Predictive factors for functional cure after sequential therapy with nucleos(t)ide analogues and pegylated interferon alfa-2b in treatment of chronic hepatitis B / 临床肝胆病杂志

Objective To investigate the independent predictive factors for functional cure after long-term nucleos(t)ide analogue (NUC) antiviral therapy followed by pegylated interferon α-2b therapy in chronic hepatitis B (CHB) patients. Methods A total of 162 CHB patients who were admitted to several hospitals in Qingdao, China, from 2018 to 2021 were enrolled as subjects, and all patients received pegylated interferon α-2b for at least 48 weeks after NUC therapy for one year or longer. According to whether HBsAg clearance was achieved at week 48 of pegylated interferon α-2b treatment, the patients were divided into functional cure group with 79 patients and non-cure group with 83 patients, and related clinical indices were compared between the two groups. The two-independent-samples t test and the Mann-Whitney U rank sum test were used for comparison of continuous data between two groups, and the chi-square test was used for comparison of categorical data between two groups. The Spearman correlation analysis was performed, and the univariate and multivariate logistic regression analyses were used to investigate the independent predictive factors for functional cure. The receiver operating characteristic (ROC) curve was plotted for related variables, and the area under the ROC curve (AUC) was used to evaluate the prediction accuracy of the variables. Results Compared with the non-cure group, the functional cure group had a significantly lower HBsAg level at baseline [21.63 (3.33-157.60) IU/mL vs 794.70 (336.10-1 185.34) IU/mL, Z =-8.869, P 1000 IU/mL (0 vs 8.4%, χ 2 =5.073, P =0.024), a significantly lower level of total bilirubin at baseline [12.60 (10.12-15.93) μmol/L vs 15.50 (11.80-24.10) μmol/L, Z =-3.611, P 2×upper limit of normal (16.5% vs 4.8%, χ 2 =5.835, P =0.016). The multivariate logistic regression analysis showed that baseline HBsAg (odds ratio [ OR ]=0.996, 95% confidence interval [ CI ]: 0.995-0.997, P < 0.001), HBsAg at week 12 of pegylated interferon α-2b treatment ( OR =0.990, 95% CI : 0.986-0.994, P < 0.001), HBsAg at week 24 of pegylated interferon α-2b treatment ( OR =0.983, 95% CI : 0.975-0.991, P < 0.001), and baseline total bilirubin ( OR =0.885, 95% CI : 0.826-0.949, P =0.001) were independent predictive factors for functional cure. The ROC curve of baseline HBsAg showed an AUC of 0.904 and the optimal cut-off value of 118.24 IU/mL; the ROC curve of HBsAg at week 12 of pegylated interferon α-2b treatment showed an AUC of 0.948 and the optimal cut-off value of 73.74 IU/mL; the ROC curve of HBsAg at week 24 of pegylated interferon α-2b treatment showed an AUC of 0.975 and the optimal cut-off value of 11.01 IU/mL; the ROC curve of baseline total bilirubin showed an AUC of 0.664 and the optimal cut-off value of 19.9 μmol/L. Conclusion Baseline HBsAg, HBsAg at week 12 of pegylated interferon α-2b treatment, HBsAg at week 24 of pegylated interferon α-2b, and baseline total bilirubin are independent predictive factors for functional cure at week 48 of pegylated interferon α-2b treatment in CHB patients receiving sequential therapy with NUC and pegylated interferon α-2b.

Effect of Lyophilization on Stability of PEG-Protein Conjugate: A Case Study with Peginterferon alfa-2b

Abstract The purpose of the present study was to develop stable lyophilized formulation of peginterferon alfa-2b which is acquiescent to the short lyophilization process. The present study evaluates the effect of buffering components and cryoprotectant(s) on depegylation of the peginterferon alfa-2b in combination with lyophilization process. Finally, a short lyophilization process was identified which can produce a stable pharmaceutical form of peginterferon alfa-2b without any depegylation during long-term storage. Formulations were analyzed mainly for depegylation by HP-size exclusion chromatography and in-vitro antiviral activity. Residual moisture content in the lyophilized product was also used as a key indicating parameter to check its role with respect to depegylation upon storage under various temperature conditions. It was observed that the peginterferon alfa-2b when formulated in presence of cryoprotectant like sucrose requires longer lyophilization process of about 5 days, irrespective of the buffering components used, to reduce the level of residual moisture content and thereby to produce the stable formulation without depegylation. A stable formulation in presence of high concentration of lactose as a cryoprotectant was developed which can withstand stresses exerted to protein-polymer conjugate during lyophilization phases without any significant depegylation. A short lyophilization process of about 48 hours can be utilized for peginterferon alfa-2b when formulated in presence of lactose as a cryoprotectant through which a stable lyophilized formulation can be produced as against longer process required when sucrose is used a cryoprotectant, which is essential from commercial point of view as lyophilization is a costly process.

Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatitis B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study) / 中华医学杂志(英文版)

<p><b>Background</b>Until now, various types of combined therapy with nucleotide analogs and pegylated interferon (Peg-INF) in patients with hepatitis B patients have been tried. However, studies regarding the benefits of de novo combination, late-add on, and sequential treatment are very limited. The objective of the current study was to identify the efficacy of sequential treatment of Peg-INF after short-term antiviral treatment.</p><p><b>Methods</b>Between June 2010 and June 2015, hepatitis B e antigen (HBeAg)-positive patients (n = 162) received Peg-IFN for 48 weeks (mono-treatment group, n = 81) and entecavir (ETV) for 12 weeks with a 48-week course of Peg-IFN starting at week 5 of ETV therapy (sequential treatment group, n = 81). The primary endpoint was HBeAg seroconversion at the end of follow-up period after the 24-week treatment. The primary endpoint was analyzed using Chi-square test, Fisher's exact test, and regression analysis.</p><p><b>Results</b>HBeAg seroconversion rate (18.2% vs. 18.2%, t = 0.03, P = 1.000) and seroclearance rate (19.7% vs. 19.7%, t = 0.03, P = 1.000) were same in both mono-treatment and sequential treatment groups. The rate of alanine aminotransferase (ALT) normalization (45.5% vs. 54.5%, t = 1.12, P = 0.296) and serum hepatitis B virus (HBV)-DNA <2000 U/L (28.8% vs. 28.8%, t = 0.10, P = 1.000) was not different in sequential and mono-treatment groups at 24 weeks of Peg-INF. Viral response rate (HBeAg seroconversion and serum HBV-DNA <2000 U/L) was not different in the two groups (12.1% vs. 16.7%, t = 1.83, P = 0.457). Baseline HBV-DNA level (7 logU/ml vs. 7.5 logU/ml, t = 1.70, P = 0.019) and hepatitis B surface antigen titer (3.6 logU/ml vs. 4.0 logU/ml, t = 2.19, P = 0.020) were lower and predictors of responder in mono-treatment and sequential treatment groups, respectively.</p><p><b>Conclusions</b>The current study shows no differences in HBeAg seroconversion rate, ALT normalization, and HBV-DNA levels between mono-therapy and sequential therapy regimens.</p><p><b>Trial Registration</b>ClinicalTrials.gov, NCT01220596; https://clinicaltrials.gov/ct2/show/NCT01220596?term=NCT01220596&rank=1.</p>

Final Report of Unmet Needs of Interferon-Based Therapy for Chronic Hepatitis C in Korea: Basis for Moving into the Direct-Acting Antiviral Era

BACKGROUND/AIMS: To evaluate the era of direct acting antivirals (DAAs), we must understand the treatment patterns and outcomes of interferon-based therapy for hepatitis C virus (HCV) infection. We aimed to elucidate the treatment rate, factors affecting treatment decisions, and efficacy of interferon-based therapy in a real-world setting. METHODS: This nationwide cohort study included 1,191 newly diagnosed patients with chronic HCV infection at seven tertiary hospitals in South Korea. Subjects were followed retrospectively until March 2015, which was just before the approval of DAA therapy. RESULTS: In total, 48.2% and 49.3% of the patients had HCV genotypes 1 and 2, respectively. Interferon-based therapy was initiated in 541 patients (45.4%). The major reasons for no treatment included ineligibility (18.9%), concern about adverse events (22.3%), cost (21.5%), and an age >75 years (19.5%). Interferon-based therapy was discontinued (18.5%) mainly due to adverse events (n=66). The intent-to-treat analysis found that the sustained virologic response (SVR) rate was 58.3% in genotype 1 patients and 74.7% in non-genotype 1 patients. CONCLUSIONS: Approximately one-third of newly diagnosed HCV patients in South Korea received interferon-based therapy and showed a suboptimal SVR rate. Diagnosis of patients at younger ages and with a less advanced liver status and reducing the DAA therapy cost may fulfill unmet needs.

