End Of Antiviral Treatment Research Articles

Evaluation of the risk of developing hepatocellular carcinoma in chronic Hepatitis C patients receiving antiviral treatment.

Chronic HC leads to the development of liver cirrhosis (LC) and hepatocellular carcinoma (HCC). The treatment of chronic HC with DAAs reduces mortality from LC and HCC.The study aimed to investigate the serological markers specific to HCC (PIVKA-II and AFP) in patients with chronic HC before and after DAA treatment. The study involved 35 HCV patients (mean age: 56.23 ± 1.45) divided into two groups. Group 1 included 15 HCV + HCC patients and Group 2 included 20 HCV non-HCC patients. At the end of treatment all the patients were HCV RNA negative. Three months after the end of antiviral treatment, HCV RNA was undetectable in all patients, while a complete biochemical and virological response was observed in 66.7% of HCV + HCC patients and 85.0% of HCV non-HCC patients. PIVKA-II levels before the initiation of antiviral treatment were high in all patients. At the end of the treatment, in the HCV non-HCC group, normalization of PIVKA-II levels was observed only in 20.0% cases, and in 60.0% of cases 3 months after the treatment. Meanwhile, in patients with HCC and chronic HCV, PIVKA-II levels were within the normal range 3 months after treatment in only 13.3% of patients. It is necessary to monitor HCV patients with cirrhosis (F4) and severe fibrosis (F3) without HCC, who have high PIVKA-II and AFP levels and/or ALT activity despite obtaining sustained virologic response 3 months after treatment with DAAs.

Clinical utility of a cytomegalovirus-specific T cell assay in assessing the risk of post-prophylaxis cytomegalovirus infection and post-treatment relapse.

Cytomegalovirus (CMV) causes significant morbidity in solid organ transplant recipients (SOTR). Measuring cell-mediated immunity (CMI) may inform the risk of CMV infection after antiviral prophylaxis and predict relapse after CMV treatment. We serially assessed CMV CMI using the QuantiFERON-CMV assay (QF-CMV; Qiagen, Germantown, MD) in two cohorts of SOTRs: during valganciclovir prophylaxis and during treatment of CMV viremia. Results of CMI were correlated with post-prophylaxis CMV infection and post-treatment relapse, respectively. Only one (4.2%) of 24 CMV D+/R- patients demonstrated positive QF-CMV by the end of valganciclovir prophylaxis. Four (16.6%) patients developed post-prophylaxis CMV infection; all four had undetectable QF-CMV at end of prophylaxis. Among 20 patients treated for CMV infection, 18 (90%) developed QF-CMV levels>.2 IU/mL by end of antiviral treatment and none developed CMV relapse. In contrast, the single patient who relapsed after completing treatment had a CMV CMI<.2 IU/ml (p=.0036). Since CMV D+/R- SOTRs are unlikely to develop adequate CMV CMI while receiving valganciclovir prophylaxis, the utility of CMV CMI monitoring for risk stratification during time of prophylaxis had limited value. Conversely, CMV CMI testing may be a useful marker of the risk of CMV relapse after antiviral treatment.

Weight Gain after Interferon-Free Treatment of Chronic Hepatitis C-Results from the German Hepatitis C-Registry (DHC-R).

