Ribavirin Dose Research Articles

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Covering the Cover

Telaprevir-based triple therapy for chronic hepatitis C patients with advanced fibrosis: a prospective clinical study

Antiviral treatment is recommended for chronic hepatitis C patients with advanced fibrosis to reduce and prevent cirrhosis-related complications. To evaluate the efficacy and safety of telaprevir (TVR)-based triple therapy for patients with advanced fibrosis in a clinical practice setting. This prospective, multicentre study consisted of 102 patients with advanced fibrosis (METAVIR score F3-4) who were infected with HCV genotype 1b. All received 12 weeks of TVR in combination with 24 weeks of pegylated interferon (PEG-IFN) α2b and ribavirin (RBV). The sustained virological response (SVR) rate was 69.6% (71 of 102). Notably, for treatment-naïve and prior relapse patients the SVR rate was over 80%. Previous treatment response, interleukin 28B polymorphism (rs8099917) and rapid virological response (undetectable HCV RNA at week 4) were independently associated with SVR. To achieve SVR, an adequate dosage of PEG-IFNα2b (≥1.2 μg/kg/week) and RBV (≥7.5 mg/kg/day) is preferable; however, the mean weight-adjusted TVR dosage had little impact on treatment outcome. Although severe blood cytopaenia and a dermatological disorder were frequently found, the rate of discontinuation due to adverse effects was 12.7%. The inosine triphosphatase CC allele (rs1127354) was independently associated with the development of severe anaemia, and lower serum albumin level (<35 g/L) was associated with the occurrence of infection. The great gain in the SVR rate by telaprevir-based triple therapy offsets the problems with adverse effects; thus, it should be considered as a potent treatment protocol for patients with advanced fibrosis, especially for those with treatment-naïve and prior relapse.

ITPA genetic variants influence efficacy of PEG-IFN/RBV therapy in older patients infected with HCV genotype 1 and favourable IL28B type.

Inosine triphosphatase (ITPA) genetic variants are strongly associated with ribavirin (RBV)-induced anaemia during pegylated interferon (PEG-IFN) plus RBV therapy. However, the treatment efficacy of ITPA genetic variants has not been fully explored. We enrolled 309 individuals infected with hepatitis C virus genotype 1, who were treated with PEG-IFN plus RBV for 48 weeks. The ITPA SNP: rs1127354 and IL28B SNP: rs8099917 were genotyped. We examined the risk factors for severe anaemia up to week 12 after the start of treatment and treatment efficacy. The incidence of severe anaemia, ≥ 3 g/dL reduction or <10 g/dL of haemoglobin (Hb) up to week 12, was more frequent in patients with CC at rs1127354 [65% (145/224), 33% (73/224)] than in those with CA/AA [25% (21/85), 6% (8/85)] (P < 0.0001). ITPA genotype, pretreatment Hb level and age were independent predictive factors for severe anaemia: Hb < 10 g/dL. In IL28B favourable type, the sustained virologic response rate was higher in ≥ 60-year-old patients with CA/AA than in those with CC [71% (22/31) vs 40% (26/65), P = 0.005], although there was no significant difference in treatment efficacy according to ITPA genetic variants in the <60-year-old patients. The proportion of patients administered ≥ 80% of the dosage of RBV was significantly higher in the patients with CA/AA than in those with CC (P = 0.025), resulting in a lower relapse rate. In conclusion, ITPA genetic variants were associated with severe RBV-induced anaemia and could influence the efficacy of PEG-IFN plus RBV treatment among elderly patients with IL28B favourable type.

