EFFICACY OF TREATMENT WITH PEGYLATED INTERFERON AND RIBAVIRIN IN PATIENTS WITH CHRONIC HCV INFECTION “UNDER REAL LIFE“ CONDITIONS

2014 ◽  
Vol 21 (1) ◽  
pp. 23-32 ◽  
Author(s):  
Danutė Speičienė ◽  
Lina Kotovienė ◽  
Artautas Mickevičius ◽  
Valentina Liakina ◽  
Jonas Valantinas
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Antiviral Treatment ◽  
Real Life ◽  
University Hospital ◽  
Genotype 1 ◽  
Genotype 3 ◽  
Life Conditions ◽  
Unsuccessful Treatment ◽  
Genotype 2

Objective. To investigate the outcomes of combined therapy of hepatitis C (HCV) patients with peginterferon and ribavirin in ”real life” practice, to compare them with data obtained in randomized clinical trials (RCT) and to evaluate possible predictors of sustained virological response (SVR). Material and methods. The retrospective study of HCV patients routinely examined and treated in the Vilnius University Hospital Santariskiu Klinikos (2003−2009 yrs) was carried out. They had undergone the treatment with combination of peginterferon alfa and ribavirin according to the Lithuanian guide. Overall 203 patients were enrolled. SVR was evaluated in 179 patients. Results. The overall rate of SVR was 43 %: in 51,3 % of naives (genotype 1 − 38,8 %, genotype 2 – 100 %, genotype 3 − 82,6 % cases) and in 28,1 % of experienced patients (genotype 1 – 17 %, and genotype 3 – 64,3 % cases). Significant relations of SVR and HCV genotype was observed: 68,9 % having genotype1 were non-responders, whereas 80 % and 75,7 % ones with genotype 2 and 3 achieved SVR (p 0.005 and p = 0.01, respectively). The inverse relation with the age (p 0.01), degree of fibrosis (p = 0.039) and previous unsuccessful treatment was confirmed by multivariate analysis. Conclusions. Data of SVR obtained „on real life“ conditions are non unambiguous: SVR of naive and experienced patients overall and those with genotype 1 were similar or slightly lower, while for patients with genotype 3 significantly higher than results presented in clinical trials. Genotype 1, previous unsuccessful antiviral treatment, older age, and advanced fibrosis were strongest negative predictors for SVR.

scholarly journals Statins in Heart Failure: The Paradox Between Large Randomized Clinical Trials and Real Life

2012 ◽  
Vol 87 (6) ◽  
pp. 555-560 ◽  
Author(s):  
Paloma Gastelurrutia ◽  
Josep Lupón ◽  
Marta de Antonio ◽  
Agustin Urrutia ◽  
Crisanto Díez ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Real Life

scholarly journals Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies

Cells ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. 476 ◽  
Author(s):  
Flavia Franconi ◽  
Ilaria Campesi ◽  
Delia Colombo ◽  
Paola Antonini
Keyword(s):  
Clinical Trials ◽  
Environmental Factors ◽  
Gender Gap ◽  
Randomized Clinical Trials ◽  
Real Life ◽  
Sex And Gender ◽  
Key Factors ◽  
And Gender ◽  
Scientific Value ◽  
Racial Ethnic

There is a clear sex–gender gap in the prevention and occurrence of diseases, and in the outcomes and treatments, which is relevant to women in the majority of cases. Attitudes concerning the enrollment of women in randomized clinical trials have changed over recent years. Despite this change, a gap still exists. This gap is linked to biological factors (sex) and psycho-social, cultural, and environmental factors (gender). These multidimensional, entangled, and interactive factors may influence the pharmacological response. Despite the fact that regulatory authorities recognize the importance of sex and gender, there is a paucity of research focusing on the racial/ethnic, socio-economic, psycho-social, and environmental factors that perpetuate disparities. Research and clinical practice must incorporate all of these factors to arrive at an intersectional and system-scenario perspective. We advocate for scientifically rigorous evaluations of the interplay between sex and gender as key factors in performing clinical trials, which are more adherent to real-life. This review proposes a set of 12 rules to improve clinical research for integrating sex–gender into clinical trials.

scholarly journals Successful Kidney Transplantation in a Recipient Coinfected with Hepatitis C Genotype 2 and HIV from a Donor Infected with Hepatitis C Genotype 1 in the Direct-Acting Antiviral Era

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Dimitrios Farmakiotis ◽  
Zoe Weiss ◽  
Amy L. Brotherton ◽  
Paul Morrissey ◽  
Reginald Gohh ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
Hepatitis C ◽  
Antiviral Treatment ◽  
Holistic Approach ◽  
Kidney Graft ◽  
Genotype 1 ◽  
Direct Acting Antiviral ◽  
First Case ◽  
Genotype 2 ◽  
Transplant Candidates

