A recent study of men co-infected with herpes simplex virus type 2 (HSV-2) and HIV revealed that drugs used to suppress HSV decrease the levels of HIV in the blood and rectal secretions, which may make patients less likely to transmit the virus. This study is published in the Journal of Infectious Diseases, now available online.
Most HIV-infected persons are also infected with HSV-2, which is the major cause of genital herpes. Prior studies demonstrated that the risk of passing HIV to a sexual partner is greater when the HIV-infected person has genital ulcers caused by HSV. Previous studies among HIV/HSV-2 co-infected persons and test-tube research have also demonstrated that HIV levels are increased during genital HSV reactivation.
In a pilot study of the effect of HSV-2 suppression on levels of HIV infectiousness, Connie Celum, MD, MPH, Richard Zuckerman, MD, MPH, and a team of researchers at the University of Washington and the research organization Impacta, in Lima, Peru performed a randomized, placebo-controlled cross-over study of daily HSV suppressive treatment in a small group of HIV/HSV-2 co-infected men who have sex with men.
Twenty men aged 22 to 41 enrolled in this trial, which took place in Peru. The men studied had no prior antiretroviral therapy and were not currently receiving antiretroviral therapy for HIV infection. Subjects were randomly assigned to the anti-HSV drug, valacyclovir 500 mg, twice daily or matching placebo for initial treatment. After eight weeks, subjects had a "washout period" in which they received twice daily placebo. Subjects then crossed over to the alternative treatment (placebo or valacyclovir) for eight weeks. Participants visited the clinic three times a week during each treatment arm. At each visit, rectal secretions were collected and weekly blood samples were obtained to determine levels of HIV.
Dr. Celum and her team of researchers found significantly reduced levels of HIV in blood by about 50 percent and rectal secretions by about 30 percent during the 8 weeks when the HIV/HSV-2 co-infected men received valacyclovir to suppress reactivation of HSV. This reduction in HIV levels could have a significant impact on transmission of HIV. Since the only intervention was daily valacyclovir to suppress HSV, this study adds weight to the other evidence that HSV-2 reactivation increases HIV replication. According to the researchers, additional "ongoing randomized trials will answer whether HSV suppression can reduce HIV transmission and address the potential for HSV suppression to delay anti-HIV therapy (antiretroviral) initiation."
Tuesday, November 20, 2007
First In Class Integrase Inhibitor, 'Isentress'(R) (Raltegravir), Recommended For European Licence For The Treatment Of HIV
'Isentress'(R) (raltegravir), Merck Sharp & Dohme Limited's (MSD) treatment for HIV infection, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) in Europe. The CHMP opinion for a conditional marketing authorisation recommends that raltegravir is used in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage. The CHMP, comprised of regulators from all European Union countries, gave the positive opinion following a review of data supporting the efficacy, safety and tolerability profile of raltegravir. Following the conclusion of the CHMP's review, its opinion will be transmitted to the European Commission (EC). If the EC adopts the opinion, raltegravir will be the first integrase inhibitor approved for use in the treatment of HIV-1 infection.
The CHMP decision will apply to the 27 countries that are members of the European Union, including the United Kingdom, Germany, France, Italy and Spain. After undergoing fast-track review by the Food and Drug Administration, raltegravir was approved in the United States on 12 October 2007. We anticipate a decision from the CHMP on the approval of the product in Q1 2008.
Chris Round, Managing Director of MSD, commented, "The advent of raltegravir, used in combination with other antiretroviral medicines, represents a significant milestone in the treatment of HIV infection. Up until now, highly treatment-experienced adult HIV patients, whose infection is not well controlled by their existing antiretroviral drugs, have had very few treatment options. With this, the first integrase inhibitor, a new treatment approach for this patient population is now within our sights."
About raltegravir Raltegravir, to be used in combination with other antiretroviral medicines, offers a new therapeutic option in the management of HIV and AIDS. Up until now, there have been drugs in use that inhibit two other enzymes that play a key role in propagating HIV infection - protease and reverse transcriptase - but there have not, to date, been any approved drugs that inhibit integrase.
Raltegravir, previously referred to as MK-0518, is the first in a new class of antiretroviral agents called integrase inhibitors. Integrase is an enzyme only found in viruses. There is no corresponding enzyme in humans. Integrase is used by HIV to insert its newly made genetic material (DNA) into the host cell's DNA. Inhibiting integrase from performing this function blocks the ability of the virus to replicate and infect new cells.