Chronic hepatitis C can be treated very effectively with direct-acting antivirals (DAA) with only minor side effects compared to an interferon-containing treatment regimen. The significance of metabolic comorbidities after HCV cure is not well defined. This study aims to investigate short- and long-term weight change of patients receiving interferon-free antiviral treatment for chronic hepatitis C. The German Hepatitis C-registry (DHC-R) is a national multicenter real-world cohort. A total of 5111 patients were followed prospectively after DAA treatment for up to 3 years. Weight change compared to baseline was analyzed at end of treatment and at years 1, 2, and 3 after completion of antiviral therapy. Regression analysis was performed to identify baseline predictors for weight change. While there was no relevant mean weight change (−0.2 kg, SD 4.3 kg) at the end of antiviral treatment, weight started to increase during long-term follow-up reaching +1.7 kg (SD 8.0 kg, p < 0.001) compared to baseline at 3 years (follow-up year 3, FU3) after completion of antiviral therapy. 48%, 31%, and 22% of patients had a weight gain greater than 1, 3, and 5 kg at FU3, respectively. During follow-up, a body mass index (BMI) <30 proved to be the only consistent predictor for weight gain. DAA treatment is followed by a substantial weight gain (+3 kg or more) in one-third of the patients during long-term follow-up. Non-obese patients seemed to be most vulnerable to weight gain. The body compartment involved in weight gain as well as the mechanism of weight gain remain to be elucidated.

Influence of Genetic Variants on Disease Regression and Outcomes in HCV-Related Advanced Chronic Liver Disease after SVR.

Genetic variants including PNPLA3-rs738409 C>G, TM6SF2-rs58542926 C>T, MBOAT7-rs641738 C>T, and HSD17B13-rs72613567 T>TA have been shown to influence progression to advanced chronic liver disease (ACLD) in patients with chronic hepatitis C (CHC). We aimed to investigate their impact on disease regression (i.e., changes in hepatic venous pressure gradient [HVPG] and non-invasive surrogates [liver stiffness measurement (LSM), von Willebrand factor (VWF), and VWF/platelet count ratio (VITRO)]) and clinical outcomes after CHC cure in 346 patients with pre-treatment ACLD. Patients carrying the PNPLA3 minor allele had more advanced liver disease prior to antiviral therapy, confirming its impact on liver disease progression. In a subgroup of 88 patients who underwent paired HVPG-measurements and were genotyped for all SNP/indels, PNPLA3/TM6SF2/MBOAT7/HSD17B13 genotypes were not associated with changes in HVPG. In line, changes in non-invasive surrogates of portal hypertension (LSM/VWF/VITRO) were comparable between carriers and non-carriers of the PNPLA3 G-allele in the overall cohort. Finally, carriage of PNPLA3 G-allele was not associated with the development of hepatic decompensation, de-novo hepatocellular carcinoma, or transplant-free mortality during a median follow-up of 42 months after the end of antiviral treatment. Therefore, genetic variants in PNPLA3/TM6SF2/MBOAT7/HSD17B13 do not impact the regression of portal hypertension and clinical outcomes in patients with pre-treatment ACLD after CHC cure.

The impact of direct-acting antiviral treatment on glycemic homeostasis in patients with chronic hepatitis C.

There is robust epidemiological evidence suggesting the link of chronic hepatitis C virus (HCV) infection with type 2 diabetes mellitus (DM). Viral clearance achieved by direct acting antiviral agents (DAAs) has been associated to significant improvements in glycometabolic control but data on the long-term effect of sustained virological response (SVR) on diabetic disease are limited. The aim of this review is to evaluate the influence of SVR after DAA-based therapy on insulin resistance (IR) and DM incidence in non-diabetic patients, on the glycemic homeostasis in diabetic patients and on their long-term hepatic and metabolic outcomes. An electronic search of Embase, PubMed, MEDLINE, Ovid and the Cochrane Database of Systematic Reviews was performed for papers regarding the effect of DAA-induced SVR on the glycometabolic control and clinical outcomes of HCV-positive diabetic patients up to September 30, 2020. Among non-diabetic patients, a significant reduction in the risk of IR and DM was reported by the vast majority of the studies; the glycometabolic control significantly improved in diabetic patients during and immediately after the end of antiviral treatment. However, whether this beneficial effect is long lasting is still matter of debate. Furthermore, at variance with data obtained during the Interferon era, DM does not seem to be an unfavorable predictive factor of hepatocellular carcinoma in cured patients. A favorable influence of DAA-induced SVR on IR and DM incidence and on glycemic control is reported by several studies. However, the long-term biochemical, metabolic and clinical impact of this endocrine benefit remains largely unknown.

