The Washington Blade; Friday, February 27, 1998
Lisa Keen

According to a report in the Feb. 20 issue of the British medical journal The Lancet, patients were given triple-drug combinations of two nucleosides and either ritonavir or a placebo for about seven months. While 38 percent of the group taking the placebo combination died, 22 percent of the ritonavir combination group did. This difference was considered significant and occurred even though the group taking the ritonavir combo saw only a relatively modest drop in their viral loads and a modest increase in their CD4 cells counts. The benefits also lasted only a few weeks. In an accompanying editorial, The Lancet said the study "has shown that clinical benefit can be obtained in advanced disease despite the poor virological results."

New CMV drugs showing promise

At this month's Retrovirus Conference in Chicago, a researcher for a multi-center study presented results showing that a new treatment for CMV retinitis that involves injections directly into the eye had significant benefits in delaying the progression of disease in the eyes.

The new drug is fomivirsen. In the study, 18 patients with newly diagnosed CMV retinitis were given immediate treatment of weekly injections for three weeks followed by injections every other week. Ten other patients with newly diagnosed CMV retinitis were given treatment but not immediately. Those patients treated immediately did not experience CMV progression for more than 71 days, while those in the other group experienced disease progression in 13 days. The Isis Pharmaceutical company expects to file a New Drug Application for the treatment with the Food and Drug Administration later this year.

On Feb. 20, Hoffman-LaRoche announced that the Food and Drug Administration approved its request to market a new 500mg version of ganciclovir, a frequently prescribed drug for the prevention of CMV retinitis. According to the company, patients on this preventative medicine can reduce their number of pills from 12 to 6 with the new capsule.

More CD4 cells with d4T versus AZT combo

Researchers at the University of Alabama reported at the Chicago conference that they believe triple-drug therapies using d4T may have an advantage over similar therapies using AZT.

AZT and d4T are two of the five nucleoside analogues approved thus far by the Food and Drug Administration. But AZT and d4T are different than the other three "nukes" in that these two tend to attack virus in the immune system's active cells while the other three tend to attack virus in the system's resting cells. Most triple-drug therapies with a combination that attacks the virus in a variety of places in the body and in its replication process. Thus, most triple-drug therapies tend to include either AZT or d4T.

According to the report in Chicago Feb. 3, the "first ever head-to-head" comparisons of AZT versus d4T combinations showed that the two drugs are "equivalent" in their abilities to attack the virus and "should both be considered first-line" options for treatment combinations. But according to Alabama researcher Kathleen Squires, the study of more than 500 patients on one of the triple-drug therapies (which also included the "resting cell nuke" 3TC and the protease inhibitor indinavir) for almost a year showed that d4T to produce a slightly greater viral load drop (1.95 versus 1.60) and a slightly greater CD4 increase (173 versus 141). The AZT combo also resulted in more "minor" gastrointestinal side effects.

A second study, presented by the University of North Carolina-Chapel Hill in a poster Feb. 3, also compared the two combinations. In the second study, involving 100 patients, the researchers found that the viral load drops produced by the two triple-drug combinations were nearly identical (1.64 versus 1.68). But the CD4 counts were again greater in the d4T group (211 versus 139).

In brief...

NEW WEB SITE: The National AIDS Treatment Advocacy Project, which sponsors informative community forums on the latest in HIV medical news, launched its new Web site Feb. 1 to provide "up-to-the-minute" reports. The address is www.natap.org.

DRUG GUIDE: The National Association of People With AIDS recently issued a user-friendly booklet which delineates the current drug options available to people with HIV, identifying their success rates in dropping viral loads and their various drawbacks. To request a copy of the booklet, entitled "Starting with NRTIs," call NAPWA at (202) 898-0414.

ALLERGY WARNING: The Food and Drug Administration issued a warning Feb. 10 against using the allergy antihistamine Hismanal with certain other drugs, including any of the currently approved protease inhibitors.

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