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1.
J Virus Erad ; 9(1): 100319, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36970063

RESUMEN

Background & aims: Despite effective direct-acting antivirals (DAAs), hepatitis C virus (HCV) prevalence is high among people who inject drugs (PWIDs) and non-adherence to therapy remains a major obstacle towards HCV elimination in this subpopulation. To overcome this issue, we have combined ongoing opioid agonist therapy (OAT) with DAAs in a directly-observed therapy (DOT) setting. Method: From September 2014 until January 2021 PWIDs at high risk of non-adherence to DAA therapy, who were also on OAT, were included into this microelimination project. Individuals received their OAT and DAAs under supervision of healthcare workers as DOT in a pharmacy or low-threshold facility. Results: In total, 504 HCV RNA-positive PWIDs on OAT (387 men, 76.8%; median age: 38 years [IQR 33-45], HIV: 4.6%; hepatitis B: 1.4%) were included into this study. Two thirds reported ongoing intravenous drug use (IDU) and half of them had no permanent housing. Only 41 (8.1%) were lost to follow-up and two (0.4%) died of reasons unrelated to DAA toxicity. Overall, 90.7% of PWIDs achieved sustained virological response 12 weeks after treatment (SVR12) (95% CI: 88.1-93.2%). By excluding those lost to follow-up and hose who had died of causes unrelated to DAAs, the SVR12 rate was 99.1% (95% CI: 98.3-100.0%; modified intention-to-treat analysis). Four PWIDs (0.9%) experienced treatment failure. Over a median follow-up of 24 weeks (IQR 12-39), 27 reinfections (5.9%) were observed in individuals with the highest IDU rates (81.2%). Importantly, even though some were lost to follow-up, all completed their DAA treatment. By using DOT, adherence to DAAs was excellent with only a total of 86 missed doses (0.3% of 25,224 doses). Conclusions: In this difficult-to-treat population of PWIDs with high rates of IDU , coupling DAA treatment to OAT in a DOT setting resulted in high SVR12 rates equivalent to conventional treatment settings in non-PWID populations.

2.
J Viral Hepat ; 25(7): 870-873, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-29316001

RESUMEN

An important subgroup of people who inject drugs (PWID) receiving opioid agonist therapy (OAT) cannot be treated in the setting of a hepatology centre and would not regularly ingest their medication when handed to them for self-administration. Our hypothesis was that chronic hepatitis C in these patients could be ideally managed if modern, interferon-free regimens were administered together with OAT under direct observation of a physician or nurse at a low-threshold facility. In this open-label, noninterventional, proof-of-concept study (ClinicalTrials.gov number, NCT02638233), 40 PWID at risk of nonadherence to direct-acting antivirals (DAA) and previously untreated chronic hepatitis C virus genotype 1 infection without cirrhosis were treated with ledipasvir/sofosbuvir for 8 weeks. Patients received antiviral treatment together with OAT under direct observation of a physician or nurse at a low-threshold facility. By following the concept of directly observed therapy, excellent adherence to antiviral therapy was achieved as follows: only 0.16% (95% CI: 0.03-0.47) of scheduled dates for ingestion of the antiviral therapy in combination with OAT were missed by the 40 patients. The rate of sustained virological response 12 weeks after end of therapy was 100% (95% CI: 91.2-100.0). Between week 12 and week 24 of follow-up reinfections were recorded in 2 of 40 patients (5%). Directly observed therapy of chronic hepatitis C is highly effective in PWID at risk of nonadherence to DAA. By this new concept, a group of difficult-to-treat patients can be cured, who could not have been treated in settings of studies published so far.


Asunto(s)
Antivirales/administración & dosificación , Bencimidazoles/administración & dosificación , Terapia por Observación Directa , Fluorenos/administración & dosificación , Hepatitis C Crónica/tratamiento farmacológico , Sofosbuvir/administración & dosificación , Abuso de Sustancias por Vía Intravenosa/complicaciones , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Genotipo , Hepacivirus/clasificación , Hepacivirus/genética , Hepacivirus/aislamiento & purificación , Humanos , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Respuesta Virológica Sostenida , Resultado del Tratamiento , Adulto Joven
3.
J Viral Hepat ; 24(4): 280-286, 2017 04.
Artículo en Inglés | MEDLINE | ID: mdl-27935166

