Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.A new study comparing two protease inhibitors used in the treatment of HIV patients showed similar efficacy and lipid effects between the two drugs. The head to head study evaluated the use of GlaxoSmithKline's Lexiva versus Bristol-Myers Squibb's Reyataz.
Subscribe to our email newsletter
Previous research has indicated that abnormal levles of lipids are associated with HIV patients on antiretroviral treatment. Abnormal lipid levels could lead to an increased risk of adverse cardiovascular events.
In total, 106 antiretroviral-naive patients took part in the study, which compared the efficacy and safety of Lexiva 1400mg/100mg to Reyataz (ATV) 300mg/100mg, each in combination with tenofovir and emtricitabine.
The patients were randomized to either treatment arm and received medication once daily. The study monitored changes in viral load, total cholesterol, HDL, LDL and triglycerides. At week 48, both treatment arms showed comparable viral suppression, changes in lipid levels, incidence of adverse effects, and CD-4 cell count improvements.
In the Lexiva arm, 75% of patients had a viral load of less than 50c/mL and 79% had a viral load of less than 400c/mL. This compared with 83% and 87% of patients taking ATV, respectively.
Treatment-related Grade 2-4 adverse events occurred in a similar proportion of patients in both arms with the exception of hyperbilirubinemia, a condition where there is too much bilirubin in the blood, which occurred in 43% of the patients in the ATV arm and in none of the patients treated with Lexiva.
A separate study provided additional information on the efficacy and impact on lipids of Lexiva with a lower dose of ritonavir – 100mg instead of 200mg-once-daily in treatment-naive patients. Ritonavir works with protease inhibitors to boost the medication level in the bloodstream making the protease inhibitor more effective in suppressing HIV.
Lexiva is indicated in combination with other antiretrovirals for the treatment of HIV infections and is usually boosted with 200mg of ritonavir. A regimen of Lexiva with a 100mg dose of ritonavir is not approved; however, it is currently being evaluated for use by the FDA, the company says.