1752. Differential Degree and Duration of Cytomegalovirus (CMV) Viremia Between WHO International Standard-Calibrated Quantitative CMV Nucleic Acid Tests: Implications for Clinical Care

BackgroundQuantitative nucleic acid amplification (QNAT) tests are cornerstone for the management of CMV disease after organ transplantation. We assessed the potential impact of viral load results obtained by two commercial WHO international standard-calibrated NAT in solid-organ (SOT) and hematopoietic stem cell transplant (HSCT) recipients.MethodsSixty-four patients (36 SOT and 28 HSCT) had plasma CMV viral load assessed using the COBAS AmpliPrep/COBAS TaqMan CMV Test (CAP/CTM; lower limit of quantification [LLoQ] at 137 IU/mL) and cobas 6800 System (cobas CMV; LLoQ at 35 IU/mL). Viral load values were correlated with clinical course and outcomes.ResultsForty-three of 64 patients (67.2%) had CMV infection or disease (asymptomatic, 67.4%; gastrointestinal disease, 16.3%; pneumonitis 4.7%) at median of 4.4 months (IQR 1.4 to 7.7) from transplantation. At CMV infection diagnosis, viral load results (mean ± SD) were almost two-fold higher when measured by cobas CMV (19,456 ± 51,618 IU/mL) compared with CAP/CTM (10,504 ± 27,744 IU/mL; P = 0.04). Time to onset of CMV viremia was significantly shorter (11.5 days; P < 0.001) while viral clearance was significantly longer (12.75 days; P < 0.001) by cobas CMV when compared with CAP/CTM. Persistent viremia was observed with cobas CMV in 44% of patients at the time of first negative results by CAP/CTM. Patients with negative results by cobas CMV at the end of antiviral treatment had a significantly lower need for re-treatment (OR 0.26, 95% CI 0.04 to 0.99, P = 0.05).ConclusionOur study highlights significant differences between CMV QNAT assays despite calibration to the WHO-international standard. The significant differences in the degree (almost two-fold), time to onset (12 days difference) and clearance (13 days difference) of CMV viremia between two automated commercial QNAT assays have direct implications in the care of transplant recipients. Persistence of low-level viremia was observed in samples that reached negative threshold by CAP/CTM, when tested using the more sensitive cobas CMV. Clearance of CMV viremia, when assessed by the more sensitive cobas CMV, was significantly associated with a lower need for re-treatment.Disclosures All authors: No reported disclosures.

Alcohol and Cannabis Consumption Does Not Diminish Cure Rates in a Real-World Cohort of Chronic Hepatitis C Virus Infected Patients on Opioid Substitution Therapy-Data From the German Hepatitis C-Registry (DHC-R).

Background:The importance of alcohol and cannabis consumption for the effectiveness of treatment of chronic hepatitis C virus (HCV) infection with direct acting antivirals (DAAs) in people on opioid substitution therapy (OST) has not been investigated in detail.Methods:We investigated sustained virological response (SVR) rates and proportion of lost to follow-up (LTFU) between OST (n = 739) and non-OST patients (n = 7008) in the German Hepatitis C-Registry (Deutsches Hepatitis C-Register, DHC-R), which is a national multicenter prospective non-interventional real-world registry. Non-OST patients comprised patients with former/current drug use (non-OST/DU; n = 1500) and patients never consuming drugs (non-OST/NDU; n = 5508).Findings:SVR 12/24 rates (intention to treat [ITT]) in patients consuming no or less than 30 g/day (women) or 40 g/day (men) were significantly higher in non-OST/NDU (range 91%-92%) vs OST patients (range 83%-86%), mainly due to significantly higher LTFU rates in OST (range 11%-12%) compared with non-OST/NDU (range 2%-3%). In non-OST/NDU with high alcohol consumption of more than 30/40 g/day, SVR 12/24 rates (ITT) were lower (85%) but did not differ to OST (85%) with high alcohol consumption. No significant differences could be seen for SVR 12/24 in per-protocol (PP) analysis independent of alcohol consumption or amount of alcohol intake. Cannabis use did not significantly influence SVR 12/24 in ITT or PP or LTFU.Conclusions:High SVR rates could be achieved in both OST and non-OST patients irrespective of alcohol or cannabis consumption. However, LTFU is more likely in patients with current or former drug use than in patients without drug history and in patients with high alcohol consumption but occurred mainly after end of antiviral treatment (EOT), leaving a high chance for HCV elimination in these patients.

