Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects.

Purpose: The objective of this study was to demonstrate comparable pharmacokinetic (PK), safety, and tolerability parameters of the adalimumab biosimilar SB5 administered via autoinjector (AI) pen or prefilled syringe (PFS).

Patients And Methods: In this phase 1, randomized, open-label, single-dose, parallel-group study, healthy subjects aged 18-55 years were randomized 1:1 to a single dose of 40 mg SB5 delivered subcutaneously via AI or PFS. PK parameters, safety, and tolerability were assessed for 57 days post-dose.

Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: A randomized, placebo-controlled trial.

Background: Before pandemic H1N1 vaccines were available, the potential benefit of existing seasonal trivalent inactivated influenza vaccines (IIV3s) against influenza due to the 2009 pandemic H1N1 influenza strain was investigated, with conflicting results. This study assessed the efficacy of seasonal IIV3s against influenza due to 2008 and 2009 seasonal influenza strains and against the 2009 pandemic H1N1 strain.

Methods: This observer-blind, randomized, placebo-controlled study enrolled adults aged 18-64years during 2008 and 2009 in Australia and New Zealand.

Late-onset bolus intravenous beta-lactam antibiotic adverse reaction: short-lived symptoms during drug administration and associated laboratory abnormalities.

Background: In the 1970s, there were 2 reports of a late-onset adverse reaction during bolus infusions of benzyl penicillin, characterized by short-lived symptoms, most commonly abdominal pain. The mechanism is not known. We set out to further characterize this reaction.

Comparative pharmacokinetics of subcutaneous trastuzumab administered via handheld syringe or proprietary single-use injection device in healthy males.

Purpose: To demonstrate pharmacokinetic (PK) comparability for a single dose of 600 mg subcutaneous (SC) trastuzumab, administered via a novel single-use injection device (SID) or handheld syringe in 119 randomized healthy male subjects.

Methods: The co-primary PK endpoints area under the time-concentration curve from the start of dosing to day 22 (AUC(0-21 days)) and maximum observed trastuzumab serum concentration (C(max)) were dose-normalized and body-weight-adjusted, and compared using geometric mean ratios (GMRs). SID performance, injection site pain, adverse events, and antidrug antibodies (ADAs) were assessed.

Effects of intravenous zoledronate on bone turnover and bone density persist for at least five years in HIV-infected men.

Context: In HIV-infected men, the antiresorptive effects of zoledronate persist for at least 2 yr after the second annual dose.

Objective: Our objective was to determine the duration of action of zoledronate in men.

Design And Setting: This was 4-yr extension of a 2-yr, double-blind, randomized, placebo-controlled trial at an academic research center.

Stable bone mineral density over 6 years in HIV-infected men treated with highly active antiretroviral therapy (HAART).

Objective: Most longitudinal studies of bone mineral density (BMD) in HIV-infected cohorts have been of short duration, typically 1-2 years. Some studies, especially of cohorts treated with highly active antiretroviral therapy (HAART), report short-term stable or increasing BMD, but other studies, often in cohorts initiating HAART, report short-term losses in BMD. We assessed BMD changes over the medium term in HIV-infected men already established on HAART at baseline.

Good outcome with trimethoprim 10 mg/kg/day-sulfamethoxazole 50 mg/kg/day for Pneumocystis jirovecii pneumonia in HIV infected patients.

Pneumocystis jirovecii pneumonia (PCP) in human immunodeficiency virus (HIV)-infected patients is usually treated with trimethoprim (TMP)-sulfamethoxazole (SMX) 1920 mg 3 times daily (approximately equivalent to TMP 15 mg/kg/day-SMX 75 mg/kg/day) for 21 days. Pharmacokinetic data suggest that lower doses would be equally efficacious and might be associated with a lower incidence of adverse effects. We conducted a retrospective review of case notes for the first episode of laboratory-confirmed PCP in HIV-infected patients treated at Auckland City Hospital, from January 1991 through December 2007.

Evolution of central nervous system multidrug-resistant Mycobacterium tuberculosis and late relapse of cryptic prosthetic hip joint tuberculosis: complications during treatment of disseminated isoniazid-resistant tuberculosis in an immunocompromised host.