RESUMEN

High rates of sustained virologic response at post-treatment week 12 (SVR12) were achieved in six phase 3 trials of ombitasvir (OBV, an NS5A inhibitor), paritaprevir (an NS3/4A protease inhibitor) co-dosed with ritonavir (PTV/r) + dasabuvir (DSV, an NS5B RNA polymerase inhibitor) (ie, 3D regimen) with or without ribavirin (RBV) in adults with chronic genotype (GT) 1 hepatitis C virus (HCV) infection. We assessed whether time to first HCV RNA value below the lower limit of quantification in patients with and without cirrhosis was associated with achievement of SVR12. Data were analysed from GT1-infected patients enrolled in six phase 3 studies of 3D ± RBV. Patients who experienced non-virologic failure were excluded from analysis. HCV RNA was determined using the Roche COBAS TaqMan RT-PCR assay (lower limit of quantification, LLOQ =25 IU/mL). SVR12 was analysed by week of first HCV RNA suppression, defined as HCV RNA

Asunto(s)
Antivirales/administración & dosificación , Genotipo , Hepacivirus/clasificación , Hepatitis C Crónica/tratamiento farmacológico , Hepatitis C Crónica/virología , Respuesta Virológica Sostenida , Adolescente , Adulto , Anciano , Anilidas , Carbamatos , Ensayos Clínicos Fase III como Asunto , Femenino , Hepacivirus/genética , Hepacivirus/aislamiento & purificación , Humanos , Masculino , Persona de Mediana Edad , Prolina , ARN Viral/sangre , Factores de Tiempo , Resultado del Tratamiento , Valina , Adulto Joven
5.
J Viral Hepat ; 21 Suppl 1: 5-33, 2014 May.
Artículo en Inglés | MEDLINE | ID: mdl-24713004

RESUMEN

Chronic infection with hepatitis C virus (HCV) is a leading indicator for liver disease. New treatment options are becoming available, and there is a need to characterize the epidemiology and disease burden of HCV. Data for prevalence, viremia, genotype, diagnosis and treatment were obtained through literature searches and expert consensus for 16 countries. For some countries, data from centralized registries were used to estimate diagnosis and treatment rates. Data for the number of liver transplants and the proportion attributable to HCV were obtained from centralized databases. Viremic prevalence estimates varied widely between countries, ranging from 0.3% in Austria, England and Germany to 8.5% in Egypt. The largest viremic populations were in Egypt, with 6,358,000 cases in 2008 and Brazil with 2,106,000 cases in 2007. The age distribution of cases differed between countries. In most countries, prevalence rates were higher among males, reflecting higher rates of injection drug use. Diagnosis, treatment and transplant levels also differed considerably between countries. Reliable estimates characterizing HCV-infected populations are critical for addressing HCV-related morbidity and mortality. There is a need to quantify the burden of chronic HCV infection at the national level.


Asunto(s)
Hepatitis C Crónica/epidemiología , Antivirales/uso terapéutico , Salud Global , Hepatitis C Crónica/mortalidad , Hepatitis C Crónica/terapia , Humanos , Incidencia , Trasplante de Hígado , Prevalencia , Análisis de Supervivencia
6.
J Viral Hepat ; 21 Suppl 1: 60-89, 2014 May.
Artículo en Inglés | MEDLINE | ID: mdl-24713006

RESUMEN

The number of hepatitis C virus (HCV) infections is projected to decline while those with advanced liver disease will increase. A modeling approach was used to forecast two treatment scenarios: (i) the impact of increased treatment efficacy while keeping the number of treated patients constant and (ii) increasing efficacy and treatment rate. This analysis suggests that successful diagnosis and treatment of a small proportion of patients can contribute significantly to the reduction of disease burden in the countries studied. The largest reduction in HCV-related morbidity and mortality occurs when increased treatment is combined with higher efficacy therapies, generally in combination with increased diagnosis. With a treatment rate of approximately 10%, this analysis suggests it is possible to achieve elimination of HCV (defined as a >90% decline in total infections by 2030). However, for most countries presented, this will require a 3-5 fold increase in diagnosis and/or treatment. Thus, building the public health and clinical provider capacity for improved diagnosis and treatment will be critical.


