AEGiS-PRn: Updated Federal Guidelines Recommend RETROVIR + EPIVIR as Part of First-Line Therapy in ART Regimens: Recommended Drugs Available as COMBIVIR Fixed Dose Tablet

Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.

Updated Federal Guidelines Recommend RETROVIR + EPIVIR as Part of First-Line Therapy in ART Regimens: Recommended Drugs Available as COMBIVIR Fixed Dose Tablet

PRNewswire - November 18, 2004

RESEARCH TRIANGLE PARK, N.C., Nov. 18 /PRNewswire/ -- Revised federal guidelines recommend RETROVIR(R) (zidovudine, ZDV) and EPIVIR(R) (lamivudine, 3TC) as one of the preferred dual nucleoside reverse transcriptase inhibitor (NRTI) "backbones" used as part of initial HIV combination therapy. RETROVIR and EPIVIR are available as COMBIVIR(R) (lamivudine and zidovudine), which delivers a fixed-dose combination of both NRTIs in a single tablet taken twice daily (BID) with or without food. The recommendations, developed by the U.S. Department of Health and Human Services (DHHS), were recently updated and published (October 29, 2004).

Dual nucleoside combinations are the most frequently used foundation of combination antiretroviral regimens. Inclusion of a protease inhibitor (PI) and/or a non-nucleoside reverse transcriptase inhibitor (NNTRI) with a dual nucleoside combination adds potency to the regimen for long-term efficacy, according to the guidelines. COMBIVIR is the most-prescribed, most-studied NRTI backbone.

"Combivir is a well-studied drug with more than 40 clinical trials involving more than 17,000 patients since 1997. Prescribing physicians and healthcare providers are familiar with these medications, which have a well-known resistance profile and favorable short-term and long-term safety profiles backed by years of experience," said Doug Manion, M.D., vice president for HIV Clinical Research for the Infectious Diseases Medicines Development Center (MDC) at GlaxoSmithKline (GSK), manufacturer of RETROVIR, EPIVIR and COMBIVIR.

According to the DHHS guidelines, regimens are designated as "preferred" for use in treatment-naive patients when clinical trial data suggest durable efficacy with acceptable tolerability in a convenient formulation. "Combivir was the first fixed-dose combination drug developed for HIV and the first in our ongoing efforts to lower the pill burden and help simplify treatment regimens for patients living with HIV," Dr. Manion said. The complete DHHS guidelines, Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents, are available at: http://aidsinfo.nih.gov/guidelines .

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, EPIVIR, and RETROVIR in combination with other antiretroviral agents are indicated for the treatment of HIV infection. EPIVIR should be used with caution in pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis. 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 lamivudine (EPIVIR and a component of COMBIVIR). 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 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.

Most frequent adverse events with COMBIVIR are headache (35 percent), nausea (33 percent), malaise/fatigue (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, RETROVIR and EPIVIR please go to http://www.treathiv.com .

At a Glance

-- The recommended antiretrovirals are available as COMBIVIR, a fixed dose combination tablet that is taken twice daily with no food or water restrictions.

-- DHHS "preferred" status is based on clinical trial data suggesting durable efficacy of a drug regimen, combined with acceptable tolerability in a convenient formulation.

-- COMBIVIR is a well-studied drug with more than 40 clinical trials involving more than 17,000 patients since 1997.

SOURCE GlaxoSmithKline

Web Site: http://aidsinfo.nih.gov/guidelines

http://www.bridgestoaccess.gsk.com

http://www.treathiv.com

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