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1.
J. bras. nefrol ; 41(1): 145-151, Jan.-Mar. 2019. tab, graf
Article in English | LILACS | ID: biblio-1002413

ABSTRACT

ABSTRACT Introduction: Anemia is a frequent multifactorial complication of CKD seen in patients on dialysis derived mainly from impaired erythropoietin (EPO) production. A less common cause of anemia in individuals with CKD is pure red cell aplasia (PRCA) secondary to the production of anti-EPO antibodies. Objective: This paper aimed two describe two cases of PRCA secondary to the production of anti-EPO antibodies including choice of treatment, patient progression, and a literature review. Materials: This study included the cases of two patients with CKD on hemodialysis with severe anemia in need of specific investigation and management. Results: Patient 1 with CKD secondary to hypertension treated with EPO for 7 months showed persistent decreases in hemoglobin (Hb) levels despite the subcutaneous administration of increasing doses of EPO; the patient required recurring blood transfusions. Workup and imaging tests were negative for the main causes of anemia in individuals with CKD on dialysis. Patient 2 with CKD secondary to adult polycystic kidney disease had been taking EPO for 2 years. The patient developed severe abrupt anemia the month he was started on HD, and required recurring transfusions to treat the symptoms of anemia. Workup and imaging findings were inconclusive. Specific laboratory tests confirmed the patients had anti-EPO antibodies. After six months of immunosuppressant therapy (corticosteroids + cyclosporine) the patients were stable with Hb > 9.0 g/dl. Conclusion: PRCA is a rare condition among patients on dialysis treated with rhEPO and should be considered as a possible cause of refractory anemia. Treating patients with PRCA may be challenging, since the specific management and diagnostic procedures needed in this condition are not always readily available.


RESUMO Introdução: Anemia é complicação frequente da Doença Renal Crônica (DRC) em pacientes dialíticos. Apresenta caráter multifatorial principalmente pela insuficiente produção de eritropoietina (EPO). Situação rara causadora de anemia na DRC é Aplasia Pura de Células Vermelhas (APCV), em decorrência da produção de anticorpos anti-EPO. Objetivo: Descrever 2 casos de APCV com formação de anticorpos anti-EPO, sua abordagem clínica, evolução e revisão de literatura. Métodos: Dois pacientes em hemodiálise que desenvolveram anemia grave, necessitando investigação e manejo específico. Resultados: Paciente nº 1: feminina, 75 anos, DRC secundária à hipertensão arterial. Após 7 meses com EPO desenvolveu queda persistente em valores de hemoglobina (Hb) mesmo com incremento em doses EPO SC, necessitando transfusões de sangue recorrentes. Extensa investigação laboratorial e de imagem resultou negativa para principais causas de anemia. Paciente nº 2: masculino, 66 anos, DRC secundária à DRPA, há 2 anos em uso de EPO. No mês de entrada em HD desenvolveu anemia severa, também exigindo transfusões recorrentes para tratamento da anemia sintomática. Extensa investigação laboratorial e por imagem, sem chegar a uma conclusão definitiva. Em ambos os casos a presença de anticorpos anti-EPO foi confirmada por exames laboratoriais específicos. Terapia imunossupressora resultou em estabilização do quadro e Hb > 9,0 g/dl em ambos os pacientes, 6 meses após início do tratamento. Conclusão: APCV é condição rara entre pacientes dialíticos que recebem EPOHuR e deve ser lembrada como causa de anemia refratária. Seu manejo específico e diagnóstico laboratorial nem sempre acessível, tornando desafiadora a condução dos casos para o nefrologista.


Subject(s)
Humans , Male , Female , Aged , Recombinant Proteins/therapeutic use , Erythropoietin/immunology , Erythropoietin/therapeutic use , Renal Dialysis/adverse effects , Red-Cell Aplasia, Pure/etiology , Antibodies, Neutralizing/blood , Kidney Failure, Chronic/drug therapy , Recombinant Proteins/adverse effects , Prednisone/administration & dosage , Prednisone/therapeutic use , Erythropoietin/biosynthesis , Erythropoietin/adverse effects , Kidney Transplantation , Treatment Outcome , Cyclosporine/administration & dosage , Cyclosporine/therapeutic use , Red-Cell Aplasia, Pure/drug therapy , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/therapeutic use , Anti-Inflammatory Agents/administration & dosage , Anti-Inflammatory Agents/therapeutic use
2.
Rev. Soc. Bras. Med. Trop ; 51(2): 146-154, Mar.-Apr. 2018. tab, graf
Article in English | LILACS | ID: biblio-897067

ABSTRACT

Abstract INTRODUCTION: Licensed for chronic hepatitis C treatment in 2011, the protease inhibitors (PIs) telaprevir (TVR) and boceprevir (BOC), which have high sustained viral responses (SVR), ushered a new era characterized by the development of direct-action drugs against the hepatitis C virus (HCV). The aim of this study was to analyze the effectiveness and safety of BOC and TVR administered with pegylated interferon and ribavirin and to share the experience of a Brazilian reference center. METHODS: A retrospective descriptive study was conducted in patients with HCV genotype 1 infection who started treatment between July 2013 and December 2015. Data were collected using a computerized system. RESULTS: A total of 115 subjects were included, of which 58 (50.4 %) had liver cirrhosis and 103 (89.6 %) used TVR. The overall SVR rate was 61.7 % (62.1 % for TVR and 58.3 % for BOC). The presence of cirrhosis was associated with a lower SVR rate, whereas patients who relapsed after prior therapy had a greater chance of showing SVR than did non-responders. The incidence of adverse drug reactions (ADRs) was high. Almost all patients (~100 %) presented with hematologic events. Furthermore, treatment had to be discontinued in 15 subjects (13 %) due to severe ADRs. CONCLUSIONS: In conclusion, the SVR rates in our study were lower than those reported in pre-marketing studies but were comparable to real-life data. ADRs, particularly hematological ADRs, were more common compared to those in previous studies and resulted in a high rate of treatment discontinuity.