Clinical Characteristics and Treatment Outcome of Peginterferon Plus Ribavirin in Patients Infected with Genotype 6 Hepatitis C Virus in Korea: A Multicenter Study

BACKGROUND/AIMS: Because of the limited geographic distribution, there have been insufficient data regarding hepatitis C virus (HCV) genotype 6 in Korea. This study aimed to investigate the clinical characteristics and available treatment outcomes of patients with genotype 6 HCV in Korea. METHODS: From 2004 to 2014, data were collected from Korean patients infected with genotype 6 HCV in eight hospitals. RESULTS: Thirty-two patients had genotype 6 HCV. The median age was 44 years, and 6c was the most common subtype. The baseline median alanine transaminase level was 88 (21 to 1,019) IU/mL, and the HCV RNA level was 1,405,000 (96,500 to 28,844,529) IU/mL. Twenty-five patients were treated with peginterferon (PEG-IFN) and ribavirin. Three follow-up losses occurred. Additionally, 13 patients attained a sustained virologic response (SVR), seven patients relapsed, and two patients exhibited a null response. The SVR rates were 40% and 75% for the 24- and more than 48-week treatments, respectively, and five of the six patients who achieved a rapid virologic response (RVR) attained a SVR. CONCLUSIONS: Korean patients infected with genotype 6 HCV are relatively young, and 6c is the most common subtype. When treated with PEG-IFN and ribavirin, the SVR rate was 52%. Similar to other genotypes, a longer duration of treatment and attainment of RVR are important for SVR.

Development of bronchiolitis obliterans organizing pneumonia during standard treatment of hepatitis C with Peg-IFNα2b

No abstract available.

Pegylated interferon combined with entecavir in treatment of HBeAg positive chronic hepatitis B / 中华全科医师杂志

Objective To evaluate the efficacy of pegylated interferon α-2a and entecavir (ETV) combination therapy for patients with HBeAg positive chronic hepatitis B (CHB).Methods Fifty eight HBeAg positive CHB patients were assigned to two groups:29 patients received ETV 0.5 mg daily for 72 weeks (ETV group) and 29 patients received ETV and pegylated interferon α-2a 180 μg weekly for 48 weeks followed by ETV alone for 24 weeks (combination group).Serum samples were collected from all patients every 12 weeks for assessment of biochemical,virological and serological responses to treatment.Results Fifty four patients completed the 72-week study,including 28 in ETV group and 26 in combination group.There were no significant differences in week 24,week 48 and week 72 of ALT normalization [72％ (21/29)vs.93％ (27/29),x2 =2.104;90％ (26/29) vs.97％ (28/29),x2 =0.269;90％ (26/29) vs.97％ (28/29),x2 =0.269],HBV DNA undetectable rate [31％ (8/26) vs.46％ (13/28),x2 =1.391;62％ (16/26) vs.57％ (16/28),x2 =0.108;77％ (20/26) vs.75％ (21/28),x2 =0.027],HBeAg loss rate[12％(3/26) vs.25％ (7/28),x2 =0.850;31％ (8/26) vs.32％ (9/28),x2 =0.012;46％ (12/26) vs.36％(10/28),x2 =0.609] and HBsAg levels (log10 IU/ml) (3.63 ± 0.45 vs.3.36 ± 1.18,t =-1.066;3.45 ±0.43 vs.3.23 ± 1.15,t =-0.915;3.36 ± 0.58 vs.2.88 ± 1.28,t =-1.762) between two regimens (all P ＞ 0.05).Among 58 patients,15 were HBeAg and anti-HBe double-positive (26％)and 43 were HBeAg mono-positive patients.The baseline HBV DNA level [(5.07 ± 1.50) vs.(6.40 ± 1.47) log10 IU/ml,t =2.858,P ＜ 0.05] and HBeAg titer [14 (4-45) vs.732 (296-1 012) S/CO,Z =-5.031,P =0.05] in double-positive patients were lower than those in mono-positive patients.The HBV DNA undetectable rate of double-positive patients was significantly higher than that of mono-positive patients in 24 weeks [10/15 vs.26％ (10/39),x2 =7.819,P ＜0.05] and 72 weeks [15/15 vs.69％ (27/39),x2 =4.287,P =0.05].The HBeAg loss rate of double-positive patients was higher than that of mono-positive patients in 12 weeks [6/15 vs.10％ (4/39),x2 =4.533,P =0.05] and 48 weeks [9/15 vs.26％ (10/39),x2 =5.608,P =0.018].This tendency was more significant in the combination therapy group,but the difference was not statistically significant.(5/6 vs.4/9,P =0.065).Conclusions Compared with Entecavir monotherapy,entecavir combined with interferon may not improve the therapeutic effect in HBeAg positive chronic hepatitis B patients.However,the therapeutic response of HBeAg/anti-HBe double-positive patients may better than that of HBeAg mono-positive patients.

