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ObjectiveTo investigate the efficacy and safety of sofosbuvir/velpatasvir alone or in combination with ribavirin in Chinese patients with genotype 3B HCV/HIV infection. MethodsA total of 299 patients with genotype 3B HCV/HIV infection who attended The Third People’s Hospital of Kunming from January 2017 to December 2020 were enrolled and treated with sofosbuvir/velpatasvir alone or in combination with ribavirin for 12 weeks， and they were followed up for 12 weeks after drug withdrawal. The patients were evaluated in terms of sustained virologic response at 12 weeks after treatment （SVR12） and adverse reactions. The independent-samples t test or the Mann-Whitney U test was 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 Agresti-Coull method was used to evaluate the 95% confidence interval （CI） of SVR12； univariate and multivariate non-conditional logistic regression analyses were used to investigate the influencing factors for SVR. ResultsThe 299 patients with genotype 3B HCV/HIV infection had a mean age of 43.92±6.84 years， among whom the male patients accounted for 77.3% （231/299）， the patients with liver cirrhosis accounted for 36.5% （109/299）， the patients with a history of antiviral therapy accounted for 13.4% （40/299）， and the patients receiving sofosbuvir/velpatasvir combined with ribavirin accounted for 27.8% （83/299）. The overall SVR was 87.0% （260/299） for all patients， and there was no significant difference in SVR12 between the patients receiving sofosbuvir/velpatasvir alone and those receiving sofosbuvir/velpatasvir combined with ribavirin （87.5% vs 85.5%， χ2=0.203， P=0.653）. There was a significant difference in SVR12 between the patients without liver cirrhosis and those with liver cirrhosis （90.0% vs 81.7%， χ2=4.256， P=0.039）， and the patients receiving antiviral therapy for the first time had a significantly higher SVR12 than the treatment-experienced patients （93.4% vs 45.0%， χ2=71.670， P<0.001）. The univariate and multivariate logistic regression analyses showed that platelet count （odds ratio ［OR］=0.957， 95%CI： 0.931 — 0.984， P=0.002）， liver stiffness measurement （OR=1.446， 95%CI： 1.147 — 1.822， P=0.002）， and experience in treatment （OR=13.807， 95%CI： 2.970 — 64.174， P=0.001） were independent influencing factors for SVR in patients with genotype 3B HCV/HIV infection. There were 41 cases of serious adverse events， all of which occurred within 2 weeks after antiviral therapy， and 28 cases were resolved without drug withdrawal or active treatment， while 13 cases were not resolved after active treatment and were resolved after the antiviral drugs were stopped for 2 — 5 days， with no similar reactions observed when the drugs were used again after remission. ConclusionSofosbuvir/velpatasvir alone or in combination with ribavirin has relatively good efficacy and safety in patients with genotype 3B HCV/HIV infection.
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Introduction: With the advent of direct-acting antivirals (DAAs), the past decade has seen a paradigm shift in the management of hepatitis C (HCV) infection in children. In this review, we summarize the various treatment options for pediatric HCV infection, highlighting the recent changes in the management. Methods: A literature search was performed using the PubMed database with the relevant keywords. Filters included were human, ages 0-18 years, and the English language. Results: Initial phase of HCV treatment using conventional or pegylated interferon and ribavirin combination regimens yielded poor outcomes in children, especially in genotypes 1 and 4, with an overall sustained virologic response of 58%. Also, treatment with interferon and ribavirin combination was associated with significant side effects in up to 52% of those treated. Presently, various combinations of direct-acting antivirals (DAAs) have been approved in children above three years of age with documented evidence of high efficacy (SVR12 of 92% to 100%) and excellent safety, and the current standard of care. Conclusion: With various DAA regimens now being approved for children above three years of age, the treatment of active HCV infection (HCV-RNA positive) in children has become simple. Besides the effectiveness of DAA therapy, public awareness about HCV transmission, better screening, and making the DAAs available at a subsidized price in the public sectors are necessary to eliminate HCV infection in India.
