treatment (SVR12) as an essential viability endpoint in a sub-gathering of beforehand untreated, non-cirrhotic GT1b patients who were qualified for treatment with IFN and had a high popular burden, characterized as a HCV RNA level ≥ 100,000 IU/mL and got no less than one measurement of the twofold visually impaired, dynamic study drug.1
In sub-think about 2, 42 GT1b treatment-innocent and IFN (with our without RBV) treatment-experienced patients with remunerated cirrhosis got open-name treatment for 12 weeks (Arm C) with SVR12 and evaluated as an auxiliary viability endpoint.1
One patient from every arm (n=3/363) accomplished on-treatment virologic disappointment [Arm A, 0.5% (n=1/215); Arm B, 0.9% (n=1/106); Arm C, 2.4% (n=1/42)].1 Across all arms, eight patients (n=8/354) accomplished post-treatment backslide [Arm A, 2.4% (n=5/209); Arm B, 1.0% (n=1/105); Arm C, 5.0% (n=2/40)].1
About AbbVie's Investigational Two Direct-Acting Antiviral HCV Treatment
For the treatment of genotype 1 unending hepatitis C infection (HCV) contamination in Japan, AbbVie's investigational, two immediate acting antiviral treatment comprises of the altered dosed mix of paritaprevir/ritonavir (150/100 mg) with ombitasvir (25 mg), dosed once day by day.
AbbVie's unending HCV treatment consolidates two immediate acting antivirals, each with a particular component of activity that objectives and restrains particular HCV proteins of the viral replication proces
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