HIV/AIDS advocates on Tuesday called on President-elect Barack Obama to adopt a comprehensive approach to domestic HIV/AIDS policy when he takes office, CQ HealthBeat reports. The groups encouraged the incoming administration to develop a national strategy to address HIV/AIDS in the U.S. and recommended implementing a domestic HIV/AIDS program modeled after the President's Emergency Plan for AIDS Relief. HIV/AIDS researcher Robert Gallo recently proposed a similar approach. "It is astonishing that [the U.S.] has never really set an overall plan and agenda for the country, with measurable outcomes, accountability established and specific timetables for getting to those results," Rebecca Haag, executive director of AIDS Action Council, said. The advocates also called for increased federal funding for HIV/AIDS prevention, treatment and research programs and called for a departure from some policies enacted under the Bush administration.
Carl Schmid, director of federal affairs at the AIDS Institute, said he is "optimistic" about Obama's election and hopes the new administration will bring "renewed leadership on the domestic HIV/AIDS front" because the disease is "still a major, significant health crisis" in the U.S. Advocates in a letter sent to Obama's transition team -- which included policy recommendations aimed at guiding him during his first 100 days in office -- encouraged the administration to support the higher amounts proposed for federal funding for HIV/AIDS prevention, treatment and research programs in competing fiscal year 2009 appropriations measures. According to Schmid, the priority given to HIV/AIDS programs in the President-elect's first budget "will be a good signal to the Obama administration's commitment to the domestic [HIV/AIDS] epidemic."
The advocates also called for an increase in federal funding for NIH, including an increase of $450 million for HIV/AIDS research. They also support additional funding for CDC, including an increase of $200 million for HIV prevention and surveillance. In addition, the group called for a $100 million increase in FY 2009 funding for the Ryan White Program and a $614.49 million increase for the program in FY 2010. Christine Lubinski, vice president of global health at the Infectious Diseases Society of America, said the Ryan White Program "has not been funded at adequate levels," adding, "We'll be looking for a budgeting increase and leadership in extending the Ryan White Care Act, which will sunset on Sept. 30."
Haag called on Obama to end some existing policies, including the ban on federal funding for needle-exchange programs, which she called "one of the most effective" tools to reduce HIV transmission. Haag also criticized abstinence-only sex education programs. According to Haag, strong leadership will be necessary to unite and coordinate the efforts of 17 federal agencies that currently work on HIV/AIDS issues. "We have asked that the national AIDS strategy be driven out of the White House," Haag said, adding that "the force of the president's leadership" will be necessary to address HIV/AIDS in the U.S. (Weyl, CQ HealthBeat, 11/25).
Friday, November 28, 2008
Ventura County, Calif., Effort Seeks To Encourage Hispanics To Talk Openly About HIV/AIDS
A task force of Hispanic community leaders in Ventura County, Calif., this week launched a campaign that aims to encourage the Hispanic community to talk openly about HIV/AIDS, the Ventura County Star reports. One-third of the Ventura County population in 2005 was Hispanic, and the group made up 60% of new AIDS cases that year, according to the Ventura County AIDS Partnership, which is launching the campaign. The subject of HIV/AIDS is sometimes considered taboo in the Hispanic community, the Star reports.
Cultural norms, taboos and myths about HIV/AIDS contribute to the spread of the disease in the Hispanic communities across the nation, according to Jesus Torres, social marketing chair of the partnership. Madhu Bajaj, executive director of the group, said he was prompted by results of local surveys, focus groups and other research to begin the initiative, called Cuidate, which means "take care" in Spanish. As part of the effort, the group is running newspaper advertisements beginning this week and lasting through February. The task force also will start training groups that teach others how to talk openly about HIV/AIDS and will first target mothers and teenage daughters.
"Our campaign tag is 'Let's start the conversation,'" Bajaj said, adding "There's a stigma. There's a silence" about HIV/AIDS in the Hispanic community. Torres said, "With this campaign, we will give the tools, resources and know-how to our Latino community so that they may protect their health" (Ventura County Star, 11/21).
