A comparison of the pharmacokinetics of Aspen Ceftriaxone and Rocephin in community-acquired meningitis.

BACKGROUND: Community-acquired bacterial meningitis (CABM) is a life-threatening condition that is common among immunocompromised individuals. Intravenous ceftriaxone, of which Rocephin (ROC) is the originator brand, is recommended as first-line therapy in South Africa. Despite concerns regarding therapeutic equivalence with generic agents, this is the first study that has been conducted comparing clinical pharmacokinetics (PK) of a generic ceftriaxone formulation with the originator. OBJECTIVE: To compare the PK and safety of Aspen Ceftriaxone (AC) and ROC in the treatment of adult CABM.Methods. A total of 63 eligible patients were randomised 1:1 to receive 2 g of either medication twice daily for a duration based on the identity of the causative organism and their physician's clinical judgment. The primary endpoint of this study was the comparison of clinical PK, specifically the concentrations of each drug in the cerebrospinal fluid with corresponding paired plasma samples. While this study was underpowered to assess efficacy, safety could be evaluated on the basis of reported adverse events. RESULTS: The two patient groups were epidemiologically similar. There were no statistically significant differences in PK between either agent, nor any difference with regard to safety. CONCLUSION: AC can be considered as equivalent to ROC with regard to PK and safety in patients with CABM.

Mortality and causes of death in HIV-positive patients receiving antiretroviral therapy at Tshepang Clinic in Doctor George Mukhari Hospital.

INTRODUCTION: Since the initiation of regular antiretroviral therapy and highly active antiretroviral therapy (HAART) in South Africa in 2004, data on effects of HAART on mortality are not available in our hospital. OBJECTIVES: We sought to describe mortality trends and causes of deaths among HIV-infected patients in the HAART era. PATIENTS AND METHODS: Consecutive HIV-infected adults who were prescribed HAART in our hospital were prospectively followed-up from July 2004 to December 2006 or until death, loss to follow-up, discontinuation of HAART or referral to another center. RESULTS: Out of 2605 HIV-infected patients analyzed at the end of 2006, 7.8% (n = 205) died. The causes of these 205 deaths were dominated by AIDS related disorders such as opportunistic infection (47.6%) and advanced AIDS status (37.3%). Non-AIDS infectious diseases, liver diseases, cardiovascular diseases, and cancers were rare. Mortality rate was higher in males (28%, p < 0.0001) than females (8%) as well as in subgroup with CD4 cell counts < 200/microl (8%, p < 0.0001) than in subgroup with CD4 cell counts > 200/microl (4.9%). There was a negative significant dose - response relationship (p for linear trend < 0.0001) between mortality and baseline CD4 cell counts among patients with CD4 cell counts < 200/microl, 13% in the CD4 < 50/microl group, 6% in the CD4 51-100/microl group, 5.5% in the CD4101-150/microl group, and 3% in the CD4 > 151/microl group. Mortality was not associated with age and HAART regimens. CONCLUSIONS: Prevention of AIDS-defining conditions and expansion of earlier access to HAART could substantially reduce mortality in resource-poor settings.