Adult ; Aged ; Antiviral Agents ; administration & dosage ; Betacoronavirus ; Coronavirus Infections ; drug therapy ; Drug Therapy, Combination ; Humans ; Interferon-alpha ; administration & dosage ; Lopinavir ; administration & dosage ; Middle Aged ; Pandemics ; Pneumonia, Viral ; drug therapy ; Randomized Controlled Trials as Topic ; Ribavirin ; administration & dosage ; Ritonavir ; administration & dosage

OBJECTIVETo evaluate the efficacy and safety of Qingkailing Injection (, QKL) for treatment of children pneumonia caused by respiratory syncytial virus (RSV).

METHODSRandomized clinical trials (RCTs) comparing QKL with ribavirin injection in the treatment of children pneumonia induced by RSV were searched in PubMed, Science Direct, Cochrane Library, Chinese VIP database, CNKI and Wanfang databases from their inception to March 2014. Meta-analyses were performed using RevMan 5.2 software. The methodological quality of the selected RCTs was evaluated by the Modified Jadad Score. The primary outcome measures were effective rate and the secondary outcomes were relief time of fever and cough.

RESULTSSeven RCTs with 992 cases published from 2008 to 2013 were identified. The meta-analysis results indicated that QKL was more effective in cure rate [risk ratios (RR)=1.32, 95% CI (1.17, 1.50), P<0.01], total effective rate [RR=1.07, 95% CI (1.02, 1.13), P=0.009] and less fever clearance time [mean difference=-0.73, 95% CI (-1.22,-0.23), P=0.004], compared with ribavirin injection in the treatment of RSV-induced children pneumonia. No dead case was reported in all trials. There were 3 trials mentioned adverse events, 2 reported no obvious adverse event occurred while 1 reported adverse events described as skin hypersensitivity, elevation of ALT, a mild abnormal of hepatic and renal function in both QKL and ribavirin group.

CONCLUSIONSQKL was an effective and relatively safe option for the treatment of RSV-induced children pneumonia. These therapeutic effects were promising but need to be interpreted with caution due to variations in the treatment and methodological weakness in the studies.

Cough ; complications ; drug therapy ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; pharmacology ; therapeutic use ; Fever ; complications ; drug therapy ; Humans ; Injections ; Pneumonia ; drug therapy ; virology ; Publication Bias ; Randomized Controlled Trials as Topic ; Respiratory Syncytial Virus Infections ; complications ; drug therapy ; virology ; Respiratory Syncytial Viruses ; physiology ; Ribavirin ; therapeutic use

No abstract available.
Antiviral Agents/*administration & dosage ; Female ; Hepatitis C, Chronic/*drug therapy ; Humans ; Interferon-alpha/*administration & dosage ; Male ; Polyethylene Glycols/*administration & dosage ; Recombinant Proteins/administration & dosage ; Ribavirin/*administration & dosage

OBJECTIVETo evaluate the efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease (HFMD).

METHODSA randomized, double-blind, placebo-controlled trial was performed. A total of 119 children with mild HFMD were randomly divided into an observed group (n=59) and a control group (n=60). In the observed group, ribavirin aerosol was given four times within the first hour, followed by once every other hour for the remaining time of the day and day 2; from days 3 to 7, it was given 4 times per day, with 2-3 sprays every time, for 7 days. In the control group, placebo was given in the same way as in the observed group. Additionally, both groups used oral antiviral liquid. The scores of clinical symptoms including oral ulcer, skin rash, nasal congestion, runny nose, sneezing, cough, and fever before and after treatment were recorded to evaluate treatment outcomes. Throat swabs were taken before treatment and 5-7 days after treatment to measure viral load by RT-PCR and to compare the negative conversion rate between the two groups.

RESULTSFifty-seven patients in the observed group and 56 patients in the control group were tested according to the original research design. After 5-7 days of treatment, the observed group had a significantly higher overall negative conversion rate of enterovirus than the control group (P<0.01). The overall marked response rate and overall response rate of the observed group were 89% and 89%, respectively, significantly higher than those of the control group (29% and 43%). During treatment, there were no adverse reactions such as dizziness, vomiting, and notable decreases in hemoglobin, white blood cells, and platelets in the two groups.

CONCLUSIONSRibavirin aerosol can be effectively and safely used for treating mild HFMD. With low dosage and few adverse reactions, it holds promise for clinical application.

