FDA Approves Another Choice for AIDS Patients
Nov. 16, 2000 (Washington) -- U.S. health officials on Wednesday approved a new combined version of three commonly used HIV-fighting drugs, offering some AIDS patients the possibility of discarding their old regimen of six pills a day in favor of taking just two pills a day.
The pill, Trizivir, is a combination of Epivir, Retrovir, and Ziagen. The three drugs are antiretroviral medications that help prevent the reproduction of HIV and minimize the odds of being infected by other viruses, like the flu.
Epivir and Retrovir already are available in a dual combined product called Combivir, but Trizivir is the first product to combine three antiretroviral drugs into a single tablet. As a result, besides simplifying some patients' drug regimen, it also is hoped that Trizivir will help these patients stick to their treatment.
A number of HIV patients on antiretroviral medications have no noticeable symptoms -- such as chronic pain -- to motivate them to take their pills, explains Seth Hetherington, MD, a clinical researcher for Glaxo Wellcome, the maker of Trizivir. And while there is no evidence that Trizivir will increase patients' compliance with their existing regimen, studies have shown that treatment adherence improves when patients are required to take fewer pills, he tells WebMD.
But Trizivir is not for everyone. The drug is not for patients that have developed a resistance to any of the drug's combined components, Hetherington cautions. The drug also is not for patients that have had an allergic reaction to Ziagen, a condition that can be life threatening if not caught in time, he says.
To minimize these risks, a patient warning card and medication guide will be distributed with each prescription, he tells WebMD. The medication guide will explain this potential side effect in simple lay English, and the warning card will summarize the most important points that patients must know about allergic reactions, Hetherington says.
The warning signs include fever, nausea, vomiting, diarrhea, sore throat, cough, shortness of breath, and extreme fatigue. But because some of these symptoms are similar to the most common side effects associated with all three drugs, it is important that patients contact their doctor before stopping the treatment, Hetherington notes. "The card is meant as a trigger. The card is not meant to be a diagnostic tool," he tells WebMD.
According to the FDA, other possible side effects of Trizivir include the accumulation of lactic acid in the blood stream due to a lack of oxygen, severe liver problems, and a decrease in white blood cells. But considering that Trizivir is just a combination of the nucleoside analogs -- the first class of anti-HIV medications developed -- the drug can still be combined with newer drugs such as protease inhibitors, the agency says.