Real-world effectiveness of peginterferon α-2b plus ribavirin in a Canadian cohort of treatment-naïve chronic hepatitis C patients with genotypes 2 or 3: results of the PoWer and RediPEN studies.

The purpose of this investigation was to assess the real-life effectiveness of pegylated interferon (peg-IFN) α-2b with ribavirin (RBV) in a cohort of treatment-naïve patients with chronic genotypes 2 (G2) or 3 (G3) hepatitis C virus (HCV) infection. A post-hoc pooled analysis of two Canadian multicenter, observational studies, RediPEN and PoWer, was carried out. A total of 1242 G2- or G3-infected patients were included. The primary outcome was sustained virologic response (SVR). Secondary endpoints included early virologic response (EVR), end-of-treatment (EOT) response, and relapse. Multivariate logistic regression was used to identify independent predictors of treatment response. SVR in G2 and G3 was 74.4 % and 63.6 %, respectively. Relapse occurred in 12.7 % and 19.1 % of G2- and G3-infected patients achieving EOT response, respectively. Overall, G3 was found to independently predict reduced SVR [odds ratio (OR) = 0.20; p = 0.007] and increased relapse (OR = 6.84; p = 0.022). Among G3-infected patients, increasing fibrosis score was the most important factor predicting reduced SVR [F2 vs. F0/F1 (OR = 0.41; p = 0.009); F3 vs. F0/F1 (OR = 0.72; p = 0.338); F4 vs. F0/F1 (OR = 0.27; p = 0.001)]. Male gender (OR = 13.16; p = 0.020) and higher fibrosis score [F2 vs. F0/F1 (OR = 9.72; p = 0.016); F3/F4 vs. F0/F1 (OR = 4.23; p = 0.113)] were associated with increased relapse in G3 patients. These results support the real-life effectiveness of peg-IFN α-2b plus ribavirin in HCV G2- and G3-infected patients. Overall, genotype was identified as the most significant predictor of treatment outcome. Fibrosis score and gender were key outcome predictors in the G3-infected population. In clinical settings, peg-INF/RBV offers an alternative for patients without access to all oral direct-acting antivirals.

Current outcome of portal vein thrombosis in adults: risk and benefit of anticoagulant therapy.

BACKGROUND & AIMS: The outcome of portal vein thrombosis in relation to associated prothrombotic states has not been evaluated. We assessed current outcome and predictors of bleeding and thrombotic events in a cohort of 136 adults with nonmalignant, noncirrhotic portal vein thrombosis, of whom 84 received anticoagulant therapy. METHODS: Multivariate Cox model analysis for event-free survival and analysis taking into account multiple events were used. RESULTS: Median follow-up was 46 months. The incidence rate of gastrointestinal bleeding was 12.5 (95% confidence interval [CI], 10-15) per 100 patient-years. Large varices were an independent predictor for bleeding. Anticoagulant therapy did not increase the risk or the severity of bleeding. The incidence rate of thrombotic events was 5.5 (95% CI, 3.8-7.2) per 100 patient-years. Underlying prothrombotic state and absence of anticoagulant therapy were independent predictors for thrombosis. In patients with underlying prothrombotic state, the incidence rates of splanchnic venous infarction were 0.82 and 5.2 per 100 patient-years in periods with and without anticoagulant therapy, respectively (P = 0.01). Two nonanticoagulated patients died of bleeding and thrombosis, respectively. CONCLUSIONS: In patients with portal vein thrombosis, the risk of thrombosis is currently as clinically significant as the risk of bleeding. The benefit-risk ratio favors anticoagulant therapy.

Pretreatment serum hepatitis C virus RNA levels and hepatitis C virus genotype are the main and independent prognostic factors of sustained response to interferon alfa therapy in chronic hepatitis C.

The aim of the study was to determine the respective influence of pretreatment serum hepatitis C virus (HCV) RNA levels and HCV genotype on the response to interferon (IFN) alfa in patients with chronic hepatitis C. We retrospectively studied 141 patients with chronic hepatitis C included in two consecutive controlled trials of IFN alfa. A sustained response was observed in 28, a response followed by relapse in 43, and no response in 70 patients. Pretreatment serum HCV RNA quantitation with the branched DNA (bDNA) assay and HCV genotyping with reverse hybridization assay (LiPA) were performed in all patients. Seventy-four percent of the patients had detectable serum HCV RNA (43%, 77% and 84%) in the three groups of patients with sustained response, relapse, and no response, respectively (P = .005). Mean serum HCV RNA level were 1.4 +/- 6 x 10(6), 4.8 +/- 6 x 10(6), and 3.9 +/- 5 x 10(6) genomes/mL in patients with sustained response, response and relapse, and no response, respectively (P < .01). Genotype 1b was found in 7%, 47%, and 46% of the patients in the three response groups, respectively. By univariate analysis, age, source, and duration of HCV infection, serum HCV RNA levels, and HCV genotypes were significantly different in the three response groups. By multivariate analysis, the only independent factors associated with sustained response were low serum HCV RNA levels and HCV genotype other than 1b. Pretreatment serum HCV RNA levels and HCV genotype are the main and independent factors associated with sustained response to IFN therapy.

