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Medical Forum / Diseases and Disorders / AIDS / December 2005Concorde: Early Treatment for H.I.V. Doesn't Prolong Survival
James Scutero posted this to misc.health.aids on July 17, 1995. susie ----- July 16, 1995, Sunday, Late Edition - Final SECTION: Section 1; Page 21; Column 1; National Desk HEADLINE: Early Treatment for H.I.V. Doesn't Prolong Survival, Study Finds BYLINE: By LAWRENCE K. ALTMAN DATELINE: WASHINGTON, July 15 Treatment of H.I.V. infection before it causes symptoms may delay its progression to AIDS but does not prolong survival, a new study has found. The study, reported today in The British Medical Journal, supports findings from the Concorde study in Europe that in 1993 called into question a standard practice of prescribing the drug AZT for people infected with H.I.V., or human immunodeficiency virus, which causes AIDS. The British study involved 436 AIDS patients at St. Mary's Hospital Medical School in London. Its authors said they hoped it would raise more discussion about the relative merits of treating the infection early or after symptoms develop and stimulate scientists to focus more studies on the quality of life among people being treated. "We are hoping to move the debate on about what we are actually doing for patients" such as whether benefits of early treatment outweigh adverse effects like nausea, vomiting and bleeding, Dr. Mark Poznansky, a co-author of the study, said in a telephone interview. Although the study is not definitive, the findings have "a sobering effect," said Dr. James W. Curran, a top AIDS official at the Centers for Disease Control and Prevention in Atlanta. Another top AIDS expert at the centers, Dr. Harold W. Jaffe, said "we are starting to get a fairly consistent message" from studies that drugs and antibiotics against AIDS-related infections "have a benefit, but survival is not prolonged depending on whether they are given early or late." The report comes at a time when growing competition from managed care is increasing pressure on American health care providers to justify costs for many standard treatments. The findings also highlight cultural differences between many American and European patients and doctors about the optimal time to begin treatment of AIDS. Doctors in the United States, acting on studies conducted by American scientists, tend to start treating the infection earlier in the course of the disease than European doctors. Also, unlike American patients, European AIDS patients have not generally pressed for early treatment. Proponents say early treatment improves the quality of life by reducing hospitalizations for the potentially fatal AIDS-related illnesses like pneumocystis carinii pneumonia. But others say treatment with AZT or similar drugs makes some patients sick. Dr. Poznansky's team in London studied 436 AIDS patients who developed AIDS from 1991 through 1993. Of these, 97, or 22 percent, learned they were infected with H.I.V. when they developed their first AIDS illness and had no previous treatment for the infection or AIDS-related illness. The remaining 339 patients were followed in clinics after they tested positive for the virus during the preceding eight years. A comparison showed that those who received early treatment suffered fewer AIDS-related infections. Yet once they became ill they died, on average, a year sooner than those who were not treated until severe symptoms began. The overall time from acquiring infection to death was similar and the later diagnosis of AIDS "did not have a detrimental effect on survival," the British authors said. Dr. Merle Sande, an AIDS expert who is chief physician at San Francisco General Hospital, said he was not surprised by the findings. He headed an independent panel of experts created by the Government in 1993, which said AZT was no longer necessarily recommended for early treatment of uncomplicated H.I.V. infection. "Most doctors feel when they are giving AZT early, they are increasing the asymptomatic period, but again and again they have learned that survival is the same," Dr. Sande said. "Nothing that has delayed progression to AIDS has ever been shown to alter survival." There are many aspects to treating