Repeated Panniculitis Induced by Pegylated Interferon Alpha 2a in a Patient with Chronic Hepatitis C / 대한소화기학회지

Pegylated interferon alpha (PEG-IFN-α) is widely used to treat chronic hepatitis C in combination with ribavirin. Many adverse effects of PEG-IFN-α, such as hematologic, psychologic, dermatologic, immunologic, and other abnormalities, have been reported, and some serious adverse events lead to PEG-IFN-α treatment discontinuation. For very rare adverse events such as panniculitis, there are no established guidelines on whether to continue PEG-IFN-α treatment. Published reports on panniculitis induced by PEG-IFN-α 2a are sparse. Herein we report a case of repeated occurrences of panniculitis in a patient with chronic hepatitis C, leading to treatment cessation.

A Study on the Anxiety of the Chronic Viral Hepatitis Patients Receiving Pegylated Interferon Therapy / 신경정신의학

OBJECTIVES: The aim of this study was to clarify anxiety symptoms associated with the pegylated interferon (PEG-IFN) treatment and to determine which factors are associated with these anxiety symptoms. METHODS: The subjects were 30 patients with hepatitis B and C viral infections who were waiting to receive PEG-IFN treatment. For assessment of depressive and anxiety symptoms, the Beck Depression Inventory and the State-Trait Anxiety Inventory were used. Patients were examined before treatment and then prospectively during the 2 weeks, 4 weeks and 1 years of therapy. We analyzed the changes in anxiety and depression symptoms, and applied multiple regression analysis to identify factors that significantly affect the anxiety symptoms. RESULTS: Compared to pre-treatment baseline, anxiety symptoms increased 2 weeks after treatment, and gradually decreased 4 weeks, and 1 year after treatment. And, we analyzed the sub-factors of depressive symptoms that affect the anxiety symptoms. After 2 weeks of treatment, cognitive-affective factors and hypochondriasis factors of depressive symptoms had an effect on anxiety symptoms. Furthermore after 4 weeks of treatment, the cognitive-affective factors had an effect on anxiety symptoms. CONCLUSION: In this study, we found a significant increase in anxiety symptoms after PEG-IFN treatment, and cognitive-affective depressive factors significantly affect anxiety symptoms.

Sudden Deafness in a Patient with Chronic Hepatitis C Treated with Peginterferon and Ribavirin Combination Therapy / 대한내과학회지

Combined peginterferon and ribavirin therapy for chronic hepatitis C is associated with several adverse side effects, but sudden deafness is uncommon. Here we report the case of a 62-year-old female with chronic hepatitis C (genotype 1b) who developed sudden deafness after completing 12 months of treatment with peginterferon alpha2a (180 microg/week) and ribavirin (1,000 mg/day). Pure-tone audiometry revealed a right-sided sensorineural hearing loss, which did not respond to 2 weeks of systemic corticosteroid therapy. Six months after the end of treatment for chronic hepatitis C, her qualitatively determined hepatitis C virus RNA level was 121,000 IU/mL. Following therapeutic failure, the patient was observed without retreatment for chronic hepatitis C or her hearing loss for a period of 12 months, during which time her hearing recovered almost completely.