Asunto(s)
Antivirales/uso terapéutico , Hepatitis C Crónica/tratamiento farmacológico , Hepatitis C Crónica/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Pruebas Diagnósticas de Rutina/estadística & datos numéricos , Erradicación de la Enfermedad , Quimioterapia Combinada/métodos , Femenino , Salud Global , Hepatitis C Crónica/diagnóstico , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Modelos Estadísticos , Prevalencia , Adulto Joven
7.
J Viral Hepat ; 21 Suppl 1: 34-59, 2014 May.
Artículo en Inglés | MEDLINE | ID: mdl-24713005

RESUMEN

The disease burden of hepatitis C virus (HCV) is expected to increase as the infected population ages. A modelling approach was used to estimate the total number of viremic infections, diagnosed, treated and new infections in 2013. In addition, the model was used to estimate the change in the total number of HCV infections, the disease progression and mortality in 2013-2030. Finally, expert panel consensus was used to capture current treatment practices in each country. Using today's treatment paradigm, the total number of HCV infections is projected to decline or remain flat in all countries studied. However, in the same time period, the number of individuals with late-stage liver disease is projected to increase. This study concluded that the current treatment rate and efficacy are not sufficient to manage the disease burden of HCV. Thus, alternative strategies are required to keep the number of HCV individuals with advanced liver disease and liver-related deaths from increasing.


Asunto(s)
Antivirales/uso terapéutico , Hepatitis C Crónica/tratamiento farmacológico , Hepatitis C Crónica/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Quimioterapia Combinada/métodos , Femenino , Salud Global , Humanos , Incidencia , Lactante , Recién Nacido , Masculino , Persona de Mediana Edad , Modelos Estadísticos , Prevalencia , Adulto Joven
8.
Aliment Pharmacol Ther ; 39(1): 104-11, 2014 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-24205831

RESUMEN

BACKGROUND: The IL28B genotype in rs12979860 predicts success of peginterferon/ribavirin (PEG/RBV) therapy in patients with chronic hepatitis C (CHC). Recently, a dinucleotide frame shift variant in ss469415590 (TT or ΔG) was described, which generates the novel interferon lambda 4 protein (IFNL4). IFNL4 ss469415590 (ΔG) allele carriers have an impaired clearance of HCV infection and response to IFN-α therapy. In this study, we compared the role of IFNL4 polymorphism with the two commonly used IL28B SNPs rs12979860 and rs8099917 on response to PEG/RBV in patients with CHC. AIM: To compare the role of IFNL4 polymorphism with the two commonly used IL28B SNPs rs12979860 and rs8099917 on response to PEG/RBV in patients with CHC. METHODS: A total of 754 PEG/RBV patients treated (male/female = 484/270; Caucasians: 98.8%; mean age: 42.8 [CI 95%: 42.0-43.6] y; genotype (GT)1: n = 435, GT2: n = 23, GT3: n = 185, GT4: n = 114) were investigated. Liver fibrosis was assessed by liver biopsy in 456 patients. Single nucleotide polymorphisms (SNPs) in ss469415590, rs12979860 and rs8099917 were analysed by RT-PCR system. RESULTS: Of the patients, 12.9% (n = 97) had the ss469415590 ΔG/ΔG genotype (IFNL4), 51.3% (n = 387) were heterozygous (TT/ΔG) and 35.8% (n = 270) had TT/TT. IFNL4 polymorphism was independently associated with SVR in GT1 (OR: 2.539, CI 95%: 1.629-3.021, P < 0.001) and GT4 (OR: 12.573, CI 95%: 3.427-46.133, P < 0.001), but not in GT3 (OR: 1.514, CI 95%: 0.933-2.458, P = 0.093). IFNL4 correlated strongly with rs12979860 (ρ = 0.988, P < 0.001), but only moderately with rs8099917 (ρ = 0.598, P < 0.001). CONCLUSIONS: These findings underscore the role of IFNL4 for treatment response in patients with CHC genotypes 1 and 4. However, due to its strong correlation with rs12979860 in IL28B, there is no benefit in additional testing for IFNL4 for treatment prediction in Caucasian patients. By contrast, IFNL4 improves prediction of response to interferon-based therapies, if SNP rs8099917 is used.