HCV-Reinfektion nach Lebertransplantation

The management of hepatitis C virus (HCV) recurrence after liver transplantation (LTx) is a major challenge in patient care. For patients with HCV GT1, treatment standard with pegylated interferon (PEG-IFN) and ribavirin (RBV) has been augmented in 2011 by first generation protease inhibitors (PI), telaprevir (TVR) and boceprevir (BOC). We report our first experiences with TVR-based triple therapy in patients with GT1-reinfection of the graft. 13 patients with histologically proven HCV GT1-reinfection of the graft received 12 weeks of PEG-IFN/RBV/TVR followed by 12 weeks of PEG-IFN/ RBV only. During the triple therapy phase immune suppression was tightly monitored, and the patients were also closely monitored for side effects. The dosage of immunosuppressants had to be reduced significantly (TAC: 30-fold; CSA 3,5-fold). Stable levels were achieved by daily or over-daily dosing of a special size application of 0,1 mg tacrolimus (Tac) bid or a minimal dose of 10 mg cyclosporine (CSA) bid or qd, respectively. In all patients hematological side effects were observed, 65 % of which required RBV dose reduction, administration of erythropoietin or blood transfusions. Increase of kidney retention values requiring infusions occurred in 50 %. All side effects were reversible. There were no early discontinuations of therapy. An early viral response (EVR) with viral decline below limit of detection was noted at week 12 in 9/13 patients and at week 12 in further 3 patients. Our preliminary results show high EVR response rates of TVR-based triple therapy in LTx patients with HCV-GT1 re-infection.

Cost-Effectiveness Analysis of Adding Low Dose Ribavirin to Peginterferon Alfa-2a for Treatment of Chronic Hepatitis C Infected Thalassemia Major Patients in Iran

BackgroundThe prevalence of hepatitis C in Iran is 1% and 18% in general population and thalassemia patients respectively. The cost effectiveness analysis of adding Ribavirin to Peginterferon alfa-2a (PEG IFN alfa-2a) as a combination treatment strategy of chronic hepatitis C in thalassemia patients in comparison with monotherapy could help clinicians and policy makers to provide the best treatment for the patients.ObjectivesIn this study we aimed to assess whether adding Ribavirin to PEG IFN alfa-2a is a cost effective strategy in different genotypes and different subgroups of 280 patients with chronic hepatitis C infection from the perspective of society in Iranian setting.Patients and MethodsA cost effectiveness analysis including all costs and outcomes of treatments for chronic hepatitis C infected thalassemia major patients was conducted. We constructed a decision tree of treatment course in which a hypothetical cohort of 100 patients received “PEG IFN alfa-2a” or “Peg IFN alfa-2a plus Ribavirin.” The cost analysis was based on cost data for 2008 and we used 9300 Iranian Rials (IR Rial) as exchange rate declared by the Iranian Central Bank on that time to calculating costs by US Dollar (USD). To evaluate whether a strategy is cost effective, one time and three times of GDP per capita were used as threshold based on recommendation of the World Health Organization.ResultsThe Incremental Cost Effectiveness Ratio (ICER) for combination therapy in genotype-1 and genotypes non-1 subgroups was 2,673 and 19,211 US dollars (USD) per one Sustain Virological Response (SVR), respectively. In low viral load and high viral load subgroups, the ICER was 5,233 and 14,976 USD per SVR, respectively. The calculated ICER for combination therapy in subgroup of patients with previously resistant to monotherapy was 13,006 USD per SVR. Combination therapy in previously resistant patients to combination therapy was a dominant strategy.ConclusionsAdding low dose of Ribavirin to PEG IFN alfa-2a for treatment of chronic hepatitis C patients with genotype-1 was “highly cost effective” and in patients with low viral load and in previous monotherapy resistant patients was “cost effective.”

Management of anaemia and other treatment complications

Antiviral treatment for hepatitis C virus infection has dramatically changed with the advent of triple therapy including telaprevir or boceprevir, which is associated with a new spectrum of adverse events. These may lead to dosage reduction and early discontinuation of therapy. An increase in the frequency and severity of anaemia was reported in clinical trials for both drugs, and skin disorders including rash and pruritus occurred more frequently with the telaprevir-based regimen. The first-line management of anaemia is ribavirin dose reductions. In cirrhotic patients, aggressive ribavirin dosage reductions, erythropoietin alpha and blood transfusions are effective in managing anaemia. Several deaths and cases of severe infections and hepatic decompensation were reported in cirrhotics treated in real-life setting. Patients with platelet count ≤ 100,000/mm(3) and serum albumin < 35 g/L should not be treated with triple therapy as it is related to a high risk of developing severe complications. The management of rashes, if well planned, does not require telaprevir discontinuation. However, approximately 5% of rashes were severe and a few cases were classified as severe cutaneous adverse reactions leading to treatment discontinuation. Successful treatment can be enhanced by a strong patient support network including a multidisciplinary team.