Despite significant advances in transplantation of HIV-infected individuals, little is known about HIV coinfected patients with hepatitis C virus (HCV) genotypes other than genotype 1, especially when receiving HCV-infected organs with a different genotype. We describe the first case of kidney transplantation in a man coinfected with hepatitis C and HIV in our state. To our knowledge, this is also the first report of an HIV/HCV/HBV tri-infected patient with non-1 (2a) HCV genotype who received an HCV-infected kidney graft with the discordant genotype (1a), to which he converted after transplant. Our case study highlights the following: (1) transplant centers need to monitor wait times for an HCV-infected organ and regularly assess the risk of delaying HCV antiviral treatment for HCV-infected transplant candidates in anticipation of the transplant from an HCV-infected donor; (2) closer monitoring of tacrolimus levels during the early phases of anti-HCV protease inhibitor introduction and discontinuation may be indicated; (3) donor genotype transmission can occur; (4) HIV/HCV coinfected transplant candidates require a holistic approach with emphasis on the cardiovascular risk profile and low threshold for cardiac catheterization as part of their pretransplant evaluation.

scholarly journals Approaches to Assessing the Quality of Observational Studies of Clinical Practice Based on the Big Data Analysis

2021 ◽  
Vol 17 (4) ◽  
pp. 584-593
Author(s):  
S. R. Gilyarevsky
Keyword(s):  
Clinical Trials ◽  
Big Data ◽  
Clinical Practice ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Hierarchy Of Evidence

The article is devoted to the discussion of the problems of assessing the quality of observational studies in real clinical practice and determining their place in the hierarchy of evidence-based information. The concept of “big data” and the acceptability of using such a term to refer to large observational studies is being discussed. Data on the limitations of administrative and claims databases when performing observational studies to assess the effects of interventions are presented. The concept of confounding factors influencing the results of observational studies is discussed. Modern approaches to reducing the severity of bias in real-life clinical practice studies are presented. The criteria for assessing the quality of observational pharmacoepidemiological studies and the fundamental differences between such studies and randomized clinical trials are presented. The results of systematic reviews of real-life clinical trials to assess the effects of direct oral anticoagulants are discussed. 

scholarly journals Carcass and pork quality traits of indigenous pure breeds (Mangalitsa, Moravka) and their crossbreads

2015 ◽  
Author(s):  
C. Radovic ◽  
M. Petrovic ◽  
N. Parunovic ◽  
D. Radojkovic ◽  
R. Savic ◽  
...  
Keyword(s):  
Phenotypic Variability ◽  
Production Performance ◽  
Pork Quality ◽  
Quality Traits ◽  
Genotype 1 ◽  
Genotype 3 ◽  
Genotype 4 ◽  
Genotype 2 ◽  
Fat Thickness ◽  
Daily Gain

Objective of this paper was to evaluate phenotypic variability of carcass side and pork quality traits of fatteners (male castrated and female heads). Investigation included 12 pigs per group of Mangalitsa (Genotype 1), Moravka (Genotype 2), cross-breed Mangalitsa with Moravka (Genotype 3) and cross-breed Moravka with Duroc boar (Genotype 4). Results show that Mangalitsa had lower daily gain (268 g) than other genotypes (p<0.001). The greatest difference for fat thickness was determined between Genotype 1 and Genotype 4. As expected, the thinnest fat and maximum value for gain and depth of Musculus longissimus (ML) had the Genotype 4. The highest value for the ML surface was found in Genotype 4(47.52 cm2) whereas for the same trait in Mangalitsa the lowest value was observed (24.16 cm2). Mangalitsa had significantly lower L*, a* and b* values of ML compared with all other groups (p<0.001). Considering the low production performance of indigenous pig breeds, crossbreeding with the Duroc breed will contribute a improvement of growth and carcass traits.

scholarly journals Pregnancy Rates with Recombinant versus Urinary Human Chorionic Gonadotropin in In Vitro Fertilization: An Observational Study

2011 ◽  
Vol 11 ◽  
pp. 1781-1787 ◽  
Author(s):  
József Zeke ◽  
Katalin Kanyó ◽  
Helga Zeke ◽  
Áron Cseh ◽  
Barna Vásárhelyi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Clinical Characteristics ◽  
Randomized Clinical Trials ◽  
Real Life ◽  
In Vitro Fertilisation ◽  
Vitro Fertilization ◽  
Equal Efficacy

