New Data Suggest Boosted Invirase® Has Similar Efficacy to Boosted Lopinavir in HIV Patients at 24 Weeks
A new interim analysis of an international, head-to-head trial suggests that HIV patients treated with the protease inhibitor Invirase® 500 (saquinavir mesylate boosted with ritonavir) achieved similar efficacy, in terms of viral suppression and increases in CD4 cells, to those treated with lopinavir/ritonavir (Kaletra®), while being less likely to develop elevated lipid levels. These results, from a planned 24-week interim analysis of all 337 patients enrolled in the Roche-sponsored Gemini study, were presented today at the 4th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Sydney, Australia.
Current treatment guidelines for highly active antiretroviral therapy (HAART) include a boosted protease inhibitor (PI) as an option for first-line treatment of HIV-infected patients. However, PI-based regimens can be associated with varying degrees of lipid abnormalities, potentially increasing the long-term risk of cerebrovascular and cardiovascular disease. As people with HIV are living longer due to advances in treatment, it is especially important to establish regimens that minimize the adverse effects on lipids to potentially reduce the risk of cardiovascular disease.
“The full interim results from the Gemini study further suggest that boosted Invirase may be a good choice for many patients, particularly those with increased cardiovascular risk,” said Dr. Jihad Slim, Infectious Disease Specialist, St. Michael’s Medical Centre and an investigator in the Gemini study. “We need to be able to offer safer options for patients on combination HIV therapy – and establishing a PI-based regimen that is associated with fewer lipid abnormalities could have a real impact on HIV management.”
Gemini: Summary of Full 24-Week Results
Efficacy results showed that 69.9 percent and 69 percent of patients, respectively, treated with Invirase/ritonavir (r) (n=166) and lopinavir/r (n=171) achieved undetectable HIV levels (less than 50 copies per mL of blood; ITT analysis). The same proportion of patients (81.3 percent) in both groups achieved undetectable of less 400 copies per mL of blood. Furthermore, the rate and extent of increases in CD4 counts were comparable in both groups, with a median increase from baseline of 127 cells per cubic mL of blood for patients in the Invirase/r group, and 134 cells for patients in the lopinavir/r group.
A total of 163 patients in the Invirase/r group and 168 patients in the lopinavir/r group were included in the safety analysis. At 24 weeks, patients treated with Invirase/r showed a lower median increase in their total cholesterol (TC) and total triglycerides (TG) than patients treated with lopinavir/r (increase of 17 versus 26 mg/dL for TC, and an increase of 14 versus 43 mg/dL for TG). In addition, there was a trend toward fewer Invirase/r-treated patients experienced an increase in their lipid profiles, above those recommended by the National Cholesterol Education Program and ACTG guidelines, than those treated with lopinavir/r. In the Invirase/r group, the proportion of patients with TC levels above those recommended in guidelines was 21.5 vs. 26.8 percent for the lopinavir/r group; for LDL levels, 49.7 vs. 40.5 percent; and in TG levels, 1.2 vs. 8.9 percent. In the Invirase/r group, five patients withdrew due to adverse events, and in the lopinavir/r group, 11 patients withdrew due to adverse events.
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