Safety and efficacy of protease inhibitors to treat hepatitis C after liver transplantation: A multicenter experience

Protease inhibitors (PI) with peginterferon/ribavirin have significantly improved SVR rates in HCV G1 patients. Their use to treat HCV recurrence after liver transplantation (LT) is a challenge. This cohort study included 37 liver transplant recipients (male, 92%, age 57 ± 11 years), treated with boceprevir (n=18) or telaprevir (n=19). The indication for therapy was HCV recurrence (fibrosis stage ≥F2 (n=31, 83%) or fibrosing cholestatic hepatitis (n=6, 16%). Eighteen patients were treatment-naive, five were relapsers and fourteen were non-responders to dual therapy after LT. Twenty-two patients received cyclosporine and fifteen tacrolimus. After 12 weeks of PI therapy, a complete virological response was obtained in 89% of patients treated with boceprevir, and 58% with telaprevir (p=0.06). The end of treatment virological response rate was 72% (13/18) in the boceprevir group and 40% (4/10) in the telaprevir group (p=0.125). A sustained virological response 12 weeks after treatment discontinuation was observed in 20% (1/5) and 71% (5/7) of patients in the telaprevir and boceprevir groups, respectively (p=0.24). Treatment was discontinued in sixteen patients (treatment failures (n=11), adverse events (n=5)). Infections occurred in ten patients (27%), with three fatal outcomes (8%). The most common adverse effect was anemia (n=34, 92%), treated with erythropoietin and/or a ribavirin dose reduction; thirteen patients (35%) received red blood cell transfusions. The cyclosporine dose was reduced by 1.8 ± 1.1-fold and 3.4 ± 1.0-fold with boceprevir and telaprevir, respectively. The tacrolimus dose was reduced by 5.2 ± 1.5-fold with boceprevir and 23.8±18.2-fold with telaprevir. Our results suggest that triple therapy is effective in LT recipients, particularly those experiencing a severe recurrence. The occurrence of anemia and drug-drug interactions, and the risk of infections require close monitoring.

Hepatitis C virus infection in hemodialysis patients

Hepatitis C virus (HCV) infection is observed in around 20% of dialysis patients and in allograft recipients and results in a significant morbidity and mortality, especially after transplantation. Its prevalence has markedly decreased in patients who are candidates for transplantation since the introduction of screening, hygiene and prevention measures, including systematic screening of blood and organ donations, use of erythropoietin, and compliance with universal hygiene rules. A liver biopsy is preferable to non-invasive biochemical and/or morphological tests of fibrosis to evaluate liver fibrosis before and even after transplantation. In HCV-infected dialyzed patients who are not candidates for renal transplantation, the indication for antiviral therapy is limited to significant fibrosis (fibrosis ≥ 2 on the METAVIR scale). Antiviral treatment should be proposed to any HCV-infected candidate for renal transplantation, whatever the baseline histopathology. The recommendation is to use standard interferon-α as monotherapy, but pegylated interferon can be used, resulting in sustained virological response, while low doses of combined ribavirin may enhance the antiviral efficacy. After transplantation, interferon-α is contra-indicated but may be used in patients for whom the benefits of antiviral treatment clearly outweigh the risks, especially that of allograft rejection. All cirrhotic patients should be screened for hepatocellular carcinoma, whose risk is enhanced by immunosuppressive regimens. Sustained suppression of necro-inflammation may result in the reversal of cirrhosis, which reduces liver-related morbidity and improves patient and allograft survival. Finally, due to the high mortality after renal transplantation, active cirrhosis must be considered to be a contraindication to kidney transplantation, but an indication to combined liver-kidney transplantation; on the contrary, inactive compensated cirrhosis may permit renal transplantation alone.

Oral ribavirin for treatment of respiratory syncitial virus and parainfluenza 3 virus infections post allogeneic haematopoietic stem cell transplantation

The prognosis for patients with respiratory syncytial virus (RSV) or parainfluenza virus type 3 (PIV3) respiratory tract infection post allogeneic haematopoietic progenitor cell transplant (HPCT) is historically poor. The use of oral ribavirin (RBV) has not been widely studied in this patient population. We examined the outcomes of 15 consecutive patients (RSV, n=13 and PIV3, n=2) treated with oral RBV post HPCT. Oral RBV was commenced at a starting dose of 10 mg/kg/day, increasing to a maximum dose of 60 mg/kg/day depending on response and tolerance. At diagnosis, seven patients had upper respiratory tract infection (URTI) and eight had lower respiratory tract infection (LRTI). The starting RBV dose of 10 mg/kg/day did not prevent the progression of URTI to LRTI in any patient. However, with dose escalation, six of the seven patients responded to RBV therapy and survived their infective episode. Of the eight patients presenting with LRTI, six patients survived their infection, again after dose escalation of RBV. There was no dose-limiting toxicity seen in any patient. Our results indicate that oral RBV has clinical efficacy in the treatment of RSV/PIV3 infection post HPCT. However, a starting dose of 10 mg/kg/day appears ineffective; we recommend a starting dose of 20 mg/kg/day in this patient group.