Prediction of a Null Response to Pegylated Interferon alpha-2b Plus Ribavirin in Patients with High Viral Load Genotype 1b Hepatitis C

BACKGROUND/AIMS: The present study aimed to clarify whether virological response within 2 weeks after therapy initiation can predict a null response to pegylated interferon alpha-2b plus ribavirin therapy in patients with high viral load genotype 1b hepatitis C. METHODS: The participants consisted of 72 patients with high viral load genotype 1b. The dynamics of viral load within 2 weeks were measured. RESULTS: Significant differences between null responders and nonnull responders were noted for interleukin (IL)-28B genotype, amino acid 70 substitution, alpha-fetoprotein, low-density lipoprotein cholesterol, hyaluronic acid, and viral response. The area under the curve (AUC) for the receiver operating characteristic curve of the hepatitis C virus (HCV) RNA level decline at 2 weeks (AUC=0.993) was the highest among the factors predicting the null response. When the cutoff value for the HCV RNA level decline at 2 weeks was set at 0.80 log, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in predicting a null response were 82%, 96%, 82%, 96%, and 94%, respectively. In comparison, values for the non-TT and mutant type of amino acid 70 substitution were similar to those for HCV RNA level decline at 2 weeks. CONCLUSIONS: Virological response at 2 weeks or the combination of IL-28B and amino acid 70 substitution are accurate predictors of a null response.

High effectiveness of peginterferon alfa-2a plus ribavirin therapy in Korean patients with chronic hepatitis C in clinical practice

BACKGROUND/AIMS: Identifying the impact of a patient's ethnicity on treatment responses in clinical practice may assist in providing individualized treatment regimens for chronic hepatitis C (CHC). The effectiveness of standard peginterferon plus ribavirin therapy and the need for triple combination therapy with protease inhibitors in Koreans remain matters of debate. These issues were investigated in the present study. METHODS: The clinical data of 272 treatment-naive Korean CHC patients who were treated in a community-based clinical trial (Clinical Trial group; n=51) and in clinical practice (Cohort group; n=221), were analyzed and compared. All were treated with standard protocols of peginterferon alfa-2a plus ribavirin therapy. RESULTS: For patients with hepatitis C virus (HCV) genotype 1, the sustained virological response (SVR) rates in the Clinical Trial and Cohort groups were 81% (21/26) and 55% (58/106), respectively, by intention-to-treat (ITT) analysis (P=0.02), and 100% (13/13) and 80% (32/40), respectively, in treatment-adherent patients (P=0.18). For patients with HCV genotype 2, the SVR rates in these two groups were 96% (24/25) and 88% (101/115), respectively, by ITT analysis (P=0.31). Adherence and treatment duration were independent predictors of SVR for genotypes 1 and 2, respectively (P<0.01 for each). Korean patients with CHC achieved high SVR rates with peginterferon alfa-2a plus ribavirin in both the clinical trial and clinical practice settings. CONCLUSIONS: Measures to raise adherence to standard therapy in clinical practice may improve the SVR rates in these patients as effectively as adding protease inhibitors, thus obviating the need for the latter.

Extensive Psoriasis Induced by Pegylated Interferon Alfa-2a and Ribavirin in the Treatment of Chronic Hepatitis C

A 56-year-old man with chronic hepatitis C was treated with pegylated interferon alfa-2a in combination with ribavirin. However, psoriatic lesions appeared and worsened dramatically during therapy. Because of the extensive skin eruptions, he stopped therapy for chronic hepatitis C and subsequently started narrow-band ultraviolet B phototherapy and topical calcipotriol/betamethasone dipropionate ointment. After this, the psoriasis improved in a slow but comprehensive manner. Our case suggests that physicians should keep in mind the possibility of psoriasis as a side effect of interferon treatment for chronic hepatitis C.

Resultados del tratamiento de la hepatitis crónica por virus C en un hospital público, en Chile / Results of chronic hepatitis C treatment in a public hospital

Background: Chronic hepatitis C is an important health problem in Chile. In 2005, the Ministry of Health started a pilot treatment program with peg interferon and ribavirin, to be developed in public hospitals all over the country. Aim: To report the results ofhepatitis C treatment obtained at our institution. Patients and Methods: Between 2005 and 2009, 63 patients were referred for treatment. In all, the viral load and genotype were determined. Peg interferon alpha-2a or alpha-2b plus ribavirin were used for therapy for up to 48 weeks in genotypes (G) 1 or 4 or 24 weeks in genotypes 2 or 3. If at the end oftreatment, viral load measured by polymerase chain reaction (PCR) was negative, it was repeated 6 months later. A negative viral load at that time was considered a sustained viral response (SVR). Results: Among the 51 patients who started treatment, 42 (80.4%) were G1,1 was G2,1 was G4 and 7 were G3. A SVR was reached in 51.1% ofG 1 and 4 and in 87.5% in G 3 and 2. In a univariate analysis, the variables significantly associated with a positive viral response were the degree offibrosis and body mass index. Conclusions: These results are similar to those obtained in other international series, demonstrating that Hispanic ethnicity does not influence the response to treatment. Our good results could be explained by the excellent compliance of the patients to the treatment. A higher degree offibrosis and a higher BMI were associated with a poor response.