people with the infection, including presumed differences in the virulence of different strains of the virus. But the British study was not designed to determine whether such viral differences existed among the participants. Despite public education programs aimed at encouraging people to get a blood test to learn whether or not they are infected, many Americans first learn they are infected when they go to the hospital for a serious AIDS illness. Dr. Jonathan Weber, a co-author of the British study, said his team realized that the findings raised questions about the benefit of early diagnosis and having medical checkups every few months. But Dr. Weber and other experts said early diagnosis of infection had important public health benefits because it helped infected individuals prevent transmitting the virus to their sex partners. ****************************************************************** >James Scutero posted this to misc.health.aids on July 17, 1995. And it is correct today in the sense that giving one drug doesn't do much unless one has very advanced AIDS. Then it may prevent death. But it's also 10 years later--and there are newer therapies used in combination. These DO have an impact when given earlier in disease progression (i.e., a higher CD4 count). George M. Carter ** for example Kress KD. HIV update: emerging clinical evidence and a review of recommendations for the use of highly active antiretroviral therapy. Am J Health Syst Pharm. 2004 Oct 1;61 Suppl 3:S3-14 Department of Medicine, Case Western Reserve University, University Hospitals of Cleveland, 2061 Cornell Road, Foley 111, Cleveland, OH 44106, USA. PURPOSE: This supplement will focus on recent trial data concerning the efficacy of certain nucleoside reverse transcriptase inhibitor (NRTI)-based highly active antiretroviral therapy (HAART) regimens, the most recent guidelines from the Department of Health and Human Services (DHHS) for the timing of antiretroviral (ARV) therapy initiation, and recommended ARV drug classes for managing treatment-naive patients with HIV. SUMMARY: When choosing an initial regimen for the treatment of HIV, it is important to carefully consider therapeutic goals. These goals include choosing HAART that is likely to maximally suppress viral replication, maintain or restore immunologic function, improve quality of life, and reduce HIV-related morbidity and mortality. The evidence-based DHHS guidelines recommend HAART regimens that are non-nucleoside reverse transcriptase inhibitor (NNRTI)- or protease inhibitor (PI)-based. DHHS, however, does not recommend the use of triple-NRTI therapy for the initial treatment of HIV unless a preferred or alternative NNRTI- or PI-based regimen cannot be used. This recommendation concerning triple-NRTI therapy is supported by results from recent trials that demonstrated inferior outcomes with triple-NRTI-containing regimens compared with NNRTI- or PI-based HAART regimens. The timing for initiation of ARV therapy continues to change over time as the DHHS guidelines have evolved. Although the benefits of initiating ARV when CD4 cell count is < 200 cells/mm3 are well established, the use of early versus late initiation of ARV therapy in patients with CD4 cell counts > 200 cells/mm3 has its own benefits and drawbacks. CONCLUSION: To successfully manage people with HIV, it is crucial to find a balance between ARV potency, tolerability, safety, and convenience while providing durable viral suppression. >>James Scutero posted this to misc.health.aids on July 17, 1995. > > And it is correct today in the sense that giving one drug doesn't do > much unless one has very advanced AIDS. Then it may prevent death. Concorde proved no benefit with one drug. However, the whole concept of these drugs didn't stop there - it went forward on the single false premise that one drug was better than no drug. > But it's also 10 years later--and there are newer therapies used in > combination. These DO have an impact when given earlier in disease > progression (i.e., a higher CD4 count). Wrong. The 2004 Standard of Care by the International AIDS Society (which has always authored the official HIV/AIDS standard of care) now says something quite different indeed - so let's take another