Tolerability profile of raltegravir
Results from pooled safety analyses from three separate studies in treatment-experienced patients taking 400 mg of raltegravir dosed twice daily plus OBT* or placebo plus OBT showed that after 24 weeks of therapy the rates of discontinuation of therapy due to adverse experiences were 2.0 percent in patients receiving raltegravir plus OBT and 1.4 percent in patients receiving placebo plus OBT.1 In addition, drugrelated clinical adverse events of moderate to severe intensity occurring in 2 percent or more patients were diarrhoea (3.7 percent vs. 3.5 percent), nausea (2.2 percent vs. 3.2 percent) and headache (2.2 percent vs. 1.4 percent) for raltegravir plus OBT and placebo plus OBT, respectively.2
Prevalence of HIV
Prevalence of HIV in the UK has shown a marked increase since the early 1980s.3 In 2005, there were an estimated 63,500 people living with HIV in the UK.3
The CHMP decision will apply to the 27 countries that are members of the European Union, including the United Kingdom, Germany, France, Italy and Spain. After undergoing fast-track review by the Food and Drug Administration, raltegravir was approved in the United States on 12 October 2007. We anticipate a decision from the CHMP on the approval of the product in Q1 2008.
Chris Round, Managing Director of MSD, commented, "The advent of raltegravir, used in combination with other antiretroviral medicines, represents a significant milestone in the treatment of HIV infection. Up until now, highly treatment-experienced adult HIV patients, whose infection is not well controlled by their existing antiretroviral drugs, have had very few treatment options. With this, the first integrase inhibitor, a new treatment approach for this patient population is now within our sights."
About raltegravir Raltegravir, to be used in combination with other antiretroviral medicines, offers a new therapeutic option in the management of HIV and AIDS. Up until now, there have been drugs in use that inhibit two other enzymes that play a key role in propagating HIV infection - protease and reverse transcriptase - but there have not, to date, been any approved drugs that inhibit integrase.
Raltegravir, previously referred to as MK-0518, is the first in a new class of antiretroviral agents called integrase inhibitors. Integrase is an enzyme only found in viruses. There is no corresponding enzyme in humans. Integrase is used by HIV to insert its newly made genetic material (DNA) into the host cell's DNA. Inhibiting integrase from performing this function blocks the ability of the virus to replicate and infect new cells.
Tolerability profile of raltegravir
Results from pooled safety analyses from three separate studies in treatment-experienced patients taking 400 mg of raltegravir dosed twice daily plus OBT* or placebo plus OBT showed that after 24 weeks of therapy the rates of discontinuation of therapy due to adverse experiences were 2.0 percent in patients receiving raltegravir plus OBT and 1.4 percent in patients receiving placebo plus OBT.1 In addition, drugrelated clinical adverse events of moderate to severe intensity occurring in 2 percent or more patients were diarrhoea (3.7 percent vs. 3.5 percent), nausea (2.2 percent vs. 3.2 percent) and headache (2.2 percent vs. 1.4 percent) for raltegravir plus OBT and placebo plus OBT, respectively.2
Prevalence of HIV
Prevalence of HIV in the UK has shown a marked increase since the early 1980s.3 In 2005, there were an estimated 63,500 people living with HIV in the UK.3
Risk Of HIV Transmission Increased By Unstable Housing Status
New studies show that there is a demonstrable correlation between a person's housing status and his or her likelihood of transmitting or getting HIV. The groundbreaking research from the Centers for Disease Control (CDC) and others has been reported in a special issue of the journal AIDS and Behavior¹.
According to researchers from the CDC, homelessness and unstable housing "increase the risk of HIV acquisition and transmission and adversely affect the health of people living with HIV." The findings prompted the researchers to issue a call to action that "homelessness be treated as a major public health issue confronting the United States."
The first publication of its kind, this special issue of AIDS and Behavior includes 18 peer-reviewed articles on the relationship of housing status and HIV risk and health outcomes, including a policy perspective from former HUD Secretary Henry Cisneros. Research studies reported in the issue show that:
* Homeless or unstably housed persons were two to six times more likely to "have recently used hard drugs, shared needles or exchanged sex" than similar low-income persons who were stably housed.
* Receipt of housing assistance enabled homeless persons with substance use and mental health problems to achieve stability over time and to cease or reduce both drug related and sexual risk behaviors.
* Over a 12-year period, housing status and receipt of housing assistance consistently predicted entry and retention in HIV medical care, regardless of demographics, drug use, health and mental health status, or receipt of other services.
These and other findings reported in the special issue add to the growing evidence that housing itself independently reduces risk of HIV infection and improves the health of persons living with HIV. This evidence challenges the prevailing "risky person" model for understanding the co-occurrence of homelessness, HIV/AIDS and poor health outcomes.
