Adult ; Antiviral Agents ; adverse effects ; therapeutic use ; Drug Therapy, Combination ; Female ; Hearing Disorders ; chemically induced ; Hepatitis C, Chronic ; drug therapy ; Humans ; Interferon-alpha ; adverse effects ; therapeutic use ; Middle Aged ; Recombinant Proteins ; adverse effects ; therapeutic use ; Ribavirin ; adverse effects ; therapeutic use

BACKGROUNDIt is the first multicenter clinical study in China to investigate zanamivir use among Chinese adolescents and adults with influenza-like illness (ILI) since 2009, when inhaled zanamivir (RELENZA(®)) was marketed in China.

METHODSAn uncontrolled open-label, multicentre study to evaluate the antiviral activity, and safety of inhaled zanamivir (as Rotadisk via Diskhaler device); 10 mg administered twice daily for 5 days in subjects ≥ 12 years old with ILI. Patients were enrolled within 48 hours of onset and followed for eight days. Patients were defined as being influenza-positive if the real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) test had positive results.

RESULTSA total of 400 patients ≥ 12 years old were screened from 11 centers in seven provinces from March 2010 to January 2011. Three hundred and ninety-two patients who took at least one dose of zanamivir were entered into the safety analysis. The mean age was 33.8 years and 50% were male. Cardiovascular diseases and diabetes were the most common comorbidities. All the reported adverse events, such as rash, nasal ache, muscle ache, nausea, diarrhea, headache, occurred in less than 1% of subjects. Mild sinus bradycadia or arrhythmia occurred in four subjects (1%). Most of the adverse events were mild and did not require any change of treatment. No severe adverse events (SAE) or fatal cases were reported. Bronchospasm was found in a 38 years old woman whose symptoms disappeared after stopping zanamivir and without additional treatment. All the 61 influenza virus isolates (43 before enrollment, 18 during treatment) proved to be sensitive to zanamivir.

CONCLUSIONSZanamivir is well tolerated by Chinese adolescents and adults with ILIs. There is no evidence for the emergence of drug-resistant isolates during treatment with zanamivir.

Adolescent ; Adult ; Antiviral Agents ; administration & dosage ; adverse effects ; therapeutic use ; Female ; Humans ; Influenza, Human ; drug therapy ; Male ; Middle Aged ; Treatment Outcome ; Zanamivir ; administration & dosage ; adverse effects ; therapeutic use

Antiviral Agents ; adverse effects ; therapeutic use ; Female ; Hepatitis C, Chronic ; complications ; drug therapy ; psychology ; Humans ; Interferon-alpha ; adverse effects ; therapeutic use ; Mental Disorders ; complications ; Middle Aged

OBJECTIVETo evaluate the efficacy and safety of oxymatrine in the treatment of chronic hepatitis B.

METHODSA multicenter randomized double-blind placebo-controlled trial was conducted. A total of 144 patients with chronic hepatitis B entered the study for 52 weeks; of them 72 received oxymatrine, and 72 received a placebo. Before and after the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reactions were observed.

RESULTSIn 144 patients, 14 were dropped and excluded due to inconsistencies in the included standard. Therefore, the efficacy and safety of 130 patients were analyzed. After being treated for 52 weeks, 70.77% of the patients in the study group had a normal ALT level, and in 43.08% and 33.33% their HBV DNA and HBeAg became negative. In the placebo group, 39.68% had normal ALT level, and 12.31% and 3.33% had their HBV DNA and HBeAg become negative. The rates of complete response and partial response in the oxymatrine group were 23.08% and 58.46%, and in the placebo group they were 3.08% and 44.62%. They were significantly higher in the oxymatrine group than in the placebo group. In the oxymatrine treated patients, 12 weeks after its withdrawal, 60.00% had a normal ALT level, 41.54% and 23.33% had both HBV DNA and HBeAg negative. In the placebo group, 31.75% had a normal ALT level, 3.08% and 1.67% had both HBV DNA and HBeAg negative. The rates of complete response and partial response in the oxymatrine group were 21.54% and 47.69%, and in the placebo group they were 0 and 41.54%. They were significantly higher in the study group than in the placebo group. The adverse reaction rates of oxymatrine in the study and the placebo group were 7.69% and 6.15%, respectively, but there was no statistical significant difference between them.

CONCLUSIONOxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.

