35 research outputs found
Intensive enteral nutrition is ineffective for individuals with severe alcoholic hepatitis treated with corticosteroids.
peer reviewedBACKGROUND & AIMS: Severe alcoholic hepatitis (AH) is a lifethreatening
disease for which adequate oral nutritional support
is recommended. We performed a randomized controlled trial to
determine whether the combination of corticosteroid and
intensive enteral nutrition therapy is more effective than corticosteroid
therapy alone in patients with severe AH. METHODS:
We enrolled 136 heavy consumers of alcohol (age, 18–75 y)
with recent onset of jaundice and biopsy-proven severe AH in
our study, performed at 18 hospitals in Belgium and 2 in
France, from February 2010 through February 2013. Subjects
were assigned randomly (1:1) to groups that received either
intensive enteral nutrition plus methylprednisolone or conventional
nutrition plus methylprednisolone (controls). In the
intensive enteral nutrition group, enteral nutrition was given
via feeding tube for 14 days. The primary end point was patient
survival for 6 months. RESULTS: In an intention-to-treat analysis,
we found no significant difference between groups in
6-month cumulative mortality: 44.4% of patients died in the
intensive enteral nutrition group (95% confidence interval [CI],
32.2%–55.9%) and 52.1% of controls died (95% CI, 39.4%–
63.4%) (P ¼ .406). The enteral feeding tube was withdrawn
prematurely from 48.5% of patients, and serious adverse
events considered to be related to enteral nutrition occurred in
5 patients. Regardless of group, a greater proportion of patients
with a daily calorie intake less than 21.5 kcal/kg/day died
(65.8%; 95% CI, 48.8–78.4) than patients with a higher intake
of calories (33.1%; 95% CI, 23.1%–43.4%) (P < .001).
CONCLUSIONS: In a randomized trial of patients with severe AH
treated with corticosteroids, we found that intensive enteral
nutrition was difficult to implement and did not increase survival.
However, low daily energy intake was associated with greater
mortality, so adequate nutritional intake should be a main goal for
treatment
Impact of Safety-Related Dose Reductions or Discontinuations on Sustained Virologic Response in HCV-Infected Patients: Results from the GUARD-C Cohort.
BACKGROUND: Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. METHODS: A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the impact of sr-RD on SVR24 (HCV RNA <50 IU/mL) were conducted in 951 Caucasian, noncirrhotic genotype (G)1 patients assigned to peginterferon alfa-2a/ribavirin for 48 weeks. The probability of SVR24 was identified by a baseline scoring system (range: 0-9 points) on which scores of 5 to 9 and <5 represent high and low probability of SVR24, respectively. RESULTS: SVR24 rates were 46.1% (754/1634), 77.1% (279/362), 68.0% (514/756), and 51.3% (203/396), respectively, in G1, 2, 3, and 4 patients. Overall, 16.9% and 21.8% patients experienced ≥1 sr-RD for peginterferon alfa and ribavirin, respectively. Among Caucasian noncirrhotic G1 patients: female sex, lower body mass index, pre-existing cardiovascular/pulmonary disease, and low hematological indices were prognostic factors of sr-RD; SVR24 was lower in patients with ≥1 vs. no sr-RD by Week 4 (37.9% vs. 54.4%; P = 0.0046) and Week 12 (41.7% vs. 55.3%; P = 0.0016); sr-RD by Week 4/12 significantly reduced SVR24 in patients with scores <5 but not ≥5. CONCLUSIONS: In conclusion, sr-RD to peginterferon alfa-2a/ribavirin significantly impacts on SVR24 rates in treatment-naive G1 noncirrhotic Caucasian patients. Baseline characteristics can help select patients with a high probability of SVR24 and a low probability of sr-RD with peginterferon alfa-2a/ribavirin.This study was sponsored by F. Hoffmann-La Roche Ltd, Basel, Switzerland. Support for third-party writing
assistance for this manuscript, furnished by Blair Jarvis MSc, ELS, of Health Interactions, was provided by F. Hoffmann-La Roche Ltd, Basel, Switzerland
