Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan.
Bottom Line: Serious adverse events were reported in 65 subjects; however, none of the three fatal cases were clearly associated with Ziagen use.These indicated that abacavir can be safely used in Japanese HIV+ population.However, the safety profile of Ziagen should be continued to be monitored through pharmacovigilance.
Affiliation: ViiV Healthcare K. K., Tokyo, 151-8566, Japan.Show MeSH
Related in: MedlinePlus
Mentions: The effectiveness analysis was performed on the subjects who received Ziagen tablet for at least 60 days and whose plasma viral load and CD4+ T-cell count before and after initiation of Ziagen treatment were available. The maximal duration of Ziagen administration was 3074 days (8.4 years). Note that, as shown in Table 2, 85.5% of HIV-positive subjects included in the present analysis had a history of antiretroviral treatment before starting Ziagen. The mean plasma viral load (HIV-RNA copies) was decreased from 3.3 ± 1.0 log copies/mL (mean ± standard deviation [SD]) before treatment to 2.7 ± 0.4 log copies/mL 3 months after the start of Ziagen administration (Figure 1A). Note that although the current detection limit of HIV-1 RNA quantification is 20–50 RNA copies/mL, it used to be 400 RNA copies/mL during the early phase of this survey; therefore, all of the values under 400 were uniformly treated as 399. The mean CD4+ T-cell count was increased from 339.1 ± 251.0/μL before treatment to 508.8 ± 264.9/μL 30 months after the start of Ziagen (Figure 1B).