Effects of Ribavirin Dose Reduction vs Erythropoietin for Boceprevir-Related Anemia in Patients With Chronic Hepatitis C Virus Genotype 1 Infection—A Randomized Trial

Treatment of hepatitis C virus (HCV) infection with boceprevir, peginterferon, and ribavirin can lead to anemia, which has been managed by reducing ribavirin dose and/or erythropoietin therapy. We assessed the effects of these anemia management strategies on rates of sustained virologic response (SVR) and safety. Patients (n= 687) received 4 weeks of peginterferon and ribavirin followed by 24 or 44 weeks of boceprevir (800 mg, 3 times each day) plus peginterferon and ribavirin. Patients who became anemic (levels of hemoglobin approximately ≤10 g/dL) during the study treatment period (n= 500) were assigned to groups that were managed by ribavirin dosage reduction (n= 249) or erythropoietin therapy (n= 251). Rates of SVR were comparable between patients whose anemia was managed by ribavirin dosage reduction (71.5%) vs erythropoietin therapy (70.9%), regardless of the timing of the first intervention to manage anemia or the magnitude of ribavirin dosage reduction. There was a threshold for the effect on rate of SVR: patients who received <50% of the total milligrams of ribavirin assigned by the protocol had a significantly lower rate of SVR (P < .0001) than those who received ≥50%. Among patients who did not develop anemia, the rate of SVR was 40.1%. Eleven thromboembolic adverse events were reported in 9 of 295 patients who received erythropoietin, compared with 1 of 392 patients who did not receive erythropoietin. Reduction of ribavirin dosage can be the primary approach for management of anemia in patients receiving peginterferon, ribavirin, and boceprevir forHCV infection. Reduction in ribavirin dosage throughout the course of triple therapy does not affect rates of SVR. However, it is important that the patient receives at least 50% of the total amount (milligrams) of ribavirin assigned by response-guided therapy. ClinicalTrials.gov number, NCT01023035.

Uso clínico de telaprevir: reglas de parada, predicción de la respuesta, duración de la terapia y manejo de los efectos adversos

Triple combination therapy with pegylated interferon, ribavirin and telaprevir is currently considered the gold standard for the treatment of chronic hepatitis C virus (HCV) infection. The most important features are an increase in rates of sustained viral response (74–79% vs 46% with pegylated interferon and ribavirin), as well as the possibility of early cessation of ineffective therapy due to the application of futility rules at weeks 4 and 12 (HCV-RNA > 1,000UI/ml), and the possibility of selecting candidates for the shortest treatments due to the clinical significance of extended rapid viral response (undetectable HCV-RNA at weeks 4 and 12 of triple therapy). Treatment length is mainly based on the stage of fibrosis and prior response to pegylated interferon and ribavirin. Thus, in both treatment-naïve patients and patients with recurrence after pegylated interferon therapy, the duration of treatment is 24 or 48 weeks (unless cirrhosis is present), depending on the presence of extended rapid viral response, while in cirrhotic patients and null responders, treatment length is 48 weeks.The main adverse effects of telaprevir therapy are anemia and skin rash. If these effects occur, the main measures that should be adopted are reduction of the ribavirin dose in anemia, and close monitoring and treatment cessation in skin rash, depending on its spread and severity.