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@#Immune responses are largely regulated by cytokines. Genetic polymorphisms of the regulatory coding regions are recognized to impact the expression of cytokines. The abnormal cytokine levels in hepatitis C virus (HCV) infection seems to be involved in disease progression, viral survival, and therapeutic response. The current study assesses the polymorphisms associated with IL-6, IL-10, IL28B, IFN-γ, TGF-β, and TNF-α on the genotypic susceptibility to HCV infection and Ribavirin response to Peg interferon. Droplet digital polymerase chain reaction (PCR) was used to assess the gene polymorphisms associated with IL-6 A/G (rs2069837), IL-10-1082 G/A (rs1800896)], IL28B C/T (rs12979860), IFN-γ +874 A/T (rs2430561), TGF-β 1-509 C/T (rs1800469) and TNF-α-308 G/A promoter (rs1800629) from stored samples of 200 healthy individuals and 300 HCV infected patients. There was a significant association of AG and AA genotypes of IL28B, IFN-γ, TGF-β1, and TNF-α over HCV susceptibility and treatment outcome. However, no association between IL-6 and IL-10 gene polymorphism to HCV susceptibility response to the treatment. The observations indicate IL28B CT, TGF-β1 CT, TT and TNF- AG with AA genotypes influence the cytokine expression, which is related to susceptibility and resistance to HCV infection and combined antiviral therapy.
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Antiviral therapy for chronic hepatitis C virus (HCV) infection has entered the era of direct antiviral agent (DAA), and up to 95% of patients could be clinically cured. Under this circumstance, HCV infection has gradually changed from relative contraindication to surgical indication for kidney transplantation. However, at present, the number of kidney transplantation from HCV-infected donors or recipients has been rarely reported in China. The short-term follow-up data of HCV-negative recipients undergoing kidney transplantation from HCV-positive renal allografts in other countries have confirmed that DAA yields high cure rate and safety in the treatment of HCV infection, and recipients could obtain favorable short-term survival and allograft outcome. However, the long-term safety of HCV-infected kidney transplantation remains to be validated by clinical trials with large sample size and long-term follow-up. In this article, the virological clearance, allograft outcome and safety of DAA use in HCV-negative recipients undergoing kidney transplantation from HCV-positive renal allografts under the intervention of DAA were investigated, aiming to evaluate clinical safety and efficacy of this pattern of kidney transplantation and deepen the understanding of safe use of HCV-positive organs.
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Background: Assessment of efficacy and safety of daclatasvir+sofosbuvir+ribavirin (DCV+SOF+RBV) for 12 weeks as compare to daclatasvir and sofusbuvirfor 24 weeks in decompensated cirrhotic patients due to hepatitis C virus (HCV) genotype 3 infection. Methods: An observational, prospective, COHORTstudy over 1 year, in decompensated cirrhosis due to G3-HCV infected adult patients. Treatment was a combination of sofosbuvir 400 mg/day+daclatasvir 60 mg/day, with or without a weight-adjusted dosing of ribavirin for 12 or 24 weeks. The primary efficacyendpoint was sustained virologic response rates 12 weeks after therapy (SVR 12). The primary safety endpoint was treatment withdrawal rates secondary to severe adverse events. Results: The32 patients were screened and 2 were excluded, one patient due toassociated HBV+, one patient due to severe anemia. 30 patients were randomized. All 30 randomized patients were divided into two groups. Group 1 was given SOF+DCV+RBV for 12 weeks while group 2 patients were given SOF+DCV for 24 weeks. 81.8% of the participants in the group1 achieved SVR 12. The 90.9% of the participants in the group 2 achieved SVR12 (p=1). No other patient or treatment basal variables influenced the treatment effectiveness. No patient treatment withdrawal secondary to severe adverse events was observed. Conclusions: Both the regimen SOF+DCV with or without RBV are highly efficacious and safe. Addition of RBV can reduce the treatment duration to 12 weeks, and it will further improve compliance and more convenient for the patients.