Asunto(s)
Antivirales/uso terapéutico , Hepatitis C Crónica/tratamiento farmacológico , Interferones/uso terapéutico , Interleucinas/genética , Ribavirina/uso terapéutico , Adulto , Femenino , Genotipo , Hepatitis C Crónica/genética , Humanos , Masculino , Persona de Mediana Edad , Polimorfismo de Nucleótido Simple , Resultado del Tratamiento
9.
Aliment Pharmacol Ther ; 38(2): 118-23, 2013 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-23710895

RESUMEN

BACKGROUND: The introduction of direct-acting anti-virals has increased sustained virological response (SVR) rates in chronic hepatitis C genotype 1 infection. At present, data on long-term durability of viral eradication after successful triple therapy are lacking. AIM: To evaluate the long-term durability of viral eradication in patients treated with triple therapy, including direct-acting anti-virals. METHODS: Patients who participated in randomised, controlled trials or an extended access programme of treatment with peginterferon-α2a/ribavirin in combination with a direct-acting anti-viral (telaprevir, danoprevir, faldaprevir, simeprevir, mericitabine, balapiravir) were followed after achieving SVR. The median follow-up after the patients was 21 (range: 7-64) months. RESULTS: One hundred and three patients with chronic hepatitis C genotype 1 infection [f/m: 34/69; GT-1b: 67 GT-1a: 34, GT-4: 2; mean age: 47.6 years (45.5-49.7; 95% CI)] achieving a SVR triple therapy were followed. Two cases of late relapses (2/103, 1.9%; 95% CI: 0.24-6.8) were observed. One patient was cirrhotic, both carried the genotype 1b and completed the prescribed treatment. The relapses occurred 8 and 12 months after cessation of anti-viral treatment. Cloning sequencing revealed identical sequence in both patients. Resistance analysis revealed no presence of viral resistance. CONCLUSION: Like the SVR after peginterferon-α2/ribavirin combination treatment, HCV eradication after triple therapy remains durable after long-term follow-up.


Asunto(s)
Antivirales/uso terapéutico , Hepatitis C Crónica/tratamiento farmacológico , Interferón-alfa/uso terapéutico , Polietilenglicoles/uso terapéutico , Ribavirina/uso terapéutico , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Hepacivirus/fisiología , Hepatitis C Crónica/genética , Hepatitis C Crónica/virología , Humanos , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Proteínas Recombinantes/uso terapéutico , Factores de Tiempo , Resultado del Tratamiento , Carga Viral
10.
Int J Clin Pract ; 66(9): 897-905, 2012 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-22805293

RESUMEN

BACKGROUND: Response to treatment among primary care patients with gastro-oesophageal disease (GERD) is variable. AIM: The GERD Management Project (GMP) evaluated the effectiveness of a structured management approach to GERD vs. standard treatment (usual care). METHODS: Data from five cluster-randomised clinical trials in adult primary care patients with symptoms of GERD were pooled. The structured pathway was based on the self-administered GERD Questionnaire (GerdQ) and was compared with standard treatment. RESULTS: 1734 patients were enrolled (structured treatment, n=834; standard treatment, n=900). The difference in the mean GerdQ score change from baseline favoured the structured pathway (-0.61; 95% CI: -0.88, -0.34; p<0.001). The odds ratio for an indication for treatment revision at the end of follow-up (structured vs. standard treatment) was 0.39 (95% CI: 0.29, 0.52; p=0.001). CONCLUSIONS: Management of primary care patients with GERD can be improved by systematic stratification of patients using a patient management tool such as the GerdQ.


Asunto(s)
Reflujo Gastroesofágico/terapia , Análisis por Conglomerados , Vías Clínicas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención Primaria de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Encuestas y Cuestionarios
14.
Eur Radiol ; 19(6): 1519-28, 2009 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-19184034

RESUMEN

Accuracy of MRI reports is taken for granted. In this paper the inter-observer reliability in the interpretation of meniscal lesions, degree of chondropathy, and integrity of the ACL was analyzed while taking the radiologist's experience and field strength into account. Fifty-two MRI studies of knees were interpreted by 11 radiologists independently. Twenty-two were acquired on 1.0-T, 20 on 1.5-T, and 10 on 3.0-T systems. Four of the radiologists had more than 5 years and seven had 3 to 5 years of experience in interpreting MRI studies. The findings were compared with the intra-operative findings. Inter-observer variance, specificity, and sensitivity were evaluated for each field strength. Inter-observer correlation ranged between 0.370 for cartilage lesions and 0.597 for meniscal tears. Correlation values did not increase with experience or field strength. The number of false reports was dependent on the observer, but not on field strength. The rate of false interpretations was significantly higher for most criteria in the less experienced group. In conclusion, inter-observer correlation was low, although the diagnostic criteria were defined. The use of the classification scheme should be standardized by uniform training. Radiologist experience seems to be more important than field strength.