Subject(s)
Humans , Male , Female , Adult , Aged , Antiviral Agents/administration & dosage , Protease Inhibitors/administration & dosage , Hepacivirus/genetics , Hepatitis C, Chronic/drug therapy , Oligopeptides/administration & dosage , Oligopeptides/adverse effects , Antiviral Agents/adverse effects , Polyethylene Glycols/administration & dosage , Polyethylene Glycols/adverse effects , Protease Inhibitors/adverse effects , Ribavirin/administration & dosage , Ribavirin/adverse effects , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Proline/administration & dosage , Proline/analogs & derivatives , Proline/adverse effects , Retrospective Studies , Treatment Outcome , Interferon-alpha/administration & dosage , Interferon-alpha/adverse effects , Hepacivirus/drug effects , Hepatitis C, Chronic/genetics , Hepatitis C, Chronic/virology , Drug Therapy, Combination , Drug-Related Side Effects and Adverse Reactions , Interferon alpha-2 , Genotype , Middle Aged
3.
Rev. Assoc. Med. Bras. (1992) ; 63(12): 1061-1064, Dec. 2017. tab
Article in English | LILACS | ID: biblio-896326

ABSTRACT

Summary Objective: The present study was designed to evaluate safety and efficacy of recombinant human granulocyte colony stimulating factor (G-CSF) injection and whether this regimen could reduce the incidence of adverse events caused by chemotherapy. Method: A total of 100 patients with colon cancer who were treated with chemotherapy in our hospital from January 2011 to December 2014 were randomly divided into two groups, with 50 patients in each group. The patients in the treatment group received G-CSF 24 hours after chemotherapy for consecutive three days; the patients in the control group received the same dose of normal saline. Routine blood tests were performed 7 days and 14 days after chemotherapy. Results: Compared with the control group, the incidences of febrile neutropenia and leukocytopenia in the treatment group were significantly lower (p<0.05). In addition, the incidence of liver dysfunction in the treatment group was lower than that of the control group, without statistical significance. The incidence of myalgia in the treatment was higher than that of the control group without statistical significance. Conclusion: The present study indicated that G-CSF injection after chemotherapy is safe and effective for preventing adverse events in colon cancer patients with chemotherapy.


Subject(s)
Humans , Male , Female , Adult , Aged , Granulocyte Colony-Stimulating Factor/administration & dosage , Granulocyte Colony-Stimulating Factor/adverse effects , Colonic Neoplasms/drug therapy , Chemotherapy-Induced Febrile Neutropenia/prevention & control , Antineoplastic Agents/therapeutic use , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Treatment Outcome , Injections , Middle Aged
4.
Arch. endocrinol. metab. (Online) ; 60(6): 596-600, Nov.-Dec. 2016. tab, graf
Article in English | LILACS | ID: biblio-827792

ABSTRACT

SUMMARY Prader-Willi syndrome (PWS) is a genetic disorder frequently characterized by obesity, growth hormone deficiency, genital abnormalities, and hypogonadotropic hypogonadism. Incomplete or delayed pubertal development as well as premature adrenarche are usually found in PWS, whereas central precocious puberty (CPP) is very rare. This study aimed to report the clinical and biochemical follow-up of a PWS boy with CPP and to discuss the management of pubertal growth. By the age of 6, he had obesity, short stature, and many clinical criteria of PWS diagnosis, which was confirmed by DNA methylation test. Therapy with recombinant human growth hormone (rhGH) replacement (0.15 IU/kg/day) was started. Later, he presented psychomotor agitation, aggressive behavior, and increased testicular volume. Laboratory analyses were consistent with the diagnosis of CPP (gonadorelin-stimulated LH peak 15.8 IU/L, testosterone 54.7 ng/dL). The patient was then treated with gonadotropin-releasing hormone analog (GnRHa). Hypothalamic dysfunctions have been implicated in hormonal disturbances related to pubertal development, but no morphologic abnormalities were detected in the present case. Additional methylation analysis (MS-MLPA) of the chromosome 15q11 locus confirmed PWS diagnosis. We presented the fifth case of CPP in a genetically-confirmed PWS male. Combined therapy with GnRHa and rhGH may be beneficial in this rare condition of precocious pubertal development in PWS.


Subject(s)
Humans , Male , Child , Prader-Willi Syndrome/drug therapy , Puberty, Precocious/drug therapy , Gonadotropin-Releasing Hormone/therapeutic use , Human Growth Hormone/therapeutic use , Prader-Willi Syndrome/diagnosis , Prader-Willi Syndrome/genetics , Puberty, Precocious/complications , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , DNA Methylation , Hormone Replacement Therapy/methods
5.
Arq. gastroenterol ; 53(1): 20-24, Jan.-Mar. 2016. tab, graf
Article in English | LILACS | ID: lil-777119

