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New Results From ARTEN Study of Nevirapine Plus Tenofovir and Emtricitabine (TDF/FTC) Versus Boosted Protease Inhibitor Regimen of Atazanavir/Ritonavir Plus TDF/FTC Revealed
Date:7/20/2009

CAPE TOWN, South Africa, July 20 /PRNewswire/ -- New data became available today at the 5(th) International AIDS Society Conference from ARTEN (Atazanavir/Ritonavir on a background of Tenofovir and Emtricitabine [Truvada(R)] versus Nevirapine). ARTEN is an open-label, multi-center and international non-inferiority clinical trial. It is the first large study to directly compare the efficacy and safety of nevirapine and ritonavir-boosted atazanavir (ATV/r) when combined with TDF/FTC, a modern backbone therapy commonly used with both nevirapine and ATV/r in clinical practice. All patients enrolled in the study had CD4+ cell counts as recommended in the prescribing information for nevirapine use (men <400 cells/mm3; women <250 cells/mm3). Nevirapine is marketed in the U.S. under the trademark name of Viramune(R) (nevirapine) tablets/oral suspension.

A total of 569 patients were in the study: 188 received once-daily nevirapine (400 mg), 188 received twice-daily nevirapine (200 mg) and 193 received ATV/r (300/100 mg once-daily). Nevirapine is not indicated for once-daily dosing. The safety and efficacy of once-daily dosing have not been established. All study participants also received tenofovir and emtricitabine (Truvada(R)).

The study's primary endpoint was virologic response at 48 weeks of treatment, with response defined as a viral load of <50 copies/mL measured at two consecutive visits prior to week 48 (i.e. suppression at weeks 24 and 36) and without subsequent rebound or change of therapy prior to week 48. In the primary analysis of the primary endpoint, the two nevirapine arms were combined. A non-inferiority endpoint with a two-tailed confidence interval of 5 percent within a 12 percent degree of certainty was applied. ARTEN follow-up is currently planned to continue for a total of 144 weeks.

"We're pleased to see that the ARTEN study met its primary endpoint," said Peter Piliero, M.D., executive director of Medical Affairs, Virology for Boehringer Ingelheim Pharmaceuticals, Inc. "The study also provides additional important data on the effect of VIRAMUNE on patient lipid profiles in antiretroviral naive patients."

Efficacy Data

Of the patients who received nevirapine in the study (n=376), 67 percent achieved the study's primary endpoint of viral load of <50 copies/mL versus 65 percent of ATV/r patients (n=193) [95% CI=0.059 to 0.98, p=0.63] at two consecutive visits prior to week 48 and without subsequent rebound or change of antiretroviral therapy prior to or at week 48.(1) In patients who began study treatment with viral loads above 100,000 copies/mL, 60 percent of nevirapine patients (n=230) and 52 percent (n=115) of ATV/r patients attained viral load of <50 copies/mL. In patients who began study treatment with viral loads below 100,000 copies/mL, 77 percent of nevirapine patients (n=146) and 85 percent of ATV/r patients (n=78) attained viral load of <50 copies/mL.(2) These results include patients who received once-daily nevirapine (400 mg). Nevirapine is not indicated for once-daily dosing. The safety and efficacy of once-daily dosing have not been established.

Lipid Profile Data

The mean increase from baseline in HDL levels was 9.7 mg/dL among nevirapine patients and 3.9 mg/dL among ATV/r patients (p<0.0001). The mean total cholesterol/HDL ratio in patients receiving nevirapine decreased from baseline (-0.24) and increased in patients receiving ATV/r (+0.13) (p =0.0001). The mean triglyceride levels decreased from baseline in the nevirapine group 0.2 mg/dL and increased 28.1 mg/dL in the ATV/r group (p <0.0001). Mean increases in LDL cholesterol were 15 mg/dL in the nevirapine group and 10.5 mg/dL in the ATV/r group (p=0.011).(3) These results include patients who received once-daily nevirapine (400 mg). Nevirapine is not indicated for once-daily dosing. The safety and efficacy of once-daily dosing have not been established

