The study indicates that treatment naïve patients on either regime achieve similar and impressive levels of viral suppression, with nearly three quarters achieving undetectable virus at 24 weeks in the intent-to-treat analysis. Notably, the results indicate that Invirase 500/r may have the added benefit of significantly fewer patients developing elevated cholesterol and triglycerides. Elevated lipids – a common side effect of several medications used to treat HIV infection, may add to the risk of developing cardiovascular disease. Now that patients are remaining on effective HIV treatment for longer, keeping a person with HIV healthy during treatment includes more than just treating the virus – it is essential that other factors that impact on patient quality of life such as high cholesterol and GI adverse events are considered.
"These early results suggest that boosted Invirase has the power to control the virus in treatment naïve patients, while also protecting their lipid profile," said Dr Jihad Slim, Infectious Disease Specialist, St Michael's Medical Centre and leader of the Gemini study. "If the final results show that boosted Invirase has such a good effect on viral suppression and lipids, we may see it being the preferred choice for many patients, especially those troubled by treatment side-effects."
About the Gemini study
The Gemini study is a Phase IIIb multi-centre, randomised open-label, 48 week study, designed to evaluate the efficacy and safety of Invirase 500/r versus lopinavir/r. These treatments are given at their approved twice-daily dosages in combination with two nucleoside reverse transcriptase inhibitors (NRTIs; emtricitabine/tenofovir (Truvada), once daily) in treatment naïve adults. Gemini enrolled 337 patients from Canada, France, Puerto Rico, Thailand and the USA. The primary endpoint of the trial is the number of patients with an HIV-1 RNA viral load of <50 copies m/L at week 48. There are two planned interim analyses.
The first interim analysis show similar rates of viral suppression and improvement of CD4 counts throughout the first 24 weeks of treatment, for the first 150 patients enrolled. Invirase 500/r demonstrated no significant increase in incidence of high cholesterol (> 200 mg/dl) or high triglycerides (> 400 mg/dl)
- Only 4% of saquinavir/r patients developed high cholesterol (> 200 mg/dl) compared with 25% of lopinavir/r patients (p=0.036)
- Only 1% of Invirase 500/r patients developed high triglycerides (> 400 mg/dl) compared with 9% of lopinavir/r patients (p=0.009)
Real life data show good lipid sparing effects of Invirase 500/r Further data presented at HIV-8 today from the RAINBOW2 and IPanema3,4 observational studies, involving collectively over 1,500 patients, provide further evidence to support the beneficial lipid effect seen in the Gemini study in a 'real life' clinical setting. Both studies demonstrated that the effect of Invirase 500/r on lipids was generally minor.
Importance of managing lipid levels in HIV treatment
The use of HIV combination therapy has been associated with an increased risk of cardiovascular disease which may be explained by the change in lipids caused by these treatments. As people with HIV are living for longer due to advances in treatment, it is especially important to establish regimens that minimise the adverse effects on lipids to reduce the risk of cardiovascular disease.
Notes for editors:
About boosted Invirase
Invirase, originally approved by the FDA in 1995, was the first protease inhibitor on the market. Its introduction represented a major milestone in the treatment of HIV/AIDS. In December 2003, the FDA approved Invirase for use in boosted dosing regimens with ritonavir (1000 mg Invirase/100 mg ritonavir bid). Co-administering Invirase with ritonavir enhances therapeutic blood levels of the drug ("boosting") and enables simplified dosing.
The Invirase 500 mg formulation received approval from the US Food and Drug Administration (FDA) in December 2004 and from the European Commission in May 2005. The new formulation significantly simplifies the Invirase dosing regimen by reducing the daily tablet count by more than half, from five tablets twice-daily to two tablets twice-daily.
Boosted Invirase provides exceptional and well proven control of HIV.5 Data from the Staccato clinical study show reductions in patients' HIV RNA recorded in the first 24 weeks on therapy that are the best ever seen in a large cohort of patients given HAART. Some 96% of patients achieved viral load reductions to <400 HIV RNA copies m/L and 89% were shown to have undetectable levels (<50 copies m/L). Over the 24 week induction phase of the study, these reductions in patient viral load were accompanied by a median increase of CD4 cells of 109 cells/mm.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceutical Division totalled 27.3 billion Swiss francs, and the diagnostics division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
- Slim, J et al. Saquinavir/r (SQV/r) BID vs lopinavir/r (LPV/r) BID plus emtricitabine/tenofovir (FTC/TDF) QD in ARV-naïve HIV-1 infected patients: GEMINI Study. Presented at HIV-8, Glasgow, 2006.
- Knechten, H et al. The RAINBOW - COHORT: successful initiation/switch with/to the new saquinavir 500mg formulation – first results from Germany. Presented at HIV-8, Glasgow, 2006.
- Sanz J. IPanem Cohort: Evolution of lipid and hepatic parameters in patients treated with SQV/r used in its 200mg and 500mg formulations. Presented at HIV-8, Glasgow, 2006.
- Ortega E. IPanem Cohort: Evolution of lipid and hepatic parameters in patients treated with SQV/r used in OD or BID dosing. Presented at HIV-8, Glasgow, 2006.
- Ananworanich J et al. A prospective study of efficacy and safety of once-daily saquinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors in treatment-naive Thai patients. Antiviral Therapy 2005; 10(6): 761-767