"The findings reported here suggest that the condition of homelessness, and not simply traits of homeless individuals, influences risk behaviors and health care utilization," says Housing and HIV/AIDS Special Editor Dr. Angela Aidala of the Columbia University Mailman School of Public Health. "This points to housing as a strategic target for intervention -- a potentially exciting new tool to end the AIDS epidemic in America."
According to researchers from the CDC, homelessness and unstable housing "increase the risk of HIV acquisition and transmission and adversely affect the health of people living with HIV." The findings prompted the researchers to issue a call to action that "homelessness be treated as a major public health issue confronting the United States."
The first publication of its kind, this special issue of AIDS and Behavior includes 18 peer-reviewed articles on the relationship of housing status and HIV risk and health outcomes, including a policy perspective from former HUD Secretary Henry Cisneros. Research studies reported in the issue show that:
* Homeless or unstably housed persons were two to six times more likely to "have recently used hard drugs, shared needles or exchanged sex" than similar low-income persons who were stably housed.
* Receipt of housing assistance enabled homeless persons with substance use and mental health problems to achieve stability over time and to cease or reduce both drug related and sexual risk behaviors.
* Over a 12-year period, housing status and receipt of housing assistance consistently predicted entry and retention in HIV medical care, regardless of demographics, drug use, health and mental health status, or receipt of other services.
These and other findings reported in the special issue add to the growing evidence that housing itself independently reduces risk of HIV infection and improves the health of persons living with HIV. This evidence challenges the prevailing "risky person" model for understanding the co-occurrence of homelessness, HIV/AIDS and poor health outcomes.
"The findings reported here suggest that the condition of homelessness, and not simply traits of homeless individuals, influences risk behaviors and health care utilization," says Housing and HIV/AIDS Special Editor Dr. Angela Aidala of the Columbia University Mailman School of Public Health. "This points to housing as a strategic target for intervention -- a potentially exciting new tool to end the AIDS epidemic in America."
$60 Million USAID Grant Goes To Indiana And Moi Universities' AMPATH Program To Combat AIDS In Kenya
AMPATH, a program that grew out of the partnership between Indiana University School of Medicine and the Moi (Kenya) University Teaching and Referral Hospital, has received a 5-year, $60-million grant to prevent and treat HIV/AIDS in Kenya. In addition, the IU School of Medicine will augment this with $6 million over the 5 years of the grant.
The principal investigator of the grant, Robert Einterz, M.D., is associate dean for international affairs at the IU School of Medicine and co-founder of the IU-Moi partnership and AMPATH. He will coordinate all the activities between IU School of Medicine, the Moi Teaching and Referral Hospital, Moi University School of Medicine and other U.S. partners and universities collaborating in the project.
"USAID made the grant to the AMPATH program because of its success in developing and implementing treatment and prevention programs in Kenya for the past decade," said Henrietta H. Fore, the administrator of USAID, director of foreign assistance and undersecretary for management. "Through President Bush's PEPFAR program, we are making resources available in countries with a substantial HIV/AIDS burden. These resources include support for prevention efforts, care and support, and treatment for affected patients," she said.
PEPFAR, the President's Emergency Plan for AIDS Relief, which is a 5-year, $15 billion program initiated in 2003, has treated over a million HIV-positive people in 15 focus countries in sub-Saharan Africa, Asia and the Caribbean. Sen. Richard G. Lugar (R-Ind.) is sponsoring legislation to renew PEPFAR at President Bush's requested increase of $30 billion over the next 5 years.
AMPATH currently provides care for 52,000 HIV-infected patients and has reduced the rate of infection significantly. With this agreement, the goal is to expand the program to provide care to an additional 150,000 Kenyans with HIV by 2012, of which at least 70,000 will be on antiretroviral drugs, and to interrupt the transmission of HIV through home-based counseling and testing in communities served by 19 facilities. In addition, the partnership intends to improve and expand control of tuberculosis, and assist and engage communities and families to meet the basic needs of 20,000 orphans and vulnerable children within the first 2 years of the grant.
"I am proud that our government is making such a dramatic commitment to saving the lives of people suffering from HIV/AIDS," said Dr. Einterz, M.D. "As a Hoosier, I am proud that IU has taken a leadership role in caring for our African neighbors with HIV. This grant supports our core services to treat HIV patients.
"Now, along with our Kenyan partners, we look forward to moving beyond this grant to pursue our groundbreaking mission of home-based counseling and testing, and expand beyond HIV to tackle maternal and infant mortality."