ABSTRACT

ABSTRACT Background The effectiveness of antiviral therapy with pegylated interferon and ribavirin for chronic hepatitis C is far from ideal and presents several adverse events. Among such events, there is the depressive episode that can even lead to treatment discontinuity Objective Analyze the incidence of depressive episodes in patients with chronic hepatitis C treated with pegylated interferon (IFN-PEG) and ribavirin, as well as the possible factors associated with its occurrence and its impact on patients' sustained virological response. Methods People with chronic hepatitis C undergoing antiviral therapy were interviewed at the baseline, at the 4th, 12th, 24th and 48th treatment weeks and 4 weeks after the end of it, using the HADS scale for tracking the depressive episode. Patients with HADS ≥9 were subjected to Beck Depression Inventory (BDI-II) to grade the episode. Clinical, sociodemographic, laboratorial and histological variables were obtained to identify factors related to the onset of depression. The sustained virological response rate (negative HCV-RNA 6 months after end of therapy) was compared among patients with and without depressive symptoms. Results The study comprised 32 patients, most men (59%) with mean age of 54±11.13 years old. Genotype non-1 was prevalent (56%) and 81% of the patients were non-cirrhotic. The depressive episode was diagnosed in 25% of the patients and the peak incidence was found in the 12th treatment week. The depressive episode was moderate in 87% of the patients and only one patient abandoned the treatment. None of the analyzed factors was associated with depressive episode onset. A trend was observed in female patients ( P=0.08). The sustained virological response rate was of 75% and 67% in patients with and without depressive episode, respectively (P =0.66). Conclusion The incidence of depressive episodes in patients with chronic hepatitis C undergoing antiviral therapy was of 25% and the 12th treatment week was the most critical one. The presence of depressive episode did not affect the sustained virological response rate.


RESUMO Contexto A terapia antiviral para a hepatite C crônica com interferon peguilado e ribavirina tem eficácia longe do ideal e é repleta de eventos adversos. Entre estes, destaca-se o transtorno depressivo que pode inclusive levar a interrupção do tratamento. Objetivos Em pacientes com hepatite C crônica tratados com interferon peguilado (IFN-PEG) e ribavirina, verificar a incidência de episódio depressivo, os possíveis fatores associados ao seu surgimento e o impacto deste sobre a resposta virológica sustentada. Métodos Portadores de hepatite C crônica submetidos à terapia antiviral foram entrevistados no Baseline, nas semanas 4, 12, 24, 48 de tratamento e quatro semanas após o término do mesmo utilizando a escala HADS para rastreamento do episódio depressivo e naqueles com HADS ≥9 o Inventário de Depressão de Beck (BDI-II) para graduação do episódio. Variáveis clínicas, sociodemográficas, laboratoriais e histológicas foram obtidas com o objetivo de identificar os fatores relacionados ao surgimento da depressão. A taxa de resposta virológica sustentada (HCV-RNA negativo seis meses após a interrupção da terapia) foi comparada entre os pacientes com e sem sintomas depressivos. Resultados Foram incluídos 32 pacientes, a maioria do sexo masculino (59%) e com média de idade de 54±11,13 anos. Prevaleceu o genótipo não 1 (56%) e 81% dos pacientes foram não cirróticos. Episódio depressivo foi diagnosticado em 25% dos pacientes sendo o pico de incidência observado na semana 12 de tratamento. O episódio depressivo foi moderado em 87% dos pacientes e motivou a interrupção em somente 1 deles. Nenhum dos fatores analisados foi associado ao surgimento de episódio depressivo observando-se uma tendência com relação ao sexo feminino ( P =0,08). A taxa de resposta virológica sustentada foi 75% e 67% nos pacientes com e sem episódio depressivo, respectivamente ( P =0,66). Conclusão A incidência de episódio depressivo em pacientes com hepatite C crônica submetidos à terapia antiviral foi de 25% e a semana 12 é a mais crítica. A presença de episódio depressivo não interferiu na taxa de resposta virológica sustentada.


Subject(s)
Humans , Male , Female , Antiviral Agents/adverse effects , Polyethylene Glycols/adverse effects , Ribavirin/adverse effects , Interferon-alpha/adverse effects , Hepatitis C, Chronic/drug therapy , Depression/chemically induced , Antiviral Agents/therapeutic use , Polyethylene Glycols/therapeutic use , Ribavirin/therapeutic use , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Prospective Studies , Cohort Studies , Interferon-alpha/therapeutic use , Hepatitis C, Chronic/psychology , Depression/psychology , Drug Therapy, Combination , Sociological Factors , Interferon alpha-2 , Middle Aged
6.
Clinical and Molecular Hepatology ; : 168-171, 2016.
Article in English | WPRIM | ID: wpr-46327

ABSTRACT

Chronic hepatitis C virus (HCV) infection is a major cause of liver cirrhosis and hepatocellular carcinoma. Combination therapy of pegylated interferon-alpha (PEG-IFN-α) and ribavirin (RBV) is a current standard treatment for chronic HCV infection in Korea, which has considerable adverse effects. Acute pancreatitis is a rare complication of PEG-IFN-α administration. We report a case of a 62-year-old female who experienced acute pancreatitis after 4 weeks of PEG-IFN-α-2a and RBV combination therapy for chronic HCV infection. The main cause of the acute pancreatitis in this case was probably PEG-IFN-α rather than RBV for several reasons. A few cases have been reported in which acute pancreatitis occurred during treatment with PEG-IFN-α-2b. This is the first report of acute pancreatitis associated with PEG-IFN-α-2a in Korea.


Subject(s)
Female , Humans , Middle Aged , Amylases/analysis , Antiviral Agents/adverse effects , Drug Therapy, Combination , Hepatitis C, Chronic/diagnostic imaging , Interferon-alpha/adverse effects , Lipase/analysis , Pancreatitis/etiology , Polyethylene Glycols/adverse effects , Recombinant Proteins/adverse effects , Republic of Korea , Ribavirin/therapeutic use , Tomography, X-Ray Computed
7.
J. appl. oral sci ; 23(2): 215-223, Mar-Apr/2015. graf
Article in English | LILACS, BBO | ID: lil-746543

