Treatment Issues, Vol 11, No 3; March 1997
Jill A. Cadman

CDC Reports on National Trends

In February, the U.S. Centers for Disease Control and Prevention (CDC) announced that AIDS surveillance data for 1996 mark the first decline in AIDS deaths nationwide since the beginning of the epidemic. The estimated number of deaths among people with AIDS, which had increased steadily though 1994, rose only slightly in 1995 and headed downward for the first time in 1996. From last January through June, the estimated number of AIDS deaths was 13% less than for the same period in 1995. The breakdown by racial/ethnic group is as follows: non-Hispanic whites had a 21% decrease, non-Hispanic blacks a 2% decrease, Hispanics a 10% decrease, Asian/Pacific Islanders a 6% decrease, and American Indians/Alaskan Natives a 32% decrease. Deaths due to AIDS did not decline among women and those infected through heterosexual contact but increased in both these groups by 3%.

According to CDC spokesperson Tammy Nunnally, the agency attributes the decline in deaths to prevention efforts that have slowed the overall epidemic and to improved treatments, especially prophylactic drugs to prevent opportunistic infections (OIs). Ms. Nunnally stated that the current downward trend in AIDS-associated deaths was not being attributed to the widespread use of new combination regimens incorporating protease inhibitors. The CDC update reads, "While it is too soon to determine the impact protease inhibitors will have on these trends, these drugs promise to further lengthen the lifespan of individuals with AIDS." Still greater reductions in AIDS mortality rates are expected for the future, provided the drugs are well tolerated and stand up to long-term use.

As the number of AIDS deaths declines, the number of people living with AIDS (AIDS prevalence) has increased substantially, up 10% since 1995. The growth in the total number of people diagnosed with AIDS each year continues to slow, according to the consistent case definition of AIDS the CDC now uses to monitor trends. There was an increase of about 3% per year from 1992 through 1994 and a 2% increase in 1995. Meanwhile the demographics of the epidemic are changing with those people infected through heterosexual contact having the greatest proportionate increase within the total AIDS population. The numbers of minorities and women with HIV are also increasing significantly. The CDC notes that as the rate of new HIV infections remains stable or increases, and AIDS deaths continue to decrease, additional resources will be needed for services, treatment and care.

New York City Confirms the Trend

Mary Ann Chiasson, Dr.P.H., the Assistant Commissioner for Disease Intervention Research of the New York City Department of Health, presented additional findings at this winter's Fourth Conference on Retroviruses and Opportunistic Infections (abstract 376). She described the downward trend in the city's HIV/AIDS mortality. New York City has only 3% of the US population but 16% of US AIDS cases. It has had more than 60,000 deaths from AIDS, which became the third leading cause of death in 1988. AIDS mortality increased six-fold from 1983 to 1986, then by about 11% per year to 19.4 deaths per day in 1994. In 1995, for the first time since the beginning of the epidemic, the death rate did not increase. It reached a plateau of 19.3 deaths per day in 1995 and began a steady decline in 1996 from 19.5 per day in January to 11.5 per day in July.

This is a drop of 41% for the first seven months of 1996. Dr. Chiasson indicated that the decline in deaths was not preceded by a dramatic decline in newly diagnosed AIDS cases in New York City and did not attribute this as a factor. She noted that the rate of new infections (measured by proxy using the number of new AIDS cases reported each year) appeared to have leveled off for several years leading up to 1995. Dr. Chiasson stated, "We would expect the number of deaths to plateau following a plateauing in AIDS cases." This was the case in 1994 and 1995 when the number of deaths remained essentially flat throughout the year. The Department of Health had expected the same in 1996, but while the rate of new infections remained stable, the rate of deaths decreased sharply in all demographic groups beginning in April of 1996. Dr. Chiasson said this trend was surprising and felt that further study was warranted to determine the cause.

The New York City Department of Health study concluded that the reasons for the decline in AIDS deaths have yet to be determined, but suggests that early diagnosis, prophylaxis for OIs and new antiviral therapies may be slowing mortality. Further increases in funding enabled the State AIDS Drug Assistance Program (ADAP) to add protease inhibitors to the formulary in July of 1996 (see Treatment Issues article Glaxo, Merck and ADAP, May 1996, page 8), but this new coverage postdated the onset of the death rate decline.

Dr. Chiasson said that the drop in the death rate preceded the widespread use of triple combination therapy with protease inhibitors but may reflect changes in treatment guidelines starting in 1994 which moved away from monotherapy and recommended combining nucleoside analogs. Dr. Chiasson also acknowledged the availability of Epivir (3TC) prior to the general use of protease inhibitors. She is hoping to conduct a study in conjunction with the CDC looking at treatment in people who died in comparison with treatment in people who did not.

Treatment and services became more widely available in New York when federal Ryan White CARE Act funding more than doubled in fiscal year 1994 (see graph). Dr. Chiasson further observed, "Deaths began to decline as funding increased. I think that the set up of these very comprehensive medical care services through Ryan White had to have had some impact on mortality by making treatments accessible to everyone. But I can't prove it. It is certainly appealing as a partial explanation."