The PEPFAR target in Kenya is to have 250,000 Kenyans on antiretroviral therapy by Sept. 30, 2009. The target for infections averted in the same timeframe through the prevention of mother-to-child transmission programs and other prevention efforts is 425,000. By September 2009, 450 orphans and vulnerable children and 250 people living with AIDS will be receiving palliative care in Kenya.
The grant was announced in Nairobi on Nov. 19 during a signing ceremony in the Ministry of Health Headquarters attended by Administrator Fore; Dr. Einterz, U.S. Ambassador to Kenya Michael E. Ranneberger; AA/AFR Katherine J. Almquist; USAID/Kenya Mission Director Erna Kerst; Joe Mamlin, M.D., IU professor emeritus and co-founder of the IU-Moi Partnership; and, Moi University and USAID administrators and staff members.
The principal investigator of the grant, Robert Einterz, M.D., is associate dean for international affairs at the IU School of Medicine and co-founder of the IU-Moi partnership and AMPATH. He will coordinate all the activities between IU School of Medicine, the Moi Teaching and Referral Hospital, Moi University School of Medicine and other U.S. partners and universities collaborating in the project.
"USAID made the grant to the AMPATH program because of its success in developing and implementing treatment and prevention programs in Kenya for the past decade," said Henrietta H. Fore, the administrator of USAID, director of foreign assistance and undersecretary for management. "Through President Bush's PEPFAR program, we are making resources available in countries with a substantial HIV/AIDS burden. These resources include support for prevention efforts, care and support, and treatment for affected patients," she said.
PEPFAR, the President's Emergency Plan for AIDS Relief, which is a 5-year, $15 billion program initiated in 2003, has treated over a million HIV-positive people in 15 focus countries in sub-Saharan Africa, Asia and the Caribbean. Sen. Richard G. Lugar (R-Ind.) is sponsoring legislation to renew PEPFAR at President Bush's requested increase of $30 billion over the next 5 years.
AMPATH currently provides care for 52,000 HIV-infected patients and has reduced the rate of infection significantly. With this agreement, the goal is to expand the program to provide care to an additional 150,000 Kenyans with HIV by 2012, of which at least 70,000 will be on antiretroviral drugs, and to interrupt the transmission of HIV through home-based counseling and testing in communities served by 19 facilities. In addition, the partnership intends to improve and expand control of tuberculosis, and assist and engage communities and families to meet the basic needs of 20,000 orphans and vulnerable children within the first 2 years of the grant.
"I am proud that our government is making such a dramatic commitment to saving the lives of people suffering from HIV/AIDS," said Dr. Einterz, M.D. "As a Hoosier, I am proud that IU has taken a leadership role in caring for our African neighbors with HIV. This grant supports our core services to treat HIV patients.
"Now, along with our Kenyan partners, we look forward to moving beyond this grant to pursue our groundbreaking mission of home-based counseling and testing, and expand beyond HIV to tackle maternal and infant mortality."
The PEPFAR target in Kenya is to have 250,000 Kenyans on antiretroviral therapy by Sept. 30, 2009. The target for infections averted in the same timeframe through the prevention of mother-to-child transmission programs and other prevention efforts is 425,000. By September 2009, 450 orphans and vulnerable children and 250 people living with AIDS will be receiving palliative care in Kenya.
The grant was announced in Nairobi on Nov. 19 during a signing ceremony in the Ministry of Health Headquarters attended by Administrator Fore; Dr. Einterz, U.S. Ambassador to Kenya Michael E. Ranneberger; AA/AFR Katherine J. Almquist; USAID/Kenya Mission Director Erna Kerst; Joe Mamlin, M.D., IU professor emeritus and co-founder of the IU-Moi Partnership; and, Moi University and USAID administrators and staff members.
Several Vaccine Trials Affected By Halt Of Merck's HIV Vaccine Trial
Several vaccine trials are being postponed or modified following the halt of Merck's experimental HIV vaccine trial, the Philadelphia Inquirer reports (Stark, Philadelphia Inquirer, 11/16). Merck in September announced that it had ended the Phase II trial, which began in late 2004 and involved HIV-negative volunteers, after the experimental vaccine failed to prevent HIV infection in participants or prove effective in delaying the progression of the virus to AIDS.
New data recently suggested that the vaccine was ineffective among some trial participants with a pre-existing immunity to a common cold virus and that the vaccine might have increased their susceptibility to HIV infection. The Merck vaccine was made from a weakened version of a common cold virus that served as a mode for providing three synthetically produced genes from HIV, known as gag, pol and nef.
After several days of discussions at an HIV Vaccine Trials Network conference last week in Seattle of Merck's trial, leaders of the trial on Monday decided to notify all of the trial's 3,000 participants whether they were given the vaccine or a placebo (Kaiser Daily HIV/AIDS Report, 11/14).
