PRNewswire - Sunday September 27, 1998

The study presented here today at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) also showed that in both genders the regimens containing Crixivan resulted in marked decreases in viral RNA and increases in CD4 cell counts.

``This is the first analysis of its kind that clearly shows that combination therapy with a potent protease inhibitor can produce dramatic reductions in clinical events in women,'' said Dawn Averitt, AIDS treatment advocate and founder of WISE, the Women Information Service Exchange. ``Women living with HIV now have additional evidence to make informed decisions about their treatment choices.''

Progression-Free Survival By Gender

The objective of the analysis was to determine whether there was consistency of treatment effects across gender in patients treated with Crixivan plus AZT(A) (200 mg every eight hours) or Crixivan monotherapy (800 mg every eight hours) compared to those treated with AZT alone (3TC(B) was added to both regimens containing AZT over the course of the study).

For both men and women, the number of HIV patients progressing to an AIDS- defining illness or death was consistently less in the arms of the study with Crixivan. Overall, 13 of the 93 women (14 percent) and 50 of the 239 men (21 percent) treated with AZT alone experienced an AIDS-defining illness or died during the course of the study.

This compared to markedly lower incidences of disease progression and death among 7 of 90 women (7.8 percent) and 14 of 242 men (5.8 percent) treated with Crixivan and AZT experienced clinical events, and 4 of 94 women (4.3 percent) and 24 of 238 men (10 percent) treated with Crixivan alone.

Clinical Benefits with Crixivan Confirmed

``This study demonstrated that Crixivan has antiretroviral activity in both women and men in terms of decreased disease progression, decreased viral RNA and increased CD4 cell counts,'' explained Randi Leavitt, M.D., senior director, Merck Research Laboratories. ``These results add to the weight of scientific and medical evidence supporting the overall impact of potent protease inhibition on the management of HIV disease, and adds to our understanding of effective management of HIV disease in women, who are, unfortunately, a rapidly growing segment of the infected population in the United States.''

According to the US Centers for Disease Control and Prevention (CDC), between 1995 and 1997, HIV incidence among women increased by 17 percent. The CDC also reported in June 1996 and again in January 1997 the first declines in the rates of AIDS-related deaths since the beginning of the HIV epidemic. The declines have been largely attributed to the use of protease inhibitors in triple therapy with reverse transcriptase inhibitors. The estimated number of deaths among women with AIDS decreased by 13 percent in 1996, however the most significant decline was among white males, 33 percent.

The overall occurrence of clinical events among women in this study was 8.6 percent for women and 13.8 percent for men. ``This difference is probably not treatment-related,'' explained Dr. Leavitt. ``It may be a reflection of the somewhat better immune status of the women who enrolled in the study.'' In general, females had higher CD4 cell counts and lower viral burdens at baseline than men. The median CD-4 cell count for female patients was 161 cells/mm3 at study entry, for men, it was 142 cells/mm3. Baseline median viral load for all enrollees was 31,000 copies/mL.

Changes in viral load and CD4 cell counts among both male and female patients in the study underscored the treatment benefits of potent protease inhibition with Crixivan regardless of gender. Approximately 26 percent of female patients treated with Crixivan alone and 27 percent of patients on the combination of Crixivan and AZT had viral levels below detection (less than 500 copies/mL) at week 48 (median follow-up week). Approximately 49 percent of men treated with Crixivan plus AZT and 32 percent treated with Crixivan alone had undetectable viral loads. No more than 13 percent of females or 10 percent of men on AZT alone had viral loads of less than 500 copies/mL at any point in the study.

There were marked treatment differences in average CD4 cell count increases over the follow-up period among women (68 cells/mm3) and men (99 cells/mm3) treated with Crixivan and AZT versus AZT alone. Similar relative improvements in CD4 cell counts were seen in the women (62 cells/mm3) and men (91 cells/mm3) treated with Crixivan versus AZT monotherapy.

Treatment with Crixivan in the study was generally well-tolerated. Ninety patients (9 percent) had adverse experiences associated with kidney stones: 40 (12.1 percent) in the Crixivan plus AZT group, 40 (12.1 percent) in the Crixivan group, and 10 (3 percent) in the AZT group. No patients discontinued due to adverse experiences associated with kidney stones. The proportions of women with kidney stone-associated adverse experiences was less than that observed in men for all treatment groups.

Important Cautionary Information About Crixivan

Crixivan is generally well-tolerated. There are side effects associated with protease inhibitors in general and Crixivan in particular. Some patients treated with Crixivan may develop kidney stones. For some, this can lead to more severe kidney problems including kidney failure. Drinking at least six glasses of water a day may help reduce the chance of forming a kidney stone.

Other side effects reported include rapid breakdown of red blood cells and liver problems. As with other protease inhibitors, increased bleeding in some patients with hemophilia and increased blood sugar levels or diabetes have been reported.

There are some common medications and AIDS-related medications that should not be taken with Crixivan. Crixivan should not be administered concurrently with terfenadine, cisapride, astemiozole, triazolam, midazolam, or ergot derivatives.

Crixivan can be taken with a light meal or on an empty stomach.

About Crixivan

More than 170,000 people with HIV/AIDS around the world are on treatment with Crixivan today, and it is now approved in more than 80 countries. Crixivan is the most widely prescribed protease inhibitor in the world.

Information about Crixivan is available on Merck's website, www.crixivan.com. Merck & Co., Inc., is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of human and animal health products, directly and through its joint ventures, and provides pharmaceutical benefit services through Merck-Medco Managed Care.

Crixivan(R) is the Merck registered trademark for indinavir sulfate. (A) Zidovudine (Retrovir(R) or AZT), Glaxo Wellcome (B) Lamivudine (Epivir(R) or 3TC), Glaxo Wellcome
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