Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Monday September 29 8:34 AM EDT
Combivir(TM) Tablets, which contain Epivir(R) (lamivudine 150 mg; 3TC) and Retrovir(R) (zidovudine 300 mg; AZT) is the first product ever to combine two antiretroviral drugs in one tablet formulation. Each tablet, to be taken twice daily, contains half of the daily dose of Epivir and Retrovir typically prescribed for patients. Through availability of this simplified, alternative dosing option, it is hoped that adherence to multiple drug regimens containing Epivir and Retrovir may be encouraged.
One tablet of Combivir can be taken twice a day and will, for many patients receiving these drugs as part of a multi-drug combination, offer the option of reducing by as many as six the number of pills to be taken each day. Many patients being treated for HIV take as many as 20 tablets or capsules per day.
Adhering to typically complex combination drug regimens presents a significant challenge to many people with HIV disease. The likelihood of adherence to a prescribed therapy is less when a regimen requires taking a high number of pills and/or which requires increased frequency of dosing. In reducing the "pill burden" and dosing requirements, patient adherence to multiple drug combinations may be enhanced.
"There is little question that patient adherence to complex combination therapy regimens is a critical issue today in the treatment of the people with HIV and AIDS," said W. David Hardy, M.D., Scientific Director of Research, Pacific Oaks Medical Center and Associate Clinical Professor, UCLA School of Medicine. "Non-adherence to therapies, which are designed to provide maximal suppression of HIV, result in less than optimal antiviral effects and, more importantly, the emergence of drug resistant virus."
Most patients currently being treated with Epivir+Retrovir as part of a multiple drug combination take one 150 mg tablet of Epivir and one 300 mg tablet of Retrovir in the morning and in the evening. The number of pills needed for this combination can be reduced from four to two by using Combivir. For many patients who currently take one 150 mg tablet of Epivir twice a day and two 100 mg capsules of Retrovir three times a day, Combivir will reduce from eight to two the number of pills needed daily for this combination, and will reduce dosing from three times per day to twice daily.
"Overcoming the dosing complexities of new combinations of drugs that we know to have a potent effect in suppressing HIV is one of the biggest challenges today in the real-world clinical management of patients with HIV," said Amy Keller, senior clinical program head for Antiviral Research at Glaxo Wellcome Inc. (NYSE:GLX). "Hopefully, the development of Combivir is just the first step in efforts by the pharmaceutical industry to improve what are extremely demanding treatment regimens for patients to follow."
In addition to the large number of pills that an individual must take each day, dosing regimens often require strict adherence to timing, food and liquid intake, and storage. Combivir Tablets do not require refrigeration and can be taken with, or without, food. The "pill burden" of triple combination therapy is also significantly impacted by an individual's need to take other medications to prevent or treat HIV-related infections, manage side effects, and improve overall health.
Epivir+Retrovir continues to be the most common two-drug nucleoside analogue foundation prescribed as part of maximally suppressive combination therapies. The widespread use of this combination is based on its sustained activity in clinical trials on surrogate endpoints for HIV (CD4 cell counts; viral load), as well as its documented effect in increasing survival and delaying progression of the disease.
Data from a study of Combivir has established its bioequivalence to the twice-a-day dosing of its separate components, Epivir and Retrovir. Although the safety of chronic dosing of Combivir has not yet been assessed, in clinical trials Epivir+Retrovir was generally well tolerated with the most commonly reported side effects including headache, nausea, malaise and fatigue, nasal congestion and runny nose, diarrhea, low white blood cell counts and anemia. Since Combivir is a fixed-dose combination tablet, it should not be used in patients who require modification of the dose of lamivudine or zidovudine (i.e. pediatric patients less than 12 years old, patients with creatinine clearance less than 50mL/min, or patients with a body weight of less than 110 pounds).
Retrovir will continue to be available as 300 mg tablets, 100 mg capsules, syrup and intravenous solution. Epivir will continue to be available as 150 mg tablets and oral solution. Glaxo Wellcome's price to wholesalers and distributors for Combivir is $7.18 per tablet or approximately $5,240 a year, which is equivalent to the price of Epivir+Retrovir dosed separately. This figure reflects the company's price to wholesalers and distributors; prices paid by pharmacies and patients may vary. Combivir is expected to be available in pharmacies by mid-October.
Glaxo Wellcome is the industry leader in HIV research and offers patients and physicians a broad portfolio of both investigational and commercially available anti-HIV therapies. In addition, the company produces a variety of drugs used in the treatment or prevention of opportunistic infections associated with AIDS.
SOURCE Glaxo Wellcome
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