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GSK Perpective on Tenofovir 934 study in NEJM
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GSK issued this press release.
"GlaxoSmithKline Perspective on Data Involving Combivir Published in New England Journal of Medicine"
Raleigh, N.C. - January 18, 2006 - Data from a Gilead Sciences open-label study of tenofovir plus emtricitabine plus efavirenz and the fixed
dose combination product Combivir (lamivudine 150 mg/zidovudine 300 mg) plus efavirenz were recently published in a peer-reviewed clinical journal. In this trial, known as Study 934, 517 treatment-na¥ve people with HIV-1 infection were randomized to either tenofovir disoproxil fumarate (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily or to GlaxoSmithKline's (GSK) fixed-dose combination Combivir 1 tablet twice a day, each in combination with efavirenz 600 mg once daily (EFV). The study was designed to show non-inferiority of tenofovir/emtricitabine plus efavirenz to Combivir plus efavirenz at 48 weeks. However, it is difficult to draw conclusions regarding comparative safety and efficacy of these regimens from a single, open-label trial.
Given the need for life-long treatment for HIV, availability of long-term safety and efficacy data is important when choosing a regimen. Combivir has a well-described safety and efficacy profile that has been derived from many short-term and long-term studies. In total, Combivir and its components have been evaluated in more than 50 randomized clinical trials involving more than 18,000 patients since 1995.
Results seen with Combivir plus EFV in this trial were positive and reinforce the value of Combivir demonstrated in previous research. The results show that the proportion of patients achieving and maintaining HIV-1 RNA less than 400 copies/mL through 48 weeks was 73 percent with Combivir plus EFV in the intent-to-treat analysis compared to 84 percent with TDF plus FTC plus EFV. In an intent-to-treat analysis, discontinuations due to adverse events are counted as treatment failures. In this trial, the higher than usual rate of anemia associated with the arm containing Combivir contributed to the difference in treatment failures. The number of virologic failures seen with Combivir was low (9 in the Combivir plus EFV arm, 4 in the TDF and FTC plus EFV arm). Nine percent of patients receiving Combivir plus EFV withdrew from the trial due to adverse events compared to 4 percent of patients receiving TDF and FTC plus EFV. Given the open label nature of this trial, public release of the 24-week results may have contributed to the higher discontinuation rate seen in the arm containing Combivir.
"We are always interested in learning more about existing treatments for HIV, but we realize the limited value of a single, open-label study to make comparisons among products," said Mark Shaefer, PharmD., acting vice president for HIV Clinical Research for the Infectious Diseases Medicines Development Center (MDC) at GSK. "Fortunately, Combivir is one of the most studied HIV therapies on the market with a wealth of information available."
It is not unusual to see slightly different rates for certain outcomes across clinical trials. In this study, six percent of patients in the Combivir plus EFV arm experienced anemia leading to discontinuation. However, this is higher than typical clinical experience. Protocol definitions of anemia, baseline hemoglobin and hematocrit levels and chance can all influence the results. The prescribing information for Combivir reports a 2.9 percent incidence of anemia. Combivir is a preferred NRTI backbone in the DHHS guidelines for the treatment of therapy-na¥ve patients. One out of five people currently taking antiretrovirals in the U.S. is taking Combivir. It is the most studied and most widely prescribed dual nucleoside combination product to date.
Product Information
HIV medicines do not cure HIV/AIDS or prevent passing HIV to others.
COMBIVIR is a combination tablet containing EPIVIR (lamivudine) and RETROVIR (zidovudine). COMBIVIR in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
EPIVIR in combination with other antiretroviral agents is indicated for the treatment of HIV infection. Patients with HIV or coinfected with HIV and hepatitis B should only receive the recommended HIV dosage of EPIVIR (300 mg/day) and not EPIVIR-HBV (100 mg/day). EPIVIR has not been adequately studied for treatment of chronic hepatitis B in coinfected patients. Some patients infected with both HIV and hepatitis B virus (HBV) have worsening of hepatitis after stopping EPIVIR. Patients should discuss any change in treatment with their doctor. Coinfected patients should be closely monitored by their doctor for at least several months after stopping treatment.
RETROVIR in combination with other antiretroviral agents is indicated for the treatment of HIV infection. Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia particularly in patients with advanced HIV disease. Prolonged use of zidovudine has been associated with symptomatic myopathy.
Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia particularly in patients with advanced HIV disease. Prolonged use of RETROVIR has been associated with symptomatic myopathy.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including COMBIVIR and other antiretrovirals.
Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy. The causal relationship, mechanism and long-term consequences of these events are currently unknown.
The most common side effects with COMBIVIR are headache (35 percent), nausea (33 percent), tiredness (27 percent) and nasal signs and symptoms (20 percent).
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.
GSK's Bridges to Access program can help provide qualified individuals with access to GSK's medications, as well as help identify insurance or other support for medications. Patients may be eligible for this program if they are not eligible for prescription drug benefits through any other private or public insurer, payer, or program. In 2004, GlaxoSmithKline donated more than $372.5 million worth of prescription drugs to 475,000 patients. For more information visit www.bridgestoaccess.gsk.com or call 1-866-PATIENT.
For full prescribing information for COMBIVIR please go to www.treathiv.com.
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