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AIM: To establish a HPLC-QqQ-MS with multiple reaction monitoring (MRM) method for pharmacokinetics and tissue distribution study of ribavirin by oral and respiratory administration. METHODS: The experiment established a high-sensitivity LC-MS analytical method for the detection of ribavirin, and the linearity, specificity, recovery, accuracy, and precision were investigated. The established methods were used to investigate the pharmacokinetics and tissue distribution of the oral and respiratory administration methods. RESULTS: The concentration of drugs in the blood through respiratory tract administration is higher, and the drug absorption is faster. Respiratory tract administration C
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ABSTRACT Despite the high sustained virologic response (SVR) rates of direct-acting antiviral (DAAs) therapy, a small number of patients does not eradicate the virus, and these patients represent a challenge. This study aims to compare the outcomes of three second-line regimens for DAAs-experienced patients with chronic hepatitis C (CHC). This prospective observational study was conducted at the Damanhur Viral Hepatitis Center from January 2017 to February 2020. We included patients with CHC who did not achieve SVR after the complete course of Sofosbuvir/Daclatasvir±Ribavirin (SOF/DAC±RBV). The primary endpoint was SVR-12 after re-treatment. This study included 360 patients (with a mean age of 51.53±11.38 years). Approximately 51.1% of the patients were males, and 65.5% had liver cirrhosis. All patients of group 1 (45 patients) received SOF/VEL/VOX over 12-weeks; SVR-12 was achieved in 44 patients (97.8%). Group 2 (28 patients) received SOF/DAC/RBV over 24-weeks; (one patient was lost during follow-ups and one patient discontinued treatment due to hepatic decompensation). SVR-12 was achieved in 25 patients (96.2%). Group 3 (287 patients) received SOF/Ombitasvir/Paritaprevir/Ritonavir/RBV) over 12-weeks. Eight patients were lost during follow-ups, and one patient discontinued treatment due to grade 4 adverse events. SVR-12 was achieved in 276 patients (99.3%). There was no difference between the groups regarding their age, gender distribution, baseline viral load or comorbidities. Adverse events (thrombocytopenia, anemia, hyperbilirubinaemia and prolonged INR) were significantly higher in group 3, while group 1 did not experience any. The three studied retreatment regimens can be used for DAAs treatment-experienced patients considering availability. The SOF/VEL/VOX combination had the least adverse events.
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Lassa fever (LF) coinfection with hepatitis B and HIV has been reported among hospitalized patients in Southwest Nigeria and HIV patients coinfected with COVID-19 have been described among hospitalized patients in North Central Nigeria, no study has reported cases of coinfection of Lassa disease and COVID-19 among health care workers (HCWs) worldwide. A case report of two HCWs who were infected with both LF virus and SARS-CoV-2 virus at same time and were successfully managed without any sequelae. Both cases presented with typical signs of LF with COVID-19 suspected, they were promptly diagnosezd with positive outcomes after treatment. While case 1 became negative for LF virus and SARS-CoV-2 after 6 and 30 days, respectively, case 2 became negative for both viruses after 14 and 32 days, respectively. The diagnosis of LF-COVID-19 coinfection in HCWs is a frightening dimension to the health risks faced by HCWs, therefore, HCWs now more than ever before want to know what comes next and how safe is the practice of medicine
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Humans , HIV , Infectious Disease Transmission, Professional-to-Patient , COVID-19 , Hepatitis B , Lassa FeverABSTRACT
Lassa fever (LF) coinfection with hepatitis B and HIV has been reported among hospitalized patients in Southwest Nigeria and HIV patients coinfected with COVID-19 have been described among hospitalized patients in North Central Nigeria, no study has reported cases of coinfection of Lassa disease and COVID-19 among health care workers (HCWs) worldwide. A case report of two HCWs who were infected with both LF virus and SARS-CoV-2 virus at same time and were successfully managed without any sequelae. Both cases presented with typical signs of LF with COVID-19 suspected, they were promptly diagnosed with positive outcomes after treatment. While case 1 became negative for LF virus and SARS-CoV-2 after 6 and 30 days, respectively, case 2 became negative for both viruses after 14 and 32 days, respectively. The diagnosis of LF-COVID-19 coinfection in HCWs is a frightening dimension to the health risks faced by HCWs, therefore, HCWs now more than ever before want to know what comes next and how safe is the practice of medicine.