According to the Inquirer, other trials have been affected by Merck's trial because the experimental vaccines have a similar structure to Merck's vaccine. Trial participants now must be warned about the potential risks highlighted in the Merck trail if they participate in experiments that use a cold-virus carrier similar to Merck's product, Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, said.
Gary Nabel, director of NIH's Vaccine Research Center, was scheduled to launch the PAVE 100 HIV vaccine trial early next year, but it recently was postponed until at least mid-2008. The PAVE vaccine uses three shots of DNA followed by a cold-virus booster shot, which has different components than the Merck vaccine. Nabel said he plans to modify the study by testing the vaccine only on people with limited exposure to colds and by increasing monitoring of patients.
Hildegund Ertl -- an immunologist at the Wistar Institute who is preparing to test an experimental HIV vaccine that uses a chimpanzee cold virus -- said the Merck trial also likely will affect her study, which is due to start in a year. "The bar will be raised," she said, adding that she hopes the chimp-based cold virus will not cause complications that the human cold virus might be causing (Philadelphia Inquirer, 11/16). Vaccines Using Some Viruses Require Further Testing, Study Says
Ertl and colleagues on Thursday in the Journal of Clinical Investigation reported that experimental HIV vaccines that typically use harmless viruses called adeno-associated viruses might damage the immune system by exhausting important cells, Reuters reports.
According to the group, AAV vaccines when tested in mice directly interfered with immune cells called CD8 T-cells, which are T-cells that a vaccine is supposed to stimulate to fight HIV. "The immune cells become exhausted," Ertl said, adding, "It is simply a defense mechanism of T-cells -- if there is too much antigen for too long a time they simply turn themselves off." The researchers said AAV vaccines should not be tested on people until more studies are conducted. Ertl said it is unclear whether her findings contributed to the developments in Merck's trial, which used an adenovirus.
Fauci said the study should be taken "with a very heavy dose of caution." He added that adenoviruses and adeno-associated viruses are very different microbes, despite the similarity of their names. "We may be dealing with apples and oranges," he said.
Pat Fast of the International AIDS Vaccine Initiative said the group has stopped testing AAV vaccines. "While we find the AAV study by Dr. Ertl and her group ... very interesting and we'll consider whether it can inform our future studies, their study was conducted in mice and there are fundamental differences between mice and humans in their respective immune responses, particularly with regard to the immune response against HIV," Fast said in a statement (Fox, Reuters, 11/15).
The study is available online (.pdf).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
New data recently suggested that the vaccine was ineffective among some trial participants with a pre-existing immunity to a common cold virus and that the vaccine might have increased their susceptibility to HIV infection. The Merck vaccine was made from a weakened version of a common cold virus that served as a mode for providing three synthetically produced genes from HIV, known as gag, pol and nef.
After several days of discussions at an HIV Vaccine Trials Network conference last week in Seattle of Merck's trial, leaders of the trial on Monday decided to notify all of the trial's 3,000 participants whether they were given the vaccine or a placebo (Kaiser Daily HIV/AIDS Report, 11/14).
According to the Inquirer, other trials have been affected by Merck's trial because the experimental vaccines have a similar structure to Merck's vaccine. Trial participants now must be warned about the potential risks highlighted in the Merck trail if they participate in experiments that use a cold-virus carrier similar to Merck's product, Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, said.
Gary Nabel, director of NIH's Vaccine Research Center, was scheduled to launch the PAVE 100 HIV vaccine trial early next year, but it recently was postponed until at least mid-2008. The PAVE vaccine uses three shots of DNA followed by a cold-virus booster shot, which has different components than the Merck vaccine. Nabel said he plans to modify the study by testing the vaccine only on people with limited exposure to colds and by increasing monitoring of patients.
Hildegund Ertl -- an immunologist at the Wistar Institute who is preparing to test an experimental HIV vaccine that uses a chimpanzee cold virus -- said the Merck trial also likely will affect her study, which is due to start in a year. "The bar will be raised," she said, adding that she hopes the chimp-based cold virus will not cause complications that the human cold virus might be causing (Philadelphia Inquirer, 11/16). Vaccines Using Some Viruses Require Further Testing, Study Says
Ertl and colleagues on Thursday in the Journal of Clinical Investigation reported that experimental HIV vaccines that typically use harmless viruses called adeno-associated viruses might damage the immune system by exhausting important cells, Reuters reports.
