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Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan.

Kurita T, Kitaichi T, Nagao T, Miura T, Kitazono Y - Pharmacoepidemiol Drug Saf (2014)

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.

View Article: PubMed Central - PubMed

Affiliation: ViiV Healthcare K. K., Tokyo, 151-8566, Japan.

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Change in plasma viral load and peripheral CD4+ T-cell count after the initiation of Ziagen therapy
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fig01: Change in plasma viral load and peripheral CD4+ T-cell count after the initiation of Ziagen therapy

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).


Safety analysis of Ziagen® (abacavir sulfate) in postmarketing surveillance in Japan.

Kurita T, Kitaichi T, Nagao T, Miura T, Kitazono Y - Pharmacoepidemiol Drug Saf (2014)

Change in plasma viral load and peripheral CD4+ T-cell count after the initiation of Ziagen therapy
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4230480&req=5

fig01: Change in plasma viral load and peripheral CD4+ T-cell count after the initiation of Ziagen therapy
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).

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.

View Article: PubMed Central - PubMed

Affiliation: ViiV Healthcare K. K., Tokyo, 151-8566, Japan.

Show MeSH
Related in: MedlinePlus