Subject(s)
Humans , Male , Female , Adult , Health Personnel , Coinfection , COVID-19 , Lassa FeverABSTRACT
Objective To investigate the influencing factors for ribavirin (RBV)-induced hemolytic anemia in the treatment of chronic hepatitis C, and to provide a reference for the early prediction of ribavirin-related hemolytic anemia in clinical practice. Methods A total of 49 patients with chronic hepatitis C who attended or were hospitalized in Hebei Petrochina Central Hospital from January 2018 to July 2019 and received antiviral therapy with direct-acting antiviral agent (DAA) and RBV were enrolled, with a major allele of C allele and a minor allele of A allele at the rs1127354 locus of the inosine triphosphate pyrophosphatase (ITPA) gene, and the patients with AA and AC genotypes were compared with those with CC genotype. During treatment, RBV was reduced to 600 mg when hemoglobin (Hb) level was < 100 g/L and was withdrawn when Hb level was < 85 g/L. Routine blood test, liver function, liver stiffness measurement, HCV RNA, HCV genotype, and ITPA genotype were measured before antiviral therapy, and the routine blood test was performed at weeks 2, 4, 8, and 12 of treatment. The Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups. Results A total of 49 patients were enrolled in this study, among whom 22 had chronic hepatitis C and 27 had liver cirrhosis, with a sustained virologic response (SVR) rate of 95.9%. The dose of RBV was reduced in 3 patients (2 in the AA/AC group and 1 in the CC group) due to anemia, and RBV was withdrawn in 3 patients (1 in the AA/AC group and 2 in the CC group); all these 6 patients had liver cirrhosis and finally achieved SVR. During the anti-HCV therapy with DAA+RBV, there was relatively mild RBV-related hemolysis, and the maximum reduction in Hb from baseline was compared between the patients with AA/AC genotype at ITPA rs1127354 and those with CC genotype, which showed no significant difference between the two groups ( Z =-0.18, P =0.87). Conclusion During the treatment with RBV+DAA, RBV is withdrawn or reduced for liver cirrhosis patients due to anemia, and no obvious statistical relation is observed between ITPA genotype and the maximum reduction in Hb from baseline. Therefore, detection of ITPA genotype before the application of RBV does not improve safety during treatment, and it is not recommended to perform conventional detection of ITPA gene polymorphisms.
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Objective To investigate the influencing factors for ribavirin (RBV)-induced hemolytic anemia in the treatment of chronic hepatitis C, and to provide a reference for the early prediction of ribavirin-related hemolytic anemia in clinical practice. Methods A total of 49 patients with chronic hepatitis C who attended or were hospitalized in Hebei Petrochina Central Hospital from January 2018 to July 2019 and received antiviral therapy with direct-acting antiviral agent (DAA) and RBV were enrolled, with a major allele of C allele and a minor allele of A allele at the rs1127354 locus of the inosine triphosphate pyrophosphatase (ITPA) gene, and the patients with AA and AC genotypes were compared with those with CC genotype. During treatment, RBV was reduced to 600 mg when hemoglobin (Hb) level was < 100 g/L and was withdrawn when Hb level was < 85 g/L. Routine blood test, liver function, liver stiffness measurement, HCV RNA, HCV genotype, and ITPA genotype were measured before antiviral therapy, and the routine blood test was performed at weeks 2, 4, 8, and 12 of treatment. The Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups. Results A total of 49 patients were enrolled in this study, among whom 22 had chronic hepatitis C and 27 had liver cirrhosis, with a sustained virologic response (SVR) rate of 95.9%. The dose of RBV was reduced in 3 patients (2 in the AA/AC group and 1 in the CC group) due to anemia, and RBV was withdrawn in 3 patients (1 in the AA/AC group and 2 in the CC group); all these 6 patients had liver cirrhosis and finally achieved SVR. During the anti-HCV therapy with DAA+RBV, there was relatively mild RBV-related hemolysis, and the maximum reduction in Hb from baseline was compared between the patients with AA/AC genotype at ITPA rs1127354 and those with CC genotype, which showed no significant difference between the two groups ( Z =-0.18, P =0.87). Conclusion During the treatment with RBV+DAA, RBV is withdrawn or reduced for liver cirrhosis patients due to anemia, and no obvious statistical relation is observed between ITPA genotype and the maximum reduction in Hb from baseline. Therefore, detection of ITPA genotype before the application of RBV does not improve safety during treatment, and it is not recommended to perform conventional detection of ITPA gene polymorphisms.
