Foster children in New York City who participated in clinical drug trials for HIV/AIDS medications did not die as a result of participation in the study, and researchers did not specifically select children to participate based on race, according to a report released Wednesday by the Vera Institute of Justice, the New York Times reports. In the late 1980s, the city’s Administration for Children’s Services developed a policy allowing HIV-positive foster children to enroll in drug trials. According to the Times, hundreds of children received HIV medications in numerous trials conducted until 2005 (Foderaro, New York Times, 1/28). After allegations that ACS might have mismanaged the trials, the city in 2005 hired the Vera Institute to evaluate whether the agency had the necessary permission to include the children in the trials, if the children met the studies’ medical criteria and if the enrollments were appropriate given the medical knowledge at the time (Kaiser Daily HIV/AIDS Report, 5/9/05).

For the report, the institute interviewed several people involved with the trials and reviewed case files, documents and correspondence. According to the Times, the researchers concluded that city officials had “acted in good faith and in the interests of the children.” Although 25 children receiving treatment died during the trial time period, the institute found that none of the 532 children involved in the trials died as a direct result of the medications. The study also found that ACS did not specifically select children of certain racial backgrounds to participate in the trials. Although the foster children who enrolled in the trials were predominantly black and Hispanic, this corresponded to the demographics of HIV-positive children in the city at the time. In addition, the report refuted the claim that ACS removed children from families who objected to the trials. However, the researchers also found that the agency kept insufficient records and did not always follow correct protocol. According to the report, a medical advisory panel did not review 30 trials involving 64 children, even though city policy requires such a review. In addition, 21 children participated in trials that the panel had reviewed but not recommended. In both cases, 13 enrollments occurred before the children were placed in foster care, according to the study. The researchers also found that ACS lacked informed consent forms from biological parents or guardians for 21% of cases, despite city regulations requiring such forms.

Timothy Ross, co-director of the Vera project, called the lack of consent forms “disturbing” but added that the institute “read through an amazing volume of material” and concluded that the children’s services agency “did research on the rules and regulations that applied, and developed a reasoned policy” for enrolling the children in the trials. However, “[t]here were clearly breakdowns in the implementation of this policy,” Ross said. John Mattingly, ACS commissioner, said the report “puts to rest the most egregious charges” made a few years ago. He added, “No children were yanked from their homes. That is all completely false.” According to Mattingly, ACS already has taken steps to ensure proper enforcement of city policies in any future medical trials involving foster children. The agency has improved its case record cataloguing and archiving systems, established an electronic retrieval system and mandated more reviews by a family court for cases when a parent is not available to provide consent. Currently, no children are enrolled in medical trials in the city, the Times reports (New York Times, 1/28).

The report is available online.

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

More than 20 sub-Saharan African countries are limiting the number of new patients receiving HIV/AIDS care because of insufficient health infrastructures and a shortage of health care workers, problems that pose a “major new obstacle” for expanding treatment programs in the region, the… Boston Globe reports. African physicians, Bush administration officials and HIV/AIDS advocates say that some sub-Saharan African countries are experiencing capacity problems in health clinics after enrolling a few thousand patients in antiretroviral drug programs, according to the Globe. Although these countries face future challenges in HIV/AIDS treatment, many people say that getting to this point “represents a significant accomplishment,” the Globe reports. “We have moved from destructive chaos four years ago, when the epidemic was wreaking havoc and little was being done, to a kind of happy chaos,” Paul Zeitz, head of the Global AIDS Alliance, said, adding, “We want these kind of problems. Now we need to rapidly upgrade health systems to improve capacity.” The largest long-term problem facing African antiretroviral treatment programs is the lack of trained health care workers, according to the Globe. Dr. Jim Yong Kim, director of the World Health Organization’s HIV/AIDS Program, said that donors will have to find ways to increase health workers’ salaries in developing countries to prevent them from leaving their jobs. Zeitz said, “There are a ton of vibrant people who would love to get trained as community health workers. It would help the unemployment problem in many countries.” Other African countries “are still not ready to start” antiretroviral drug treatment programs, the Globe reports. “[D]rug-distribution systems are a massive, massive problem,” Mark Dybul, deputy chief of the President’s Emergency Plan for AIDS Relief, said, adding, “It’s not just the supply chain, it’s capacity overall. We’re going from doubling or tripling the number of people on therapy, and the production capacity isn’t there” (Donnelly, Boston Globe, 2/24).

