GSK presents Lexiva and atazanavir comparability study results

GlaxoSmithKline (GSK) has presented the results of a clinical trial comparing Lexiva (fosamprenavir calcium) and atazanavir, two protease inhibitors used in the treatment of patients with HIV.

In the head-to-head study presented at the International Aids Society conference in Sydney, the compounds showed similar efficacy and comparable lipid effects.

The Alert study measured viral load and triglycerides, in addition to HDL, LDL and total cholesterol, in patients administered with the drugs, noting that at week 48 of treatment, patients in both arms of the study showed similar rates of viral suppression and CD-4 cell count improvements, in addition to comparable changes in lipid levels, while the drugs also had a similar safety profile.

An additional study also presented at the conference explored the effect on the efficacy and impact of lipids of administration of Lexiva with a reduced dose of ritonavir, with patients receiving a daily dose of 100 mg of the latter compound, rather than 200 mg.

“Lexiva is indicated in combination with other antiretrovirals for the treatment of HIV infections and is usually boosted with 200 mg of ritonavir,” GSK reports.

It adds that treatment of Lexiva with a reduced 100 mg dose of ritonavir is not currently approved with regulatory bodies, but is currently being evaluated by the US Food and Drug Administration.

In August 2006, Lexiva was recommended as a treatment for HIV patients by the International Aids Society.