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Antiviral/immunomodulatory combination therapy: Pegylated interferon alpha 2a and ribavirin in patients with chronic hepatitis C virus infection  [PDF]
Deli? Dragan,Mitrovi? Nikola,Popovi? Nata?a,Uro?evi? Aleksandar
Srpski Arhiv za Celokupno Lekarstvo , 2012, DOI: 10.2298/sarh1210612d
Abstract: Introduction. Chronic hepatitis C virus (HCV) infection can progress to liver cirrhosis that causes bleeding from the gastrointestinal tract, liver failure and primary hepatocellular carcinoma. Use of standard therapeutic option consists of recombinant pegylated interferon alpha 2a/b with ribavirin in order to eradicate virus and prevent complications. Objective. The aim of investigation was to evaluate efficiency of combination therapy (pegylated interferon alpha 2a/b plus ribavirin) in patients with chronic HCV infection and to estimate predictive factors for successful treatment. Methods. A total of 387 patients with confirmed diagnosis of hepatitis C were evaluated (aged 18-65 years of both genders). Patients were treated with pegylated interferon alpha 2a/b and ribavirin according to a standard regimen lasting 24 or 48 weeks, dependent on virus genotype. Results. Negative HCV RNA (PCR assay) was recorded in 79.7% of patients at the end of treatment. Six months after completed therapy, negative HCV RNA, i.e. stained virologic response (SVR) was assessed in 70.5% of patients. Statistical summary of our results concerning SVR confirmed better efficiency of combination therapy for the following parameters compared to other investigated variables: age ≤40 (84.3% vs. 59.l%; p<0.0005), absence of cirrhosis (75.6% vs. 58.3%; p=0.003), lack of genotype 1 (86.6% vs. 61.8%; p<0.0005), and in patients who received full doses of pegylated interferon alpha 2a (78.3% vs. 63.3%; p=0.002). Conclusion. Combination therapy of recombinant pegylated interferon alpha 2a with ribavirin leads to SVR in the majority of treated patients (70.5%). Successful treatment depends on a variety of host and virus factors.
Efficacy of combined antiviral therapy with pegylated interferon α-2a and ribavirin for chronic hepatitis C infection in intravenous drug users  [PDF]
Ru?i? Maja,Fabri Milotka,Kla?nja Biljana,Pobor Marta
Srpski Arhiv za Celokupno Lekarstvo , 2010, DOI: 10.2298/sarh1002043r
Abstract: Introduction. Hepatitis C Virus infection represents not just a medical, but also a socio-economic problem. It is estimated that among 170 million infected, 60% belongs to the category of intravenous drug users (IDUs). Objective. The aim of this paper was to compare the response to the combined therapy of pegylated interferon alfa 2a and ribavirin, in the group of patients with HCV infection who were intravenous drug users (IDUs) and in patients who were identified in the other way of transmission of HCV. Also to identify the influence of the therapy on diseases of addiction, during the course of HCV infection and on the effects of the combined therapy of pegylated interferon alfa 2a and ribavirin. Methods. We conducted a retrospective-prospective study, on 60 patients, treated with combined antiviral therapy-pegylated interferon alfa 2a and ribavirin. 30 patients were from the group of IDUs, and 30 patients from other epidemiological groups. Results. There were significant differences between the age of the patients (30.2±7.1 vs. 39.3±11.2 years; p=0.002), but no significant difference in the duration of the HCV infection between the two groups of patients (8.9±7.4 vs. 13.1±7.0 years; p>0.05). A large number of the patients in the group of IDUs had a problem with the abstinence of the drug abuse. In this group, there was the influence of alcohol (30%) and other substances with potential hepatotoxicity: marihuana (23.3%) and psycho-active drugs (73.6%). Staging of the liver fibrosis was not influenced by those two parameters and was similar in both groups (p>0.05). The genotype 3a was dominant in intravenous drug users (50.0%) and genotype 1b in the control group of the patients (76.6%). In both groups, SVR was achieved at a higher percentage (86% vs. 70.00%; p>0.05), but among the intravenous drug users the relapses of HCV infection were at a lower percentage (3.3% vs. 20.0%; p=0.044). Side effects were noticed in solitary cases in both of the examined groups, but severe side effects were found only in the control group of the patients. Relapse of drug abuse was noticed in 6.66% of cases. Conclusion. We have registered that the group of intravenous drug users has the same or even better response to the antiviral therapy than other epidemiological groups and that the use of drugs does not change the course of HCV infection.