“Reprinted with permission from kaisernetwork kaisernetwork. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork/dailyreports/hiv.. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

Health officials in the Seattle area are hosting a soccer tournament in an effort to teach African and Caribbean immigrants about HIV/AIDS and undergo testing for the virus, the Seattle Times reports. The second “Kick HIV/AIDS Away” soccer tournament in Tukwila, Wash., is being hosted by Public Health Seattle and King County, and the People of Color Against AIDS Network is providing no-cost testing and counseling. Recognizing that soccer is one of the most popular sports in Africa, Martin Ndegwa, a Kenyan immigrant and health education worker for Covenant Missions International, came up with the idea for a tournament after seeing an increase in the number of new HIV/AIDS cases in the immigrant community. “We are able to reach communities that are very hard to (reach),” Ndegwa said of outreach at the tournament. Almost 40 people were tested at last year’s event, and Ndegwa said he hopes more will be tested this year. During the first weekend of the tournament, more than 25 people were tested, and 80 more are signed up to be tested next weekend (Casavant, Seattle Times, 9/19).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

International research group led by Yasushi Okamura, a professor in Japanese National Institute for Physiological Sciences, Okazaki, and Peter Larsson, a professor in Oregon Health & Science University, Oregon, US, found that a single protein of VSOP, Voltage Sensor Only Protein/ Hv1, can carry protons even without making a multimeric complex. Since VSOP is known to be expressed in phagocytes such as macrophage and neutrophil that remove infected pathogens, this finding may help to design new medications for enhancing the activities of innate immunity. They report this work in Proceeding National Academy of Sciences (published online on the week of June 16, 2008).

Usually, ion channels on cell membrane form a multimeric complex to make an assembling hole to carry ions though it. Surprisingly, the research group found that this VSOP protein forms a dimer but each single subunit can carry proton without any assembling hole. They concluded it by using the techniques of FRET (Fluorescence Resonance Energy Transfer) and biochemistry,

The VSOP keeps cell inside alkaline condition. This finding helps to understand how VSOP regulates pH condition during the process of removing pathogens such as fungi, bacteria and virus.

“It is still not clear that how proton can go through a single VSOP protein, but here we clearly showed that a single subunit of VSOP can carry protons without making any assembling hole. This finding may help to design new medications for promoting activities of innate immunity or prevention of abnormal state of immunity such as asthma”, said Professor Okamura.

###

Source: Yasushi Okamura

National Institute for Physiological Sciences Continue reading →

Did you know that filling out your census card will help computer scientists model how diseases spread in the United States?

Over the last four years, researchers at RTI International in North Carolina have been transforming data from the 2000 census-which described the country’s 281 million people and 116 million households-into a virtual U.S. population. They finished the “synthetic population” last year, and they plan to update it when the 2010 census results come out.

The scientists developed the synthetic population as part of the National Institute of General Medical Sciences’ Models of Infectious Disease Agent Study (MIDAS) at the National Institutes of Health. By integrating the population into their computer models, MIDAS researchers can better simulate the spread of an infectious outbreak through a community and identify the best ways to intervene.

The synthetic population doesn’t exactly reproduce your hometown in silico, but it comes pretty close. The census protects citizens’ privacy, so the RTI researchers couldn’t duplicate John Smith from Manhattan or Jane Doe from Iowa City. Nor could they take each neighborhood home, apartment building, college dorm, family farm and sprawling ranch and plop it down at their exact addresses on the computer.

But the census data did give them the population, household sizes, family incomes and residents’ ages and ethnicities for every town, county and state. Plugging all this information into their computers allowed the researchers to create a mirror-country that has the same overall demographics as our actual one.

“The synthetic population looks statistically exactly like the real population,” says Irene Eckstrand, who directs the MIDAS program. “It has all the characteristics of real communities but doesn’t invade anyone’s privacy.”