ABSTRACT

Injectable bone substitutes and techniques have been developed for use in minimally invasive procedures for bone augmentation. Objective : To develop a novel injectable thermo-sensitive alginate hydrogel (TSAH) as a scaffold to induce bone regeneration, using a minimally invasive tunnelling technique. Material and Methods : An injectable TSAH was prepared from a copolymer solution of 8.0 wt% Poly(N-isopropylacrylamide) (PNIPAAm) and 8.0 wt% AAlg-g-PNIPAAm. In vitro properties of the material, such as its microstructure and the sustained release of recombinant human bone morphogenetic protein-2 (rhBMP-2), were investigated. Then, with the subperiosteal tunnelling technique, this material, carrying rhBMP-2, was injected under the labial periosteum of the maxillary anterior alveolar ridge in a rabbit model. New bone formation was evaluated by means of X-ray, micro-computed tomography (micro-CT), fluorescence labelling, histological study, and immunohistochemistry study. Results : The material exhibited good injectability and thermo-irreversible properties. SEM showed an interconnected porous microstructure of the TSAH. The result of ALP activity indicated sustained delivery of BMP-2 from the TSAH from days 3 to 15. In a rabbit model, both TSAH and TSAH/rhBMP-2 induced alveolar ridge augmentation. The percentage of mineralised tissue in the TSAH/rhBMP-2 group (41.6±3.79%) was significantly higher than in the TSAH group (31.3±7.21%; p<0.05). The density of the regenerating tissue was higher in the TSAH/rhBMP-2 group than in the other groups (TSAH group, positive control, blank control; p<0.05). Conclusions : The TSAH provided convenient handling properties for clinical application. To some extent, TSAH could induce ridge augmentation and mineral deposition, which can be enhanced when combined with rhBMP-2 for a minimally invasive tunnelling injection. .


Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Young Adult , Brain Injuries/drug therapy , Brain/drug effects , Interleukin 1 Receptor Antagonist Protein/therapeutic use , Receptors, Interleukin-1/antagonists & inhibitors , Brain Injuries/immunology , Brain Injuries/pathology , Brain/immunology , Brain/pathology , Cytokines/analysis , Cytokines/immunology , Interleukin 1 Receptor Antagonist Protein/administration & dosage , Interleukin 1 Receptor Antagonist Protein/adverse effects , Receptors, Interleukin-1/immunology , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use
8.
Braz. j. infect. dis ; 19(1): 15-22, Jan-Feb/2015. tab
Article in English | LILACS | ID: lil-741237

ABSTRACT

Introduction: in Brazil, chronic hepatitis C in patients coinfected with the human immunodeficiency virus (HIV) is treated with pegylated interferon (Peg-IFN) and ribavirin (RBV). However, few studies have evaluated the effectiveness of this treatment in this particular population. The identification of the factors that predict sustained virological response (SVR) under current clinical practice would enable clinicians to more accurately estimate the probability of achieving an SVR and therefore utilize the appropriate therapeutics, especially in the era of direct-acting antiviral (DAA) agents. Aims: the primary aim of our study was to determine the SVR rate under current clinical practice. The secondary aims were as follows: (1) to determine the factors before and during treatment that predict SVR; and (2) to identify the causes of treatment interruption. Methods: within a cohort of HIV/hepatitis C virus (HCV)-coinfected patients in Brazil, we performed a retrospective analysis of those individuals treated with Peg-IFN and RBV. Results: among the 382 analyzed patients, SVR was observed in 118 [30.9% (95% confidence interval (CI): 26.3-35.8)], which included 25.9% (75/289) of the patients with genotypes 1 and 4 and 48.2% (41/85) of those with genotypes 2 and 3. After multivariate analyses the independent positive predictors for SVR after treatment for chronic hepatitis C with PegIFN and RBV were: absence of an AIDS-defining illness (p = 0.001), HCV viral load lower than 600,000 IU/mL at the onset of treatment (p = 0.003), higher liver enzyme levels (p = 0.039) at baseline, infection with genotypes 2 or 3 (p = 0.003), and no transient treatment interruption (p = 0.001). The treatment was interrupted in 25.6% (98/382) of the patients because of adverse events (11.3%, 43/382), virologic failure (7.8%, 30/382), and dropout (6.5%, 43/382). The main adverse events were cytopenia and psychiatric disorders. Conclusions: ...


Subject(s)
Adult , Female , Humans , Male , Middle Aged , Antiviral Agents/administration & dosage , Hepatitis C, Chronic/drug therapy , Interferon-alpha/administration & dosage , Polyethylene Glycols/administration & dosage , Ribavirin/administration & dosage , Antiviral Agents/adverse effects , Cohort Studies , Drug Therapy, Combination , Genotype , Hepacivirus/genetics , Hepatitis C, Chronic/virology , Interferon-alpha/adverse effects , Polyethylene Glycols/adverse effects , Retrospective Studies , RNA, Viral , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Ribavirin/adverse effects , Treatment Outcome , Viral Load
9.
Yonsei Medical Journal ; : 935-943, 2015.
Article in English | WPRIM | ID: wpr-40871

ABSTRACT

PURPOSE: Beroctocog alfa is a second generation recombinant factor VIII manufactured by removing the B-domain from factor VIII. This prospective clinical trial was conducted to evaluate the efficacy, safety, and pharmacokinetics of beroctocog alfa in patients of ages > or =12 years previously treated for severe hemophilia A. MATERIALS AND METHODS: Seventy subjects received beroctocog alfa as an on-demand treatment for acute hemorrhage. RESULTS: The final hemostatic effect was excellent in 35 subjects (50%) and good in 26 subjects (37.1%). The drug showed an overall efficacy rate of 87.1%. The majority of acute hemorrhages was treated by administering the study drug once (86.2%) or twice (10.0%), and the mean dose administered per single infusion was 28.55+/-6.53 IU/kg. Ten subjects underwent 12 surgical procedures, and hemostatic efficacy was excellent in seven cases (58.3%) and good in five cases (41.7%), showing a 100% efficacy rate. A total of 52 of 88 subjects (59.0%) experienced 168 adverse events. There were 18 serious adverse events (10.7%) in 11 subjects, and two (mild dyspnea and facial edema) in one subject were related to the study drug. Only one subject formed a de novo factor VIII inhibitor, for an occurrence rate of 1.4% (one-sided 95% upper confidence limit: 3.85%). The final elimination half-life was 13.3 h and 12.6 h at baseline and 6 months after administration, respectively. CONCLUSION: Our results suggest that beroctocog alfa is safe and efficacious as either an on-demand treatment for acute hemorrhage or a surgical prophylaxis in patients with hemophilia A.