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Hepatic C virus (HCV) infection is a special case in Egypt due to its historical aspects, epidemiology, risk factors, andgenotype. Therefore, an urgent need arose to assess the HCV progression and efficacy of the used antiviral drugs. Thisstudy aimed to evaluate the role of different miRNAs types and blood dielectric measurements in the early diagnosisand prognosis of HCV in Egyptian patients. The study was carried out on a total of 80 blood samples. Twenty of theseblood samples were withdrawn from healthy volunteers and were served as the control group (G1). Sixty HCV patientsamples were divided according to the received treatment into four groups (15 for each). The second group (G2)included HCV patient samples, who did not receive any treatment. The third (G3), fourth (G4), and fifth (G5) groupsincluded the samples of HCV patients who were treated with Sovaldi (400mg) for 1, 2, and 3 months, respectively. G3,G4, and G5 were simultaneously administered Ribavirin (200 mg) and Daclatasvir (60mg) daily for 3 months. Theobtained results demonstrated the upregulation of miR-21, miR-155, and miR-205 and downregulation of miR-122and miR-133a in all HCV patients. HCV patients who did not receive any treatment showed a lower conductivity dueto the action of the virus; either the free charges on the surface of the red blood cells (RBCs) or membrane deformationor alterations were reduced. Noticeable improvement reached to nearly normal values in different miRNA expressionsand RBC dielectric relaxations was achieved by Sovaldi treatment.
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The aim of this study is to develop and validate a method that is simple, precise, sensitive, and rapid compared tousing the liquid chromatography–tandem mass spectrometry method for the quantitative determination of Ribavirin(antiviral drug) in its tablet formulation. The development and validation of the method were achieved using a column(Zorbax 50 mm × 4.6 mm × 5 µm) with mobile phase ammonium formate (pH: 7.50): acetonitrile in the ratio (30:70,v/v) with the flow rate of 0.5 ml/min. The retention time for Ribavirin was 1.1 minutes with the total run time of2.5 minutes. The linearity range for Ribavirin was from 2 to 100 ng/ml with a correlation coefficient of 0.9956. Thedetection and quantitation limits of Ribavirin are 0.7 and 2 ng/ml, respectively. The percentage recovery of Ribavirinranged from 94.00% to 98.33%. The percentage relative standard deviation for intraday and interday precision resultswas found to be 0.67%–2.11% and 1.92%–3.11%, respectively. The new method developed for Ribavirin drug wasfound to be rapid, sensitive, selective, and economical. The established method was the evaluation of Ribavirin in itsmarketed formulation (tablet). The values obtained from the analysis were found out to be within the acceptable limitsas per the International Council for Harmonisation (ICH) guidelines.
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Ribavirin is a widely used nucleoside antiviral drug. During the epidemic of coronavirus disease 2019 (COVID-19), ribavirin was recommended for empirical treatment in the Clinical Management of Human Infection with COVID-19 (trial guidance v6). However, due to the large inter-individual variations in dose-response relationship, and extremely long terminal half time, it is necessary to perform therapeutic drug monitoring and individualized dose adjustment for ribavirin in special populations. In this article, the pharmacokinetics and therapeutic drug monitoring of ribavirin in different populations are reviewed in order to provide reference for clinical rational use and individualized medication of ribavirin for treatment of COVID-19.
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Objective In order to solve the obvious adverse reactions of ribavirin, to develop ribavirin liposome inhalation powder and to evaluate its quality characteristics. Methods The ribavirin liposomes were prepared by the thin film dispersion method, and then lyophilized to prepare ribavirin liposome powder. The appearance, fluidity, bulk density, encapsulation efficiency, particle size of the complex solution, PDI, potential and hydrophilicity were examined. Results Ribavirin liposome powder has good morphology, particle size, potential, fluidity and hydrophilicity, which can meet the basic requirements of powder medicine for drug administration. Conclusion The technique of preparing ribavirin liposome powder aerosol preparation by this method is feasible, and it provides the basic technology for future in vivo and in vitro studies.