According to the group, AAV vaccines when tested in mice directly interfered with immune cells called CD8 T-cells, which are T-cells that a vaccine is supposed to stimulate to fight HIV. "The immune cells become exhausted," Ertl said, adding, "It is simply a defense mechanism of T-cells -- if there is too much antigen for too long a time they simply turn themselves off." The researchers said AAV vaccines should not be tested on people until more studies are conducted. Ertl said it is unclear whether her findings contributed to the developments in Merck's trial, which used an adenovirus.
Fauci said the study should be taken "with a very heavy dose of caution." He added that adenoviruses and adeno-associated viruses are very different microbes, despite the similarity of their names. "We may be dealing with apples and oranges," he said.
Pat Fast of the International AIDS Vaccine Initiative said the group has stopped testing AAV vaccines. "While we find the AAV study by Dr. Ertl and her group ... very interesting and we'll consider whether it can inform our future studies, their study was conducted in mice and there are fundamental differences between mice and humans in their respective immune responses, particularly with regard to the immune response against HIV," Fast said in a statement (Fox, Reuters, 11/15).
The study is available online (.pdf).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
AMA Recommends Routine HIV Testing While Protecting Patient Autonomy, Privacy
The American Medical Association recently updated its HIV testing policy to include guidelines supporting routine HIV testing, while continuing to advocate for the protection of patient privacy and autonomy, the AP/Google.com reports (AP/Google.com, 5/14).
"Understanding and treatment of HIV has grown substantially over the past few decades," Ardis Hoven, an AMA board member, said, adding, "new policy calls on physicians to routinely test consenting adult patients for HIV and reflects the reality that if HIV is detected early patients can lead full and productive lives" (AMA release, 11/13).
CDC in September 2006 released revised recommendations on HIV testing in the U.S. The recommendations advise that HIV tests become a routine part of medical care for residents ages 13 to 64 and that requirements for written consent and pretest counseling be dropped. According to a study published last month in PLoS One, more than 30 states have laws that hamper doctors from implementing the recommendations (Kaiser Daily HIV/AIDS Report, 10/11).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Understanding and treatment of HIV has grown substantially over the past few decades," Ardis Hoven, an AMA board member, said, adding, "new policy calls on physicians to routinely test consenting adult patients for HIV and reflects the reality that if HIV is detected early patients can lead full and productive lives" (AMA release, 11/13).
CDC in September 2006 released revised recommendations on HIV testing in the U.S. The recommendations advise that HIV tests become a routine part of medical care for residents ages 13 to 64 and that requirements for written consent and pretest counseling be dropped. According to a study published last month in PLoS One, more than 30 states have laws that hamper doctors from implementing the recommendations (Kaiser Daily HIV/AIDS Report, 10/11).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Virus Used In HIV Vaccines Weakens Immune System
A new US study has shown that some of the viruses used as carriers in clinical trials for HIV-1 vaccines weaken the immune system and may do more harm than good.
Researchers primed the immune systems of laboratory mice by exposing them to fragments of HIV carried by rAAV (recombinant adeno-associated virus (rAAV) vector), a type that has been used recently in human trials. This resulted in the anticipated creation of special T cells against HIV, but they didn't work properly. They couldn't fight against infection, they didn't release enough cytokines to activate an appropriate immune response, and they didn't reproduce when exposed to HIV in a booster.
The study is the work of Dr Hildegund C.J. Ertl, director of the Wistar Institute Vaccine Center, an independent nonprofit biomedical research institute based in Philadelphia, Pennsylvania, and colleagues, and is published in the November 16th online issue of the Journal of Clinical Investigation.
Leading efforts in human trials to develop an HIV vaccine have depended on the use of viruses to carry scraps of HIV virus as a way to get the patient's immune system to make antibodies against HIV.
However, more recently, evidence has been coming forward that some of these viral "vectors" may weaken the immune system and should not be used.
This study from Ertl and colleagues gives further evidence of this, and suggests that some viral vectors could do more harm than good.
Ertl and colleagues found that while the rAAV based vaccine managed to stimulate the immune system to produce T cells specifically against HIV, as intended, those same T cells also undermined the immune system in various ways.
"Put simply", said Ertl, these results "mean that AAV vaccines against HIV may potentially cause harm and that, without additional pre-clinical studies, they should not be used in humans".
Using laboratory mice, Ertl and colleagues primed the immune system against HIV with an experimental rAAV based vaccine. Then, as would be done in a typical vaccine regimen, they followed this with a booster immunization using a vaccine based on another viral vector, adenovirus (Ad). They also carried out some booster immunizations using other viral vectors.