Clinical significance of detectable and quantifiable HCV RNA at the end of treatment with ledipasvir/sofosbuvir in GT1 patients.

AASLD/IDSA treatment guidelines for hepatitis C virus (HCV) infection state that testing for quantitative HCV RNA can be considered at the end of antiviral treatment (EOT) with interferon-free regimens. However, it remains unclear how to respond to a detectable or even quantifiable HCV RNA result. The aim of this study was to analyse the frequency and predictive value of detectable and quantifiable HCV RNA results at the EOT in patients with HCV genotype 1 infection treated with ledipasvir (LDV) and sofosbuvir (SOF)±ribavirin (RBV) in a large real-world cohort. A retrospective analysis of the DHC-R (Deutsches Hepatitis C-Register, German Hepatitis C-Registry) cohort was performed including all patients who were treated with LDV/SOF±RBV and in whom HCV RNA testing was done with either the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or the Abbott RealTime HCV assay (ART). The frequency of detectable HCV RNA at the EOT was 7% in this real-world study involving 471 patients. Furthermore, 3% of the patients (n=14/471) even had quantifiable viral load at the EOT. Detectable and quantifiable results were more frequent if the ART was used for testing. However, SVR was achieved by 32/33 patients (97%) with detectable and even by all 14 patients (100%) with quantifiable HCV RNA results at the EOT. Detectable and even quantifiable HCV RNA results are quite frequent if highly sensitive HCV RNA assays are used. However, treatment prolongation is not indicated, as SVR rates remain high in these patients.

Combined use of direct antiviral drugs - paritrapevir, ritonavir, ombitasvir and dasabuvir in the treatment of patients with HCV-deterministic compensated cirrhosis in real clinical practice

Objective: To evaluate the effi cacy and safety of a combination of direct antiviral drugs - paritrapeprivir, ritonavir, ombitasvir and dasabuvir in patients with compensated cirrhosis of HCV-etiology. Materials and methods : A prospective cohort study involved 30 patients with compensated cirrhosis of the liver with HCV etiology (class A in Child-Pugh) caused by the 1b genotype of the virus. All patients received a formal combination of direct antiviral drugs - paritrapeprivir, ritonavir, ombitasvir and dasabuvir (PROD) for 12 weeks. Effi cacy evaluation was conducted to achieve a sustained virologic response 24 weeks aft er the end of antiviral treatment (VDU 24). Results: Two weeks aft er the start of treatment the virus stopped being detected in 21 people (70%), aft er 4 weeks - in all patients. VDU 24 was also achieved in 100% of cases. One patient, operated prior to the initiation of antiviral treatment for hepatocellular carcinoma (HCC), relapsed both HCC and HCV infection 36 weeks aft er the end of the antiviral treatment. Adverse events in the form of mild headache and nausea were noted only in two patients (6.7%) and had an unexpressed and short duration. Conclusions: in real clinical practice, high effi cacy of direct antiviral drugs - PROD in patients with compensated cirrhosis of HCV-etiology (in 96.7% of patients) was demonstrated at a relatively low incidence (6.7%) of side eff ects.