Body Mass Index and Nonresponse to Antiviral Treatment in Korean Patients with Genotype 2 and 3 Chronic Hepatitis C / 전남의대학술지

Pegylated-interferon plus ribavirin is the standard treatment for chronic hepatitis C. Sustained virological response (SVR) rates of up to 80% are reported in genotype 2 and 3 chronic hepatitis C cases. Obesity, a modifiable risk factor, may have a deleterious effect on antiviral treatment. We performed this study to examine the efficacy and safety of pegylated-interferon and ribavirin therapy in Korean patients with genotype 2 and 3 chronic hepatitis C and to investigate the risk factors for nonresponse to antiviral treatment. A total of 121 patients were treated with peginterferon alpha-2a 180 mcg/week plus ribavirin 800 mg/day for 24 weeks. The end-of-treatment virologic response (ETVR), the SVR, the end-of-treatment biochemical response (ETBR), the sustained biochemical response (SBR), and the adverse events were analyzed. The ETVR and SVR were 94.1% and 89.1%, respectively. The ETBR was 80.2% and the SBR was 96%. Multivariate analysis showed that a body mass index of 25 and over was the only independent factor that affected the SVR (odds ratio=10.5, 95% confidence interval: 2.006-54.948, p=0.005). Twenty patients (16.5%) dropped out at the end of treatment, and 7 (5.8%) patients discontinued treatment because of treatment-related adverse events. Our study showed that combination therapy with pegylated-interferon and ribavirin as an initial treatment for genotype 2 and 3 chronic hepatitis C is very effective and safe, and that body mass index is an independent risk factor for nonresponse to antiviral treatment in patients with genotype 2 and 3 chronic hepatitis C.

Body Mass Index and Nonresponse to Antiviral Treatment in Korean Patients with Genotype 2 and 3 Chronic Hepatitis C / 전남의대학술지

Pegylated-interferon plus ribavirin is the standard treatment for chronic hepatitis C. Sustained virological response (SVR) rates of up to 80% are reported in genotype 2 and 3 chronic hepatitis C cases. Obesity, a modifiable risk factor, may have a deleterious effect on antiviral treatment. We performed this study to examine the efficacy and safety of pegylated-interferon and ribavirin therapy in Korean patients with genotype 2 and 3 chronic hepatitis C and to investigate the risk factors for nonresponse to antiviral treatment. A total of 121 patients were treated with peginterferon alpha-2a 180 mcg/week plus ribavirin 800 mg/day for 24 weeks. The end-of-treatment virologic response (ETVR), the SVR, the end-of-treatment biochemical response (ETBR), the sustained biochemical response (SBR), and the adverse events were analyzed. The ETVR and SVR were 94.1% and 89.1%, respectively. The ETBR was 80.2% and the SBR was 96%. Multivariate analysis showed that a body mass index of 25 and over was the only independent factor that affected the SVR (odds ratio=10.5, 95% confidence interval: 2.006-54.948, p=0.005). Twenty patients (16.5%) dropped out at the end of treatment, and 7 (5.8%) patients discontinued treatment because of treatment-related adverse events. Our study showed that combination therapy with pegylated-interferon and ribavirin as an initial treatment for genotype 2 and 3 chronic hepatitis C is very effective and safe, and that body mass index is an independent risk factor for nonresponse to antiviral treatment in patients with genotype 2 and 3 chronic hepatitis C.