Pure red cell aplasia caused by pegylated interferon-α-2a plus ribavirin in the treatment of chronic hepatitis C  [cached]
Cheng-Shyong Chang,Sheng-Lei Yan,Hsuan-Yu Lin,Fu-Lien Yu
World Journal of Gastroenterology , 2011, DOI: 10.3748/wjg.v17.i16.2155
Abstract: Pure red cell aplasia (PRCA) is a rare hematological disorder which is characterized by severe anemia, reticulocytopenia and almost complete absence of erythroid precursors in bone marrow. The pathophysiology of PRCA may be congenital or acquired. To our knowledge, there is only one case report in the English literature of PRCA after pegylated interferon combination therapy for chronic hepatitis C. We report a second case of PRCA after pegylated interferon combination treatment for chronic hepatitis C. The diagnosis of PRCA was confirmed by the typical findings of bone marrow biopsy. The possible etiologies of our case are also discussed in this paper.
Sequence Heterogeneity in NS5A of Hepatitis C Virus Genotypes 2a and 2b and Clinical Outcome of Pegylated-Interferon/Ribavirin Therapy  [PDF]
Ahmed El-Shamy, Ikuo Shoji, Soo-Ryang Kim, Yoshihiro Ide, Susumu Imoto, Lin Deng, Seitetsu Yoon, Takashi Fujisawa, Satoshi Tani, Yoshihiko Yano, Yasushi Seo, Takeshi Azuma, Hak Hotta
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0030513
Abstract: Pegylated-interferon plus ribavirin (PEG-IFN/RBV) therapy is a current standard treatment for chronic hepatitis C. We previously reported that the viral sequence heterogeneity of part of NS5A, referred to as the IFN/RBV resistance-determining region (IRRDR), and a mutation at position 70 of the core protein of hepatitis C virus genotype 1b (HCV-1b) are significantly correlated with the outcome of PEG-IFN/RBV treatment. Here, we aimed to investigate the impact of viral genetic variations within the NS5A and core regions of other genotypes, HCV-2a and HCV-2b, on PEG-IFN/RBV treatment outcome. Pretreatment sequences of NS5A and core regions were analyzed in 112 patients infected with HCV-2a or HCV-2b, who were treated with PEG-IFN/RBV for 24 weeks and followed up for another 24 weeks. The results demonstrated that HCV-2a isolates with 4 or more mutations in IRRDR (IRRDR[2a]≥4) was significantly associated with rapid virological response at week 4 (RVR) and sustained virological response (SVR). Also, another region of NS5A that corresponds to part of the IFN sensitivity-determining region (ISDR) plus its carboxy-flanking region, which we referred to as ISDR/+C[2a], was significantly associated with SVR in patients infected with HCV-2a. Multivariate analysis revealed that IRRDR[2a]≥4 was the only independent predictive factor for SVR. As for HCV-2b infection, an N-terminal half of IRRDR having two or more mutations (IRRDR[2b]/N≥2) was significantly associated with RVR, but not with SVR. No significant correlation was observed between core protein polymorphism and PEG-IFN/RBV treatment outcome in HCV-2a or HCV-2b infection. Conclusion: The present results suggest that sequence heterogeneity of NS5A of HCV-2a (IRRDR[2a]≥4 and ISDR/+C[2a]), and that of HCV-2b (IRRDR[2b]/N≥2) to a lesser extent, is involved in determining the viral sensitivity to PEG-IFN/RBV therapy.
