New studies provide more evidence that AIDS "cocktail treatments," the three drug combinations containing Protease Inhibitors (PIs), cannot be the significant or sole cause of decreased AIDS deaths or increased survival in people diagnosed with AIDS.

Researchers from the Centers for Disease Control and Prevention (CDC) in Atlanta report that throughout 1996, the first year in which the drug combinations known as Highly Active Anti-Retroviral Therapy (HAART) were credited with decreasing AIDS deaths, less than 20% of HIV positives actually held prescriptions for HAART. Also worth noting is the researchers' assumption that number of prescriptions written indicate the actual number of people taking the prescribed drugs and complying with strict dosage requirements.

In a second study, reported in the March 7th issue of The Journal of the American Medical Association, evidence is presented that treatment containing Protease Inhibitors is no better or worse than treatment with combinations of nucleoside analogs such as AZT and ddI. In other words, according to mainstream AIDS researchers, adding a PI to an AZT-ddI combo doesn't seem to make much difference to "viral load". The patient's health is typically ignored in this study.

In a third study, in the March 14th issue of The Journal of the American Medical Association, we learn that improved survival rates attributed to the PI combinations contrast with the researchers' own statement that the greatest percentage reductions in death among AIDS diagnosed persons occured in 1995, the year before the new drugs had been approved for general use, and in 1996, the year that less than 20% of HIV positives had prescriptions for PI cocktails.

In other words, the miracles ascribed to the PI combos all happened before just about anyone had access to Protease Inhibitors. Truly miraculous.

Instead of correlating with the introduction of HAART, increased survival rates among AIDS patients correlate with improved treatment for individual opportunistic infection, declining doses of toxic drugs like AZT, ddI and 3TC, and with the 1993 change in the AIDS definition that allowed HIV positives without clinical illness be classified as AIDS patients.

In 1993, the definition of AIDS was once again expanded by the US Centers for Disease Control when four new conditions were added to the definition of AIDS. This new definition caused an explosion in the number of people that could be called AIDS patients. One of the conditions for an AIDS diagnosis added that year was having a CD4 T-cell count of 200 or less at some point during a given year.

From 1993 forward, the majority of AIDS cases have been occurring in individuals with NO CLINICAL ILLNESS. These people are called AIDS patients only because at some point during a given year, they had a CD4 T-cell count of <200. Again, these are clinically healthy people who as of 1993, are labeled AIDS cases.

"When you suddenly label large numbers of illness-free, symptom-free people HIV positives as "AIDS patients", this must result in increased survival in the overall AIDS patient population. This has to do with the labeling, not with the effects of any treatment.

See: Changing the AIDS Definition Increases AIDS Survival Rates

Study One:

Tuesday February 20, 2001 Prescriptions for HIV Differ Among Risk Groups By Alan Mozes NEW YORK (Reuters Health) - The number of HIV positive individuals who are being prescribed anti-retroviral treatment has more than tripled in the US over the last few years, according to researchers. However, investigators also note that current prescription rates differ among risk groups--with gay males and whites more likely to be prescribed such medications than either male or female heterosexual injection-drug users or blacks. "Gaps by race, ethnicity and risk by sex have narrowed...however, differences in (highly active antiretroviral therapy) prescription persisted over time," noted study lead author Dr. A. McNaughten of the Centers for Disease Control and Prevention (CDC) in Atlanta. McNaughten presented her findings at the recent 8th Conference on Retroviruses and Opportunistic Infections in Chicago. McNaughten's team analyzed and compared data gathered between 1996 and 1999 by the Adult/Adolescent Spectrum of HIV Disease project. The project followed almost 17,000 patients in 11 U.S. cities, all of whom were eligible to receive highly active anti-retroviral therapy (HAART). On the positive side, the researchers found that the proportion of patients who were prescribed HAART rose from just under 20% in 1996 to almost 70% in 1999. They noted that this increase may be attributable to a general rise in insurance coverage for such medications across the board. McNaughten and her colleagues also found that some of the prescription gaps that existed in 1996 had narrowed by 1999. In particular, groups that had been drug-using heterosexual men and women--were no longer falling behind by 1999. However, McNaughten and her colleagues emphasized that, over the 4- year period, blacks and injection-drug users continued to be less likely than whites and men who have sex with men to be prescribed HAART. "We are encouraged that the gaps in HAART prescription have narrowed over time and hopeful that this trend will continue," McNaughten told Reuters Health. "However, continued monitoring of differences in HAART prescription by gender, race, ethnicity, risk behaviors and other factors is needed to help identify populations needing assistance in receiving HIV-related care and treatment."