Also in New York City, the St. Vincent's Hospital AIDS Center, located in the heart of the hard-hit Greenwich Village/Chelsea neighborhoods, conducted a study to look specifically at the impact of new antiviral therapies on inpatient and outpatient hospital utilization. From the beginning of the epidemic until 1994, St. Vincent's has experienced annual increases in patient admissions and total hospital stays for HIV-related illnesses. These figures leveled off in 1994 and then began decreasing significantly by the end of 1995. At the same time, the number of individuals served on an outpatient basis steadily increased.

In 1994, St. Vincent's began implementing certain changes in the delivery of care including increased utilization of homecare and outpatient infusion services for the management of opportunistic infections (OIs). Besides advances in antiviral therapy, the advent of prophylaxis for OIs such as MAC, fungal infections, toxoplasmosis and CMV is among the possible factors behind the drop in patient admissions

Gabriel Torres, M.D., the director of the AIDS Center, also presented study results at the Fourth Conference on Retroviruses (abstract 264). Dr. Torres reported that in 1994, prior to the availability of protease inhibitor therapy, the average number of inpatients (average inpatient daily census) peaked at 136 for HIV-related conditions. During 1995, protease inhibitors and Epivir (3TC) were available to patients only through clinical trials or expanded access programs. The average inpatient census during this year dropped 5%. In late 1995 3TC and the first protease inhibitor, saquinavir, were approved by the FDA. ADAP was not yet covering protease inhibitors, but 3TC was immediately added to the formulary. There was a significant drop in the average inpatient census beginning at the end of 1995, with a concomitant rise in outpatient visits. In the first quarter of 1996, ritonavir and indinavir also received FDA approval. From 1995 to 1996, the inpatient census dropped by 24% to an average of 79 patients in 1996, inpatient admissions dropped by 10.5%, total inpatient days fell by 23.6%, and the average length of stay was shortened by 15.9%

During this same period, the medical center experienced a 33% increase in ambulatory visits. These included visits for HIV testing and counseling, primary medical care and early intervention services.

According to Dr. Torres, "The introduction of protease inhibitors into anti-HIV treatment regimens has had a dramatic effect on treatment patterns in our clinic and on our patients' daily lives. We are seeing fewer infections and fewer hospitalizations. In addition, greater public awareness of the existence of new, potent treatment options clearly has led more people to seek care before they become seriously ill."

Across the Country and Overseas

The St. Vincent's figures are consistent with New York statewide aggregate data from 30 designated AIDS Centers, which show average length of stay dropping by one day for each of the years from 1993 to 1996. Total admissions for HIV/AIDS declined from 60,157 to 54,448 from 1994 to 1995. In Philadelphia, lower AIDS death rates were reported, but activists there expressed concern at disparities between blacks and whites. From 1995 to 1996, deaths dropped by 41% for whites and only 13% for blacks.

Peter Ruane, M.D., of Tower Infectious Disease Medical Associates in Los Angeles, reported results at the Fourth Conference on Retroviruses (abstract 262) of a two-year study conducted at Tower. Tower provides primary care to approximately 480 HIV-infected patients, 50% of whom meet the CDC definition of AIDS. The study was designed to examine the effects of adding additional antivirals on medical services provided and on the actual cost of care.

Tower began recommending dual combination therapy in early 1995 and in 1996 added treatment guidelines that called for triple combination therapy with protease inhibitors. By October, 1996 approximately 62% of patients had been prescribed a protease inhibitor (up from 9% in 1995). Dr. Ruane stated that "hospital days began to drop when we started prescribing double combination therapy with AZT and 3TC, but they dropped farther -- and faster -- when we added protease inhibitors."

Utilization of medical care dropped by every measure, including hospital stays and referrals to specialists. For example, the mean number of patients receiving home care fell 93%, from 67.6 to 5. Dr. Ruane attributed this to the reduced incidence of opportunistic infections. He stated that "among compliant patients, we have not seen a new case of CMV in a year."

There was an equally dramatic increase in medication cost between 1994 and 1996, 116% for patients with CD4 counts above 50 and 301% for patients with CD4 counts under 50. However, Dr. Ruane concluded that for each dollar of increased spending on drug therapies, $2 was saved on overall treatment costs, especially for the patients with under 50 CD4 cells.

The French experience apparently mirrors the decreasing mortality rates in the U.S. The number of AIDS deaths fell in 1996 for the first time since the start of the epidemic. The Ministry of Health released a statement that 2,285 people had died of AIDS in France last year, a decrease of 25% from 1995. The number of new cases also fell, in contrast to the U.S.. French officials attributed the declines to improved drugs and preventive programs.

Looking Ahead

Clearly the efforts to control the AIDS epidemic through research, prevention and treatment are finally beginning to pay off. Whether the benefits of combination therapy with protease inhibitors are already evident in the downward trends in AIDS deaths and hospitalization, or whether we are just beginning to see their true impact remains to be clarified. Either way, the trend should continue as long, and only as long, as new drugs are developed and added to the antiviral armamentarium before HIV develops widespread resistance to existing agents.

It is distressing that certain sectors of the population have not reaped the same benefits from advances in health care. AIDS is threatening to become a disease in which patients' outcome is determined more by socio-economic standing than by the state of medical science.

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