Abstract
PurposeTo obtain safety and effectiveness data on a combined anti-HIV drug, Epzicom (abacavir 600 mg/lamivudine 300 mg), a post-marketing surveillance on Epzicom that was required by the Japanese regulatory authority was conducted between January 2005 and December 2010.MethodsA joint survey (HIV-related drug [HRD] survey) has been conducted involving manufacturers of drugs for treatment of HIV infection in Japan. Safety and effectiveness data from total 624 cases (1107.3 person-years) registered to the HRD surveys and received Epzicom were obtained. Adverse drug reactions (ADRs) were defined as adverse events (AE) of which association with Epzicom could not be ‘ruled out’.ResultsIt was found that the incidence of ADR was 32.4% (202/624 cases) on the case basis. In addition, the frequently reported ADR included hyperlipidaemia (59 cases), hypertriglyceridaemia (21 cases), blood bilirubin increased (19 cases), gamma-glutamyltransferase increase (14 cases), blood triglyceride increase (14 cases) and rash (14 cases). Serious AEs were seen in 19 patients (30 events), including one death (no evident association with Epzicom). There were four cases (0.6%) of survey-defined ‘hypersensitivity’, and the incidence was 0.9% (4/445) among abacavir naïve patients; none of which was reported as serious. No case of myocardial infarction was reported. One pregnant case who delivered a normal baby by caesarean section was reported to have experienced aggravation of anaemia and nausea.ConclusionsThe post-marketing surveillance indicated that the incidence of both ischaemic heart disease and hypersensitivity associated with Epzicom was considerably low, suggesting that this drug can be safely used in the Japanese population.
Highlights
In recent years, prognosis of human immunodeficiency virus type 1 (HIV-1) infection has been markedly improved by combinational antiretroviral therapy.It is no exaggeration to say that adherence to cART is the most important critical factor to determine success/failure of this therapy
The post-marketing surveillance indicated that the incidence of both ischaemic heart disease and hypersensitivity associated with
Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd
Summary
Prognosis of human immunodeficiency virus type 1 (HIV-1) infection has been markedly improved by combinational antiretroviral therapy (cART).It is no exaggeration to say that adherence to cART is the most important critical factor to determine success/failure of this therapy. Prognosis of human immunodeficiency virus type 1 (HIV-1) infection has been markedly improved by combinational antiretroviral therapy (cART). Epizicom is a fixed-dose combination tablet developed by GlaxoSmithKline, containing 300 mg of lamivudine and 600 mg of abacavir, for the purpose of improving adherence to drug intake and enabling once-daily oral administration of the backbone (one tablet/dose). Lamivudine has been used in many overseas clinical studies to show its effectiveness against HIV infection,[5,6,7,8,9,10] and it is listed as a favourable NRTI backbone combination in international and local HIV treatment guidelines as of 2012.2–4 Because this combined drug was approved in the USA in August 2004 and in Europe in December 2004, it has been approved in more than 40 countries by March 2011. The application for approval of Epzicom in Japan was subjected to preferential review as anti-HIV drug, and its review by the regulatory authority was made quickly on the
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