Inosine triphosphatase deficiency helps predict anaemia, anaemia management and response in chronic hepatitis C therapy

Anaemia frequently complicates peginterferon/ribavirin therapy for chronic hepatitis C infection. Better prediction of anaemia, ribavirin dose reduction or erythropoietin (EPO) need, may enhance patient management. Inosine triphosphatase (ITPA) genetic variants are associated with ribavirin-induced anaemia and dose reduction; however, their impact in real-life clinic patient cohorts remains to be defined. We studied 193 clinic patients with chronic hepatitis C infection of mixed viral genotype (genotype 1/4 n = 123, genotype 2/3, n = 70) treated with peginterferon/ribavirin. Patients were genotyped for ITPA polymorphisms rs1127354 and rs7270101 using Taqman primers. Hardy-Weinberg equilibrium was present. Estimated ITPA deficiency was graded on severity (0-3, no deficiency/mild/moderate/severe, n = 126/40/24/3, respectively). Multivariable models tested the association with anaemia at 4 weeks of treatment [including decline in haemoglobin (g/dL); haemoglobin <10 g/dL and haemoglobin decline >3 g/dL]; ribavirin dose reduction and EPO use and explored sustained viral response (SVR) to peginterferon/ribavirin. More severe ITPA deficiency was associated with less reduction in haemoglobin level (P <0.001; R(2) = 0.34), less ribavirin dose reduction (OR 0.42; (95% CI = 0.23-0.77); P = 0.005) and less EPO use [OR 0.53; (0.30-0.94); P = 0.029]. ITPA deficiency was associated with SVR [OR: 1.70; (1.02-2.83); P = 0.041] independently of clinical covariates (adjusted R(2) = 0.31). In this clinical cohort, ITPA deficiency helped predict the risk of on-treatment anaemia, ribavirin dose reduction, need for EPO support and was associated with SVR. For patients on HCV regimens including peginterferon/ribavirin, testing for ITPA deficiency may have clinical utility.

Effect of the Haoqinqingdan decoction on damp-heat syndrome in rats with influenza viral pneumonia

ObjectiveTo investigate the effect of Chinese medicine prescription-Haoqinqingdan decoction on damp-heat syndrome in rats with influenza viral pneumonia and its influence on the immune function. MethodsA total of 48 Wistar rats were randomly divided into the normal control group, the damp-heat syndrome model group, the Haoqinqingdan decoction group (high, medium and low dose group) and the ribavirin group. The body temperature and weight of rats in each group were recorded after modeling. After treatment for 6 d, the concentration of T lymphocyte subgroup (CD3+CD4+, CD3+CD8+) was determined by flow cytometry. The OD value of IFN-γ/IL-4 was detected by double-antibody sandwich ELISA method, and its concentration was acquired through conversion. ResultsAfter modeling, the temperature and weight of rats in each modeling group showed the increasing trend (P<0.01). From the second day of treatment, there was significant difference in the body mass between groups, and the rat weight of the control group was higher than in the modeling group (P<0.05 or 0.01). With the advances of treatment, only the temperature in the medium and high dose Haoqinqingdan decoction groups declined significantly (P<0.05). After treatment, the CD4+/CD8+ ratio of the damp-heat syndrome model group decreased more significantly compared with the control group. Elevated CD3+ CD8+ percentages and declined CD4+/CD8+ ratios can be observed in the low dose group and ribavirin group (P<0.05). Moreover, the CD3+ CD4+ percentage of ribavirin group was lower than in the control group (P<0.05). After treatment, the IFN-γ and IFN-γ/ IL-4 levels in the peripheral blood of rats in the damp-heat syndrome group were obviously higher than in the control group (P<0.05). ConclusionsCompared with ribavirin, the high dose Haoqinqingdan decoction can improve the ratio of T lymphocyte subgroup and Th1/Th2 cell balance more effectively.

Efficacy and Safety of Pegylated Interferon Alfa-2b and Ribavirin Combination Therapy Versus Pegylated Interferon Monotherapy in Hemodialysis Patients: A Comparison of 2 Sequentially Treated Cohorts

