Safety analysis of Epzicom® (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan.
Bottom Line: To 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.It was found that the incidence of ADR was 32.4% (202/624 cases) on the case basis.The 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.
Affiliation: ViiV Healthcare K.K., Tokyo, 151-8566, Japan.Show MeSH
Related in: MedlinePlus
Mentions: Effectiveness analysis was performed on only TN patients whose HIV surrogate markers (plasma viral load and CD4 + T-cell count) at baseline and after the start of Epzicom were available. Among the TN patients who received therapy including Epzicom for 12 consecutive months, the percentages of patients with plasma HIV-RNA <400 copies/mL and <50 RNA copies/mL were 97.5% (130/134) and 74.6% (101/134), respectively. In addition, among the TN patients treated for 24 consecutive months, the percentages were 97.5% (74/76) and 73.7% (56/76), respectively (Figure 1a). When the patients were stratified according the baseline HIV-RNA level (cutoff level: 100 000 copies/mL), plasma viral load at 12 and 24 months was <400 copies/mL in the majority cases, whereas the percentage of cases <50 RNA copies/mL was lower regardless of the baseline viral load (<100 000 RNA copies/mL, 77.8% [12 months], 80.0% [24 months]; >100 000 RNA copies/mL, 70.5% [12 months], 61.5% [24 months]) (Figure 1b and 1c). The mean CD4 + T lymphocyte count increased from 180/μL (baseline) to 444/μL after 24 months of the Epzicom treatment (Figure 2).