Safety and efficacy of entecavir in adefovir-experienced patients.

BACKGROUND AND AIM: Suboptimal viral suppression with adefovir (ADV) poses a challenge in managing chronic hepatitis B. Few studies have evaluated the efficacy of entecavir (ETV) in ADV-experienced patients. Our aim is to assess treatment effectiveness of ETV in ADV-experienced patients. METHODS: ADV-experienced patients switched to ETV were enrolled from six US clinics. Patients completed a median of 24 months of ETV after switch. Patients were categorized into partial responders (detectable HBV-DNA at switch) or complete responders (undetectable HBV-DNA at switch) to ADV. Primary and secondary outcome measurements were complete viral suppression (CVS, HBV-DNA < 60 IU/mL) and biochemical response (BR, alanine aminotransferase [ALT] < 40 U/L), respectively. RESULTS: A total of 120 patients were included in the analysis (80 ADV partial responders; 40 ADV complete responders). In partial responders, CVS rate was 84% after 24 months of ETV. BR rate was 58% at switch to ETV and increased to 90% after 24 months. All complete responders continued to experience CVS after switch. On multivariate analysis inclusive of age, male gender, ALT level at switch, and history of lamivudine (LAM) exposure, we identified positive, hepatitis B e antigen status before ADV and higher HBV-DNA level at time of switch as significant independent negative predictors of CVS. In eight patients with ADV resistance, seven achieved CVS after 24 months of ETV, and all achieved BR. CONCLUSION: In ADV-experienced patients, high rates of CVS and BR can be achieved/sustained after switching to ETV, including those with ADV resistance or with prior exposure to LAM.

Randomized controlled trial of pegylated interferon-alfa 2a and ribavirin in treatment-naive chronic hepatitis C genotype 6.

UNLABELLED: Hepatitis C virus (HCV) genotype is an important criteria in determining duration of therapy and predictor of sustained virologic response (SVR) to pegylated interferon (PEG IFN) and ribavirin (RBV) therapy. Optimal duration of therapy for patients with HCV genotype 6 is not known. We conducted a multicenter, open-label randomized controlled trial of patients with HCV genotype 6 at five gastroenterology clinics in the western U.S. Patients were stratified by viral load and histologic stage and assigned to receive PEG IFN-α2a 180 µg subcutaneously weekly and weight-based oral RBV 800 to 1,200 mg daily for 24 or 48 weeks. Primary outcome measurement was SVR rate by intention-to-treat analysis. From February 2005 to October 2007 a total of 60 patients (age 51 ± 10 years, 47% male, log HCVRNA 6.3 ± 1.1 IU/mL) were enrolled: 27 patients to 24 weeks and 33 patients to 48 weeks of therapy. In the 24-week and 48-week groups, 96% and 97% achieved early virologic response (P = 0.90); 89% versus 94% achieved end of therapy virologic response (P = 0.48). SVR was achieved in 70% versus 79% of patients assigned to 24 weeks versus 48 weeks (P = 0.45). Rapid virologic response (RVR) was a significant predictor of SVR in the 48-week group and trending towards significance in the 24-week group: 82% and 83% of those with RVR achieved SVR versus 33% and 29% for the 24-week and 48-week groups, respectively (P = 0.07 and P = 0.02). CONCLUSION: There was no significant difference in SVR rates in patients with HCV genotype 6 treated with PEG IFN-α2a and RBV for 24 versus 48 weeks.

Successful promotion of hepatitis B vaccinations among Vietnamese-American children ages 3 to 18: results of a controlled trial.

OBJECTIVE: Chronic infection with the hepatitis B virus is endemic in Southeast Asian populations, including Vietnamese. Previous research has documented low rates of hepatitis B vaccine coverage among Vietnamese-American children and adolescents ages 3 to 18. To address this problem, we designed and tested in a controlled trial 2 public health outreach "catch-up" campaigns for this population. DESIGN: In the Houston, Texas metropolitan area, we mounted a media-led information and education campaign, and in the Dallas metropolitan area, we organized a community mobilization strategy. We evaluated the success of these interventions in a controlled trial, using the Washington, DC metropolitan area as a control site. To do so, we conducted computer-assisted telephone interviews with random samples of approximately 500 Vietnamese-American households in each of the 3 study sites both before and after the interventions. We assessed respondents' awareness and knowledge of hepatitis B and asked for hepatitis B vaccination dates for a randomly selected child in each household. When possible, we validated vaccination dates through direct contact with each child's providers. RESULTS: Awareness of hepatitis B increased significantly between the pre- and postintervention surveys in all 3 areas, and the increase in the media education area (+21.5 percentage points) was significantly larger than in the control area (+9.0 percentage points). At postintervention, significantly more parents knew that free vaccines were available for children in the media education (+31.9 percentage points) and community mobilization (+16.7 percentage points) areas than in the control area (+4.7 percentage points). An increase in knowledge of sexual transmission of hepatitis B virus was significant in the media education area (+14.0 percentage points) and community mobilization (+13.6 percentage points) areas compared with the control area (+5.2 percentage points). Parent- or provider-reported data (n = 783 for pre- and n = 784 for postintervention surveys) suggest that receipt of 3 hepatitis B vaccinations increased significantly in the community mobilization area (from 26.6% at pre- to 38.8% at postintervention) and in the media intervention area (28.5% at pre- and 39.4% at postintervention), but declined slightly in the control community (37.8% at pre- and 33.5% at postintervention). Multiple logistic regression analyses estimated that the odds of receiving 3 hepatitis B vaccine doses were significantly greater for both community mobilization (odds ratio 2.15, 95% confidence interval 1.16-3.97) and media campaign (odds ratio 3.02, 95% confidence interval 1.62-5.64) interventions compared with the control area. The odds of being vaccinated were significantly greater for children who had had at least 1 diphtheria-tetanus-pertussis shot, and whose parents were married, knew someone with liver disease, had heard of hepatitis B, and had greater knowledge about hepatitis B. The odds of being vaccinated were significantly lower for older children. CONCLUSIONS: Both community mobilization and media campaigns significantly increased the knowledge of Vietnamese-American parents about hepatitis B vaccination, and the receipt of "catch-up" vaccinations among their children.