We report a case of disseminated isoniazid-resistant tuberculosis in an immunocompromised patient with evolution of rifampin (rifampicin) resistance in the central nervous system. This was cured with intraventricular and oral treatment but was followed by a late relapse of the original infection in a prosthetic hip joint. We provide drug levels in cerebrospinal fluid and serum.

Effects of intravenous zoledronate on bone turnover and BMD persist for at least 24 months.

The duration of the antiresorptive effects of the intravenous bisphosphonate, zoledronate, is not known. Recently, we reported that two annual 4-mg doses of zoledronate suppressed bone turnover and increased BMD in HIV-infected men over 24 mo. We set out to determine the persistence of these effects after two doses of zoledronate.

Bone mineral density remains stable in HAART-treated HIV-infected men over 2 years.

Objective: Recently we reported that human immunodeficiency virus (HIV)-infected Caucasian men treated with highly active antiretroviral therapy (HAART) have normal weight-adjusted bone mineral density (BMD), in contrast to most other cross-sectional analyses, which have reported low BMD in HIV-infected patients. We have now addressed the question of whether there is accelerated BMD loss over time in HIV-infected men.

Design: A 2-year, prospective, longitudinal study.

Annual zoledronate increases bone density in highly active antiretroviral therapy-treated human immunodeficiency virus-infected men: a randomized controlled trial.

Context: Recent studies have reported low bone mineral density (BMD) in HIV-infected patients. Annual iv administration of 4 mg zoledronate has been shown to increase BMD and suppress bone turnover in postmenopausal women.

Objective: The objective of the study was to determine whether annual administration of 4 mg zoledronate will increase BMD in HIV-infected men receiving highly active antiretroviral therapy.

Bone mineral density is not reduced in HIV-infected Caucasian men treated with highly active antiretroviral therapy.

Objective: Recent studies have reported low bone mineral density (BMD) in patients infected with human immunodeficiency virus (HIV). Frequently these findings have been attributed to treatment with highly active antiretroviral therapy (HAART). We sought to determine whether BMD in HIV-infected men treated with HAART for at least 3 months is different from that in healthy controls, and, if so, what HIV-related factors might explain this finding.

Hydrocephalus in herpes simplex type 2 meningitis.

A 34-year-old woman presented to hospital with symptoms of meningitis, later confirmed to be due to herpes simplex virus type 2. She developed hydrocephalus on day 2 of her admission. We describe the first case of hydrocephalus associated with herpes simplex type 2 meningitis in an adult.

Leprosy in a backpacker.

Leprosy is the most common cause of peripheral neuropathy in the developing world. It is not expected to be acquired by visitors traveling through these countries. We present a backpacker who contracted leprosy during brief stays in endemic countries.

Outpatient Parenteral Antimicrobial Therapy (OPAT): a review of experience at Auckland Hospital.

Aim: To review the Auckland Hospital Outpatient Parenteral Antimicrobial Therapy (OPAT) Service.

Methods: Patients (>15 years of age) were referred to the Service and assessed for suitability for outpatient therapy by an infectious diseases physician and a specialist nurse. Patient demographics, referring service, site of infection, and infecting organism, antimicrobial agent/s and outcomes of treatment including complications were recorded.

Gram-negative bacillary meningitis after cranial surgery or trauma in adults.

In order to assess the clinical features, aetiology, treatment and outcome of post-neurosurgical and post-traumatic Gram-negative bacillary meningitis (GNBM) we performed a retrospective review of all adult patients admitted to the Department of Neurosurgery who had Gram-negative bacilli cultured from cerebrospinal fluid (CSF) following a neurosurgical procedure or traumatic head/spinal injury. During the 12 y of the review 33 patients had CSF isolates of Gram-negative bacilli that were thought to be significant. The median patient age was 47 y (range 22-77 y) and 21 (64%) were male.

Three days of intravenous benzyl penicillin treatment of meningococcal disease in adults.

New Zealand has experienced an epidemic of predominantly serogroup B meningococcal disease during the past decade. In a prospective study, we treated adults (age, >15 years) with meningococcal disease with intravenous benzyl penicillin (12 MU [7.2 g] per day) for 3 days.