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As hepatites virais são uma das maiores causas de transplantes hepáticos no mundo, com destaque para hepatite C (HCV), com mais de 240 milhões de pessoas infectadas. A história da HCV é marcada pela evolução silenciosa da doença, afetando negativamente o diagnóstico, sendo que os primeiros sintomas manifestam-se apenas na fase aguda e avançada da doença, comprometendo a eficácia do tratamento. Estudos apontam que cerca de 350 mil pessoas perdem a vida anualmente em decorrência da doença. O tratamento dos casos de HCV era feito pela combinação dos medicamentos interferon e ribavirina, no entanto, essa combinação tem como um grande problema a limitação de seu uso em alguns pacientes e, principalmente, seus intensos efeitos colaterais. Esse estudo se dedicou a apresentar os novos tratamentos, através de revisão de literatura, com coleta de dados em Pubmed, SciElo, entre outros bancos de dados, servindo como um informativo às pessoas doentes e seus familiares. A revisão apontou que uma avaliação da gravidade da doença hepática deve ser feita com a finalidade de fornecer subsídios ao processo de decisão sobre o regime de tratamento mais adequado. Essas novas terapias foram introduzidas e demonstraram melhores resultados, perfil de segurança e eficácia.
Viral hepatitis is one of the biggest causes of liver transplants in the world, with hepatitis C (HCV), with more than 240 million people infected all over the world. The history of HCV is marked by the silent evolution of the disease, negatively affecting the diagnosis, and the first symptoms manifest only in the acute and advanced stage of thedisease, compromising the effectiveness of the treatment. Studies indicate that about 350,000 people die each year from the disease.The treatment of HCV cases was made by the combination of interferon and ribavirin, however, this combination has a major problem limiting its use in some patients and especially its intense side effects. This study was dedicated to presenting the new treatments, through literature review, with data collection in Pubmed, SciELO, among other databases, serving as an informative to sick people and their families. The review pointed out that an assessment of the severity of liver disease should be done in order to provide input to the decision process o n the most appropriate treatment regimen. These new therapies were introduced and demonstrated better results, safety profile and efficacy
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Protease Inhibitors , Ribavirin , Interferons , Hepatitis C/therapyABSTRACT
Adenovirus pneumonia is a common type of pneumonia in immunocompetent and immunocompromised patients, and its prognosis is poor.Antiviral therapy includs ganciclovir, valganciclovir, cidofovir, brincidofovir, ribavirin and so on.Among them, cidofovir and brincidofovir have obvious antiviral activity against adenovirus in vitro and in vivo, but further RCT results are still needed.Therefore, antiviral therapy of adenovirus pneumonia still needs further study.
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Objective To evaluate the effect of Jinqiao-Reduqing granule in the treatment of children with herpes angina fever.Methods A total of 90 children with herpes angina were randomly divided into two groups,with 45 cases in each group.Both groups received the symptom-supported treatment.On this basis,the control group took ribavirin granules,while the observation group took Jinqiao-Reduqing granule.Both groups were treated for 4 days.The symptoms and signs were scored before and after treatment.The fever abatement time,herpes subsidence time,salivation disappearance time and appetite recovery time were observed and recorded.The serum levels of IL-2,IL-6,IL-10 and TNF-α were detected by ELISA,and peripheral blood levels of CD4+,CD8+,CD4+/CD8+ were detected by flow cytometry.Results After treatment,the scores of symptoms and signs in the observation group were significantly lower than those in the control group (3.02 ± 2.89 vs.6.88 ± 2.31;t=6.999,P＜0.01).The time of fever abatement (16.8 ± 3.2 h vs.29.9 ± 4.4 h,t=16.202),herpes subsidence (72.3 ± 5.4 h vs.96.7 ± 6.2 h,t=19.765),salivation disappearance (26.4 ± 2.0 h vs.46.3 ± 3.6 h,t=32.479) and appetite recovery (19.6 ± 4.2 h vs.39.7 ± 4.9 h,t=20.907) were significantly earlier than those in the control group (P＜0.01).After treatment,the serum levels of IL-2,IL-6,IL-10 and TNF-α in the observation group were lower than those in the control group (t were 4.974,4.410,6.447 and 4.767,respectively,all Ps＜0.01);CD4+ levels and CD4+/CD8+ were significantly higher than those in the control group (t were 4.033,6.860,all Ps＜ 0.01),and CD8+ levels was significantly lower than those in the control group (t=4.928,P＜0.01).Conclusions The Jinqiao-Reduqing granule can shorten the time of symptoms subsidence,reduce the level of inflammatory cytokines and improve the immunity of children with herpes angina fever.