Randomized clinical trials (RCTs) demonstrated the equal efficacy of urinary human chorionic gonadotropin (uhCG) and recombinant hCG (rhCG) products in in vitro fertilisation (IVF). However, limitations inherent with RCTs necessitate the reinforcement of RCT results in real-life. We retrospectively analyzed pregnancies after treatment with rhCG and uhCG products (n=391, and 96, resp.). We found that laboratory-verified pregnancy occurred more frequently in rhCG patients than in those on uhCG (43% versus 30%,P=0.02). The association remains significant (P=0.002) after its adjustment for clinical characteristics. The prevalence of laboratory-verified pregnancies was higher with GnRH agonist use (P=0.012) and BMI under 30 kg/m2(P=0.053) while decreased the age (P=0.014) and the number of previous failed attempts (P=0.08). Similar (but not significant) trends were observed with rates of pregnancy filled the 24th week. These results reinforce RCTs supporting the notion that rhCG is more efficient as uhCG during IVF.

scholarly journals Molecular Epidemiological Analysis of Cryptosporidiumspp. in the United Kingdom: Results of GenotypingCryptosporidium spp. in 1,705 Fecal Samples from Humans and 105 Fecal Samples from Livestock Animals

2000 ◽  
Vol 38 (11) ◽  
pp. 3984-3990 ◽  
Author(s):  
J. McLauchlin ◽  
C. Amar ◽  
S. Pedraza-Díaz ◽  
G. L. Nichols
Keyword(s):  
Late Summer ◽  
Temporal Variations ◽  
Broad Host Range ◽  
Genotype 1 ◽  
Genotype 3 ◽  
Oocyst Wall ◽  
Fecal Samples ◽  
The United Kingdom ◽  
Genotype 2 ◽  
History Of

Cryptosporidium present in 1,705 fecal samples from humans and 105 from livestock animals were analyzed by PCR-restriction fragment length polymorphism of the Cryptosporidium oocyst wall protein. Overall, genotype 1 (human exclusive type) was detected in 37.8% of the samples from humans, genotype 2 (broad host range) was detected in 61.5%, a third genotype designated genotype 3 (Cryptosporidium meleagridis) was detected in 0.3%, and both genotypes 1 and 2 were recovered from 0.4%. All samples from livestock yielded genotype 2. Among 469 patients infected during eight drinking water-related outbreaks, five outbreaks were predominantly due to genotype 1, and three were due to genotype 2. Fifty-four samples were collected from patients involved with five swimming pool-associated outbreaks: two outbreaks were due to genotype 1, one was due to genotype 2, and the remaining two involved both genotypes 1 and 2. Among 26 family outbreaks and 1 children's nursery outbreak (2 to 3 members per group), the same genotype was recovered from the different members of each outbreak: 13 were due to genotype 1, and 14 were due to genotype 2. In eighteen patients reporting contact with animals and/or farms, genotype 1 was recovered from one patient and genotype 2 was recovered from the remaining 17. Among the sporadic cases, there were distinct geographical and temporal variations in the distribution of the genotypes. The spring peak in cases was due to genotype 2. Genotype 1 was significantly more common in patients infected during the late-summer–autumn peak and in those with a history of foreign travel.

scholarly journals Prevalence of hepatitis C virus infection and HCV genotypes among hemophiliacs in the State of Bahia, Northeastern Brazil: analysis of serological and virological parameters

2005 ◽  
Vol 38 (6) ◽  
pp. 496-502 ◽  
Author(s):  
Luciano Kalabric Silva ◽  
Maria Betânia Souza da Silva ◽  
Gisele Barreto Lopes ◽  
Itatiana Ferreira Rodart ◽  
Fernando Quadros Costa ◽  
...  
Keyword(s):  
The State ◽  
Northeastern Brazil ◽  
Hepatitis C Virus Infection ◽  
Genotype 1 ◽  
Genotype 3 ◽  
Genotype 2 ◽  
Hcv Transmission ◽  
Inhibitory Antibodies ◽  
Hcv Genotype 1 ◽  
Infection Markers

The objective of the present study was to analyze HCV serological and virological parameters from hemophiliacs in the State of Bahia. Anti-HCV was investigated by ELISA in a cohort of 268 hemophiliacs A/B who were followed-up in a reference unit for hemotherapy in the State of Bahia. HCV viremia and genotypes were also determined from a subset of 66 anti-HCV seropositive hemophiliacs. Seroprevalence among hemophiliacs was 42.2% (95% CI 36.5-48.1) and was significantly higher (p<0.05) according to age >10 years, presence of factor VIII/IX inhibitory antibodies and other infection markers. None of the hemophiliacs less than 5 years of age were anti-HCV seropositive. Viremia was detectable in 77.3% (51/66). HCV genotype 1 (74%) was the most prevalent followed by genotype 3 (22%) and genotype 2 (4%). Our results indicate that HCV prevalence is still high among hemophiliacs, although HCV transmission was not observed in young hemophiliacs.

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