Pegylated interferon 2a and 2b in combination with ribavirin for the treatment of chronic hepatitis C in HIV infected patients
Ravinder Dhillon,Simona Rossi,Steven K Herrine
Therapeutics and Clinical Risk Management , 2008,
Abstract: Ravinder Dhillon, Simona Rossi, Steven K HerrineDepartment of Medicine, Division of Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, PA, USAAbstract: Coinfection with hepatitis C virus (HCV) and HIV is an increasingly recognized clinical dilemma, particularly since the advent of highly active antiretroviral therapy. Several studies of this population have demonstrated both more rapid progression of liver disease and poorer overall prognosis compared to HCV monoinfected patients. Consensus guidelines, based primarily on the results of 4 major randomized trials, recommend treatment with peginterferon and ribavirin for 48 weeks in coinfected patients. However, this current standard of care is associated with lower response rates to therapy than those seen in monoinfected patients. Important predictors of response include HCV genotype, pretreatment HCV RNA level, and presence of rapid virologic response (RVR) and early virologic response (EVR). Use of weight-based ribavirin dosing appears to be safe and enhances the likelihood of sustained virologic response (SVR). Adverse effects most commonly encountered are anemia and weight loss. Mitochondrial toxicity can occur in the setting of concomitant nucleoside reverse transcriptase inhibitor use, especially didanosine, abacavir, and zidovudine, and these should be discontinued before initiation of ribavirin therapy. Discontinuation of therapy should be considered in patients failing to demonstrate EVR, though ongoing trials are investigating a potential role for maintenance therapy in these patients. Peginterferon combined with weight-based ribavirin is appropriate and safe for treatment of HCV in HIV – HCV coinfected patients. This review summarizes the data supporting these recommendations.Keywords: hepatitis C, human immunodeficiency virus, peginterferon, ribavirin
Response of HCV Yemeni Patients to Sofosbuvir/Ledipasvir in Combination with Ribavirin
Abdulgafoor Kassim, Ramea Alathwary, Talal Al-hogami
Open Access Library Journal (OALib Journal) , 2019, DOI: 10.4236/oalib.1105507
Objectives: To study the effectiveness and safety of ledipasvir-sofosbuvir plus ribavirin treatment in Yemeni patient with HCV infection. Design: Prospective study of sixty-five Yemeni patients confirmed with HCV infection during the period from January 2017 to April 2018. Setting: Gastrointestinal and liver diseases specialized center in Ibb city, Yemen. Subjects: Patients with proved HCV infection by PCR. Results: We collected 65 cases with HCV infection. They were 19 (29.2%) males and 46 (70.8) females with age ranged between 18 years and 70 years and the mean age was 47.98 ± 11.90 years. sixteen (24.6%) of them had compensated liver cirrhosis and the remainder were non-cirrhotic healthy individual. The early virological response reported in 100% of cases while the sustained virological response (SVR) reported in 90.8%. The reported side effects of our patients were fatigue in (24.6%), abdominal pain in (13.8%), diarrhea in (10.8%), insomnia in (9.2%), headache in (7.7%), and nausea/vomiting in (7.7%). Conclusion: The Sofosbuvir-ledipasvir plus Ribavirin treatment was highly effective and safe for the treatment of hepatitis C patients in Yemen.
Pegylated interferon alfa and ribavirin for children with chronic hepatitis C  [cached]
Irit Rosen,Michal Kori,Orly Eshach Adiv,Baruch Yerushalmi
World Journal of Gastroenterology , 2013, DOI: 10.3748/wjg.v19.i7.1098
Abstract: AIM: To study current treatment options for pediatric hepatitis C infection and their associated success rates. METHODS: We retrospectively reviewed charts of thirty children who had been treated with combination therapy of pegylated interferon alfa plus ribavirin for chronic hepatitis C infection. Patients had been treated with ribavirin (15 mg/kg per day) and either pegylated interferon alfa 2a (180 mg/m2 once weekly) or pegylated interferon alfa 2b (1.5 mg/kg once weekly). Patients’ follow-up included subjective assessment of complaints, physical examination including weight and height, as well as laboratory evaluations for viral load [before treatment, at 12 wk, and 6 mo following treatment completion, as determined by sustained viral response (SVR)], complete blood count, liver enzymes, alkaline phosphatase, bilirubin, renal function tests, and thyroid function tests. For patients not achieving a two log decrease in viral load at treatment week 12, treatment was discontinued and the patient was considered a treatment non-responder. RESULTS: Thirty children aged 3-18 years were included in the study. Twenty patients (11 males, 9 females) received pegylated interferon alfa 2b and ten patients (6 males, 4 females) received pegylated interferon alfa 2a. Twenty-three patients were infected with genotype 1, six patients were infected with genotype 3, and one