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Objective To evaluate the efficacy of Huangqi injection combined with ribavirin in the treatment of viral myocarditis in children.Methods A total of 89 children with viral myocarditis were randomly divided into treatment group (45 cases) and control group (44 cases) by random number table method.The control group received ribavirin intravenously on the basis of routine treatment,and the treatment group was given Huangqi injection intravenously on the basis of the control group.Both groups were treated continuously for 14 days.The Serum creatine kinase (CK),creatine kinase MB (CK-MB),lactate dehydrogenase (LDH) and aspartate transaminase (AST) were detected by automatic biochemical analyzer.The Serum IL-6,IL-8 and TNF-α were detected by ELISA.The level of CD3+,CD4+,and the ratio of CD4+/CD8+ in peripheral blood was measured by flow cytometry,and the clinical efficacy was evaluated.Results After treatment,the level of serum CK (110.19 ± 12.17 U/L vs.143.81 ± 17.53 U/L,t=10.530),CK-MB (18.43 ± 4.40 U/L vs.30.28 ± 5.21 U/L,t=11.602),LDH (139.57 ± 10.36 U/L vs.162.18 ± 13.22 U/L,t=8.992),AST (24.14 ± 2.19 U/L vs.35.58 ± 3.34 U/L,t=19.150) in the treatment group were significantly lower than those in the control group (P＜0.01).The Serum level of IL-6,IL-8 and TNF-α in the treatment group were significantly lower than those of the control group (t=14.884,17.043 and 14.364,respectively,P＜0.01).The level of CD3+,CD4+,and the ratio of CD4+/CD8+ in peripheral blood of the treatment group was significantly higher than that of the control group (t=6.256,0.219 and 3.895,respectively,P＜0.01).Conclusions The Huangqi injection combined with ribavirin can significantly reduce the degree of myocardial injury and inflammation in children with viral myocarditis,and improve the immune function of children with viral myocarditis.
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Objective@#To evaluate the efficacy and safety of sofosbuvir (Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.) combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection.@*Methods@#Treatment-naïve or treatment experienced genotype 2 chronic hepatitis C patients from sixteen research centers of China were screened. All subjects received once-daily dose of sofosbuvir (400 mg) combined with ribavirin (body weight < 75 kg, 1 000 mg/day, 400 mg in the morning and 600 mg in the evening; body weight > 75 kg, 1 200 mg/d, 600 mg in the morning and 600 mg in the evening) for 12 weeks. Patients were followed-up for a period of 12 weeks after discontinuation of treatment. Continuous variables were expressed as mean ± standard deviation. The proportion of subjects with virologic response at different follow-up time points and 95% confidence intervals were estimated by maximum likelihood ratio and Clopper-Pearson interval.@*Results@#132 cases with genotype 2 chronic hepatitis C virus infection from sixteen research centers of China were included, 12 cases of whom were associated with cirrhosis, and the remaining 120 cases were not associated with cirrhosis. One hundred and thirty-one cases completed the study, and one patient lost to follow-up at week 4 after the end of treatment. The sustained virological response rate was 96.2% (95% confidence interval: 92.37% - 99.16%) after 12 weeks of drug withdrawal. Virological relapse occurred in four cases. Of the 132 subjects enrolled in the study, 119 (90.2%) reported 617 adverse events during treatment, of which 359 (76.5%) were TEAE related to sofosbuvir and/or ribavirin. There were nine TEAEs of grade 3 and above, and six cases (4.5%) of them had six severe adverse events. Only one serious adverse event was associated with sofosbuvir and ribavirin (unstable angina pectoris). There were no adverse events leading to drug discontinuation or death.@*Conclusion@#Sofosbuvir combined with ribavirin has a high SVR rate in the treatment of genotype 2 chronic hepatitis C virus infection, and most of the adverse events occurred were mild with acceptable safety profile.