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EPZICOM + atazanavir regimen provided comparable efficacy to EPZICOM + atazanavir/ritonavir regimen in treatment-naïve HIV-infected patients - press release
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Press release from GSK
Cape Town, South Africa, July 22, 2009 - GlaxoSmithKline (GSK) announced today clinical trial results that showed patients taking an HIV treatment regimen of EPZICOM® (abacavir (ABC) and lamivudine) and atazanavir experienced similar efficacy to subjects taking EPZICOM and atazanavir boosted with ritonavir. All patients in this study had achieved virologic suppression on an initial regimen of EPZICOM and atazanavir/ritonavir prior to randomization. At 84 weeks, results from the randomized phase of the Atazanavir- Ritonavir Induction with Epzicom Study (ARIES) show that patients in the ritonavir-sparing group performed similarly to patients in the continuation group taking ritonavir. Overall, patients in both treatment arms showed good virologic response.
Both treatment regimens were generally well tolerated over 84 weeks. Subjects in the ritonavir-sparing arm experienced greater reductions in total cholesterol, triglyceride and bilirubin levels compared to those in the continuation arm. These results were presented at the 5th International AIDS Society Conference on HIV Pathogenesis Treatment and Prevention in Cape Town, South Africa.
"Any steps we can take to reduce the number of pills for HIV patients is helpful in lowering medication costs," said Judith Ng-Cashin, M.D. Vice President for Infectious Diseases, GlaxoSmithKline. "These data show that a ritonavir-sparing regimen of EPZICOM and atazanavir is an effective option for appropriate therapy naive patients who have achieved virologic suppression taking EPZICOM and ritonavir-boosted atazanavir."
ARIES Study Results
A total of 419 patients completed the 36-week Induction phase and met eligibility criteria to continue in the 48-week randomized phase, which compared the ritonavir-sparing regimen, EPZICOM+atazanavir 400 mg (n=210) once daily to the continuation regimen EPZICOM+atazanavir/r 300 mg/100 mg (n=209) once daily. The primary efficacy endpoint was the percentage of subjects who achieved an HIV viral load <50 copies (c)/mL at week 84 using the 'time to loss of virologic response' (TLOVR) algorithm.
Eighty-six (86) percent of patients (n=181) in the ritonavir-sparing group achieved an HIV viral load <50 c/mL compared to 81 percent (n=169) in the EPZ+atazanavir/r treatment arm at 84 weeks. Using a secondary endpoint, HIV viral load <400 c/mL, 92 percent and 86 percent of patients, respectively, achieved this virologic endpoint. Few subjects had protocol-defined virologic failure in either the ritonavir-sparing arm (n=1) or the continuation arm (n=7).
The overall incidence of treatment-related grade 2-4 adverse events (AEs) during the randomization phase was comparable in both treatment arms, with 10 percent in the ritonavir-sparing arm and 14 percent in the continuation arm. Those events leading to study discontinuation were 1 percent and 3 percent, respectively. From weeks 36-84, significantly greater decreases in total cholesterol (-14, 6 mg/dL; P<0.0001), triglycerides (-34, -4 mg/dL; P<0.0001) and total cholesterol/HDL ratio (-0.34, 0; P=0.0004) were observed in patients in the ritonavir-sparing arm compared to those in the continuation arm, respectively. The decrease in total bilirubin from week 36 to week 84 was significantly larger in the ritonavir-sparing arm compared to the continuation arm (P<0.0001)
The ARIES Trial
The ARIES trial is the first large North American study utilizing HLA-B*5701 screening to reduce the risk for ABC hypersensitivity reaction (HSR) as a study-inclusion criteria. The trial screened a total of 725 patients for the presence of the HLA-B*5701 allele. Forty-one patients (5.7%) were HLA-B*5701-positive and were excluded from participation due to their higher risk for developing an ABC HSR. The trial enrolled 515 HLA-B*5701-negative patients who subsequently initiated an abacavir-containing regimen. Through 84 weeks of treatment, less than 1 percent of these HLA-B*5701-negative patients were diagnosed with clinically suspected HSR. All four patients who were diagnosed with a clinically suspected ABC HSR underwent abacavir skin patch testing at least six weeks after resolution of HSR symptoms. Skin patch test results were negative for all four subjects. Skin patch testing was used as a research tool in this clinical trial setting and should not be used to aid in the clinical diagnosis of abacavir hypersensitivity.
About Abacavir and Hypersensitivity
Abacavir sulfate (abacavir) is a nucleoside reverse transcriptase inhibitor with an established safety and efficacy profile in HIV treatment. Abacavir is a component in the GSK products ZIAGEN®, TRIZIVIR® and EPZICOM®. The most significant treatment-limiting event known to occur with abacavir is a hypersensitivity reaction, which occurs in approximately eight percent of patients and usually emerges within the first six weeks of therapy.