The number and types of houses in your county match those in the corresponding synthetic county. And each home is in an appropriate place-on a residential patch of land, not in a lake or the middle of an airport.

Disease modelers can manipulate all or selected parts of the new, ready-made synthetic population. They can model the entire country or just one town.

They can program the virtual citizens-or agents, as modelers call them-to behave in certain ways. For instance, in an outbreak simulation, one agent may get vaccinated while another refuses.

Having populations already on hand can help speed up disease-spread simulation and allow modelers and policymakers to keep pace with real outbreaks, including the H1N1 pandemic.

Plus, modelers no longer need to wrangle raw census data for each model and can focus instead on refining their simulations, says Bill Wheaton, a research geographer who oversees the project at RTI.

The synthetic population will also help modelers study the impact of social networks on disease spread. Researchers can track where agents work or go to school, who they live with and who they’re likely to meet running errands. Since people get sick when they come into contact with others who’ve been infected, studying these social patterns in models should be helpful in understanding them in the real world.

Next, the researchers want to create international synthetic populations. They’ve already finished one for the 110 million people in Mexico, and they’re currently working on another one for India.

Modeling many countries is important, says Wheaton, because “infectious disease is not a one-country problem-it spreads around the globe.”

Source
NIH, National Institute of General Medical Sciences (NIGMS) Continue reading →

GlaxoSmithKline (GSK) and Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) today announced preliminary 48-week results from a head-to-head clinical study that indicated that Lexiva (Telzir; fosamprenavir calcium) 700 mg plus ritonavir 100 mg given twice daily was comparable (non-inferior) to Kaletra (lopinavir/ritonavir fixed-dose combination) given twice daily in treatment-naive HIV patients. All
patients in the study also received a once-daily fixed-dose combination of
abacavir 600 mg and lamivudine 300 mg as the backbone of antiretroviral
therapy.

In the study, which enrolled 887 patients, 73 percent of patients
receiving Lexiva/ritonavir maintained suppression of viral replication
(less than 400 copies/mL plasma HIV RNA) after 48 weeks of dosing, compared with 71 percent of patients receiving Kaletra (Intent-to-Treat Analysis).

The results will be submitted to the FDA and other health regulatory
authorities when the final analysis is concluded.

Lexiva/ritonavir was compared to Kaletra in this study due to Kaletra’s
position as the preferred HIV protease inhibitor in HIV treatment
guidelines developed by the United States Department of Health and Human Services (DHHS) and the International AIDS Society (IAS). Based on these results from this study, researchers have concluded that Lexiva appears to be comparable to Kaletra and has met the primary endpoints of this non-inferiority trial.

GSK will present results from the study at a medical conference in
2006. Lexiva was co-discovered by Vertex and GlaxoSmithKline.

KLEAN Study Design and Results

The results announced today are from the KLEAN study, a randomized, open-label study of the safety and efficacy of Lexiva, dosed as 700 mg twice daily, in combination with 100 mg ritonavir twice daily, versus Kaletra, dosed as 400 mg in a fixed-dose combination with 100 mg ritonavir twice-daily, in 887 treatment-naive HIV infected adults for 48 weeks. All patients in the study received concomitant treatment with a once-daily fixed-dose combination of 600 mg abacavir and 300 mg lamivudine.

Preliminary results indicated that 73 percent of patients receiving
Lexiva plus ritonavir in combination therapy maintained suppression of
viral replication (less than 400 copies/mL plasma HIV RNA) after 48 weeks of dosing, compared with 71 percent of patients receiving Kaletra in combination therapy (95 percent CI, -3.26,5.47). The treatments were found to be non-inferior. These preliminary analyses therefore suggest that Lexiva has comparable activity to Kaletra based on the proportion of
patients who have less than 400 copies/mL HIV RNA at 48 weeks of dosing.

Both regimens were generally well-tolerated. A total of 6 percent of
subjects withdrew due to adverse events. Adverse events in this study were consistent with those described in product information for Lexiva and Kaletra.