When they looked at the resulting immune response using follow up assays, they found that in all booster immunization cases, the HIV specific T cells induced by the rAAV vector were ineffective at preventing infection, regardless of time between prime and booster. The T cells protected poorly against HIV, they failed to secrete sufficient levels of cytokines, chemicals that stimulate the immume response, and they did not replicate sufficiently in response to the booster.
The results indicate a condition known as "T cell exhaustion", something that has been observed before with HIV, hepatitis B and hepatitis C, and some cancers like melanomas, said the researchers.
The researchers concluded that:
"Our data suggest that rAAV vectors induce functionally impaired T cells and could dampen the immune response to a natural infection."
Ertl questioned the rationale for injecting people with "a vaccine that's going to have a detrimental effect".
"AAV vaccines against HIV may do more harm than good by robbing people of their natural immune response to HIV," she warned.
Researchers primed the immune systems of laboratory mice by exposing them to fragments of HIV carried by rAAV (recombinant adeno-associated virus (rAAV) vector), a type that has been used recently in human trials. This resulted in the anticipated creation of special T cells against HIV, but they didn't work properly. They couldn't fight against infection, they didn't release enough cytokines to activate an appropriate immune response, and they didn't reproduce when exposed to HIV in a booster.
The study is the work of Dr Hildegund C.J. Ertl, director of the Wistar Institute Vaccine Center, an independent nonprofit biomedical research institute based in Philadelphia, Pennsylvania, and colleagues, and is published in the November 16th online issue of the Journal of Clinical Investigation.
Leading efforts in human trials to develop an HIV vaccine have depended on the use of viruses to carry scraps of HIV virus as a way to get the patient's immune system to make antibodies against HIV.
However, more recently, evidence has been coming forward that some of these viral "vectors" may weaken the immune system and should not be used.
This study from Ertl and colleagues gives further evidence of this, and suggests that some viral vectors could do more harm than good.
Ertl and colleagues found that while the rAAV based vaccine managed to stimulate the immune system to produce T cells specifically against HIV, as intended, those same T cells also undermined the immune system in various ways.
"Put simply", said Ertl, these results "mean that AAV vaccines against HIV may potentially cause harm and that, without additional pre-clinical studies, they should not be used in humans".
Using laboratory mice, Ertl and colleagues primed the immune system against HIV with an experimental rAAV based vaccine. Then, as would be done in a typical vaccine regimen, they followed this with a booster immunization using a vaccine based on another viral vector, adenovirus (Ad). They also carried out some booster immunizations using other viral vectors.
When they looked at the resulting immune response using follow up assays, they found that in all booster immunization cases, the HIV specific T cells induced by the rAAV vector were ineffective at preventing infection, regardless of time between prime and booster. The T cells protected poorly against HIV, they failed to secrete sufficient levels of cytokines, chemicals that stimulate the immume response, and they did not replicate sufficiently in response to the booster.
The results indicate a condition known as "T cell exhaustion", something that has been observed before with HIV, hepatitis B and hepatitis C, and some cancers like melanomas, said the researchers.
The researchers concluded that:
"Our data suggest that rAAV vectors induce functionally impaired T cells and could dampen the immune response to a natural infection."
Ertl questioned the rationale for injecting people with "a vaccine that's going to have a detrimental effect".
"AAV vaccines against HIV may do more harm than good by robbing people of their natural immune response to HIV," she warned.
Mozambique To Revise National HIV/AIDS Prevention Strategy, Health Minister Says
The Mozambican government has decided to revise its national HIV/AIDS prevention strategy after finding that the current efforts have not been effective in controlling the disease, Health Minister Ivo Garrido, recently said, AIM/AllAfrica.com reports. Garrido, who also serves as the spokesperson for the Steering Council of the country's National AIDS Council, said a meeting of the council held on Monday highlighted 10 areas that should guide the revision.
He said that the AIDS council will seek to increase coordination between HIV/AIDS advocacy groups in the country; develop a mechanism for gauging the effectiveness of HIV prevention strategies; and improve HIV counseling and testing programs. The review also will address the definition of "high-risk groups," Garrido said. He said that he believes "almost everybody" is at risk but added that a task group was established to investigate this issue.
Garrido said the Steering Council hopes to have "proposals on coordination" by early next year. The country in 2004 had an estimated HIV prevalence of 16.2% among adults ages 15 to 49 (AIM/AllAfrica.com, 11/14).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
He said that the AIDS council will seek to increase coordination between HIV/AIDS advocacy groups in the country; develop a mechanism for gauging the effectiveness of HIV prevention strategies; and improve HIV counseling and testing programs. The review also will address the definition of "high-risk groups," Garrido said. He said that he believes "almost everybody" is at risk but added that a task group was established to investigate this issue.
