Final Gemini Study Results Confirm Boosted Invirase Was as Effective as Kaletra While Providing an Improved Triglyceride Profile for HIV Patients

Final 48-week results from an international head-to-head trial, presented today at the 11th European AIDS Conference (EACS), Madrid, demonstrated that treatment-naive HIV patients treated with the protease inhibitor Invirase® 500mg tablets (saquinavir mesylate), boosted with ritonavir, achieved similar levels of viral suppression and increases in CD4 cells compared to those treated with Kaletra® (lopinavir/ritonavir), a commonly used protease inhibitor. Furthermore, fewer patients treated with Invirase developed elevated triglyceride levels.

“We urgently need HIV treatment options with more favorable lipid profiles, and this is why I welcome the results from the Gemini study,” said Professor Sharon Walmsley, Associate Professor of Medicine in the Division of Infectious Diseases, University of Toronto, Canada, and lead investigator on the Gemini study. “These data are of considerable importance because they confirm that Invirase offers treatment-naïve patients an effective treatment to control the virus with significantly smaller increases in triglyceride levels than lopinavir, the most commonly prescribed PI.”

Current treatment guidelines for highly active antiretroviral therapy (HAART) include a boosted protease inhibitor (PI/r) as an option for first-line treatment of HIV-infected patients. However, all PI-based regimens can be associated with varying degrees of lipid abnormalities, potentially increasing the risk of developing metabolic syndrome and long-term risk of cerebrovascular and cardiovascular disease. As people with HIV are living for longer due to advances in treatment, it is especially important for trials to explore, and for physicians to consider, the lipid profiles of the various treatment options.

Gemini: Summary of 48-Week Results

These highly anticipated findings are from the final, 48-week analysis of all 337 patients in the Gemini study. The data show that boosted Invirase 500 was not inferior to lopinavir/r, with 64.7 percent and 63.5 percent of patients treated with Invirase/r and lopinavir/r, respectively, achieving undetectable HIV (less than 50 copies per mL of blood. A similar number of patients in both groups (approximately 73 percent) achieved undetectable HIV of less than 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 178 for the Invirase/r-treated patients and 204 for lopinavir/r patients. Finally, the results demonstrate that there was no statistically significant difference in the number of virological failures between the two treatment groups. Adverse events were reported with similar frequency in both study arms.

At 48 weeks, patients treated with Invirase/r showed a lower median increase in their total triglycerides (TG) than patients treated with lopinavir/r (increase of 14 versus 55 mg/dL for TG). In addition, the number of Invirase/r-treated patients who experienced an increase in their lipid levels above those recommended by National Cholesterol Education Program (NCEP) guidelines, as measured by total cholesterol and triglyceride levels, was numerically lower than those treated with lopinavir/r. In the Invirase/r group, the proportion of patients with total cholesterol levels above those recommended in guidelines at week 48 was 31 percent vs. 39 percent for the lopinavir/r group; in TG levels, one percent vs. nine percent; and for LDL levels, 34 vs. 24 percent.