Intravenous anidulafungin followed optionally by oral voriconazole for the treatment of candidemia in Asian patients: results from an open-label Phase III trial.

BACKGROUND: Candidemia is a significant cause of morbidity and mortality in hospitalized patients, particularly in Asia. Anidulafungin has been reported to be an effective treatment for candidemia in Western populations, but little is known about its efficacy in Asian patients, where the clinical presentation and epidemiology may be different. METHODS: An open-label study of anidulafungin for the treatment of candidemia was recently conducted in several Asian countries. Treatment was initiated with intravenous anidulafungin, given for at least 5 days, with the option to complete treatment with oral voriconazole. The primary endpoint was global (clinical and microbiological) response, and the primary analysis was the proportion of patients in the modified intent-to-treat population with successful global response at the end of therapy. Secondary analyses included proportion with successful global response in clinically relevant patient subgroups. The safety and tolerability profile of anidulafungin and voriconazole in this population was also investigated. RESULTS: Forty-three patients were studied, including 42 in the modified intent-to-treat population. Eighteen patients were > 65 years, the largest age subgroup, and 21 had central venous catheters. The most common Candida species causing infection were C. tropicalis (n = 18) and C. albicans (n = 10). In the primary analysis, 73.8% had a successful global response at end of therapy. Success rates in subgroups were: 72.2% for C. tropicalis and 71.4% for C. albicans infection, 58.8% for patients > 65 years, and 81.0% for patients with central venous catheters. Safety and tolerability were comparable with the known profiles for anidulafungin (and voriconazole). CONCLUSIONS: Although the epidemiology of Candida infections was different in this open-label study, the efficacy of anidulafungin in Asian patients with documented candidemia was consistent with previous studies in Western populations. No new safety concerns were identified. TRIAL REGISTRATION: http://www.clinicaltrials.gov identifier NCT00537329.

Randomized, double-blind, placebo-controlled trial of oromucosal low-dose interferon following prednisone withdrawal for chronic hepatitis B infection in Filipino patients.

OBJECTIVE: To evaluate the efficacy and safety of oromucosal low-dose human lymphoblastoid interferon alpha (IFN-alpha-n1 [INS]) following steroid withdrawal in Filipino patients with chronic replicative hepatitis B virus (HBV) infection. STUDY DESIGN: Randomized, double blind, placebo-controlled trial on IFN-alpha-n1 [INS], two tablets of 200 IU each or placebo, given sublingually once daily for eight months following steroid or placebo priming and withdrawal. RESULTS: A statistically significant clearance of hepatitis B e antigen (HBeAg) (50%) and seroconversion to positive antibody to HBeAg (anti-HBe) (42.9%) was noted in those given IFN-alpha-n1 [INS] compared with the placebo group. Clearance of serum HBV-DNA was not significantly different and none cleared HBsAg in both groups. More patients (57%) had normalization of ALT on IFN-alpha-n1 [INS] compared with controls (31.3%). Oromucosal IFN-alpha-n1 [INS] was devoid of any evidence of toxicity. CONCLUSION: This study conducted on a limited number of patients demonstrates the potential efficacy of oromucosal IFN-alpha-n1 [INS] in chronic HBV infection with therapeutic benefit equal to parenterally administered interferon alpha (IFNalpha) but without the side effects of myelosuppresion. Owing to the small population studied, we are unable to extrapolate these findings to the general population of patients with chronic HBV infection. A large-scale study is needed to confirm these findings.