STANFORD, Calif.--(Business Wire)--
HIV-positive patients who don`t seek medical attention until they have a serious
AIDS-related condition can reduce their risk of death or other complications by
half if they get antiretroviral treatment early on, according to a new
multicenter trial led by researchers at the Stanford University School of
Medicine.
The study results could lead to widespread changes in treatment for HIV
patients, particularly those diagnosed at an advanced stage, experts say.
"Even in San Francisco, one of the first epicenters of HIV in the United States,
we still find that many people still present late in the course of their illness
with an opportunistic infection," said Mitch Katz, MD, San Francisco`s director
of health, who was not involved in the study. "This study shows that it is
life-saving to treat those persons with antiretroviral drugs while they are
still in the hospital. The results of this study will change practices
throughout the world."
Some 60,000 to 70,000 newly HIV-infected individuals are identified every year
in the United States, according to recently revised figures from the federal
Centers for Disease Control and Prevention. A growing number of these patients,
particularly minorities, youth, injection-drug users and those in poor rural
areas, are being diagnosed late in the disease process when they`ve already
developed life-threatening conditions, said Andrew Zolopa, MD, associate
professor of infectious diseases and geographic medicine at Stanford and first
author of the study. When these patients come for treatment of these
complications, doctors are often reluctant to give them anti-AIDS drugs at the
same time, fearing the two therapies could interfere with one another.
"A lot of people wait, thinking, `Let`s get the patient out of acute crisis, and
then we`ll deal with the underlying HIV infection later,`" said Zolopa. "But
that answer is wrong. If we`re more aggressive with HIV drugs, we can reduce
AIDS-related complications and death by 50 percent. It`s a substantial clinical
benefit."
The study was conducted by the AIDS Clinical Trials Group, the world`s largest
clinical trial organization. Results will be published May 18 in the online
journal PLoS-ONE.
William Powderly, MD, dean of medicine at the University College Dublin School
of Medicine, said the study addresses one of the last, longstanding unknowns in
the management of AIDS.
"Clinicians have long grappled with the question of whether or not early
treatment with antiviral drugs will help people who come to the hospital with
advanced infections, such as pneumonia," said Powderly, MD, the study`s senior
author. "The answer is clearly yes. Early antiviral treatment for HIV improves
the clinical outcome, including the likelihood of surviving in the next few
months. It probably does so by improving the immune system and therefore adds to
the ability to resist these infections."
The study findings, presented in abstract form at an earlier scientific meeting,
are already starting to change clinical practices. The International AIDS
Society, the CDC and the British AIDS Society all have adopted guidelines that
recommend that early antiretroviral treatment be considered in patients with an
opportunistic infection, Zolopa noted.
The study involved 262 patients at 39 sites across the United States, from
Puerto Rico to Seattle. An additional 20 patients were enrolled in a hospital in
Johannesburg, South Africa. Eighty-five percent of the patients were men whose
median age was 28. They were an ethnically diverse group: 37 percent were black,
36 percent Hispanic, 23 percent white and 5 percent Asian.
The patients all had one or more opportunistic infection, with the most common
ones being pneumocystis jirovecii pneumonia, cryptococcal meningitis and serious
bacterial infections. Patients with tuberculosis were excluded from the study
because it was unclear what the optimal antiviral treatment was for these
patients, Zolopa said.
The patients, who were enrolled between May 2003 and August 2006, were separated
into two groups: those who got antiretroviral treatment early and those for whom
this treatment was delayed until their opportunistic infections had been dealt
with. The patients were all offered antiretroviral drugs free of charge. The
drugs for the study were supplied by Abbott Laboratories (lopinavir/ritonavir),
Gilead Sciences (tenofovir and emtricitabine) and Bristol-Myers Squibb
(stavudine).
The patients in the early intervention arm of the study were treated with ARVs
within an average of 12 days, while those in the deferred group received the
treatment within an average of 45 days after the start of treatment for the
opportunistic infection. Among the patients treated early, there were 20 (14.2
percent) who died or developed another significant AIDS-related complication.
That compared with 34 patients (24.1 percent) in the deferred group who died or
suffered a new complication.
In addition, the patients in the early treatment group saw a much swifter
recovery of their immune systems. The early group patients saw their T-cell
counts, a measure of the immune cells destroyed by the AIDS virus, increase to
more than 100 within four weeks. In the deferred treatment group, it took 12
weeks for the patients` T cells to reach that same level, the researchers
reported.
"I was quite impressed at how rapidly these T cells could rise in these
patients," Zolopa said. "By starting ARVs early you can effectively reduce the
window of vulnerability where another AIDS-related complication could develop."
Zolopa said there was no difference between the two sets of patients in their
adherence to their prescribed regimens. One concern in treating patients with
ARVs soon after being diagnosed with AIDS is that they might not stick to their
treatments and could then develop drug resistance. But adherence did not prove
to be an issue, he noted.
"Starting the therapies early didn`t scare people off," he said.
According to Zolopa, the study results probably provide some guidance for
patients in developing countries, though each country would have to determine
its own strategy for initiating ARVs in patients with advanced AIDS.
"These results do have important implications across the globe," he said.
Although the study did not include patients with tuberculosis, the most common
AIDS-related complication among patients in sub-Saharan Africa, early ARV
treatment has been shown in other, more recent studies to be of value in those
patients with TB, Powderly said.
Zolopa said implementing the study findings could entail some logistical
challenges, as hospitals will have to develop interdisciplinary teams, including
pulmonary specialists, emergency physicians, pharmacists and others, in
coordinating early treatment for these critically ill patients as they come into
the system.
Other researchers in the study are Janet Andersen, ScD, and Lauren Komarow, both
with Harvard School of Public Health; Ian Sanne, MD, of the South African
College of Physicians; Alejandro Sanchez, MD, of the USC Keck School of
Medicine; Evelyn Hogg with Social & Scientific Systems, Inc.; and Carol Suckow
with the Frontier Science and Technology Research Foundation.
The study was funded by the National Institutes of Health through the Division
of AIDS.
The Stanford University School of Medicine consistently ranks among the nation`s
top 10 medical schools, integrating research, medical education, patient care
and community service. For more news about the school, please visit
http://mednews.stanford.edu. The medical school is part of Stanford Medicine,
which includes Stanford Hospital & Clinics and Lucile Packard Children`s
Hospital. For information about all three, please visit
http://stanfordmedicine.org/about/news.html.
Stanford University School of Medicine
Ruthann Richter, 650-725-8047 (Print Media)
richter1@stanford.edu
M.A. Malone, 650-723-6912 (Broadcast Media)
mamalone@stanford.edu
Copyright Business Wire 2009