Impact of safety-related dose reductions or discontinuations on sustained virologic response in HCV-infected patients: Results from the GUARD-C Cohort
Background: Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. Methods: A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the impact of sr-RD on SVR24 (HCV RNA <50 IU/mL) were conducted in 951 Caucasian, noncirrhotic genotype (G)1 patients assigned to peginterferon alfa-2a/ribavirin for 48 weeks. The probability of SVR24 was identified by a baseline scoring system (range: 0-9 points) on which scores of 5 to 9 and <5 represent high and low probability of SVR24, respectively. Results: SVR24 rates were 46.1 % (754/1634), 77.1% (279/362), 68.0% (514/756), and 51.3% (203/396), respectively, in G1,2, 3, and 4 patients. Overall, 16.9% and 21.8% patients experienced 651 sr-RD for peginterferon alfa and ribavirin, respectively. Among Caucasian noncirrhotic G1 patients: female sex, lower body mass index, pre-existing cardiovascular/pulmonary disease, and low hematological indices were prognostic factors of sr-RD; SVR24 was lower in patients with 651 vs. no sr-RD by Week 4 (37.9% vs. 54.4%; P = 0.0046) and Week 12 (41.7% vs. 55.3%; P = 0.0016); sr-RD by Week 4/12 significantly reduced SVR24 in patients with scores <5 but not 655. Conclusions: In conclusion, sr-RD to peginterferon alfa-2a/ribavirin significantly impacts on SVR24 rates in treatment-naive G1 noncirrhotic Caucasian patients. Baseline characteristics can help select patients with a high probability of SVR24 and a low probability of sr-RD with peginter-feron alfa-2a/ribavirin
Response of Black African patients with hepatitis C virus genotype 4 to treatment with peg-interferon and ribavirin
Aim : To compare responses to therapy of Black African (BA)
and non-Black African (non- BA) patients with hepatitis C virus
genotype 4 (HCV-4) residing in Belgium.
Methods : In this retrospective multicenter study, 473 patients
with HCV-4 were selected from databases at 7 Belgian centers ;
209 treatment-naïve patients (154 BA) had received treatment with
peg-interferon (peg-IFN) plus ribavirin (RBV) and were included
in the study.
Results : There was a greater percentage of female patients in the
BA group than in the non- BA group ; BA patients were also older,
had a greater body mass index, and more frequently had abnormal
glucose metabolism. The route of contamination was more frequently
unknown in BA than in non-BA patients and BA patients
had more HCV-4 subtypes. There were no differences in other demographic
factors between the groups. Sustained viral response
(SVR) and complete early viral response rates were significantly
lower and relapse rates significantly higher in BA than in non-BA
patients. There were no differences between groups in rates of dose
modification or in drug tolerance.
Conclusion : In our cohort, treatment-naïve BA patients with
HCV-4 who were treated with peg-IFN and ribavirin had a much
lower SVR rate than treatment-naïve non-BA patients with HCV-
4 who were treated with peg-IFN and ribavirin, and a higher
relapse
rate, possibly related to a weaker response to interferonbased
therapy. Treatment may need to be adapted in this population
Ethnic epidemiological profiles and antiviral therapy among patients infected with hepatitis C virus genotype 4: a multicenter study from Belgium.
Background: Hepatitis C virus genotype 4 (HCV-4) is the most prevalent genotype in Central Africa. A large population of Black African individuals, among whom HCV-4 infection is widespread, resides in Belgium.
Aim: To compare epidemiology, clinical characteristics and any differences in receipt of HCV therapy in two populations of HCV-4 patients residing in Belgium.
Methods: This retrospective multicenter study selected 473 patients from seven hospital databases and compared them according to ethnic origin, i.e., Black African (n=331) or not (n=142), for epidemiological, clinical, biological and histological characteristics. Interleukin 28B polymorphism (CC-genotype) was evaluated in a second cohort of 69 Black African and 30 non-Black African patients.