look-see: After years of promoting "early ARV" treatment as "life-saving", the pharma shills on this newsgroup are STILL biting their tongues over the July 2004 revision of the HIV Standard of Care as published in JAMA: "For less severely compromised individuals (ie, asymptomatic individuals with CD4 cell counts > 200/microL), there are no definitive data from prospective, randomized controlled studies to determine when antiretroviral therapy is associated with a survival benefit." My favorite parts are the disclosures about the outrageous conflicts of interest by the doctors who have been misleading about HIV treatment since the first AZT studies. Enjoy! susie ____ In the 7/14/04 JAMA article titled "Treatment for Adult HIV Infection: 2004 Recommendations of the International AIDS Society-USA Panel," Yeni et al. state: "Randomized clinical trials have demonstrated a survival benefit with the use of antiretroviral therapy by patients with severe immunodeficiency. For less severely compromised individuals (ie, asymptomatic individuals with CD4 cell counts > 200/microL), there are no definitive data from prospective, randomized controlled studies to determine when antiretroviral therapy is associated with a survival benefit. In the absence of such data, the decision to initiate therapy should be made based on survival and disease progression information obtained from observational studies, the consequences of moderate degrees of immune deficiency, and the long-term safety of antiretroviral drugs." --------------------------------- JAMA.2004 Jul 14;292:251-265. Treatment for Adult HIV Infection 2004 Recommendations of the International AIDS Society-USA Panel Patrick G. Yeni, MD; Scott M. Hammer, MD; Martin S. Hirsch, MD; Michael S. Saag, MD; Mauro Schechter, MD, PhD; Charles C. J. Carpenter, MD; Margaret A. Fischl, MD; Jose M. Gatell, MD, PhD; Brian G. Gazzard, MA, MD; Donna M. Jacobsen, BS; David A. Katzenstein, MD; Julio S. G. Montaner, MD; Douglas D. Richman, MD; Robert T. Schooley, MD; Melanie A. Thompson, MD; Stefano Vella, MD; Paul A. Volberding, MD Abstract: Context Substantial changes in the field of human immunodeficiency virus (HIV) treatment have occurred in the last 2 years, prompting revision of the guidelines for antiretroviral management of adults with established HIV infection. Objective To update recommendations for physicians who provide HIV care regarding when to start antiretroviral therapy, what drugs to start with, when to change drug regimens, and what drug regimens to switch to after therapy fails. Data Sources Evidence was identified and reviewed by a 16-member noncompensated panel of physicians with expertise in HIV-related basic science and clinical research, antiretroviral therapy, and HIV patient care. The panel was designed to have broad US and international representation for areas with adequate access to antiretroviral management. Study Selection Evidence considered included published basic science, clinical research, and epidemiological data (identified by experts in the field or extracted through MEDLINE searches using terms relevant to antiretroviral therapy) and abstracts from HIV-oriented scientific conferences between July 2002 and May 2004. Data Extraction Data were reviewed to identify any information that might change previous guidelines. Based on panel discussion, guidelines were drafted by a writing committee and discussed by the panel until consensus was reached. Data Synthesis Four antiretroviral drugs recently have been made available and have broadened the options for initial and subsequent regimens. New data allow more definitive recommendations for specific drugs or regimens to include or avoid, particularly with regard to initial therapy. Recommendations are rated according to 7 evidence categories, ranging from I (data from prospective randomized clinical trials) to VII (expert opinion of the panel). Conclusion Further insights into the roles of drug toxic effects, drug resistance, and pharmacological interactions have resulted in additional guidance for strategic approaches to antiretroviral management. Author Affiliations: Department of Infectious Diseases, Hospital Bichat-Claude Bernard, X. Bichat Medical School, Paris, France (Dr