Pegylated interferon (peginterferon; interferon with an attached polyethylene glycol molecule) monotherapy is the recommended treatment for chronic hepatitis C virus (HCV) infection in hemodialysis patients. Limited data concerning peginterferon alfa-2b and ribavirin treatment in this population are available. 2 prospective observational cohort studies. From 2007-2009, a total of 26 patients received peginterferon alfa-2b monotherapy. From 2009-2012, an additional 26 patients were treated with peginterferon alfa-2b and ribavirin. Peginterferon alfa-2b monotherapy, 1.0 μg/kg/wk, versus peginterferon alfa-2b, 1.0 μg/kg/wk, and ribavirin, 200 mg, 3 times per week. Treatment durations were 24 and 48 weeks for HCV genotypes non-1 and 1, respectively. End-of-treatment virologic response and sustained virologic response (SVR) were undetectable HCV RNA at the end of treatment and 24 weeks after treatment ended, respectively. SVR and treatment-related withdrawal rate were evaluated by intention-to-treat (ITT) and per-protocol (PP) analyses. Severe anemia was defined as nadir hemoglobin level <8 g/dL. Patients who received combination therapy had a higher end-of-treatment virologic response than patients who received monotherapy (85% vs 62% in ITT [P = 0.03] and 100% vs 80% in PP [P = 0.03]). The SVR rate was higher in the combination-treatment cohort than in the monotherapy cohort (62% vs 27% in ITT [P = 0.01] and 73% vs 35% in PP [P = 0.01]). Patients who received combination therapy had a significantly higher rate of severe anemia than those who received monotherapy (58% vs 27%; P = 0.03). However, treatment withdrawal rates were similar between the combination (15%) and monotherapy (23%) groups. Comparison of 2 sequential cohorts rather than a randomized control study. Peginterferon alfa-2b and ribavirin combination therapy provided a higher SVR rate than peginterferon alfa-2b monotherapy for treatment-naive dialysis patients with chronic HCV infection through careful monitoring of hematologic parameters and ribavirin dose modification. Severe anemia was significantly higher in patients receiving combination therapy than patients treated with monotherapy.

PWE-126 Telaprevir With Adjusted dose of Ribavirin in Naive Chc-G1: Efficacy and Treatment in Chc In Hemodialysis Population. Target C (Rct)

IntroductionChronic hepatitis C (CHC) in Hemodialysis population is 3%. Standard of care (SOC) offers reduced dose of Peg IFN Alfa (p-IFNα) and reduced Ribavirin doses eliciting sub optimal SVR of...

PWE-129 Pegylated Interferon Alfa, Nitazoxanide, Telaprevir, Ribavirin, in Genotype 1 Undergoing Prior Experienced Chc-A Randomized Placebo Control Clinical Pilot Trial (Intrigue-C)

IntroductionChronic Hepatitis C is a global challenge with End stage liver disease and rising Hepatocellular Carcinoma. Peg Interferon Alfa and Ribavirin was the backbone of therapy. Recently introduced Directly Acting...

PIN103 - Treatment Burden Associated With Peginterferon-Based Antiviral Therapy For Patients With Chronic Hepatitis C (Chc) In Japan

Several randomized studies confirmed the efficacy and safety of peginterferon-based antiviral therapy for patients with hepatitis C virus infection. However, various types of patients who were not included in those studies are possibly seeking antiviral therapy in daily practice. The study aim was to analyze those patients and their treatment situation in a real-world setting. A large claims database (Medical Data Vision, Japan; 4/2010 - 6/2012) was retrospectively analyzed. The study patients were those who had evidence of CHC (ICD10: B182) and initiated either the combination therapy with peginterferon + ribavirin (PR) or the triple therapy with peginterferon + ribavirin + telaprevir (PR+T) from November, 2011. A total of 207 patients were identified, with 136 patients initiating PR (median age 56 years) and 71 patients initiating PR+T (median age 60 years). A quarter of patients were aged ≥65 in both therapy groups. 6% of patients given PR and 13% of patients given PR+T were previously diagnosed with hepatocellular carcinoma (HCC). Mean initial doses of peginterferon and ribavirin were similar between PR and PR+T however, mean adherence to the ribavirin dose in PR+T was 78% and lower than PR (95%). Patients requiring hospitalizations for treatment initiation were significantly different between PR and PR+T (71% vs. 93%, P<0.01); lengths of stay were 11.8 and 18.5 days in PR and PR+T, respectively (P<0.01), P-values were not changed after adjusting for patient age, gender, and previous diagnosis of HCC and cirrhosis. The study found that a quarter of patients were elderly and the majority of patients required hospitalization to start treatment with either PR or PR+T. More effective and safer treatment is desirable. Further research is needed to understand how differences in the characteristics of the patients treated with PR+T versus PR impact on treatment adherence and hospitalization patterns observed.