Subject(s)
Adult , Female , Humans , Male , Middle Aged , Consumer Product Safety , Dyspnea , Factor VIII/adverse effects , Hemophilia A/drug therapy , Hemorrhage/prevention & control , Hemostasis , Hemostasis, Surgical/methods , Prospective Studies , Recombinant Proteins/adverse effects , Treatment Outcome
10.
Clinical and Molecular Hepatology ; : 125-130, 2015.
Article in English | WPRIM | ID: wpr-128620

ABSTRACT

BACKGROUND/AIMS: Chronic hepatitis C (CHC) is a major comorbidity in patients with hemophilia. However, there are no published data on the efficacy of antiviral therapy in Korea. We assessed the safety and efficacy of combination therapy with peginterferon alpha-2a plus ribavirin for CHC in hemophilia. METHODS: Patients (n=115) were enrolled between March 2007 and December 2008. Seventy-seven patients were genotype 1 or 6, and 38 patients were genotype 2 or 3. We evaluated rapid virologic responses (RVRs), early virologic response (EVRs), end-of-treatment response (ETRs), sustained virologic response (SVRs), and relapses. Safety evaluations included adverse events and laboratory tests. RESULTS: Eleven patients were excluded from the study because they had been treated previously. Among the remaining 104 treatment-naive patients, RVR was achieved in 64 (60.6%), ETR was achieved in 95 (91.3%), and SVR was achieved in 89 (85.6%). Relapse occurred in eight patients (8.9%). Common adverse events were hair loss (56.7%) and headache (51.0%). Common hematologic adverse events were neutropenia (22.1%), anemia (27.9%), and thrombocytopenia (3.8%). However, there were no serious adverse events such as bleeding. RVR was the only predictor of SVR in multivariate analysis. CONCLUSIONS: Peginterferon alpha-2a plus ribavirin combination treatment produced a favorable response rate in CHC patients with hemophilia without serious adverse events.


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Antiviral Agents/adverse effects , Drug Therapy, Combination , Fatigue/etiology , Genotype , Headache/etiology , Hemophilia A/complications , Hepacivirus/genetics , Hepatitis C, Chronic/complications , Interferon-alpha/adverse effects , Liver/pathology , Neutropenia/etiology , Polyethylene Glycols/adverse effects , RNA, Viral/blood , Recombinant Proteins/adverse effects , Recurrence , Republic of Korea , Ribavirin/adverse effects , Treatment Outcome
11.
Journal of Korean Medical Science ; : 378-384, 2015.
Article in English | WPRIM | ID: wpr-224776

ABSTRACT

Gaucher disease is a lysosomal storage disease for which enzyme replacement therapy has proven to be effective. A switch-over clinical trial was performed to evaluate the efficacy and safety of Abcertin(R) (ISU Abxis, Seoul, Korea) in subjects with type 1 Gaucher disease who were previously treated with imiglucerase. Five Korean patients with type 1 Gaucher disease were enrolled. Previous doses of imiglucerase ranged from 30 to 55 U/kg every other week. The same dose of Abcertin(R) was administered to all patients for 24 weeks. Primary efficacy endpoints were changes in hemoglobin levels and platelet counts, and the secondary efficacy endpoints included changes in liver and spleen volumes, serum biomarkers, skeletal status and bone mineral density (BMD). During the study period, no statistically significant changes were observed in all parameters including hemoglobin levels and platelet counts, liver and spleen volumes, skeletal status and BMD. Abcertin(R) administration was continued in three patients for another 24 weeks as an extension of the study. Hemoglobin levels and platelet counts were maintained in all three patients. In conclusion, the efficacy and safety of Abcertin(R) are similar to those of imiglucerase, and Abcertin(R) is an effective therapeutic agent for patients with type 1 Gaucher disease (Clinical Trial Registry No. NCT02053896 at www.clinicaltrials.gov).


Subject(s)
Adolescent , Adult , Child , Female , Humans , Male , Biosimilar Pharmaceuticals/adverse effects , Enzyme Replacement Therapy/adverse effects , Gaucher Disease/blood , Glucosylceramidase/adverse effects , Recombinant Proteins/adverse effects
12.
The Korean Journal of Internal Medicine ; : 792-800, 2015.
Article in English | WPRIM | ID: wpr-195240

ABSTRACT

BACKGROUND/AIMS: Thyroid dysfunction (TD) is more likely to occur in patients with chronic hepatitis C (CHC) and is particularly associated with interferon (IFN) treatment. The purpose of this study was to investigate the incidence, outcomes, and risk factors for TD during pegylated interferon (PEG-IFN) and ribavirin (RBV) combined therapy in patients with CHC. METHODS: A total of 242 euthyroid patients with CHC treated with PEG-IFN/RBV were included. Thyroid function and autoantibodies were measured at baseline, and virologic response and thyroid function were assessed every 3 months during therapy. RESULTS: TD developed in 67 patients (27.7%) during the PEG-IFN/RBV treatment. The types of TD were subclinical hypothyroidism (50.7%), hypothyroidism (14.9%), thyroiditis (11.9%), subclinical hyperthyroidism (10.4%), and hyperthyroidism (10.4%). Most of the patients with TD recovered spontaneously; however, seven patients (10.4%) needed thyroid treatment. The sustained virological response rate was higher in patients with TD than those without (65.7% vs. 49.1%, p = 0.02). Baseline thyroid stimulating hormone (TSH) concentrations (odds ratio [OR], 2.09; 95% confidence interval [CI], 1.96 to 8.77; p < 0.001), presence of the thyroid peroxidase antibody (OR, 8.81; 95% CI, 1.74 to 44.6; p = 0.009), and PEG-IFNalpha-2b (OR, 3.01; 95% CI, 1.43 to 6.39; p = 0.004) were independent risk factors for the development of TD. CONCLUSIONS: TD developed in 27.7% of patients with CHC during PEG-IFN/RBV treatment, and 10.4% of these patients needed thyroid treatment. TD is associated with a favorable virologic response to PEG-IFN/RBV. Assessment of TSH and thyroid autoantibodies at baseline and close monitoring of thyroid function during PEG-IFN/RBV therapy are necessary for early detection and management of IFN-induced TD.


