Autor: |
Altraif, Ibrahim H., Sanai, Faisal, Babatin, Mohammed A., Alalwan, Abduljaleel A., Abdo, Ayman A., Alhamoudi, Waleed, Peedikayil, Musthafa, Alghamdi, Hamdan, Alsohaibani, Fahad, Alswat, Khalid A., Murtaza, Shazia, Alghamdi, Abdullah, Altraif, Sara, Aljumah, Abdulrahman, Handoo, Fayaz A., AlBekairy, Abdulkareem M., Al-ashgar, Hamad I., Alquaiz, Mohammed, Alblawi, Mohammed A., AlTamimi, Waleed |
Předmět: |
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Zdroj: |
Journal of Interferon & Cytokine Research; Nov2017, Vol. 37 Issue 11, p488-493, 6p |
Abstrakt: |
Optimal doses of Ribavirin (RBV) for hepatitis C virus (HCV) treatment are not known. To assess the safety and efficacy of PegIFNalfa-2a in combination with an adjusted (ADJ) RBV dose based on early pharmacokinetics versus a fixed standard (STD) dose of RBV in chronic HCV genotype (GT) 4-naive patients in a randomized trial. One hundred eighty-one patients were randomized. The baseline variables were similar in both arms and females were 50.3% of the patients, 76.5% had minimal-moderate fibrosis (F0-2). Sustained virologic response (SVR) was achieved in 99 (54.7%) subjects. SVR was seen in 50/90 (55.6%) of ADJ dose of RBV and 49/91 (53.9%) of STD dose subjects. Prematurely withdrawal or discontinuation of treatment prematurely in the ADJ RBV arm occurred in 11/90 patients (12.2%) compared with 6/91 subjects (6.6%) in the STD arm ( P = 0.214). Similarly, virologic relapse was seen in 14/90 (15.6%) patients of the ADJ arm and 12/91 (13.2%) of the STD arm. Anemia grade 3-4 was seen in 36.7% in ADJ versus 17.6% in STD arm ( P = 0.003). Occurrence of rapid virologic response and absences of F4 fibrosis predicted SVR in a univariate analysis. However, age, gender, weight, presence of diabetes, baseline alanine aminotransferase, and vitamin D levels were not significantly different in patients achieving SVR. ADJ higher doses of RBV based on its early pharmacokinetics-based RBV do not improve SVR rates in HCV GT4 treated in combination with peg-IFN alpha-2-a versus STD therapy. Patients on ADJ higher doses of RBV experienced higher rates of anemia and require more erythropoietin without increasing SVR. [ABSTRACT FROM AUTHOR] |
Databáze: |
Complementary Index |
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