УРОКИ ИССЛЕДОВАНИЯ IDEAL

Combination therapy with pegylated interferon-α and ribavirin is the modern standard of chronic hepatitis C treatment [1-3] in Russian Federation [4]. This particular regimen provides achieving of sustained virological response (SVR) in 42-28% of patient with genotype 1 chronic hepatitis C [5,6]. IDEAL (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) study was designed to assess the most optimal and effective antiviral therapy regiment. IDEAL was randomized, in parallel groups, multicenter phase IIIb study to assess efficacy and safety of two combination regiment with pegylated interferon alfa-2b (dosing regimens: 1,5 and 1,0 mcg/kg/week) and ribavirin, administered according to body weight (800–1400 mg/day) compared with pegylated interferon alfa-2a 180 mcg/week in combination with ribavirin 1000–1200 mg/day in genotype 1 chronic hepatitis C patients.Современным стандартом лечения хронического гепатита С (ХГС) является комбинация пегилированного ИФН-α (Пег-ИФН-α) и рибавирина [1–3], в том числе в Российской Федерации [4], обеспечивающая формирование стойкого вирусологического ответа (СВО) у 42–48% больных ХГС при инфицировании 1 генотипом HCV [5, 6]. Для определения наиболее эффективной ПВТ в этой категории больных было предпринято исследование IDEAL (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) – рандомизированное, в параллельных группах, мультицентровое клиническое исследование IIIb фазы по оценке эффективности и безопасности комбинации Пег-ИФН-α2b в двух дозировках (1,5 и 1,0 мкг/кг/нед) с рибавирином, назначаемом по массе тела (800–1400 мг/сут) в сравнении с Пег-ИФН-α2а 180 мкг/нед в комбинации с рибавирином 1000–1200 мг/сут у больных ХГС, инфицированных HCV 1 генотипа

The expirience of IDEAL

Combination therapy with pegylated interferon-α and ribavirin is the modern standard of chronic hepatitis C treatment [1-3] in Russian Federation [4]. This particular regimen provides achieving of sustained virological response (SVR) in 42-28% of patient with genotype 1 chronic hepatitis C [5,6]. IDEAL (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) study was designed to assess the most optimal and effective antiviral therapy regiment. IDEAL was randomized, in parallel groups, multicenter phase IIIb study to assess efficacy and safety of two combination regiment with pegylated interferon alfa-2b (dosing regimens: 1,5 and 1,0 mcg/kg/week) and ribavirin, administered according to body weight (800–1400 mg/day) compared with pegylated interferon alfa-2a 180 mcg/week in combination with ribavirin 1000–1200 mg/day in genotype 1 chronic hepatitis C patients

PREGNANCY WITH PRIMARY SCLEROSING CHOLANGITIS

Primary sclerosing cholangitis (PSC) is autoimmune disease characterized by inflammation and sclerosis of the bile duct, which leads to the development of secondary biliary cirrhosis. Many women with primary sclerosing cholangitis are at reproductive age (mean age of onset is 40 years old, but the cases of the disease in other age groups were described). There is a risk of negative impact of primary sclerosing cholangitis in the mother (exacerbation PSC) and the fetus (intrauterine fetal hypoxia, premature birth), but overall prognosis for the mother and child is favorable (if pregnant does not have cirrhosis of the liver complications). Pregnant women with varicose veins of the esophagus have a high maternal mortality. Ursodeoxycholic acid is the drug of choice for the treatment of pruritus in pregnant women with primary sclerosing cholangiti

Efficacy and safety of the Russian protease inhibitor narlaprevir at treatment-naive and earlier treated noncirrhotic patients with the 1st genotype chronic hepatitis C (PIONEER study)

Aim of investigation. To estimate efficacy and safety of narlaprevir (NVR) with ritonavir (RTV), pegilated interferon (peg-IFN) and ribavirin (RBV) at treatmentnaïve and earlier treated noncirrhotic patients with chronic hepatitis C caused by the 1st virus genotype in double blind placebo-controlled 3rd phase study (PIONEER). Material and methods. The main group received NVR (200 mg od orally) in combination to RTV (100 mg) and pegIFN/RBV for 12 weeks that was followed by peg-IFN/ RBV for 12 weeks. Comparison group received pegIFN/ RBV for 48 weeks, for the first 12 weeks in combination to placebo. Results. The sustained virologic response in 24 weeks after treatment termination (SVR24) in the main group (NVR/RTV, PEG IFN/RBV)) was achieved in 89.1% (163/183) of treatment-naïve and 69.7% (69/99) of earlier treated patients. SVR24 was achieved in 86.5% (32/37) of patients with relapse after previous peg-IFN/ RBV treatment course. The viral load decreased for the mean of 5.3 log10 in 2 weeks and 5.9 log10 in 4 weeks of treatment in the main group vs 1.5 log10 in 2 weeks and 2.5 log10 in 4 weeks in comparison group. In treatment-naïve patients from the main group SVR24 was achieved in 90.8% at initial METAVIR F0-F2 liver fibrosis stage and in 75% at F3 liver fibrosis stage. In those who were previously treated by peg-IFN/RBV, in the main group SVR-24 was attained in 72.6% at liver fibrosis stage F0-F2 and in 53.3% with F3 liver fibrosis stage. NVR/RTV addition to peg-IFN/RBV treatment did not alter safety profile as compared to peg-IFN/RBV therapy. Conclusions. In PIONEER study the narlaprevir combination therapy was characterized by high efficacy, convenience of administration and favorable safety profile