Yeni); Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY (Dr Hammer); Department of Immunology and Infectious Diseases, Harvard Medical School, Boston, Mass (Dr Hirsch); Department of Medicine, University of Alabama, Birmingham (Dr Saag); Department of Preventive Medicine, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brasil (Dr Schechter); Department of Biomedicine, Brown University School of Medicine, Providence, RI (Dr Carpenter); Department of Medicine, University of Miami School of Medicine, Miami, Fla (Dr Fischl); Department of Medicine, University of Barcelona, Barcelona, Spain (Dr Gatell); Department of HIV Medicine, Chelsea and Westminster Hospital, London, England (Dr Gazzard); International AIDS Society-USA, San Francisco, Calif (Ms Jacobsen); Department of Medicine, Stanford University Medical Center, Stanford, Calif (Dr Katzenstein); Department of Medicine, University of British Columbia, Vancouver (Dr Montaner); Departments of Pathology and Medicine, University of California and San Diego VA Healthcare System, San Diego (Dr Richman); Department of Medicine, University of Colorado School of Medicine, Denver (Dr Schooley); AIDS Research Consortium of Atlanta, Ga (Dr Thompson); Istituto Superiore di Sanità, Rome, Italy (Dr Vella); Department of Medicine, University of California and San Francisco Veterans Affairs Medical Center, San Francisco (Dr Volberding). =================================================== Financial disclosures of AIDS researchers - 7/14/04 JAMA JAMA, July 14, 2004 Vol 292, No. 2 251-265 Treatment for Adult 2004 Recommendations International AIDS Society- USA Panel Patrick G. Yeni, MD Scott M. Hammer, MD Martin S. Hirsch, MD Michael S. Saag, MD Mauro Schechter, MD, PhD Charles C. J. Carpenter, MD Margaret A. Fischl, MD Jose M. Gatell, MD, PhD Brian G. Gazzard, MA, MD Donna M. Jacobsen, BS David A. Katzenstein, MD Julio S. G. Montaner, MD Douglas D. Richman, MD Robert T. Schooley, MD Melanie A. Thompson, MD Stefano Vella, MD Paul A. Volberding, MD Patrick G. Yeni, MD Dr Yeni has received research grants for site investigator from GlaxoSmithKline, Bristol- Myers Squibb, Boehringer Ingelheim, Roche, Tibotec/Virco, and Gilead. Dr Yeni has received honoraria for advisory positions and lecture sponsorships from Abbott Laboratories, Bristol-Myers Squibb, Boehringer Ingelheim, Roche, Tibotec/Virco, and Merck Sharp and Dohme. Scott M. Hammer, MD Dr Hammer has received research grants for site investigator from Roche, GlaxoSmithKline, and Merck. Dr Hammer has been a consultant for Bristol-Myers Squibb, GlaxoSmithKline, Merck, Shionogi, Pfizer, Boehringer Ingelheim, Shire, Gilead, and Tibotec/ Virco. Martin S. Hirsch, MD Dr Hirsch has received research support from Takeda. Dr Hirsch has been a consultant for Schering Plough, GlaxoSmithKline, and Bristol-Myers Squibb. Michael S. Saag, MD Dr Saag has received research support from Abbott Laboratories, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Ortho Biotech/Johnson&Johnson, Pfizer/Agouron, and Hoffmann- LaRoche. Dr Saag has been a consultant for Abbott Laboratories, Boeringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, OrthoBiotech/Johnson & Johnson, Pfizer/Agouron, Roche, Schering-Plough, Shire Pharmaceutical, TherapyEdge, Tibotec/ Virco, Trimeria, Vertex, and ViroLogic. Dr Saag has received honoraria for positions on the speakers bureau for Abbott Laboratories, Boeringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, OrthoBiotech, Johnson & Johnson, Pfizer, Agouron, Roche, Schering-Plough, Shire Pharmaceutical, TherapyEdge, Tibotec/Virco, Trimeria, Vertex, and ViroLogic. Margaret A. Fischl, MD Dr Fischl has received research grants from Abbott Laboratories, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, and Ortho Biotech. Dr Fischl has received honoraria for continuing medical education programs from GlaxoSmithKline. Dr Fischl has served as an advisor for Agouron Pharmaceuticals and GlaxoSmithKline. Brian G. Gazzard, MA, MD Dr Gazzard has received research grants from Abbott Laboratories, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Bristol-Myers Squibb, and Johnson &Johnson. Julio S. G. Montaner, MD Dr Montaner has received grants from Abbott Laboratories, Agouron Pharmaceuticals, Shire