Important Prescribing and Safety Information

LEXIVA is indicated in combination with other antiretroviral agents for
the treatment of HIV infection in adults. The PI-experienced patient study
was not large enough to reach a definitive conclusion that LEXIVA/ritonavir and lopinavir/ritonavir are clinically equivalent. Once-daily administration of LEXIVA/ritonavir is not recommended for PI-experienced patients. LEXIVA does not cure HIV or prevent passing HIV to others.

You should not take LEXIVA if you have had an allergic reaction to
LEXIVA or AGENERASE(R) (amprenavir). High blood sugar, diabetes or
worsening of diabetes, and bleeding in hemophiliacs have occurred in some patients taking protease inhibitors. When you start taking HIV medicines, your immune system may get stronger and could begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your doctor. Changes in body fat may occur in some patients taking antiretroviral therapy. The cause and long-term health effects of these conditions are not known at this time. Skin rashes can occur in patients taking LEXIVA. Rarely, rashes were severe or life threatening. Opportunistic infections can develop when you have HIV and your immune system is weak. It is very important that you see your healthcare provider regularly while you are taking LEXIVA to discuss any side effects or concerns. Most common side effects in clinical studies were diarrhea, headache, nausea, rash, and vomiting. In most cases, these side effects did not cause people to stop taking their medicine.
For full prescribing information for LEXIVA, please visit
treathiv

About GlaxoSmithKline

GlaxoSmithKline is one of the world’s leading research-based
pharmaceutical and healthcare companies and an industry leader in HIV
research and therapies. The company is engaged in basic research programs designed to investigate new targets to treat HIV.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company’s strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex’s product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.Vertex’s press releases are available at vrtx.

Safe Harbor Statement

This press release may contain forward-looking statements. While
management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause Vertex’s actual results to vary materially. These risks and uncertainties include, among other things, the risks that full analysis of the data, including an ongoing detailed safety analysis, or further
testing, will not reflect the preliminary results reported in this press
release, or support any or all of the conclusions provided in this press
release; and other risks listed under Risk Factors in Vertex’s Form 10-K
filed with the Securities and Exchange Commission on March 16, 2006.

Lexiva is a registered trademark of the GlaxoSmithKline group of
Companies.

Kaletra is a registered trademark of Abbott Laboratories.

Vertex Pharmaceuticals Incorporated
vrtx

View drug information on Kaletra Capsules and Oral Solution; Lexiva. Continue reading →

The SARS coronavirus that sparked a global panic three years ago uses a key coat protein, called S2, to gain entry into human host cells.

Now, a team of biochemists at the Weill Medical College of Cornell University in New York City has identified four important steps in this process — each of which could be a potent new target for drugs or vaccines aimed at stopping SARS, should it reappear.

“S2-mediated entry into the host cell is vital to infection. By identifying mechanisms important to infection, we’re a step closer to pharmaceuticals that can break that chain of events,” explains senior researcher Dr. Min Lu, associate professor of biochemistry at Weill Cornell Medical College.

His team will publish their findings in the May 16 issue of Structure.

Severe acute respiratory syndrome (SARS) was first reported in Asia in February 2003. Over the next few months, the illness spread to more than two dozen countries in North America, South America, Europe and Asia before the global outbreak was contained.

According to the World Health Organization, 8,098 people worldwide became sick with SARS during the outbreak, and 774 died. Since that time, there has not been another SARS outbreak.

The threat remains, however, and scientists have raced to discover some kind of viral Achilles’ heel that will both give them a better understanding of how SARS spreads, and how it might be controlled.

“Because of years of research into HIV, scientists already know a lot about how these types of viruses gain entry into cells,” Dr. Lu notes.

In the case of SARS, the S2 protein lying on the virus’ outer membrane is the “fusion machine” that allows the virus to fuse its outer membrane with that of the host cell. Once this fusion occurs, the virus can insert its genome into the host cell, where it replicates, bursts forth, and spreads to new cells.

“So, understanding how S2 works is key to stopping infection,” Dr. Lu says. “The molecule’s heptad-repeat regions have unusual structural and thermodynamic features.”

Using biophysical methods, his team has discovered and described the conformations of four distinct S2 “domains” — structures and polymorphic interactions of the two heptad-repeat regions that are released and then refolded as membrane fusion occurs.