Study Two:

Wednesday March 7, 2001 Study Backs HIV Drug Combination NEW YORK (Reuters Health) - A combination of anti-HIV drugs that lacks the powerful protease inhibitors that have helped cut AIDS death rates might be just as effective at halting disease progression as those including protease inhibitors, researchers said Tuesday. The study, sponsored by GlaxoSmithKline, the world's largest maker of HIV drugs, suggests that doctors might be able to keep the protease inhibitors in reserve for use if the disease worsens. However, other researchers urged caution in saying the protease-free cocktail is equally effective. Dr. Schlomo Staszewski, from Klinikum der Johann Wolfgang Goethe- Universitat in Frankfurt, Germany, and colleagues randomly assigned 562 HIV-positive people who had never been treated with AIDS drugs to receive treatment with one of two combinations. Some patients were given GlaxoSmithKline's abacavir (Ziagen) with 3TC and AZT, others got the Merck & Co. protease inhibitor indinavir (Crixivan) with 3TC and AZT. Like 3TC and AZT, abacavir is in the class of drugs known as nucleoside analogues. After 48 weeks of treatment, 51% of patients in both groups had the levels of HIV in their blood reduced to less than 400 copies per milliliter of blood, the authors report in the March 7th issue of The Journal of the American Medical Association. The investigators found no difference between the treatment combinations in their effects on blood levels of the CD4+ immune cells that are attacked by HIV. When protease inhibitors were first introduced in the mid-1990s, many in the AIDS field believed that they could be combined with reverse transcriptase medications to form powerful drug ``cocktails'' that might reduce HIV infection to the status of a controlled, chronic disease, much like diabetes. For many that has proved true, but the capacity of the virus to mutate and develop resistance to drugs means that patients need to switch regimens. ``The (protease-free) regimen offers several potential advantages, including twice daily dosing, low pill burden, low drug interaction risk, and the potential to reserve other drug classes for future therapy,'' the authors point out. However, Staszewski's team notes that ``this regimen also has several potential disadvantages including limited data on long-term efficacy, clinical progression, or toxicity, and the risk for hypersensitivity reactions.'' In a related editorial, Dr. Benjamin Djulbegovic, from the University of South Florida in Tampa, and Dr. Mike Clarke, from the Cochrane Centre in Oxford, England, warn that ``clinicians should be cautious about arguing for equivalence based on a randomized trial of efficacy, and then using arguments about toxicity...as a basis for suggesting the superiority of one of the treatments.'' SOURCE: The Journal of the American Medical Association 2001;285:1155

Study Three:

March 14, 2001 The Journal of the American Medical Association

This intriguing CDC article concerns survival after an AIDS diagnosis during the treatment era in the United States 1984 -1997 among 394,705 persons with a diagnosed AIDS-defining Opportunistic Infection (OI).

Lee et al. state: "...estimates of survival for the remaining 394,705 cases showed that median survival time improved with each successive year of OI diagnosis, from 11 months for persons with AIDS diagnosed in 1984 to 46 months for persons with AIDS diagnosed in 1995. The greatest 1-year increase in median survival time was from 21 months for persons with an OI diagnosed in 1994 to 46 months for those with an OI diagnosed in 1995."

"For each year of diagnosis in 1993-1997, the probability of survival for at least 24 months among persons with an immunologic diagnosis was 67%, 71%, 80%, 87%, and 90%, respectively. The probability of survival for at least 48 months was 48%, 60%, and 73% among persons in whom immunologic AIDS was diagnosed in 1993-1995. Among persons with an initial OI diagnosis in 1993-1997, the probability of survival for at least 24 months was 49%, 52%, 63%, 74%, and 80%, respectively. The probability of survival for at least 48 months was 33%, 42%, and 56% among persons with an initial OI diagnosis in 1993-1995.

"The annual percentage reduction in adjusted risk of death following AIDS diagnosis was not constant over the period. We saw the greatest percentage reductions in risk of death among persons with AIDS diagnosed in 1995 and 1996. Persons among whom AIDS was diagnosed in these years likely had survived long enough to take advantage of new multidrug regimens, including those with protease inhibitors. We saw a smaller reduction in risk of death for persons in whom AIDS was diagnosed in 1997, which mirrors the slowing rate of decline in AIDS deaths reported in 1998. This may reflect maximization of benefits of new therapies. Suboptimal adherence and viral resistance may be limiting factors. Further study is required to determine the impact of adherence and resistance on survival at the population level."

(Note that the authors do not explore the possibility that the smaller reduction in death in 1997 and 1998 may be due to the devastating health effects of the new therapies)

See the complete article at:

http://jama.ama-assn.org/issues/current/abs/joc01916.html

The studies here were provided and analyzed by Jason Nusbaum, Alive & Well's Communications Director. Any questions can be answered by writing to Jason at JasonNusbaum@aol.com

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