Hepatitis C virus eradication improves immediate and delayed episodic memory in patients treated with interferon and ribavirin

BackgroundChronic hepatitis C virus (HCV) infection is associated with impairment of cognitive function and mood disorders. Our aim was to evaluate the impact of sustained virological response (SVR) on cognitive function and mood disorders.MethodA prospective exploratory one arm study was conducted. Adult clinically compensated HVC patients were consecutively recruited before treatment with interferon and ribavirin for 24 to 48 weeks, according to HCV genotype. Clinical, neurocognitive and mood assessments using the PRIME-MD and BDI instruments were performed at baseline, right after half of the expected treatment has been reached and 6 months after the end of antiviral treatment. Exclusion criteria were the use of illicit psychotropic substances, mental confusion, hepatic encephalopathy, hepatocellular carcinoma, severe anemia, untreated hypothyroidism, Addison syndrome and major depression before treatment.ResultsThirty six patients were enrolled and 21 completed HCV treatment (n = 16 with SVR and n = 5 without). Regardless of the viral clearance at the end of treatment, there was a significant improvement in the immediate verbal episodic memory (p = 0.010), delayed verbal episodic memory (p = 0.007), selective attention (p < 0.001) and phonemic fluency (p = 0.043). Patients with SVR displayed significant improvement in immediate (p = 0.045) and delayed verbal episodic memory (p = 0.040) compared to baseline. The baseline frequency of depression was 9.5%, which rose to 52.4% during treatment, and returned to 9.5% 6 months after the end of treatment, without significant difference between patients with and without SVR. Depressive symptoms were observed in 19.1% before treatment, 62% during (p = 0.016) and 28.6% 6 months after the end of treatment (p = 0.719).ConclusionsEradication of HCV infection improved cognitive performance but did not affect the frequency of depressive symptoms at least in the short range.

Efficacy of dual therapy in patients &gt;65 years old with alanine transaminase flare during chronic hepatitis C genotype 2

Hepatitis C virus (HCV)-related chronic hepatitis is characterized by different clinical outcomes as well as by distinct biochemical and virological patterns. According to guidelines concerning dual therapy, high rates of sustained virological response (or HCV-RNA undetectable 24 weeks after the end of antiviral treatment) has been obtained in patients with persistent HCV infection, caused by genotype 2 (CHC G2). Dual therapy (pegylated interferon plus ribavirin) might be an useful strategy not only in the treatment of younger patients (≤65 years old, that is generally considered as age limit for the beginning of the antiviral treatment) but also of older patients (>65 years old) experiencing an alanine aminotransferase (ALT) flare (with value of ALT-alanine transaminase ≥400 U/L). In fact the progress of fibrosis can advance quicker exactly during the transaminase breakthrough. We report our experience in the treatment of two Italian patients with CHC G2, one of them was a never treated (naive) woman, whereas the other was a previously treated man with several co-morbidities. Both patients presented an excellent virological response to dual therapy despite unfavorable predictive factors, such as old age (>65 years), ALT flare and possible moderate hepatic fibrosis.

MicroRNA profile before and after antiviral therapy in liver transplant recipients for hepatitis C virus cirrhosis

Management of hepatitis C virus (HCV) recurrence is a major challenge after liver transplantation. Significant dysregulated expression of HCV receptors (i.e. claudin-1, occludin, tetraspanin CD81, scavenger receptor type B1) has been shown recently during HCV infection. This might facilitate hepatocytic entry and reinfection of HCV. MicroRNAs (miRs) play role in the regulation of gene expression. We aimed to characterize miR expression profiles related to HCV infection and antiviral therapy in adult liver transplant recipients, with special emphasis on miRs predicted to target HCV receptors. Twenty-eight adult liver transplant recipients were enrolled in the study. Paired biopsies were obtained at the time of HCV recurrence and at the end of antiviral treatment. MiRs for HCV receptors were selected using target prediction software. Expression levels of miR-21, miR-23a miR-34a, miR-96, miR-99a*, miR-122, miR-125b, miR-181a-2*, miR-194, miR-195, miR-217, miR-221, and miR-224 were determined by reverse transcription-quantitative polymerase chain reaction. miR-99a* and miR-224 expressions were increased in HCV recurrence samples, while miR-21 and miR-194 were decreased in comparison to normal liver tissue. Increased expressions of miR-221, miR-224, and miR-217 were observed in samples taken after antiviral therapy when compared with HCV recurrence samples. High HCV titer at recurrence was associated with higher level of miR-122. Samples at recurrence of HCV and after antiviral therapy revealed distinct HCV-related miR expression profiles, with significant dysregulation of those miRNAs potentially targeting mRNAs of HCV receptors. In particular, miR-194 and miR-21 might be involved in the regulation of HCV receptor proteins' expression during HCV infection and antiviral therapy.

