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New Study Indicates Boosted Invirase 500 Patients Achieve Similar Levels of Viral Suppression to Boosted Lopinavir but with a Better Lipid Profile

Glasgow, Scotland, November 13 (ots/PRNewswire)

- Patients Treated With Boosted Invirase 500 Were Significantly
Less  Likely to Develop Elevated Lipids Than Boosted Lopinavir
Promising head to head results presented today indicate that the
boosted protease inhibitor (PI/r) Invirase 500/r appears to achieve
similar levels of viral suppression compared to the most commonly
used PI, lopinavir/r, while significantly fewer patients developed
elevated lipids. These results are from a planned 24 week interim
analysis of 150 patients from the Gemini study presented at the HIV-8
congress in Glasgow [1].
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)
Also, fewer gastro-intestinal (GI) adverse events were seen in the
Invirase 500/r arm (14% vs. 23%) with lower incidences of nausea and
diarrhoea.
Real life data show good lipid sparing effects of Invirase 500/r
Further data presented at HIV-8 today from the RAINBOW[2]  and
IPanema[3],[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).
1. 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.
2. 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.
3. 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.
4. 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.
5. 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

Contact:

Contact: Janet Kettels, Roche, + 1-862-259-9084 (mobile), Peter
Impey, Ketchum, +44-7976-734-493 (mobile)

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