Галина46 писал(а):Гилеад просто так трешку бы из своих лап не отдал, раз отдал, значит результативность так себе у леда.
LEXA писал(а):Если б лед работал бы - он бы уже был в ЕАСЛ - Гилеад проплатил бы..
Галина46 писал(а):Я видела КИ по леду у трешки, результат хуже чем по пегу.
Прежде чем говорить, почитай вот это! Видела она КИ
661 стр. [url]http://ilc-congress.eu/wp-content/uploads/2016/abstracts/20160416_sat/sat_ilc2016_no_embargo_lr.pdf[/url]
SAT-183
LEDIPASVIR/SOFOSBUVIR WITH RIBAVIRIN FOR 12 WEEKS IS EFFECTIVE AND SAFE IN TREATMENT-NAÏVE GENOTYPE-3 HEPATITIS C-INFECTED PATIENTS IN CANADA
Background and Aims: Interferon-free regimens have demonstrated lower response rates in genotype (GT) 3 HCV-infected patients as compared to GT1 patients.
Ledipasvir/sofosbuvir (LDV/SOF) with ribavirin (RBV) for 12 weeks resulted in a 100% SVR12 rate among treatment-naïve GT3 patients with and without cirrhosis in a single center Phase 2 trial. In this study, we evaluated the safety, tolerability and efficacy of LDV/SOF + RBV for 12weeks in GT 3 patients at 15 sites in Canada. Methods: Treatment-naïve GT3 HCV-infected patients with or without compensated cirrhosis received open-label LDV/SOF+RBV for 12weeks. The primary endpointwas SVR12. Secondary endpoints included safety, tolerability, viral resistance, and additional efficacy outcomes.
Results:
111 patients were randomized and treated: 61% male, 70% white, 23% Asian, 62% carried the non-CC IL28B allele, and 34% had compensated cirrhosis.
Overall, the SVR4 rate was 92% (102/111). Virologic outcomes are shown in the Table 1. One patient (<1%) discontinued treatment due to liver cancer (hepatocellular carcinoma or cholangiocarcinoma) and died 22 days posttreatment. Adverse events (AEs) occurring in >10% of patients were fatigue, headache, nausea, insomnia, dizziness, diarrhea and irritability. Four patients had serious AEs, none was related to treatment. Fourteen (14%) patients experienced grade 3 or 4 laboratory abnormalities, the majority of which were consistent with RBV therapy.
Conclusions:
LDV/SOF + RBV for 12 weeks in treatment-naïve patients with chronic HCV GT 3 infection led to high SVR4 rates.[/b] Treatment was safe and well-tolerated; the profile was consistent with that observed in the LDV/SOF + RBV groups in the Phase 3 studies. Complete SVR12 data will be presented.