Interferon-α-induzierte Reaktivierung einer Sarkoidose bei einer Patientin mit chronischer Hepatitis C

The data on reactivation of sarcoidosis during treatment with interferon-alfa is unsatisfactory. We here report the case of a female patient with a history of sarcoidosis more than 20 years ago. Due to chronic hepatitis C the patient was treated with pegylated interferon-alfa and ribavirin. Beginning in the 32(nd) week, the patient developed a reactivation of sarcoidosis. The antiviral therapy was continued until week 48 without administration of systemic steroids. Six month after the end of antiviral treatment the sarcoidosis was in remission and the hepatitis C was cured.

Factors influencing long‐term changes in mental health after interferon‐alpha treatment of chronic hepatitis C

Antiviral treatment with interferon-alpha (IFN-alpha) is associated with several acute psychiatric side effects. Little is known about long-term effects on mental health after treatment independent from viral response and the influence of pre-existing psychiatric risk-factors. To evaluate long-term effects of antiviral treatment with interferon-alpha (IFN-alpha) on mental health in patients with psychiatric risk factors. We prospectively investigated long-term mental health changes in 81 hepatitis C virus-infected patients. Psychiatric outcome was measured with the Montgomery-Asberg Depression Scale (MADRS), Brief Psychiatric Rating Scale, the Global Social Functioning Scale and the Global Clinical Impression Scale 6 months after the end of antiviral treatment with IFN-alpha and ribavirin. Six months after antiviral therapy, 49% of the patients showed a worsening and 27.2% an improvement of depression scores. The most important predictor for a long-term improvement of depression scores was a pre-treatment MADRS score > or =5 (OR 14.21, 95% CI: 2.51-81.30). Patients with pre-existing psychiatric disorders (OR = 0.117, 95% CI: 0.024-0.558), methadone substitution (OR = 0.20, 95% CI: 0.045-0.887) or genotype 2/3 (OR = 0.341, 95% CI: 0.138-0.845) were significantly less likely to show a long-term worsening of depressive symptoms. Pre-existing psychiatric risk factors increase the chance for a long-term improvement and reduce the risk for a long-term worsening of mental health after antiviral treatment of chronic hepatitis C with IFN-alpha.

Clearance of HCV by Combination Therapy of Pegylated Interferon α-2a and Ribavirin Improves Insulin Resistance

Background/AimsChronic hepatitis C virus (HCV) infection is associated with a higher risk of the development of insulin resistance. If HCV is a causal factor for insulin resistance, then clearance of HCV might decrease insulin resistance. The aim of this study was to elucidate the effects of clearance of HCV on insulin resistance.MethodsWe analyzed 28 patients with HCV infection who received combination treatment of 180 µg of pegylated interferon α-2a and ribavirin at our institution from May 2004 to November 2006. Insulin resistance was calculated according to the homeostasis model assessment of insulin resistance (HOMA-IR) method.ResultsTwenty-two patients (78.6%) achieved sustained virologic response (SVR), where the fasting plasma glucose level significantly decreased after antiviral treatment. Fasting serum insulin and HOMA-IR also significantly decreased after antiviral treatment, whereas the BMI value was not significantly affected. For the nonresponders (n=6), no significant changes were evident in BMI, fasting plasma glucose, fasting serum insulin, and HOMA-IR at 6 months after the end of antiviral treatment. Logistic regression analysis indicated that the only independent factor contributing to the reduction of insulin resistance was the complete disappearance of HCV RNA at 6 months after the end of antiviral treatment (SVR).ConclusionsThe clearance of HCV by the combination therapy of pegylated interferon α-2a and ribavirin improves insulin resistance by reducing fasting serum insulin and glucose levels.