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Antiviral Agents/adverse effects , Autoantibodies/blood , Biomarkers/blood , Drug Therapy, Combination , Hepatitis C, Chronic/diagnosis , Incidence , Interferon-alpha/adverse effects , Polyethylene Glycols/adverse effects , Recombinant Proteins/adverse effects , Republic of Korea , Retrospective Studies , Ribavirin/adverse effects , Thyroid Diseases/chemically induced , Thyroid Gland/drug effects , Time Factors , Treatment Outcome
13.
Clinics ; 69(8): 547-553, 8/2014. tab, graf
Article in English | LILACS | ID: lil-718187

ABSTRACT

OBJECTIVES: Anemia is a common complication among chronic kidney disease patients on hemodialysis, occurring mostly due to erythropoietin deficiency. This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos, a biologics manufacturer affiliated with the Brazilian government, with those of a commercially available product currently used in Brazil (a biosimilar epoetin formulation). METHODS: The sample size needed to enable demonstration of noninferiority with a statistical power of 85% for a between-group difference in hemoglobin levels of no more than 1.5 g/dL was calculated. In total, 74 patients were randomly assigned to receive the epoetin formulation from Bio-Manguinhos (n = 36) or the biosimilar epoetin formulation (n = 38) in a double-blind fashion. The inclusion criteria were current epoetin therapy and stable hemoglobin levels for at least 3 months prior to the study. The primary and secondary outcomes were mean monthly hemoglobin levels and safety, respectively. The dose was calculated according to international criteria and adjusted monthly in both groups according to hemoglobin levels and at the assistant physicians' discretion. Iron storage was estimated at baseline and once monthly. Clinicaltrials.gov: NCT01184495. RESULTS: The study was conducted for 6 months after randomization. The mean baseline hemoglobin levels were 10.9±1.2 and 10.96±1.2 g/dL (p = 0.89) in the Bio-Manguinhos epoetin and biosimilar epoetin groups, respectively. During the study period, there was no significant change in hemoglobin levels in either group (p = 0.055, ANOVA). The epoetin from Bio-Manguinhos was slightly superior in the last 3 months of follow-up. The adverse event profiles of the two formulations were also similar. CONCLUSIONS: The epoetin formulations tested in this study are equivalent in efficacy ...


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Anemia/drug therapy , Biosimilar Pharmaceuticals/therapeutic use , Erythropoietin/therapeutic use , Anemia/complications , Brazil , Biosimilar Pharmaceuticals/administration & dosage , Biosimilar Pharmaceuticals/adverse effects , Double-Blind Method , Erythropoietin/administration & dosage , Erythropoietin/adverse effects , Follow-Up Studies , Hemoglobins/analysis , Iron/blood , Iron/therapeutic use , Renal Dialysis , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Renal Insufficiency, Chronic/complications , Treatment Outcome
14.
Arq. bras. oftalmol ; 77(3): 178-181, May-Jun/2014. tab, graf
Article in English | LILACS | ID: lil-723838

ABSTRACT

Purpose: To identify the effect of pegylated interferon α-2b and ribavirin treatment in the ocular fundus examination, visual acuity, and visual field. Methods: Prospective observational study was performed at the Hepatology Clinic of São José Regional Hospital and at the Vitreoretinal Department at the Sadalla Amin Ghanem Eye Hospital in patients with chronic hepatitis C before and during treatment with pegylated interferon α-2b together with ribavirin. Results: Six (37.5%) of 16 patients developed retinopathy during the treatment, two of which (12.5%) presented retinal hemorrhage, and four patients (6 eyes) presented cotton-wool spots (25%) that regressed during the treatment. One patient (6.25%) presented transient decrease in visual acuity during the treatment and recovered spontaneously without specific therapy. Conclusion: Recommended treatment methods for hepatitis C may cause transient retinopathy, commonly without any damage to visual function in most patients. Although ocular involvement is rare, follow-up with an ophthalmologist is recommended during the course of the hepatitis C medication. .


Objetivo: Identificar possíveis mudanças no exame de fundo de olho após o início do tratamento, bem como alterações na acuidade visual e campo visual. Métodos: Estudo observacional prospectivo realizado na Clínica de Hepatologia do Hospital Regional de São José e no Departamento de Vítreo e Retina do Hospital de Olhos Sadalla Amin Ghanem, em pacientes com hepatite C crônica antes e durante o tratamento com interferon peguilado α-2b associado à ribavirina. Resultados: Six (37,5%) dos 16 participantes desenvolveram retinopatia durante o tratamento, dois dos quais (12,5%) apresentaram hemorragia retiniana unilateral, e quatro pacientes com exsudatos algodonosos (25%), seis olhos, que regrediu durante o tratamento. Um participante (6,25%) apresentou diminuição transitória da acuidade visual durante o tratamento com recuperação espontaneamente sem tratamento específico. Conclusão: O tratamento recomendado para a hepatite C pode estar associado com o desenvolvimento de retinopatia transitória, geralmente sem dano à função visual na maioria dos pacientes. Embora o envolvimento ocular seja raro, o acompanhamento com o médico oftalmologista é recomendado durante todo o uso da medicação. .