Results: Compared to other patients, the Black African patients were more likely to be female and were older, more commonly overweight, more frequently had abnormal glucose metabolism and arterial hypertension; they were less likely to have dyslipidemia, a history of alcohol consumption or ALT elevation. The route of infection was more frequently unknown in Black African than in other patients. Black African patients had more HCV-4 subtypes, were less frequently of IL28B CC-genotype and had less severe liver fibrosis. The proportion of patients who received antiviral treatment was similar in the two groups.
Conclusion: In this Belgian cohort, patients with HCV-4 infection were more frequently of Black African origin than of other origin. Infected Black African patients were more commonly female, older at diagnosis, and had more co-morbidities than other patients; they also had less advanced liver fibrosis than infected non-Black African patients and fewer had a CC genotype. The number of patients treated with antiviral therapy was similar in the two groups
Hepatitis C genotype 4 response rate to pegylated interferon and ribavirin treatment in Belgium is similar to genotype 1
Background and aims : Patients with genotype 4 (G4) chronic
hepatitis C from the Middle East respond better to treatment than
genotype 1 (G1) patients. There are few data on the response rates
to treatment of G4 patients living in Western Europe. Many G4
patients in Belgium originate from Central Africa, and their
response to treatment seems lower.
Methods : We analysed the data from 2 randomized phase III
studies conducted in Belgium, BerNar-1 and BerNar-2, comparing
the sustained virological response (SVR) to pegylated interferon
and ribavirin of 78 G4 patients (34 Caucasians, 44 Blacks) and 477
G1 patients (455 Caucasians, 12 Blacks), and assessing the predictors
of SVR.
Results : Baseline characteristics of G4 and G1 patients were
similar except mainly for race. Complete early virological response
(cEVR) was similar in G4 (73.2%) and G1 (68.1%). cEVR was
also similar between Black and Caucasian G4 and between Black
and Caucasian G1 patients. Partial early virological response was
similar for G4 and G1. SVR was similar for G4 (51.3%) and G1
(51.8%). There was a trend for a higher SVR in Caucasians than in
Blacks. In multivariate analysis, the only predictors for SVR were
the presence of cirrhosis, HCV viral load, age < 40 vs 40 yrs, and
treatment status (relapsers vs naïve).
Conclusions : G4 patients in Belgium have the same SVR as G1
patients. It is lower than the SVR described in Arab countries,
especially for Black G4 patients. (Acta gastro enterol. belg., 2010, 73,
229-234)
Liver damage caused by therapeutic vitamin A administration: estimate of dose-related toxicity in 41 cases.
Clinical presentation, changes in liver function test results, and liver morphology were examined in 41 consecutive patients with vitamin A hepatoxicity. The cause of liver disease was suspected at initial interview in only 13 instances, whereas histological evidence of fat-storing cell hyperplasia with fluorescent vacuoles led to the diagnosis in the remaining cases. Cirrhosis was found in 17, mild chronic hepatitis in 10, noncirrhotic portal hypertension in 5, and "increased storage" alone in 9 cases. During a mean follow-up period of 4.6 years, 6 patients died of causes related to the liver disease. A precise appraisal of drug consumption was obtained in 29 cases. Among them the total cumulative intake was the highest in patients with cirrhosis (423 +/- 103 x 10(6) IU) and significantly lower in those with noncirrhotic liver disease (88.5 +/- 41; P less than 0.02). The smallest continuous daily consumption leading to cirrhosis was 25,000 IU during 6 years, whereas higher daily doses (greater than or equal to 100,000 IU) taken during 21/2 years resulted in similar histological lesions. It was concluded that at least in some western countries chronic vitamin A consumption might represent an appreciable cause of chronic liver disease, the recognition of which mainly relies on expert liver biopsy interpretation. The data also indicate that prolonged and continuous consumption of doses in the low "therapeutic" range can result in life-threatening liver damage