Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
PRNewswire - October 31, 2004
In this open-label trial known as Study 934, approximately 500 treatment- naive people with HIV-1 infection received either tenofovir disoproxil fumarate (TDF) 300 mg + emtricitabine (FTC) 200 mg once daily or 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 the new treatment compared with the control at 48 weeks. The 24-week results from the preliminary analysis show the proportion of patients achieving and maintaining HIV-1 RNA less than 400 copies/mL through 24 weeks was 87 percent with TDF/FTC/EFV and 78 percent with Combivir/EFV in the intent-to-treat analysis. Although Combivir was associated with a higher incidence of treatment discontinuations due to adverse events (9 vs 3 percent) in this early timeframe, the two arms were virologically equivalent. Given the need for life-long treatment for HIV, availability of long-term safety and efficacy data is important when choosing a regimen.
"Combivir is a well-studied and well-understood drug with more than 40 clinical trials involving more than 12,500 patients since 1997. We are always interested in learning more about new and existing drugs for the treatment of HIV," said Doug Manion, M.D., vice president for HIV Clinical Research for the Infectious Diseases Medicines Development Center (MDC) at GSK.
GSK recommends caution when evaluating these results, for several reasons. First, durable suppression of HIV replication has not been demonstrated with the combination of TDF and FTC. Second, the non-blinded nature of this study allows outcomes to be influenced by patient and investigator biases, which is why double-blind methodology is a more robust method. Third, premature public release of data may render uninterpretable study results at a later time point in this open-label trial.
Combivir is a preferred NRTI backbone in the DHHS guidelines for the treatment of therapy-naive patients. One out of three 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(R) (lamivudine) and RETROVIR(R) (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(R) (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.
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 2003, GlaxoSmithKline donated more than $205 million worth of prescription drugs to 400,000 patients. For more information visit http://www.bridgestoaccess.gsk.com or call 1-866-PATIENT.
For full prescribing information for COMBIVIR please go to http://www.treathiv.com.
SOURCE GlaxoSmithKline
Web Site: http://www.bridgestoaccess.gsk.com
http://www.treathiv.com
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