Garrido said the Steering Council hopes to have "proposals on coordination" by early next year. The country in 2004 had an estimated HIV prevalence of 16.2% among adults ages 15 to 49 (AIM/AllAfrica.com, 11/14).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Opinion Piece Examines HIV/AIDS Policy Views Of Giuliani Adviser
A recent opinion piece by Sally Pipes -- president and CEO of the Pacific Research Institute, a think tank that receives some funding from drug companies -- about intellectual property rights and compulsory licenses for patented antiretroviral drugs is "frightening," Andrew Green, a publishing fellow, writes in the American Prospect. If Pipes were "just running a think tank with pharmaceutical funding, it could be read as a shill piece and dismissed. But there's more to Pipes' biography: She is also a health care adviser to Rudy Giuliani," the former New York City mayor who is running for the Republican presidential nomination, Green adds (Green, American Prospect, 11/15).
In her opinion piece, Pipes says it was a "staggering display of cluelessness" for Rep. Tom Allen (D-Maine) and Sen. Sherrod Brown (D-Ohio) to sponsor a resolution that praises the Thai government for its decision to issue compulsory licenses to make generic versions of patented antiretroviral drugs. She adds that Thailand's actions "threaten to upset the economic incentives that allow Western firms to produce novel cures," saying, "Without patent protections, the drug industry as we know it would collapse, and development of new drugs would be significantly curtailed" (Kaiser Daily HIV/AIDS Report, 10/18).
Pipes opinion piece "can be read both as a signal that her role is expanding and as a preview of the HIV/AIDS policy she is encouraging Giuliani to adopt, specifically one without regard for the immediate need for as many cheap generic antiretrovirals as possible," Green writes. According to Green, while this is "cause for concern," the "real crisis" is that "Giuliani might actually be receptive to her arguments."
Giuliani has "expressed an interest in continuing and possibly expanding the President's Emergency Plan for AIDS Relief," but it is "apparent" he has "thought little about what that actually means," Green says. In addition, Giuliani has not described his HIV prevention strategy or whether he would expand treatment options, according to Green. "His lack of investment or concern about the issue leaves him vulnerable to insiders like Pipes, whose business-first agendas are prepackaged," Green writes. He adds that it is "not outlandish to think that [Giuliani] might make AIDS relief contingent on buying brand-name antiretrovirals" or "levy trade restrictions and financial penalties on countries, like Thailand, that determine the best way to immediately reach the most HIV/AIDS patients is to produce their own antiretrovirals."
Green suggests that all presidential candidates "study the AIDS policy Democrat John Edwards has introduced," adding that the "first move Giuliani should make, though, is to send Pipes back to the sideline and hire some advisers whose values aren't predicated on profit margins" (American Prospect, 11/15).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
In her opinion piece, Pipes says it was a "staggering display of cluelessness" for Rep. Tom Allen (D-Maine) and Sen. Sherrod Brown (D-Ohio) to sponsor a resolution that praises the Thai government for its decision to issue compulsory licenses to make generic versions of patented antiretroviral drugs. She adds that Thailand's actions "threaten to upset the economic incentives that allow Western firms to produce novel cures," saying, "Without patent protections, the drug industry as we know it would collapse, and development of new drugs would be significantly curtailed" (Kaiser Daily HIV/AIDS Report, 10/18).
Pipes opinion piece "can be read both as a signal that her role is expanding and as a preview of the HIV/AIDS policy she is encouraging Giuliani to adopt, specifically one without regard for the immediate need for as many cheap generic antiretrovirals as possible," Green writes. According to Green, while this is "cause for concern," the "real crisis" is that "Giuliani might actually be receptive to her arguments."
Giuliani has "expressed an interest in continuing and possibly expanding the President's Emergency Plan for AIDS Relief," but it is "apparent" he has "thought little about what that actually means," Green says. In addition, Giuliani has not described his HIV prevention strategy or whether he would expand treatment options, according to Green. "His lack of investment or concern about the issue leaves him vulnerable to insiders like Pipes, whose business-first agendas are prepackaged," Green writes. He adds that it is "not outlandish to think that [Giuliani] might make AIDS relief contingent on buying brand-name antiretrovirals" or "levy trade restrictions and financial penalties on countries, like Thailand, that determine the best way to immediately reach the most HIV/AIDS patients is to produce their own antiretrovirals."
Green suggests that all presidential candidates "study the AIDS policy Democrat John Edwards has introduced," adding that the "first move Giuliani should make, though, is to send Pipes back to the sideline and hire some advisers whose values aren't predicated on profit margins" (American Prospect, 11/15).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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