The Combination Therapy with Peg-interferon Alfa and Ribavirin for Chronic Hepatitis C in Korea as an Initial Treatment / 고신대학교의과대학학술지

OBJECTIVES: The combination therapy with peginterferon and ribavirin has been used to treat chronic hepatitis C for several years in Korea but there is a few report about the results of the treatment. We evaluated safety and efficacy of the combination therapy with Peg-interferon and ribavirin and analyzed factors that may affect treatment. METHODS: Total 72 untreated chronic hepatitis C patients were administered pegylated interferon alfa-2a (180microg/week) or alfa-2b (1.5microg/kg/week) and ribavirin (800 mg/day in genotype 2, 1000-1200 mg/day in genotype 1). Duration of the treatment was 24 weeks in genotype 2 and 48 weeks in genotype 1. Response of the treatment was evaluated by rapid virologic response (RVR), early virologic response (EVR), end treatment virologic response (ETR), sustained virologic response (SVR) and adverse event. RESULTS: The RVR, EVR, ETR, SVR were 61.8%, 82.5%, 88.9% and 80.5% retrospectively. The SVR of genotype 1 was 63.4% and non-genotype 1 was 96.7%. Genotype (Odds ratio: 14.92) was an independent predictor of the SVR. Leukocytopenia, flu-like symptoms, itching, rash and anemia were common adverse events of the combination therapy and if then we reduced dose and there was one case of cessation. CONCLUSIONS: The combination therapy with Peg-interferon and ribavirin shows efficacy to the Korean patients with chronic hepatitis C as an initial treatment. Genotypes 2 and 3 were more likely to have a sustained virologic response.

Resultados del tratamiento con peginterferón alfa-2a y ribavirina en pacientes con hepatitis crónica C / Results of treatment with peginterferon plus ribavirin in patients with chronic hepatitis C

Background: The current treatment recommendation for chronic hepatitis C virus infection is the combination of peginterferon and ribavirin for 24 or 48 weeks, depending on the viral genotype. The aim of the therapy is to obtain a sustained virological response. Aim: To report our experience in the treatment of chronic hepatitis C. Material and Methods: Analysis of 52 patients treated between September 2000 and June 2009. Patients with genotype 1 or 5 were treated with peginterferon alpha 2a (180 ug/week) and ribavirin (1000 mg/day for those weighing less than 75 kg and 1200 mg/day for those weighing more than 75 kg) during 48 weeks. Patients with genotypes 2 and 3 were treated for 24 weeks with the same dose of peginterferon and ribavirin 800 mg /day. Results: Viral genotypes 1, 2, 3 and 5 were present in 81, 4, 11 and 4 percent of patients, respectively. Twenty four patients (46 percent), 18 with genotype 1, achieved a sustained viral response. Age was the only variable that infl uenced the response to treatment. Conclusions: Approximately half of the patients with chronic hepatitis C, achieve a sustained viral response with peginterferon and ribavirin.

A Case of Interstitial Pneumonitis and Pancytopenia Following the Combination Therapy of Pegylated Interferon and Ribavirin / 결핵및호흡기질환

The combination therapy of pegylated interferon and ribavirin is the mainstay of treatment for chronic hepatitis C patients. Anti-viral therapy is commonly associated with side effects such as headache, fever, myalgia, and arthralgia. However, anti-viral therapy can continue because these side effects are mostly mild and can be improved with supportive management. Anti-viral therapy should be stopped promptly if serious side effects, such as interstitial pneumonitis or hemolytic anemia occur, although those serious side effects are rare. There were a few case reports of interferon-related interstitial pneumonitis worldwide. In Korea, one atypical case report of interstitial pneumonitis has been reported, which followed the combination therapy of interferon-alpha and ribavirin in a patient with chronic hepatitis C. We present a case of interstitial pneumonitis and pancytopenia following the combination therapy of pegylated interferon and ribavirin in a patient with chronic hepatitis C.

A Case of Interstitial Pneumonitis and Pancytopenia Following the Combination Therapy of Pegylated Interferon and Ribavirin / 결핵및호흡기질환

The combination therapy of pegylated interferon and ribavirin is the mainstay of treatment for chronic hepatitis C patients. Anti-viral therapy is commonly associated with side effects such as headache, fever, myalgia, and arthralgia. However, anti-viral therapy can continue because these side effects are mostly mild and can be improved with supportive management. Anti-viral therapy should be stopped promptly if serious side effects, such as interstitial pneumonitis or hemolytic anemia occur, although those serious side effects are rare. There were a few case reports of interferon-related interstitial pneumonitis worldwide. In Korea, one atypical case report of interstitial pneumonitis has been reported, which followed the combination therapy of interferon-alpha and ribavirin in a patient with chronic hepatitis C. We present a case of interstitial pneumonitis and pancytopenia following the combination therapy of pegylated interferon and ribavirin in a patient with chronic hepatitis C.