Safety/Tolerability Data

In the nevirapine group, the most common adverse event was rash/eruptions/exanthema (16.0 percent). Of the nevirapine-associated rashes that resulted in discontinuation, 76.2 percent (16 of 21) were identified during the two-week lead-in phase. The rate of hepatitis as reported by investigators was 1.6 percent in patients who received once-daily nevirapine, 2.1 percent in patients who received twice-daily nevirapine and 0.0 percent in patients who received ATV/r. Rates of liver enzyme elevations were 5.9 percent in patients who received once-daily nevirapine, 7.4 percent in patients who received twice-daily nevirapine and 1.6 percent in patients who received ATV/r. The rate of serious adverse events seen at 48 weeks in patients was 9.6 percent in the nevirapine group and 8.8 percent in the ATV/r group. Discontinuation due to adverse events was 13.6 percent in the nevirapine arms (51 of 376 patients), and 3.6 percent in the ATV/r arm (7 of 193 patients).(4) These results include patients who received once-daily nevirapine (400 mg). Nevirapine is not indicated for once-daily dosing. The safety and efficacy of once-daily dosing have not been established.

VIRAMUNE Important Safety Information

VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV infection.

VIRAMUNE does not cure HIV or AIDS, and has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination.

VIRAMUNE can cause severe liver disease and skin reactions that can cause death. These reactions occur most often during the first 18 weeks of treatment, but can occur later. Patients need to ask their HCP about how to recognize symptoms of skin and liver problems. VIRAMUNE should be discontinued and not restarted in patients who have any of these reactions.

Any patient can experience liver problems with VIRAMUNE, but women and patients who have higher CD4+ counts when they begin VIRAMUNE treatment have a greater risk. A woman with CD4+ >250 cells/mm3, or a man with CD4+ >400 cells/mm3 should not begin taking VIRAMUNE unless they and their HCP have decided that the benefit of doing so outweighs the risk. Women, including pregnant women, with CD4+ cell counts >250 cells/mm3 are at the greatest risk.

Do not take VIRAMUNE if you have severe liver problems.

The dose of VIRAMUNE for adults is one 200-mg tablet daily for the first 14 days, followed by one 200-mg tablet twice daily. VIRAMUNE is always taken with other anti-HIV medications. The 14-day lead-in period is important because it can help reduce your chances of getting a potentially serious skin rash. Patients who have a skin rash during the first 14 days should immediately contact their HCP and not increase their VIRAMUNE dose to twice a day. The total duration of the once-daily lead-in dosing period should not exceed 28 days, at which point an alternative regimen may need to be started.

Other side effects that patients have experienced include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. Changes in body fat may occur in patients receiving antiretroviral therapy. Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy.

Please see full Prescribing Information, including boxed WARNING, for VIRAMUNE at www.VIRAMUNE.com.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and approximately 41,300 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

References:

(1) Soriano, V et al., Prospective comparison of Nevirapine and Atazanavir/ritonavir both combined with Tenofovir DF/Emtricitabine in treatment-naive HIV-1 infected patients: ARTEN Study week 48 results 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009), July 19 -22, 2009, Poster LBPEB07.

(2) Data on File

(3) Soriano, V et al., Prospective comparison of Nevirapine and Atazanavir/ritonavir both combined with Tenofovir DF/Emtricitabine in treatment-naive HIV-1 infected patients: ARTEN Study week 48 results 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009), July 19 -22, 2009, Poster LBPEB07.

(4) Soriano, V et al., Prospective comparison of Nevirapine and Atazanavir/ritonavir both combined with Tenofovir DF/Emtricitabine in treatment-naive HIV-1 infected patients: ARTEN Study week 48 results 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009), July 19 -22, 2009, Poster LBPEB07.


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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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