patient was infected with genotype 2. Twenty patients (67%) achieved SVR. Treatment success rates were 90% with pegylated interferon alfa 2a vs 55% with pegylated interferon alfa 2b. Although a trend was noted for improved outcomes in the group receiving pegylated interferon alfa 2a, there were no statistically significant outcome differences between the two treatment groups (P = 0.1). Treatment success was 56.5% for patients infected with genotype 1 virus, compared to 100% for patients infected with other genotypes (P = 0.064). There was no difference in treatment response between males and females. A cut-off age of twelve years was used to dichotomize younger vs older participants; however, no difference in treatment response was observed between these groups. Using multivariate regression analysis, we could not determine predictors for achieving SVR from among the variables we examined (age, sex, and viral genotype). Although we noted a trend toward SVR with peginterferon alfa-2a, there was no statistical difference between the two peginterferons. A high incidence of adverse reactions to treatment was noted. Twenty-five patients (83%) suffered from at least one adverse reaction, but most experienc
Pegylated Interferon and Ribavirin Treatment of Chronic Hepatitis C Coinfection in a Patient with Human Immunodeficiency Virus Infection  [cached]
Figen Kaptan,Nesrin Türker,Bahar ?rmen,Sibel El
Klimik Journal , 2011,
Abstract: Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection is seen frequently due to similar routes of transmission. In coinfected patients, progression of chronic hepatitis C (CHC) infection is accelerated. In this study, a 44-year old male patient with HIV/HCV (genotype 1b) coinfection is evaluated. For the treatment of CHC, pegylated interferon alpha 2a 180 mg per week and ribavirin 1000 mg/day were used for 48 weeks and sustained virologic response was achieved. During the course of CHC treatment no adverse effect was seen.
Pegylated Interferon and Ribavirin for the Treatment of Chronic Hepatitis C
William Kemp and Stuart Roberts
Clinical Medicine Insights: Therapeutics , 2012, DOI: 10.4137/CMT.S4015
Abstract: The management of chronic hepatitis C (CHC) is a rapidly evolving field. New treatment paradigms are emerging due to an improved understanding of the host-viral interaction and the recent development of novel anti-viral therapies. Nevertheless, combination therapy with pegylated interferon (PEG-IFN) and ribarivin (RBV) remains the cornerstone of the treatment of CHC and will likely remain so for the foreseeable future. Over the past decade treatment regimens involving peginterferon plus ribavirin therapy have evolved from initial fixed dosing schedules to more recent individualized response-guided schedules that utilize on-treatment virological responses to determine treatment duration. The future of CHC treatment in the near to medium term is likely to involve the use of PEG-IFN and RBV in conjunction with potent and specific direct acting anti-viral agents (DAA) (protease +/ polymerase inhibitors). This review will focus on the use of PEG-IFN and RBV in the treatment of CHC as well as provide insight into how DAA agents may be used with this therapy as we enter the era of specifically targeted antiviral therapy for HCV.
Acute inflammatory demyelinating polyneuropathy associated with pegylated interferon 2a therapy for chronic hepatitis C virus infection  [cached]
Vijay Khiani, Thomas Kelly, Adeel Shibli, Donald Jensen, Smruti R Mohanty
World Journal of Gastroenterology , 2008,
Abstract: The combination of pegylated interferon (Peg-IFN) and ribavirin is the standard of care for chronic hepatitis C virus (HCV) infection treatment. In general, common side effects related to this combination therapy are mild and are very well tolerated. However, peripheral neuropathy including demyelinating polyneuropathy related to Peg-IFN is extremely rare. We present the first case of an acute inflammatory demyelinating polyneuropathy (AIDP) associated with Peg-IFN-α 2a (Pegasys) after 16 wk of a combination therapy with Pegasys and ribavirin in a 65-year-old woman with chronic HCV infection. She developed tingling, numbness, and weakness of her upper and lower extremities and was hospitalized for acute neurological deficits. Her clinical course, neurological findings, an electromyogram (EMG), nerve conductions studies (NCS), muscle biopsy, and a sural nerve biopsy were all consistent with AIDP likely related to Pegasys use. The patient recovered completely with the use of intravenous immunoglobulin (IVIG) including physical therapy and neurological rehabilitation. It is very important that gastroenterologists and/or hepatologists recognize this rare neurological complication related to Peg-IFN treatment very early, since it requires a prompt discontinuation of therapy including an immediate referral to a neurologist for the confirmation of diagnosis, management, and the prevention of long-term neurological deficits.
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