Subject(s)
Adult , Female , Humans , Male , Middle Aged , Young Adult , Antiviral Agents/adverse effects , Fundus Oculi , Hepatitis C, Chronic/drug therapy , Interferon-alpha/adverse effects , Polyethylene Glycols/adverse effects , Retinal Diseases/chemically induced , Ribavirin/adverse effects , Fluorescein Angiography , Prospective Studies , Risk Factors , Recombinant Proteins/adverse effects , Time Factors , Treatment Outcome , Visual Acuity/drug effects , Visual Fields/drug effects
15.
Rev. Assoc. Med. Bras. (1992) ; 60(1): 35-39, Jan-Feb/2014. tab
Article in English | LILACS | ID: lil-710314

ABSTRACT

Objective To assess the incidence rate and severity of depressive symptoms in different time points (12, 24 and 48 weeks) in Brazilian patients with HCV treated with PEG IFN plus ribavirin. Methods We conducted an observational prospective study using the Beck Depression Inventory (BDI) and the Center for Epidemiologic Studies Depression Scale (CES-D). Results Fifty patients were included. The assessments with either scale showed the highest score of depressive symptoms in the 24th week of treatment; the mean BDI score before treatment was 6.5 ± 5.3 and the mean CES-D was 10.9 ± 7.8. After 24 weeks, the mean BDI was 16.1 ± 10.2 and mean CES-D was 18.6 ± 13.0; 46% were diagnosed with depression according to combined BDI and CES-D scores. The somatic/psychomotor subscales were highly correlated with overall scale scores . Subjects with history of substance and alcohol abuse had higher risk for IFN-induced depression. Conclusion Treatment with PEG IFN was associated with a high incidence rate of depressive symptoms in this sample of Brazilian patients, as measured by CES-D and BDI. Alcohol and substance abuse increase the risk of PEG IFN-induced depression. .


Objetivo Avaliar a incidência e a gravidade de sintomas depressivos em diferentes intervalos (12, 24 e 48 semanas) em pacientes brasileiros com HCV tratados com PEG IFN mais ribavirina. Métodos Foi feito um estudo prospectivo observacional, usando o Inventário de Depressão de Beck (BDI) e a Escala de Rastreamento Populacional de Depressão (CES-D). Resultados Foram incluídos 50 pacientes. As avaliações com ambas as escalas mostraram os maiores escores de depressão na 24a semana de tratamento; o escore BDI médio antes do tratamento foi de 6,5 ± 5,3 e o CES-D foi 10,9 ± 7,8. Após 24 semanas, o BDI médio foi 16,1± 10,2 e o CES-D foi 18,6 ± 13,0; de acordo com os escores combinados BDI e CES-D, 46% receberam diagnóstico de depressão. As subescalas somática e psicomotora tiveram alta correlação. Indivíduos com história de abuso de substâncias e de álcool apresentaram maior risco de desenvolver depressão por PEG IFN. Conclusão O tratamento com PEG IFN associou-se a uma alta incidência de sintomas depressivos nessa população de pacientes brasileiros, de acordo com a BDI e CES-D. Abuso de álcool e substâncias aumentam o risco de depressão induzida por PEG IFN. .


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Antiviral Agents/adverse effects , Depression/chemically induced , Hepatitis C/drug therapy , Interferon-alpha/adverse effects , Polyethylene Glycols/adverse effects , Ribavirin/adverse effects , Alcohol-Related Disorders/complications , Brazil/epidemiology , Drug Therapy, Combination , Depression/epidemiology , Incidence , Prospective Studies , Psychometrics , Recombinant Proteins/adverse effects , Substance-Related Disorders/complications , Time Factors
16.
Braz. j. infect. dis ; 18(1): 48-52, Jan-Feb/2014. tab
Article in English | LILACS | ID: lil-703055

ABSTRACT

Background: Tolerance and response to antiviral HCV treatment is poor in advanced fibrosis. The aim of this study was to assess SVR rate and its predictive factors in HCV advanced fibrosis patients treated in real life with full dose PEG-IFN plus RBV and to evaluate the adverse events related to treatment. Methods: A multicentric, retrospective study was conducted at six university hospitals. METAVIR F3 and F4 HCV monoinfected patients who were treated with PEG-IFN and RBV had their data analyzed. A stepwise logistic regression analysis was performed to identify the variables independently related to SVR. Adverse events were recorded during treatment. Results: 308 patients were included, 75% genotype 1 and 23% genotype 3. METAVIR F3 was present in 39% and F4 in 61% of patients. The median Child Pugh score for F4 patients was 5 (5–9). The global SVR rate was 34%, 11% were relapsers and 55% were nonresponders. SVR rates were similar between patients treated with PEG-IFN alfa 2a or alfa 2b (p = 0.24). SVR rates according to Child–Pugh score were 26% (Child A) and 18% (Child B). The independent factors related to SVR in F4 patients were genotype 3, RVR and fewer Child Pugh score points. Treatment interruption occurred in 31% patients and death occurred in 1.9%, all with liver cirrhosis. Conclusion: Treatment of HCV in patients with advanced fibrosis should not be postponed. However, a very careful evaluation of cirrhotic patients must be performed before treatment is indicated and careful monitoring is required during treatment. .