Competency-Based Certification Project. Phase III: content validity, standard setting and criterion-related validity.

This is the final article in a three-part series explaining the CAMRT's Competency-Based Certification Project--an effort to make the Association's certification process more job-relevant. The first article (Journal, August 1994) explained the job analysis process used to specify and validate the list of duties and tasks required of entry-level medical radiation technologists, the imaging and treatment procedures they perform, and the equipment they use. The second article (Journal, October 1994) explained the process for developing an examination blueprint by reviewing the CAMRT's examinations and summaries of clinical experience in the context of competency-based evaluation and the job analysis validation in each discipline. This article examines the development of assessment standards for certification examinations and summaries of clinical experience. It provides an overview of the steps necessary to develop a valid and defensible licensure/certification process after development of the examination content is complete.

Competency-Based Certification Project. Phase II: Examination blueprint.

This is the second of three articles explaining the C.A.M.R.T.'s Competency-Based Certification Project--an effort to make the certification process more job-relevant. The first article (August 1994 Journal) explained the job analysis process used to specify and validate the list of duties and tasks of entry-level medical radiation technologists, the imaging and treatment procedures they perform, and the equipment they use. This article discusses how the results of the project's job analysis will help determine the content of the certification process. It explains the work involved in reviewing the C.A.M.R.T.'s examinations and summaries of clinical experience in the context of competency-based evaluation and the job analysis validation in each discipline. The resulting "examination blueprint" will become a key document for persons involved in the C.A.M.R.T.'s certification process. This article briefly describes the examination blueprint's components and related concepts. The third and final article of this series will examine the development of assessment standards for certification examinations and summaries of clinical experience.

Competency-based certification project. Phase I: Job analysis.

The Canadian Association of Medical Radiation Technologists (C.A.M.R.T.) is transforming its existing certification process into a competency-based process, consistent with the knowledge and skills required by entry-level radiography, radiation therapy and nuclear medicine technology practitioners. The project concurs with the change in focus advocated by the Conjoint Committee on Allied Medical Education Accreditation. The Committee supports new accreditation requirements that, among other things, place more emphasis on competency-based learning outcomes. Following is the first of three papers prepared by the C.A.M.R.T. to explain the project and the strategy for its implementation, focusing respectively on each phase. This paper discusses Phase One: the job analysis.

The changing scene of hepatic vein thrombosis: recognition of asymptomatic cases.

BACKGROUND/AIMS: Hepatic vein thrombosis is thought to be manifested by ascites, abdominal pain, and hepatomegaly, with a uniformly poor prognosis. However, new imaging techniques allow for the diagnosis of hepatic vein thrombosis in asymptomatic cases. The aim of our study was to re-evaluate symptoms and prognosis in patients with hepatic vein thrombosis. METHODS: Eighty-one patients with hepatic vein thrombosis were analyzed. Forty-seven patients were admitted from 1970 to June 1987 (group I, before Doppler ultrasonography and magnetic resonance imaging were introduced at our hospital) and 34 from July 1987 to June 1991 (group II). RESULTS: When comparing the two groups, age, sex ratio, and causes of hepatic vein thrombosis did not differ. Eight group II patients (asymptomatic patients) had no ascites, hepatomegaly, or abdominal pain. One major hepatic vein remained patent in 41% of group II patients, compared with 12% in group I (P < 0.05). Intrahepatic collaterals were seen in 79% of group II patients, compared with 21% of group I patients (P < 0.01). All asymptomatic patients had large intrahepatic and portasystemic collaterals. At 3 years, death occurred in 22% of group II patients and in 45% of group I patients. No asymptomatic patient died. CONCLUSIONS: Asymptomatic hepatic vein thrombosis is associated with the spontaneous development of large intrahepatic and portosystemic collaterals. In asymptomatic patients, prognosis at 3 years seems to be good, and surgical therapy may not be required.