Adolescent ; Adult ; Aged ; Alkaloids ; adverse effects ; therapeutic use ; Antiviral Agents ; adverse effects ; therapeutic use ; Double-Blind Method ; Female ; Hepatitis B, Chronic ; drug therapy ; Humans ; Male ; Middle Aged ; Quinolizines

Antiviral Agents ; adverse effects ; therapeutic use ; Child ; Hepatitis B, Chronic ; complications ; drug therapy ; Humans ; Interferon Type I ; adverse effects ; therapeutic use ; Male ; Vitiligo ; chemically induced ; etiology

In therapy of chronic hepatitis B, there are new and exciting developments in antivirals such as nucleotide analogues. Adefovir dipivoxil is an oral prodrug of adefovir, a nucleotide analogue of adenosine monophosphate. This agent has a potent in vitro and in vivo effect against herpes virus, retroviruses, and hepadnaviruses. In the hepatitis B virus (HBV) setting, adefovir dipivoxil inhibits both the wild type and lamivudine-resistant HBV strains. The safety profile of adefovir dipivoxil 10 mg is excellent, but higher doses can produce renal tubular damage, particularly when the drug is used for prolonged therapy. Adefovir dipivoxil is an important new addition to the current first-line treatments for HBeAg positive and negative chronic hepatitis B, as well as being rescue therapy for lamivudine-resistant HBV strains. It is also licensed for use in adults with decompensated liver disease, as well as compensated liver disease where there is evidence of active viral replication, persistently elevated serum alanine aminotransferase levels and active liver inflammation and fibrosis. However, a longer follow-up is needed to establish the long term safety and efficacy of adefovir dipivoxil in patients with chronic HBV infection.
Adenine/adverse effects/*analogs & derivatives/*therapeutic use ; Antiviral Agents/adverse effects/*therapeutic use ; Hepatitis B, Chronic/*drug therapy ; Humans ; Liver Diseases/drug therapy ; *Phosphonic Acids

OBJECTIVETo investigate the effectiveness of foscarnet sodium in the treatment of severe chronic hepatitis B.

METHODSTwo hundred and eight patients were enrolled in a multicenter, double-blind, controlled study. The patients received foscarnet sodium (foscarnet group) or saline (control group) injections for 4 weeks, and were then followed for 24 weeks.

RESULTSHBV DNA negative rate was 12.8% in the foscarnet group and 7.1% in the control group at the end of treatment; and it was 5.5% and 3.0% at the end of the follow-up period respectively (P > 0.05). The rate of HBV DNA decrease of more than 2 log copies/ml was 53.2% in the foscarnet group and 16.2% in the control group at the end of treatment, and 23.9% and 8.1% (P < 0.01) respectively at the end of the follow-up period. The rate of HBV DNA < 10(5) copies/ml was 64.2% and 30.3% at week 4 in the two groups respectively, and 40.4% and 22.2% (P < 0.01) at the end of the follow-up period. HBeAg negative rate was 17.3% and 5.8% at the end of the treatment, and 22% and 5.4% at the end of the follow-up period (P < 0.01). The rate of HBeAg seroconversion was 12.7% and 3.7% at week 4, and 16.7% and 1.5% at the end of the follow-up period. Response rate was 60.6% and 21.2% at the end of week 4 (P < 0.05).

CONCLUSIONFoscarnet sodium injection has a good effect on severe chronic hepatitis B patients and it is safe to use on them.

Adolescent ; Adult ; Antiviral Agents ; adverse effects ; therapeutic use ; Double-Blind Method ; Female ; Foscarnet ; adverse effects ; therapeutic use ; Hepatitis B, Chronic ; drug therapy ; Humans ; Male ; Middle Aged ; Young Adult

Pegylated interferon and ribavirin combination therapy is accepted as the standard antiviral treatment for chronic hepatitis C regardless of HCV genotype. This combination therapy achieves higher response rates than previous therapy, but, nevertheless, a large proportion of patients suffer from treatment failure or adverse events. Recent clinical studies of viral kinetics during antiviral treatment have led to the introduction of response-guided therapy, the concept of 'customized therapy depending on viral response', which focuses on modulation of the treatment period depending on the viral response to create a sustained viral response without unnecessary medication and costs. New upcoming direct-acting antivirals (DAAs) maximize response rate, and triple therapy including DAAs along with pegylated interferon and ribavirin combination therapy could soon be the standard therapy. In this article, we reviewed the factors affecting treatment, response guided treatment, retreatment after failure of standard treatment, management of adverse events during treatment, and new treatment options.
Anemia, Hemolytic/drug therapy/etiology ; Antiviral Agents/adverse effects/*therapeutic use ; Erythropoietin/therapeutic use ; Hepatitis C, Chronic/*drug therapy ; Humans ; Individualized Medicine ; Interferon-alpha/adverse effects/therapeutic use ; Polyethylene Glycols/adverse effects/therapeutic use ; Protease Inhibitors/therapeutic use ; RNA, Viral/analysis ; Recombinant Proteins/adverse effects/therapeutic use ; Ribavirin/adverse effects/therapeutic use