Aerosols ; Antiviral Agents ; therapeutic use ; Child ; Child, Preschool ; Double-Blind Method ; Female ; Hand, Foot and Mouth Disease ; drug therapy ; Humans ; Infant ; Infant, Newborn ; Male ; Ribavirin ; administration & dosage ; adverse effects ; therapeutic use

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.
Administration, Oral ; Adult ; Aged ; Antiviral Agents/*administration & dosage ; Area Under Curve ; Drug Therapy, Combination ; Female ; Genotype ; Hepatitis C, Chronic/*drug therapy/genetics ; Humans ; Injections, Subcutaneous ; Interferon-alpha/*administration & dosage ; Male ; Medication Adherence ; Polyethylene Glycols/*administration & dosage ; Prospective Studies ; RNA, Viral/metabolism ; Recombinant Proteins/administration & dosage ; Ribavirin/*administration & dosage ; Treatment Outcome ; Viral Load ; Young Adult

Currently, the most widely prescribed standard therapy for chronic hepatitis C consists of pegylated-interferon combined with ribavirin. Although the response rate to interferon-based treatments has improved since interferon monotherapy was first combined with ribavirin, and then pegylated-interferon was adopted, patients eligible for this treatment are limited; the side effects are unbearable in some patients, and the response rates are still unsatisfactory for those who have unfavorable clinical features. Achievements in molecular research have led to the discovery of enormous molecules with anti-hepatitis C virus (HCV) activity. Telaprevir, boceprevir, simeprevir, and sofosbuvir have already been approved by the U.S. Food and Drug Administration and many new drugs are being evaluated in ongoing clinical trials. We review the clinical efficacy of approved new anti-HCV drugs, along with many promising treatment options under development.
Hepatitis C, Chronic* ; Humans ; Interferons ; Ribavirin ; United States Food and Drug Administration ; Simeprevir

OBJECTIVETo perform a preliminarily study on the relationship between the duration and dosage of ribavirin treatment and its antiviral effect against chronic hepatitis C.

METHODSA total of 69 patients with chronic hepatitis C whose hemogloblin (HGB) level had decreased to 100 g/L were divided into two groups for receiving a reduced dosage of ribavirin when their HGB level fell to less than or equal to 100 g/L or for withdrawal of the ribavirin treatment when their HGB level fell to less than or equal to 80 g/L (restricted group), or for receiving a reduced dosage when the HGB level fell to less than or equal to 80 g/L or for withdrawal of the ribavirin treatment when the HGB level fell below less than or equal to 60 g/L (adjusted group).The rates of sustained virological response (SVR), relapse, and incidence of adverse effects were statistically compared between the two groups.

RESULTSThe adjusted group had a significantly higher SVR rate than the restricted group (91.17% vs.74.29%, P = 0.049). At the 2-year follow-up after treatment withdrawal, there were significantly less cases of relapse in the adjusted group than in the restricted group (23.07% vs.6.45%, P = 0.038).The adjusted group had lower incidence rates of severe anemia and cardiovascular events but there was no significant difference from these rates in the restricted group (P more than 0.05).Subgroup analysis of the adjusted group showed that the patients with HCV-RNA baseline level of less than 5 lg copy/ml had a significantly higher SVR rate than the patients with HCV-RNA baseline level of more than 5 lg copy/ml (100% vs.76.92%, P = 0.021), and that the patients infected with non genotype-1 had a significantly higher SVR rate than patients infected with genotype-1 (100% vs.70.00%, P = 0.005).

CONCLUSIONWhen patients with chronic hepatitis C develop anemia during the course of anti-HCV ribavirin therapy with Peg-IFNat2a, adjustment of the ribavirin treatment duration and dosage can increase the likelihood of achieving and sustaining SVR and decrease the rate of relapse; these treatment adjustments are not associated with changes in severe adverse effects.The adjustment approach, however, shows more benefit for patients with lower viral load and non genotype-1 infection.

Antiviral Agents ; administration & dosage ; therapeutic use ; Female ; Genotype ; Hepatitis C Antibodies ; Hepatitis C, Chronic ; drug therapy ; Humans ; Interferon-alpha ; Male ; Ribavirin ; administration & dosage ; therapeutic use ; Treatment Outcome ; Viral Load

OBJECTIVETo determine the role of hepatitis C virus (HCV) genotype 1 b genetic variation in the open reading frame for treatment outcomes of the pegylated-interferon/ribavirin (peg-IFN/RBV) combination therapy by examining patients from Henan Province with chronic hepatitis C (CHC).