“This process occurs in a series of steps the virus has devised over time to protect itself as it penetrates the cell,” Dr. Lu explains.

Identifying these steps is crucial to the development of antiviral drugs that might fight SARS.

“HIV research has already proved the concept that various stages in membrane fusion can be useful targets for drug therapy, and many powerful antivirals are focused on inhibiting one of these intermediate steps,” Dr. Lu observes.

Already, agents called C-peptides look promising in their ability to block one of the four domains outlined in the study.

The identification and structural determination of the four distinct conformations of S2 also suggest a potential strategy for SARS vaccine development.

“Because it lies on the outer membrane, S2 is really the prime target for neutralizing antibodies,” Dr. Lu says. “Right now, development of a SARS vaccine remains a long shot, but this kind of research at least gives us a place to start.”

According to Dr. Lu, the stabilized forms of a soluble coat protein complex might lead to useful immunogens in efforts to elicit neutralizing antibodies.

“That’s our next challenge. Once we have the structural model of the complex, we can build on what we’ve learned to fight SARS, before it threatens us again,” he says.

The study was funded by grants from the National Institutes of Health and the Irma T. Hirschl Trust.

Co-authors include lead researchers Dr. Yiqun Deng and Dr. Jie Liu, as well as Dr. Qi Zheng and Wei Yong — all of Weill Cornell Medical College in New York City.

NewYork-Presbyterian Hospital
Weill Cornell Medical Center
Weill Cornell Medical College
nyp
medrnell.edu Continue reading →

The Senate on Wednesday passed by voice vote a compromise bill (HR 6143) that would reauthorize the Ryan White CARE Act, which provides funding for HIV/AIDS programs in the U.S., CQ HealthBeat reports (Wayne, CQ HealthBeat, 12/6). Sen. Edward Kennedy (D-Mass.) — ranking Democrat on the Health, Education, Labor and Pensions Committee — and HELP Chair Michael Enzi on Tuesday announced that Sen. Hillary Rodham Clinton (D-N.Y.) and other New York and New Jersey lawmakers agreed to the proposal crafted by Kennedy. Senators from California, New Jersey and New York earlier this year blocked Senate consideration of a House-approved bill sponsored by Rep. Mary Bono (R-Calif.) that would change CARE Act funding formulas so that rural areas experiencing increasing numbers of HIV/AIDS cases would receive higher funding amounts and urban areas’ funding would decrease. Kennedy’s proposal calls for strengthening “hold harmless” provisions and maintaining funding levels so that states would not receive less than 95% of their 2006 funding levels; counting all HIV-positive people for funding regardless of where they live or how the data are reported; maintaining the funding pool for prescription drugs and therapeutics; continuing HHS development of a framework addressing HIV/AIDS in the U.S. and a follow-up report of their progress in 2008; and maintaining a four-year transition period for states with code-based reporting systems to switch to names-based reporting systems without penalization. The compromise also would repeal the Ryan White program after three years, forcing Congress to write a new law and reconsider the program’s structural challenges before then, Senate aides said (Kaiser Daily HIV/AIDS Report, 12/6). “We must address the epidemic of today, not yesterday, and make sure the federal funds follow the person being treated — wherever they live,” Enzi in a statement said after the bill was passed, adding, “This bill will modernize the (law) to ensure that federal dollars to treat HIV/AIDS finally go to the people who are most in need” (CQ HealthBeat, 12/6). “The bill turns out to be a far better bill than we anticipated we could get out of this Congress,” Ernest Hopkins, director of federal Affairs for the San Francisco AIDS Foundation, said, adding, “We owe much to the advocacy of the New York and New Jersey senators. This revised bill benefits their states and California and San Francisco in particular” (Epstein, San Francisco Chronicle, 12/7).