Subject(s)
Female , Humans , Male , Middle Aged , Antiviral Agents/administration & dosage , Hepatitis C, Chronic/drug therapy , Interferon-alpha/administration & dosage , Liver Cirrhosis/etiology , Polyethylene Glycols/administration & dosage , Ribavirin/administration & dosage , Antiviral Agents/adverse effects , Drug Therapy, Combination/methods , Genotype , Hepacivirus/genetics , Hepatitis C, Chronic/complications , Hepatitis C, Chronic/virology , Interferon-alpha/adverse effects , Predictive Value of Tests , Polyethylene Glycols/adverse effects , Retrospective Studies , RNA, Viral/genetics , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Ribavirin/adverse effects , Severity of Illness Index , Viral Load
17.
The Korean Journal of Internal Medicine ; : 370-374, 2014.
Article in English | WPRIM | ID: wpr-62912

ABSTRACT

Various adverse events have been reported during combination therapy with pegylated (PEG)-interferon-alpha and ribavirin, although opportunistic infections, especially cryptococcal meningitis, are very rare. A 61-year-old woman complained of headaches and a fever during treatment of a chronic hepatitis C virus (HCV) infection. She had been treated for 7 months. Her headaches were refractory to analgesics, and she developed subtle nuchal rigidity. The cerebral spinal fluid (CSF) revealed a white blood cell count of 205/mm3, 51 mg/dL protein, 35 mg/dL glucose, and negative Cryptococcus antigen. The CSF culture resulted in no growth. Five days later, the CSF was positive for Cryptococcus antigen. We administered amphotericin B and flucytosine, followed by fluconazole. Approximately 2 months later, she was discharged. For the first time, we report a case of cryptococcal meningitis during the treatment of chronic HCV with PEG-interferon-alpha and ribavirin.


Subject(s)
Female , Humans , Middle Aged , Antifungal Agents/therapeutic use , Antiviral Agents/adverse effects , Cryptococcus neoformans/immunology , Drug Therapy, Combination , Hepatitis C, Chronic/diagnosis , Immunocompromised Host , Interferon-alpha/adverse effects , Meningitis, Cryptococcal/drug therapy , Opportunistic Infections/diagnosis , Polyethylene Glycols/adverse effects , Recombinant Proteins/adverse effects , Ribavirin/adverse effects , Time Factors , Treatment Outcome
19.
Rev. Soc. Bras. Med. Trop ; 45(5): 655-656, Sept.-Oct. 2012. ilus
Article in English | LILACS | ID: lil-656224

ABSTRACT

The treatment of chronic hepatitis C has frequent side effects such as cytopenias and neuropsychiatric symptoms. However, pulmonary toxicity associated with interferon is rarely described. This paper describes the clinical case of a 67-year-old female patient with chronic hepatitis C who presented an acute onset of dry cough, dyspnoea, and fever 36 weeks after the use of pegylated interferon alfa-2a and ribavirin. The lung biopsy confirmed the diagnosis of a bronchiolitis obliterans organizing pneumonia (BOOP). Corticotherapy was initiated, with clinical and radiological improvement. This paper aims to advise physicians to this occasional, though severe, adverse event related to hepatitis C virus (HCV) treatment.


O tratamento da hepatite C crônica apresenta efeitos colaterais frequentes como citopenias e sintomas neuropsiquiátricos. Contudo, a toxicidade pulmonar associada ao interferon é raramente descrita. Relatamos o caso de uma paciente com 67 anos que apresentou início agudo de tosse, dispnéia e febre após 36 semanas de uso do interferon peguilado alfa-2a e ribavirina. A biópsia pulmonar confirmou o diagnóstico de bronquiolite obliterante com pneumonia em organização, com significativa melhora clínico-radiológica após instituída a corticoterapia. Este relato de caso visa alertar os médicos para a possibilidade desse ocasional, embora grave, evento adverso associado ao tratamento da hepatite C.


Subject(s)
Aged , Female , Humans , Antiviral Agents/adverse effects , Cryptogenic Organizing Pneumonia/chemically induced , Hepatitis C, Chronic/drug therapy , Interferon-alpha/adverse effects , Polyethylene Glycols/adverse effects , Cryptogenic Organizing Pneumonia/pathology , Lung/pathology , Recombinant Proteins/adverse effects
20.
Braz. j. infect. dis ; 16(5): 448-451, Sept.-Oct. 2012. tab
Article in English | LILACS | ID: lil-653433

ABSTRACT

Interferon-α based therapy for chronic hepatitis C (CHC) is associated with thyroiditis and thyroid dysfunction (TD). This study investigated whether TD during pegylated interferon-a (PEG-IFN) plus ribavirin treatment favors sustained viral response (SVR), and also the association between TD and PEG-IFN formulations. This retrospective study was performed in CHC patients who had received PEG-IFN plus ribavirin and had been followed for six months after treatment. Several factors were compared between patients with and without TD. 119 patients were included in the study. De novo incidence of TD was found to be 16.8%, and 16 of the 18 patients with TD achieved SVR. Although this rate was higher than patients without TD according to univariate analysis, logistic regression analysis revealed that there was not a significant association between TD and SVR, whereas baseline thyroperoxidase antibody (anti-TPO) positivity was the only significant predictor of TD. Moreover, TD was not associated with PEG-IFN type. Both interferon-a and hepatitis C virus (HCV) contribute to TD during antiviral therapy. It seems that there is no association between thyroid toxicity and viral clearance or type of PEG-IFN; however, anti-TPO positivity before treatment is the strongest predictor for TD during antiviral therapy.


Subject(s)
Female , Humans , Male , Middle Aged , Antiviral Agents/adverse effects , Hepatitis C, Chronic/drug therapy , Interferon-alpha/adverse effects , Polyethylene Glycols/adverse effects , Ribavirin/adverse effects , Thyroid Diseases/chemically induced , Thyroid Gland/physiopathology , Drug Therapy, Combination/adverse effects , Drug Therapy, Combination/methods , Retrospective Studies , Recombinant Proteins/adverse effects , Thyroid Diseases/physiopathology , Viral Load
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