Symptoms of a hypersensitivity reaction to abacavir include combinations of at least two of the following: fever, rash, constitutional symptoms, gastrointestinal symptoms and respiratory symptoms that become more severe with continued dosing and may become potentially life-threatening. These symptoms may overlap with adverse events related to other HIV medications and other medical conditions, contributing to difficulty in diagnosis on the basis of symptoms alone.
Results from HLA-B*5701 testing to assess risk for abacavir HSR should never substitute for appropriate clinical vigilance for ABC HSR and patient management in individuals undergoing treatment with abacavir-containing products.
About HLA-B*5701 Screening
HLA-B*5701 screening should be performed in patients without prior abacavir exposure.
It is important to discontinue abacavir permanently if hypersensitivity cannot be ruled out, regardless of the result of the HLA-B*5701 testing.
HLA-B*5701 testing should never be performed to support a decision to re-challenge with abacavir.
HLA-B*5701 screening for the risk of abacavir hypersensitivity should never substitute for appropriate clinical vigilance and patient management in individuals undergoing treatment with abacavir-containing products.
Skin patch testing was a research tool used in this study to detect an immunologic skin reaction to abacavir. Its utility in clinical practice, however, has not been established.
Important Information about EPZICOM
EPZICOM, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in adults.
EPZICOM is one of 3 medicines containing abacavir. Before starting EPZICOM, your healthcare professional will review your medical history in order to avoid the use of abacavir if you have experienced an allergic reaction to abacavir in the past.
In one study, more patients had a severe hypersensitivity reaction in the abacavir once-daily group than in the abacavir twice-daily group.
EPZICOM should not be used as part of a triple-nucleoside regimen.
EPZICOM does not cure HIV infection/AIDS or prevent passing HIV to others.
Important Safety Information
EPZICOM contains abacavir, which is also contained in ZIAGEN® (abacavir sulfate) and TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine). Patients taking EPZICOM may have a serious allergic reaction (hypersensitivity reaction) that can cause death.
If you get a symptom from 2 or more of the following groups while taking EPZICOM, stop taking EPZICOM and call your doctor right away:
1. Fever
2. Rash
3. Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
4. Generally ill feeling, extreme tiredness, or achiness
5. Shortness of breath, cough, or sore throat
Carefully read the Warning Card that your pharmacist gives you and carry it with you at all times.
If you stop EPZICOM because of an allergic reaction, NEVER take EPZICOM or any other abacavir-containing medicine (ZIAGEN, TRIZIVIR) again. If you take EPZICOM or any other abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may include very low blood pressure or death.
Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B-5701 than if you do not.
If you stop EPZICOM for any other reason, even for a few days, and you are not allergic to EPZICOM, talk with your healthcare professional before taking it again. Taking EPZICOM again can cause a serious or life-threatening reaction, even if you never had an allergic reaction before. If your healthcare professional tells you that you can take EPZICOM again, start taking it when you are around medical help or people who can call a doctor if you need one.
A build-up of lactic acid in the blood and an enlarged liver, including fatal cases, has been reported.
Do not take EPZICOM if your liver does not function normally.
Some patients infected with both hepatitis B virus (HBV) and HIV have worsening of hepatitis after stopping lamivudine (a component of EPZICOM). Discuss any change in treatment with your doctor. If you have both HBV and HIV and stop treatment with EPZICOM, you should be closely monitored by your doctor for at least several months.
Worsening of liver disease (sometimes resulting in death) has occurred in patients infected with both HIV and hepatitis C virus who are taking anti-HIV medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking EPZICOM as well as interferon with or without ribavirin and you experience side effects, be sure to tell your doctor.
When you start taking HIV medicines, your immune system may get stronger and could begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your doctor.
Some HIV medicines, including those containing abacavir (ZIAGEN®, EPZICOM®, and TRIZIVIR®), may increase your risk of heart attack.
Changes in body fat may occur in some patients taking antiretroviral therapy. These changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from the legs, arms, and face may also occur. The cause and long-term health effects of these conditions are not known at this time.
Some HIV medicines, including those containing abacavir (ZIAGEN, EPZICOM or TRIZIVIR), may increase your risk of heart attack. If you have heart problems, smoke, or suffer from diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes, tell your doctor.
The most common side effects seen with the drugs in EPZICOM dosed once-daily were allergic reaction, trouble sleeping, depression, headache, tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain, abnormal dreams, and anxiety. Most of the side effects do not cause people to stop taking EPZICOM.
For additional important information about EPZICOM please visit www.epzicom.com.
For additional important information about ZIAGEN please visit www.treathiv.com
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and an industry leader in HIV research and therapies. The company is engaged in basic research programs designed to investigate new targets to treat HIV. For full information on GSK's HIV medications, please visit www.treatHIV.com.
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