Asunto(s)
Lesiones del Ligamento Cruzado Anterior , Ligamento Cruzado Anterior/patología , Aumento de la Imagen/métodos , Traumatismos de la Rodilla/diagnóstico , Imagen por Resonancia Magnética/métodos , Meniscos Tibiales/patología , Lesiones de Menisco Tibial , Adolescente , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Adulto Joven
16.
J Viral Hepat ; 14(11): 775-81, 2007 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-17927613

RESUMEN

Prediction of treatment response is clinically important in chronic hepatitis C virus (HCV) genotype 4 infection. Early viral kinetics is useful in this respect for genotype 1 but interpretation is dependent on assay linearity and reproducibility. The VERSANT HCV RNA 3.0 (bDNA-3.0) and the COBAS Amplicor HCV Monitor 2.0 (HCM-2.0) have been widely used quantitative assays. We wanted to comparatively evaluate the two tests in a large genotype 4 sample. Genotyping was performed by NS5b sequencing. Viral load was tested in parallel in 32 patients at least six times on antiviral therapy with interferon alpha (IFNalpha). Totally, 198 samples within a quantitative range from undetectable to about 7 x 10(6) IU/mL (bDNA-3.0) were obtained and compared. Twenty-two samples with viral load above 500 000 IU/mL tested by HCM-2.0 were 1:100 diluted and retested. Quantitative values were fitted to a third order polynomial (M = 0.118303 + 1.07503 x V+ 0.0112128 x V(2) - 0.0055504 x V(3); M...HCM-2.0, V...bDNA-3.0, both log IU/mL) showing progressive nonlinearity of HCM-2.0 above 100 000 IU/mL but better clinical sensitivity with respect to bDNA-3.0. Dilution lead to a gain of at least a factor of 2.7 and thus, overestimation compared with bDNA-3.0. Deviation from linearity and overestimation upon dilution by HCM-2.0 are similar with HCV genotype 4, compared with other HCV genotypes. Differences in test performance were not detected for subtypes but for individual patients possibly related to specific quasi-species patterns. The interpretation of viral kinetic data becomes difficult due to overestimation upon dilution of baseline values by HCM-2.0.


Asunto(s)
Virus de la Hepatitis B/genética , Hepatitis B Crónica/virología , ARN Viral/sangre , Genotipo , Hepatitis B Crónica/sangre , Hepatitis B Crónica/tratamiento farmacológico , Humanos , Interferón alfa-2 , Interferón-alfa/uso terapéutico , Polietilenglicoles , Reacción en Cadena de la Polimerasa , ARN Viral/química , ARN Viral/genética , Proteínas Recombinantes , Sensibilidad y Especificidad , Análisis de Secuencia de ADN , Estadísticas no Paramétricas , Carga Viral/métodos , Proteínas no Estructurales Virales/química , Proteínas no Estructurales Virales/genética
18.
Gut ; 52(6): 879-85, 2003 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-12740346

RESUMEN

BACKGROUND: In patients undergoing transjugular intrahepatic portosystemic shunt (TIPS), prognostic scores may identify those with a poor prognosis or even those with a clear survival benefit. The Child-Pugh score (CPS) is well established but several drawbacks have led to development of the model of end stage liver disease (MELD). AIM: The aim of the study was to compare the predictive power of CPS and MELD, to validate the original MELD formula, and to assess the predictive value of the determinants used in the two prognostic scores outside of a study setting. PATIENTS: A total of 501 patients underwent elective TIPS placement and 475 patients fulfilled the inclusion criteria. METHODS: Data of all patients undergoing elective TIPS in one university hospital and four community hospitals in Vienna, Austria, between 1991 and 2001, were analysed retrospectively. The main statistical tests were Cox proportional hazards regression model, the log rank test, Kaplan-Meier analysis, and concordance c statistics. RESULTS: Median follow up was 5.2 years and median survival was 4.6 years. During follow up, 230 patients died, 75 within three months after TIPS placement. In stepwise proportional hazards analyses, independent predictors of death were creatinine level, bilirubin level, age, and refractory ascites. MELD was better in predicting survival in a stepwise Cox model but both scores were equally predictive in c statistics for one month, three month, and one year survival. Renal function was the strongest independent predictor of survival. CONCLUSIONS: Although MELD was the primary predictor of overall survival in multivariate analysis, c statistics showed that both scores can be used for patients undergoing TIPS with equal accuracy. For assessing prognosis in patients undergoing TIPS implantation, there seems little reason to replace the well established Child-Pugh score.