Poor response to hepatitis C treatment in elderly patients

Introduction. Treatment of genotype 1 chronic hepatitis C in elderly patients has been associated with low rates of a sustained virological response (SVR), but the reasons are unclear. Objective. To determine the SVR rate in patients ≥ 60 years with genotype 1 chronic hepatitis C treated with Peg-IFN and ribavirin, and to identify risk factors related to treatment response in this specific group of patients.Material and methods. Patients were divided into < 60 years (non-elderly) and >60 years (elderly) and were compard regarding clinical, laboratory and histological characteristics and response to treatment.Results. A total of 231 patients were included in the study. The elderly group (n=89) presented a predominance of women, more advanced hepatic disease, higher glucose, cholesterol and LDL levels, lower hemoglobin levels, and a larger proportion of overweight subjects. The SVR rate was lower (25 vs. 46%) and anemia, ribavirin dose reduction and use of filgrastim and erythropoietin were more frequent in elderly patients. Negative predictive factors of SVR in the whole group (n = 231) were glucose ≥ 100 mg/dL and age ≥ 60 years. In the elderly group, only pretreatment variables (lower serum glucose and higher hemoglobin levels) were associated with SVR.Conclusion. The SVR rate was low in elderly patients. However, this poor response was not due to poor tolerance, but mainly to pretreatment conditions. Among elderly patients, the best candidates for hepatitis C treatment are those with elevated pretreatment hemoglobin levels and adequate glycemic control.

Sa1056 Real World Experience With Telaprevir-Based Triple Therapy for Genotype 1 Chronic Hepatitis C: More Than 100 Treated Patients in an Inner-City Hepatology Practice

A S L D A b st ra ct s were included in the study. Hemoglobin less than 14.0g/dl at W1 and W2 of treatment was associated with subsequent decrease in ribavirin dose (p = 0.0005 and 0.0002, respectively), and addition of erythropoietin (p = 0.0145 and 0.0001, respectively). Drop in hemoglobin of.2g/dl from baseline atW2was also significantly associated with addition of erythropoietin (p = 0.0005). Hemoglobin at W1 or W2 was not associated with requirement for blood transfusion or with extended rapid virological response (eRVR), end of therapy response (ETR) or sustained virological response (with 4, 12 and 24 week follow-up; SVR4, SVR12 and SVR24 respectively). Undetectable viral load at W2 was associated with eRVR (p = 0.0025), ETR (p = 0.027), SVR4 (p = 0.037) and SVR12 (p = 0.0007). Undetectable viral load at W1 was not significantly associated with eRVR (p = 0.08), ETR or SVR4, SVR12 and SVR24. Conclusions In patients being treated with P, R, PI for CHC, undetectable viral load at W2 is associated with eRVR, ETR, SVR4 and SVR12. Early anemia (at W1 or W2) is associated with subsequent ribavirin dose reduction and addition of erythropoietin. Early monitoring of hemoglobin at W1 and W2 and of HCV RNA at W2may be helpful in patient management.

Sa1055 Final Results of a Clinical Trial of a 2-Week Lead-in Therapy With Interferon Beta Plus Ribavirin Before Peginterferon alpha-2B Plus Ribavirin for Chronic Hepatitis C With Genotype 1 and High Viral Loads

A S L D A b st ra ct s were included in the study. Hemoglobin less than 14.0g/dl at W1 and W2 of treatment was associated with subsequent decrease in ribavirin dose (p = 0.0005 and 0.0002, respectively), and addition of erythropoietin (p = 0.0145 and 0.0001, respectively). Drop in hemoglobin of.2g/dl from baseline atW2was also significantly associated with addition of erythropoietin (p = 0.0005). Hemoglobin at W1 or W2 was not associated with requirement for blood transfusion or with extended rapid virological response (eRVR), end of therapy response (ETR) or sustained virological response (with 4, 12 and 24 week follow-up; SVR4, SVR12 and SVR24 respectively). Undetectable viral load at W2 was associated with eRVR (p = 0.0025), ETR (p = 0.027), SVR4 (p = 0.037) and SVR12 (p = 0.0007). Undetectable viral load at W1 was not significantly associated with eRVR (p = 0.08), ETR or SVR4, SVR12 and SVR24. Conclusions In patients being treated with P, R, PI for CHC, undetectable viral load at W2 is associated with eRVR, ETR, SVR4 and SVR12. Early anemia (at W1 or W2) is associated with subsequent ribavirin dose reduction and addition of erythropoietin. Early monitoring of hemoglobin at W1 and W2 and of HCV RNA at W2may be helpful in patient management.