House Consideration, Comments
Lawmakers in the House have been “noncommittal” about passing the Kennedy bill by the end of the week, CQ Today reports (Wayne, CQ Today, 12/6). Kevin Smith, spokesperson for House Majority Leader John Boehner (R-Ohio), said “no decision” has been made on the legislation. According to CQ HealthBeat, Kennedy’s compromise bill “represents a significant departure from the balance [House Committee on Energy and Commerce Chair Joe] Barton [R- Texas] negotiated between urban and rural lawmakers on his committee” (CQ HealthBeat, 12/6). Barton — who co-wrote and supported the original version of the reauthorization bill, which was passed by the House in September — said he is dissatisfied with the Senate’s amendment of the CARE Act bill and with the Senate’s rejection of separate legislation (HR 6164) that would restructure the NIH. Barton said that the revisions to the CARE Act bill are “not as good as the House-passed bill” and that he “could certainly” vote against the bill. However, he first wants to see what happens to the NIH bill — which he helped to write — in the Senate. “I want there to be a Ryan White reauthorization,” Barton said, adding that the Senators “did the right thing” in passing the bill. Although Barton said he will “try to accommodate them,” he added that it would be “much easier” for him to support the legislation if the Senate first passed the NIH bill (CQ Today, 12/6).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

The risk of HIV transmission via heterosexual intercourse is highest early in the course of HIV infection, before most
infected people know their HIV status, according to a new study published in the May 1 issue of The Journal of Infectious
Diseases, now available online.

Conducted by a group of investigators led by Maria J. Wawer of Columbia University, the study is the first to present
empirical data showing that the rate of heterosexual HIV transmission per coital act varies over the course of HIV infection.
The investigators found that the risk of transmission was highest early in infection, then dropped, then rose again late in
infection.

Wawer and colleagues followed a cohort of over 15,000 adults living in rural villages in Rakai, Uganda. From this population,
they retrospectively identified 235 heterosexual couples in whom one partner was infected with HIV and the other partner was
uninfected and monogamous. Study participants provided a blood sample and answered questions about their health and behavior,
including questions on number of sexual partners and coital frequency, at 10-month intervals for up to 40 months.

From analysis of these data, the researchers found that during early infection (the approximately two-and-a-half month period
after HIV seroconversion), the average rate of HIV transmission was five- to twelve-fold higher than during established
infection. The infection rate was 8.2 per 1000 coital acts during early infection, compared to 0.7 to 1.5 per 1000 coital
acts during established infection. The rate rose again during late-stage infection, 25 to 26 months prior to death, to 2.8
per 1000 coital acts. Among partners with newly acquired HIV infection, more than 40 percent transmitted to their partners
within approximately 5 months.

These results reflect transmission rates for heterosexual vaginal intercourse only, the authors noted, and cannot be applied
to HIV transmission via anal intercourse or injection drug use, since neither behavior was reported by study participants. In
addition to early or late infection, other factors associated with increased transmission from the HIV-infected partner were
younger age, increased viral load, and genital ulcer disease.

The study in Uganda was a collaboration between the Uganda Virus Research Institute and researchers at Makerere University,
Kampala, and Columbia University and Johns Hopkins University in the United States. The study was approved by human subjects
ethics boards in Uganda and the United States. All participants were offered HIV counseling and testing, health education on
HIV prevention, condoms and access to STD treatment, all provided at no cost.

In an accompanying editorial, Myron S. Cohen and Christopher D. Pilcher of the University of North Carolina at Chapel Hill
discussed the implications of this work for HIV prevention efforts. Traditionally, they explained, efforts have focused on
those who are not yet infected and on those with established infection. The highest rate of transmission in the study,
however, occurred in early infection, when few infected persons are aware of their infection status or receive the
antiretroviral drugs used to treat HIV infection. Cohen and Pilcher recommended that increased attention be paid to those
recently infected, and that measures such as partner notification, counseling services, and novel biological interventions be
developed specifically for persons with early HIV infection.

“The challenge now,” they said, “is to waste no time finding the most creative strategies to incorporate the results of this
study into global HIV prevention efforts.”