Biochemical, Boehringer Ingelheim, Bristol-Myers Squibb, DuPont Pharma, Gilead Sciences, GlaxoSmithKline, Roche, Kucera Pharmaceutical, Merck Frosst Laboratories, Pharmacia & Upjohn, and Trimeris. Dr Montaner has received honoraria for speaking from Abbott Laboratories, Agouron Pharmaceuticals, Shire Biochemical, Boehringer Ingelheim, Bristol-Myers Squibb, DuPont Pharma, Gilead Sciences, GlaxoSmithKline, Hoffmann-La Roche, Kucera Pharmaceutical, Merck Frosst Laboratories, Pharmacia & Upjohn, and Trimeris Inc. Dr Montaner holds 2 US patents, one regarding use of nevirapine and another regarding pharmacological applications of mitochondrial DNA assays. Dr Montaner has 2 patent applications that are pending, one regarding pharmacological applications of mitochondrial DNA assays and another regarding sepsis. Robert T. Schooley, MD Dr Schooley has received grants from GlaxoSmithKline, Bristol-Myers Squibb, Merck, and Tibotec/Virco. Dr Schooley has been a consultant for Abbott Laboratories, Pfizer, Hoffmann-LaRoche, GlaxoSmithKline, BristolMyers Squibb, Merck, Vertex, ViroLogic, and Tibotec/Virco. Melanie A. Thompson, MD Dr Thompson has received grants from Abbott Laboratories, Agouron/ Pfizer Pharmaceuticals, Boeringer Ingelheim, Bristol-Myers Squibb, Chiron Corporation, GlaxoSmithKline, Gilead Sciences, Merck Research Laboratories, Oxo-Chemie, Roche, Serono, Theratechnologies, Triangle Pharmaceuticals, Trimeris, and VaxGen. Dr Thompson has been a consultant for Abbott Laboratories, Agouron/Pfizer Pharmaceuticals, GlaxoSmithKline, Gilead Sciences, Serono, and Triangle Pharmaceuticals. Dr Thompson has received honoraria for lecture sponsorships and continuing medical education from Abbott Laboratories, Agouron/ Pfizer Pharmaceuticals, Boeringer Ingleheim, Bristol-Myers Squibb, GlaxoSmithKline, Gilead Sciences, Roche, Serono, Triangle Pharmaceuticals, and Trimeris. Mauro Schechter, MD, PhD Dr Schechter has received honoraria from Abbott Laboratories, Bristol-Myers Squibb, GlaxoSmithKline, Merck, and Roche. Dr Schechter has been a consultant for Abbott Laboratories, BristolMyers Squibb, GlaxoSmithKline, Merck, and Roche. Jose M. Gatell, MD, PhD Dr Gatell has served in advisory positions for Roche, Bristol-Myers Squibb, Merck Sharp and Dohme, GlaxoSmithKline, Gilead, Boehringer Ingelheim, Abbott Laboratories, Tibotec/ Virco. Brian G. Gazzard, MA, MD Dr Gazzard has received lectureship fees from Abbott Laboratories, Boehringer Ingelheim, Pfizer, GlaxoSmithKline, Bristol-Myers Squibb, and Johnson & Johnson. David A. Katzenstein, MD Dr Katzenstein has held advisory positions at Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck, ViroLogic, Visible Genetics, and the Doris Duke Charitable Trust. Dr Katzenstein holds a US patent for polymerase chain reaction assays monitoring antiviral therapy and making therapeutic decisions in the treatment of AIDS. Stefano Vella, MD Dr Vella has received lecture sponsorship for satellite symposia and continuing medical education programs from Merck, Agouron, Gilead, Boehringer Ingelheim, and Roche. Paul A. Volberding, MD Dr Volberding has received honoraria from Gilead, Bristol-Myers Squibb, GlaxoSmithKline, and Boehringer Ingelheim. Dr Volberding has been a consultant for Pfizer, Bristol-Myers Squibb, and Shire. Douglas D. Richman, MD Dr Richman has been a consultant for Abbott Laboratories, Bristol-Myers Squibb, Chiron, Gilead, GlaxoSmithKline, Merck, Novirio, Pfizer, Roche, Takeda, Triangle, and ViroLogic. Corresponding Author: Patrick G. Yeni, MD, Hospital Bichat-Claude Bernard, 46 Rue Henri-Huchard, 75877 Paris Cedex 18, France (Patrick.Yeni@Bch .Ap-Hop-Paris.Fr). >>>James Scutero posted this to misc.health.aids on July 17, 1995. >> [quoted text clipped - 13 lines] >now says something quite different indeed - so let's take another >look-see: Nope. It's correct...my phrase tho was not specific--so I agree with the IAS to a certain extent. I was thinking more of people with very low CD4 counts (below 50) that AZT monotherapy could bring back from the brink of dying. I watched that happen many times in those horrible days...but it didn't help people for very long. Too many then died. Some more recent data since that SoC suggests starting between 200 and 