Hepatocellular carcinoma (HCC) is a primary concern for patients with chronic hepatitis B (CHB). Antiviral therapy has been reasonably the focus of interest for HCC prevention, with most studies reporting on the role of the chronologically preceding agents, interferon-alfa and lamivudine. The impact of interferon-alfa on the incidence of HCC is clearer in Asian patients and those with compensated cirrhosis, as several meta-analyses have consistently shown HCC risk reduction, compared to untreated patients. Nucleos(t)ide analogues also seem to have a favorable impact on the HCC incidence when data from randomized or matched controlled studies are considered. Given that the high-genetic barrier agents, entecavir and tenofovir, are mainly used in CHB because of their favorable effects on the overall long-term outcome of such patients, the most clinically important challenge is the identification of patients who require close HCC surveillance despite on-therapy virological remission. Several risk scores have been developed for HCC prediction in CHB patients. Most of them, such as GAG-HCC, CU-HCC and REACH-B, have been developed and validated in Asian untreated and treated CHB patients, but they do not seem to offer good predictability in Caucasian CHB patients for whom a newer score, PAGE-B, has been recently developed.
Antiviral Agents/adverse effects/*therapeutic use ; Carcinoma, Hepatocellular/etiology ; Hepatitis B, Chronic/*drug therapy ; Humans ; Interferon-alpha/adverse effects/therapeutic use ; Liver Cirrhosis/complications ; Liver Neoplasms/etiology ; Nucleotides/adverse effects/chemistry/therapeutic use ; Risk Factors

OBJECTIVETo evaluate the efficacy and safety of hydrochloride valacyclovir in treatment of varicella in pediatric patients between April 2006 and March 2007.

METHODSA randomized controlled multi-center clinical trial was conducted in 5 pediatric centers, i.e., Children's Hospital of Fudan University, Children's Hospital of Zhejiang University, Children's Hospital of Nanjing Medical University, Pediatric Department of Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology and Children's Hospital, Chongqing University of Medical Sciences. Patients who were clinically diagnosed as varicella without any complications and were beyond 3 years of age were enrolled into the study from the out-patient clinics. The subjects were divided into two groups randomly, one was treated with hydrochloride valacyclovir, the other with ribavirin. There were 128 cases in the group treated with hydrochloride valacyclovir and 132 cases in control group treated with ribavirin. The treatment duration of two groups was five days. The clinical efficacy and safety were evaluated after the first day and the fourth day of the treatment and within three days after the end of the treatment. The clinical efficacy was assessed by efficacy index.

RESULTS(1) The efficacy index on the fourth day of the therapy (0.80 +/- 0.24) in the valacyclovir group was significantly higher than that of ribavirin control group (0.59 +/- 0.37) (t = 5.42, P < 0.01). The efficacy index at the end of the treatment (0.86 +/- 0.14) in the hydrochloride valacyclovir group was also significantly higher than that (0.70 +/- 0.30) of the ribavirin control group (t = 5.43, P < 0.01). (2) In the valacyclovir and ribavirin groups, the effective rates on the fourth day of the therapy were 94.53% and 72.7% respectively (chi2) = 22.38, P < 0.01). The effective rates at the end of the therapy were 99.2% and 88.6%, respectively (chi(2) = 12.60, P < 0.01). The rates of cure of the two groups were 33.6% and 25.0% (chi2) = 2.32, P > 0.05). (3) No severe adverse drug reactions were observed in any of the two groups.

CONCLUSIONSThe hydrochloride valacyclovir was safe, reliable and convenient in treatment of uncomplicated varicella in children.

Acyclovir ; adverse effects ; analogs & derivatives ; therapeutic use ; Antiviral Agents ; adverse effects ; therapeutic use ; Chickenpox ; drug therapy ; Child ; Child, Preschool ; Female ; Humans ; Male ; Valine ; adverse effects ; analogs & derivatives ; therapeutic use