Founded in 1904, The Journal of Infectious Diseases is the premier publication in the Western Hemisphere for original
research on the pathogenesis, diagnosis, and treatment of infectious diseases; on the microbes that cause them; and on
disorders of host immune mechanisms. Articles in JID include research results from microbiology, immunology, epidemiology,
and related disciplines. JID is published under the auspices of the Infectious Diseases Society of America (IDSA). Based in
Alexandria, Va., IDSA is a professional society representing more than 8,000 physicians and scientists who specialize in
infectious diseases. Nested within the IDSA, the HIV Medicine Association (HIVMA) is the professional home for more than
2,700 physicians, scientists and other health care professionals dedicated to the field of HIV/AIDS. HIVMA promotes quality
in HIV care and advocates policies that ensure a comprehensive and humane response to the AIDS pandemic informed by science
and social justice. For more information, visit idsociety.

Contact: Steve Baragona
sbaragonaidsociety
703-299-0412
Infectious Diseases Society of America
idsociety Continue reading →

Expanded HIV screening can increase patient life span, prevent the spread of the disease, and is cost effective,
researchers at Yale, Harvard and the Massachusetts General Hospital report in the February 10 issue of the New England
Journal of Medicine (NEJM).

The study’s findings are part of a two-paper series in NEJM on the value of expanded HIV screening in the United States. The
Yale/Harvard study used different data and methods than another study by VA, Duke and Stanford researchers, yet both teams
reached roughly the same conclusions.

“The publication of these papers represents a golden opportunity to jump-start the expansion of HIV testing services in the
U.S.,” said Yale lead author A. David Paltiel, associate professor of health and policy administration in the Department of
Epidemiology and Public Health at Yale School of Medicine. “Our findings, coupled with those of our colleagues, firmly
establish the great value of expanded screening.”

Paltiel and his team developed a mathematical model of HIV screening and treatment to predict the costs and benefits of HIV
counseling, testing and referral. They found that routine, voluntary HIV screening every three to five years is
cost-effective by U.S. standards, in all but the lowest-risk populations. Frequent HIV screening in moderate-to-high-risk
populations could produce life expectancy gains at costs that compare favorably to many commonly employed screening
interventions in other chronic conditions, including breast cancer, colorectal cancer, diabetes and hypertension. Paltiel
said that even in settings with HIV infection levels similar to the U.S. general population, one-time screening could deliver
excellent return on investment.

“HIV is a severe disease that, left untreated, produces substantial morbidity and mortality,” said Paltiel. “It has a long
asymptomatic phase, which can be diagnosed using very effective, inexpensive tests. Most importantly, early detection speeds
linkage to proven, life-prolonging care and effective counseling to prevent further transmission.”

Rochelle Walensky, assistant professor of medicine at Harvard and a co-author of the study, added, “The HIV epidemic is no
longer confined to a handful of easily identifiable risk groups, yet current approaches to HIV testing are still focused on
these sub-populations. The result is that 280,000 Americans with HIV remain unaware of their infection. Efforts to promote
and finance routine, population-based HIV screening should be pursued aggressively.”

Douglas K. Owens, M.D., of the VA Palo Alto Health Care System, and his team at the VA, Stanford and St. Michael’s Hospital
in Toronto, led another study in NEJM, which strongly supports Paltiel’s findings. They developed a computer model to
estimate the health benefits and expenditures of performing voluntary HIV screening programs in health care settings. They
also found that screening for HIV infection is cost-effective relative to other commonly accepted screening programs and
medical treatments.

Referring to the Yale/Harvard findings, Owens said, “It’s exciting that a completely independent analysis had the same
findings as we did. Both of these studies show that screening is life-prolonging and affordable.”

The Yale/Harvard study was funded by the National Institute of Mental Health, the National Institute on Drug Abuse, the
National Institute of Allergy and Infectious Diseases, and the United States Centers for Disease Control and Prevention.

Other authors on the study included Milton C. Weinstein and George R. Seage III of Harvard School of Public Health; Kenneth
A. Freedberg of the Massachusetts General Hospital, Harvard School of Public Health and Boston University School of Public
Health; April D. Kimmel and Hong Zhang of the Massachusetts General Hospital and Harvard Medical School; and Elena Losina of
Boston University School of Public Health.

Citation: NEJM, Vol. 352, Number 6, February 10, 2005.

Karen N. Peart – karen.peartyale.edu
Yale University Continue reading →