Asunto(s)
Indicadores de Salud , Derivación Portosistémica Intrahepática Transyugular , Adulto , Anciano , Femenino , Estudios de Seguimiento , Hepatitis Viral Humana/cirugía , Humanos , Cirrosis Hepática Alcohólica/cirugía , Masculino , Persona de Mediana Edad , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Análisis de Supervivencia , Resultado del Tratamiento
19.
Wien Med Wochenschr ; 152(5-6): 128-34, 2002.
Artículo en Alemán | MEDLINE | ID: mdl-11998561

RESUMEN

Helicobacter pylori (H. p.) causes active chronic antrum gastritis in all infected patients. In a relatively small percentage complications of H. p.-gastritis including duodenal ulcer, gastric ulcer, giant fold gastritis, lymphocytic gastritis, autoimmune gastritis, gastric carcinoma and gastric MALT lymphoma may develop. Strongly recommended indications for eradication therapy include gastroduodenal ulcer disease, giant fold gastritis, lymphocytic gastritis, autoimmune gastritis, gastric MALT lymphoma, atrophic gastritis, corpus-predominant gastritis, post gastric cancer resection and patients who are first degree relatives of gastric cancer patients. Eradication therapy is controversial in patients with gastroesophageal reflux disease, functional dyspepsia and in patients in whom treatment with nonsteroidal antiinflammatory drugs (NSAID) or long-term treatment with proton pump inhibitors (PPI) is planned.


Asunto(s)
Infecciones por Helicobacter/diagnóstico , Helicobacter pylori , Gastropatías/diagnóstico , Antiulcerosos/uso terapéutico , Ensayos Clínicos como Asunto , Infecciones por Helicobacter/tratamiento farmacológico , Humanos , Recurrencia , Gastropatías/tratamiento farmacológico
20.
Hepatology ; 34(5): 1006-11, 2001 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-11679972

RESUMEN

The initial clearance of hepatitis C virus (HCV) during interferon-alfa therapy is dose-dependent. Therefore, higher initial interferon doses (induction therapy) may improve treatment results. This concept was tested in a prospective, randomized controlled trial. Previously untreated patients with chronic hepatitis C were randomized to receive 3 different interferon doses during the first 14 weeks of therapy (Group A, n = 130: 10 MU IntronA [AESCA-Schering Plough, Traiskirchen, Austria]/day for 2 weeks, followed by 10 MU/2 days for 12 weeks; Group B, n = 124: 5 MU/day for 14 weeks; Group C, n = 119; 5 MU/2 days for 14 weeks) followed in all by 5 MU/2 days for 24 weeks. Throughout the whole study all patients received 1 to 1.2 g ribavirin/day. On treatment, no differences in viral clearance rates were observed. Sustained response rates were also not different among the groups (A: 48.5%, B and C: 41.3%, intent to treat). When data were analyzed according to genotypes, sustained response was almost twice as high in patients with genotype 1 receiving high-dose interferon induction therapy (A: 44.2%, B: 28.6%, C: 27%, P <.05). In contrast, results were not different in genotype 3a patients (A: 61.3%, B: 75.9%, C: 56.3%; P >.1). These data indicate that high-dose interferon induction therapy may improve the outcome of interferon/ribavirin combination therapy in genotype 1 patients.


Asunto(s)
Antivirales/uso terapéutico , Hepatitis C Crónica/tratamiento farmacológico , Inductores de Interferón/uso terapéutico , Ribavirina/uso terapéutico , Adulto , Antivirales/efectos adversos , Quimioterapia Combinada , Femenino , Hepatitis C Crónica/virología , Humanos , Inductores de Interferón/efectos adversos , Masculino , Persona de Mediana Edad , Pacientes Desistentes del Tratamiento , Estudios Prospectivos , Ribavirina/efectos adversos , Resultado del Tratamiento , Carga Viral
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