350 is wiser as the nadir CD4 count in one's life (the lowest it has ever been) is predictive of outcome. >After years of promoting "early ARV" treatment as "life-saving", >the pharma shills on this newsgroup are STILL biting their [quoted text clipped - 10 lines] >conflicts of interest by the doctors who have been misleading >about HIV treatment since the first AZT studies. Definitely something people should be aware of and concerned about. However, since you cite this information, I take it this means you also recognize the value of combination therapy in the management of HIV disease--at least for people with CD4+ counts below 200.... George M. Carter >>>>James Scutero posted this to misc.health.aids on July 17, 1995. >>> [quoted text clipped - 16 lines] > Nope. It's correct...my phrase tho was not specific--so I agree with > the IAS to a certain extent. You only agree to the extent where the IAS contradicts your pharmaceutical Talking Points Strategy Guide. pity > I was thinking more of people with very > low CD4 counts (below 50) that AZT monotherapy could bring back from > the brink of dying. I watched that happen many times in those horrible > days...but it didn't help people for very long. Too many then died. People with AIDS were continually getting better - then worse - then better. AZT had nothing to do with the getting better part and had a lot to do with the getting worse part. >>After years of promoting "early ARV" treatment as "life-saving", >>the pharma shills on this newsgroup are STILL biting their [quoted text clipped - 16 lines] > also recognize the value of combination therapy in the management of > HIV disease--at least for people with CD4+ counts below 200.... That is where you agree with the IAS standard of care. I can't disagree with those who start getting sick and use the drugs until they feel better and then stop. They seem to be the ONLY ones who actually benefit from these drugs. So there, George Mary - I said it: the antiviral cocktails seem to work for those with severe immune dysfunction who use them intermittently in response to clinical symtoms. Of course, I think these drugs downregulate Tregs at the moment when Treg provocation is at its highest - thus these drugs have nothing to do with lowering any silly-assed virus. Are you happy now? Are you ever happy? susie snip >I can't disagree with those who start getting sick and use the drugs >until they feel better and then stop. They seem to be the ONLY ones >who actually benefit from these drugs. Well, gosh, golly we agree. Who knew? >So there, George Mary - I said it: the antiviral cocktails seem to >work for those with severe immune dysfunction who use them intermittently >in response to clinical symtoms. LOL...you finally got it...but then...who are you? Susie, age 9? I doubt it. >Are you happy now? Are you ever happy? Actually, yes. Generally, I am happy. George M. Carter > snip >>I can't disagree with those who start getting sick and use the drugs >>until they feel better and then stop. They seem to be the ONLY ones >>who actually benefit from these drugs. > > Well, gosh, golly we agree. Who knew? But you left off the best part about the Tregs. >>So there, George Mary - I said it: the antiviral cocktails seem to >>work for those with severe immune dysfunction who use them intermittently >>in response to clinical symtoms. > > LOL...you finally got it...but then...who are you? No, I just gave it to you. I've had it all along. > Susie, age 9? I doubt it. Don't you ever indulge your inner child, George Mary? >>Are you happy now? Are you ever happy? > > Actually, yes. Generally, I am happy. Now that you have won the discussion, are you having another Happy Twinkie Day in the Big City? Is it snowing and bitter cold there like it is where I am? susie "Susie, age 9" <nomail@noway.com> wrote in message > Is it snowing and bitter cold there like it is where I am? Oooooooh sh.t, it finally happened, a cold day in hell. > "Susie, age 9" <nomail@noway.com> wrote in message >> >> Is it snowing and bitter cold there like it is where I am? >> > Oooooooh sh.t, it finally happened, a cold day in hell. It is always interesting to see who picks up the details. susie |
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