Cirrhosis Regression in Chronic Hepatitis C: An Old Tale With a New Ending

Cirrhosis Regression in Chronic Hepatitis C: An Old Tale With a New Ending

Rituximab combined with Peg-interferon-ribavirin in refractory hepatitis C virus-associated cryoglobulinaemia vasculitis

Objectives:To report the results of a pilot study using rituximab combined with Peg-interferon (IFN) α2b-ribavirin in severe refractory hepatitis C virus (HCV) related mixed cryoglobulinaemia (MC) vasculitis.Methods:Sixteen consecutive patients with...

Frequency of very low HCV viremia detected by a highly sensitive HCV-RNA assay

Background Only limited data is available on the frequency and clinical significance of very low hepatitis C viremia (<600 IU/ml) determined by novel sensitive methods for HCV quantification. Study design We evaluated the new Abbott m2000 RealTime PCR assay in 3213 consecutive anti-HCV-positive sera as well as in 50 HCV-recovered patients with sustained virological response to standard antiviral therapy. Results The assay showed a linear range between 10 1 IU/ml and 10 7 IU/ml for HCV genotypes 1–6. An HCV viremia below 600 IU/ml was detected more often with the m2000 RealTime PCR assay than with the Cobas Amplicor™ assay in viremic sera (7.1% versus 1.8%). Seventy-seven cases with HCV levels below 100 IU/ml not related to ongoing antiviral therapy were identified. An HCV-RNA of less than 12 IU/ml was found in nine of the 50 SVR patients. Two patients had a viral load of 34 IU/ml and 84 IU/ml, respectively, one of those showed persistently elevated ALT levels over a period of 5 years after the end of antiviral treatment. Conclusion An HCV viremia below 600 IU/ml can be detected in almost every 40th anti-HCV-positive sera using real-time PCR based assays. Low persisting HCV-RNA in patients after antiviral therapy may be associated with mild liver inflammation in single cases.

Efficacy and tolerance of α-2b interferon therapy on HCV infection of hemodialyzed patients

A high frequency (25%) of anti-hepatitis C virus (HCV) antibodies is observed in French hemodialyzed patients; this is associated with detectable viremia in 85% and results in chronic hepatitis in more than 90%. We conducted a pilot study to examine the tolerance and efficacy of alpha-2b Interferon therapy upon HCV infection in hemodialyzed patients. Nineteen anti-HCV positive hemodialyzed patients were given a standard alpha-2b interferon regimen (3 megaunits subcutaneously three times weekly, following each hemodialysis) over six months as a treatment of biopsy-proven chronic hepatitis (N = 16) or acute hepatitis (N = 3). Thirteen of these 19 had increased levels of aminotransferase at the time of treatment. Serum HCV RNA was tested qualitatively and quantitatively by the polymerase chain reaction and the bDNA test, respectively, at the beginning and at the end of antiviral treatment, and a third time at least six months after the end of therapy (mean follow-up 18 +/- 9 months). HCV genotype was determined in the 15 patients who had detectable HCV RNA before treatment. The biological response (long-term response, relapse or non-response) was defined as usual according to the serum aminotransferase levels during therapy and at least six months after. A post-treatment liver biopsy, allowing comparison with semiquantitative pathological scores, was performed in 14 patients. Only one of the 19 treated patients did not complete therapy because of poor tolerance, while 18 of the 19 fairly tolerated a complete six month course of alpha-2b interferon.(ABSTRACT TRUNCATED AT 250 WORDS)