METHODSThirty-seven treatment naive patients infected with HCV genotype 1b were included in the study. Prior to initiation of a 48-week course of peg-IFN/RBV therapy, peripheral blood was drawn for sequencing of the viral ORF 5'-half. Patients were assessed at the end of the 48 weeks of treatment and at a 6-month follow-up appointment. The patient data was stratified according to the status of sustained viral response (SVR) group and non-response (NR) and statistical analysis was performed to determine the correlation between detected genetic variations and treatment response status.

RESULTSGenetic variability in the ORF 5'-half was significantly higher among the individuals in the SVR group than among those of the NR group. Significant differences were found in the gene regions encoding p7, NS2 and NS3. For p7, the NR group had actual and expected frequencies of special mutation of 9.0 and 17.4 and total mutation of 77.0 and 68.6, while the SVR group had actual and expected frequencies of special mutation of 42.0 and 33.6 and total mutation of 124.0 and 132.4 (x2 =7.725, P =0.05). For NS2, the NR group had actual and expected frequencies of special mutation of 36.0 and 54.3 and total mutation of 270.0 and 251.7, while the SVR group had actual and expected frequencies of special mutation of 106.0 and 87.7 and total mutation of 388.0 and 406.3 (x2 = 12.16, P less than 0.01). For NS3, the NR group had actual and expected frequencies of special mutation of 49.0 and 53.4 and total mutation of 241.0 and 236.6, while the SVR group had actual and expected frequencies of special mutation of 81.0 and 76.6 and total mutation of 335.0 and 339.4 (x2 =6.745, P =0.043). The inter-patient genetic variations in the NS3 gene were concentrated in the protease domain. Furthermore, there was a strong correlation between HCV diversity in p7 and treatment outcome.

CONCLUSIONThe genetic data reported here provides strong support for the role of NS2, NS3 and p7 in antagonizing the peg-IFN/RBV response during the treatment of HCV infections. We conclude that higher inter-patient viral genetic diversity correlates with successful treatment and may modulate the efficacy of antiviral therapy in CHC patients of Henan.

Adult ; Drug Therapy, Combination ; Female ; Genotype ; Hepacivirus ; genetics ; Hepatitis C, Chronic ; drug therapy ; virology ; Humans ; Interferons ; administration & dosage ; therapeutic use ; Male ; Middle Aged ; Open Reading Frames ; Ribavirin ; administration & dosage ; therapeutic use ; Treatment Outcome

The purpose of this study is to investigate the applicability of a natural swelling matrix derived from boat-fruited sterculia seed (SMS) as the propellant of osmotic pump tablets. The sugar components, static swelling, water uptake and viscosity of SMS were determined and compared with that of polythylene oxide (WSR-N10 and WSR-303). Both ribavirin and glipizide were used as water-soluble and water-insoluble model drugs. Then, the monolayer osmotic pump tablets of ribavirin and the bilayer osmotic pump tablets of glipizide were prepared using SMS as the osmotically active substance and propellant. SMS was mainly composed of rhamnose, arabinose, xylose and galactose and exhibited relatively high swelling ability. The area of the disintegrated matrix tablet was 20.1 times as that at initial after swelling for 600 s. SMS swelled rapidly and was fully swelled (0.5%) in aqueous solution with relative low viscosity (3.66 +/- 0.03) mPa x s at 25 degrees C. The monolayer osmotic pump tablets of ribavirin and the bilayer osmotic pump tablets of glipizide using SMS as propellant exhibited typical drug release features of osmotic pumps. In conclusion, the swelling matrix derived from boat-fruited sterculia seed, with low viscosity and high swelling, is a potential propellant in the application of osmotic pump tablets.
Arabinose ; chemistry ; isolation & purification ; Chemistry, Pharmaceutical ; Delayed-Action Preparations ; Drug Carriers ; Galactose ; chemistry ; isolation & purification ; Glipizide ; administration & dosage ; chemistry ; Osmosis ; Plants, Medicinal ; chemistry ; Rhamnose ; chemistry ; isolation & purification ; Ribavirin ; administration & dosage ; chemistry ; Seeds ; chemistry ; Solubility ; Sterculiaceae ; chemistry ; Tablets ; Technology, Pharmaceutical ; methods ; Viscosity ; Water ; Xylose ; chemistry ; isolation & purification

Antiviral Agents ; administration & dosage ; therapeutic use ; DNA, Viral ; blood ; Hepacivirus ; genetics ; Hepatitis C, Chronic ; drug therapy ; virology ; Humans ; Interferon-alpha ; administration & dosage ; therapeutic use ; Ribavirin ; administration & dosage ; therapeutic use ; Standard of Care