For dose preparation for each subject, 70 ml of sterile water for irrigation was added to the bottle containing the 700-mg mixture of [14 C]abacavir succinate and [12 C]abacavir succinate powders. The safety and efficacy of abacavir/lamivudine in children weighing less than 25 kg has not been established.Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on posology can be made. In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness). For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines. These metabolites are excreted in the urine. The subjects in the low viral load stratum remained blinded and on-study.Analysis of the data from subjects in the low viral load stratum showed no demonstrable difference between the nucleoside backbones in the proportion of patients free of virological failure at week 96. A similar effect was not seen in rats even at very high systemic exposure. This recurrence is usually more severe than on initial presentation, and may include life-threatening hypotension and death. Overall the available data from observational cohorts and from randomised trials show some inconsistency so can neither confirm nor refute a causal relationship between abacavir treatment and the risk of myocardial infarction. Results at 48 weeks indicated that the abacavir/lamivudine group was associated with a similar virologic outcome (non-inferior) compared to the abacavir plus lamivudine group, based on proportions of subjects with HIV-1 RNA < 50 copies/ml (90% and 85% respectively, 95% CI -2.7, 13.5).A genotypic sensitivity score (GSS) has not been established by the MAH for the abacavir/lamivudine combination. Patients were stratified at screening based on plasma HIV-1 RNA levels < 100,000 and ≥ 100,000 copies/mL.An interim analysis from ACTG 5202 revealed that abacavir/lamivudine was associated with a statistically significantly higher risk of virological failure as compared to emtricitabine/tenofovir (defined as viral load >1000 copies/mL at or after 16 weeks and before 24 weeks or HIV-RNA level >200 copies/mL at or after 24 weeks) in subjects with a screening viral load ≥100,000 copies/mL (estimated hazard ratio: 2.33, 95% CI: 1.46, 3.72, p=0.0003).
Abacavir/Lamivudine is contraindicated in patients with moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Studies in animals showed that neither abacavir nor lamivudine had any effect on fertility (see section 5.3).No studies on the effects on ability to drive and use machines have been performed. Readily available genotypic drug resistance interpretation algorithms and commercially available susceptibility tests have established clinical cut offs for reduced activity for abacavir and lamivudine as separate drug entities that predict susceptibility, partial susceptibility or resistance based upon either direct measurement of susceptibility or by calculation of the HIV-1 resistance phenotype from the viral genotype. This site uses cookies. Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.Abbreviations: ↑ = Increase; ↓ = decrease; ↔ = no significant change; AUC = area under the concentration versus time curve; Cmax = maximum observed concentration; CL/F = apparent oral clearanceInteraction studies have only been performed in adults.As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.