Cultural norms, taboos and myths about HIV/AIDS contribute to the spread of the disease in the Hispanic communities across the nation, according to Jesus Torres, social marketing chair of the partnership. Madhu Bajaj, executive director of the group, said he was prompted by results of local surveys, focus groups and other research to begin the initiative, called Cuidate, which means "take care" in Spanish. As part of the effort, the group is running newspaper advertisements beginning this week and lasting through February. The task force also will start training groups that teach others how to talk openly about HIV/AIDS and will first target mothers and teenage daughters.
"Our campaign tag is 'Let's start the conversation,'" Bajaj said, adding "There's a stigma. There's a silence" about HIV/AIDS in the Hispanic community. Torres said, "With this campaign, we will give the tools, resources and know-how to our Latino community so that they may protect their health" (Ventura County Star, 11/21).
Monday, November 24, 2008
Young Travellers in Australia at Higher HIV Exposure Risk
HIV-positive people receiving treatment for the virus might be at an increased risk of developing heart disease and type 2 diabetes because some antiretroviral drugs can cause fat on the arms, legs, face and buttocks to move to the stomach, researchers at Australia's Garvan Institute said Monday, the Sydney Morning Herald reports. According to the Herald, excess weight around the waist can increase a person's chances of developing cardiovascular and metabolic disorders, but physicians say newer classes of drugs, which do not cause fat redistribution, are too expensive for most people.
Katherine Samaras -- lead author of the study, which was published in the journal Obesity -- said the findings indicate that older antiretrovirals, still commonly used in Australia, can give many HIV-positive patients the same level of heart disease risk seen in obese people with sedentary lifestyles. The Herald also reports the study found that antiretrovirals can cause fat cells to create inflammatory molecules promoting certain diseases. Samaras said, "When fat cells are healthy, they help maintain our metabolism, but if they become too large or are affected by drugs, such as HIV medications, they can produce" numerous chemicals linked to heart disease. She added, "We also have the problem that the older drugs are off-patent now and very cheap, so they are the frontline treatment" in developing countries. According to Samaras, "There are drugs on the market which do not have these side effects, but they are not yet on" Australia's pharmaceutical benefits programs and are "too expensive for most people. The primary concern is to optimize viral suppression, that is reduce the virus load in the body, to minimize its effects." She added that physicians should ensure that their HIV-positive patients are regularly screened for diabetes (Benson, Sydney Morning Herald, 11/18).
Katherine Samaras -- lead author of the study, which was published in the journal Obesity -- said the findings indicate that older antiretrovirals, still commonly used in Australia, can give many HIV-positive patients the same level of heart disease risk seen in obese people with sedentary lifestyles. The Herald also reports the study found that antiretrovirals can cause fat cells to create inflammatory molecules promoting certain diseases. Samaras said, "When fat cells are healthy, they help maintain our metabolism, but if they become too large or are affected by drugs, such as HIV medications, they can produce" numerous chemicals linked to heart disease. She added, "We also have the problem that the older drugs are off-patent now and very cheap, so they are the frontline treatment" in developing countries. According to Samaras, "There are drugs on the market which do not have these side effects, but they are not yet on" Australia's pharmaceutical benefits programs and are "too expensive for most people. The primary concern is to optimize viral suppression, that is reduce the virus load in the body, to minimize its effects." She added that physicians should ensure that their HIV-positive patients are regularly screened for diabetes (Benson, Sydney Morning Herald, 11/18).
Increased Diabetes Risk with Antiretrovirals
HIV-positive people receiving treatment for the virus might be at an increased risk of developing heart disease and type 2 diabetes because some antiretroviral drugs can cause fat on the arms, legs, face and buttocks to move to the stomach, researchers at Australia's Garvan Institute said Monday, the Sydney Morning Herald reports. According to the Herald, excess weight around the waist can increase a person's chances of developing cardiovascular and metabolic disorders, but physicians say newer classes of drugs, which do not cause fat redistribution, are too expensive for most people.
Katherine Samaras -- lead author of the study, which was published in the journal Obesity -- said the findings indicate that older antiretrovirals, still commonly used in Australia, can give many HIV-positive patients the same level of heart disease risk seen in obese people with sedentary lifestyles. The Herald also reports the study found that antiretrovirals can cause fat cells to create inflammatory molecules promoting certain diseases. Samaras said, "When fat cells are healthy, they help maintain our metabolism, but if they become too large or are affected by drugs, such as HIV medications, they can produce" numerous chemicals linked to heart disease. She added, "We also have the problem that the older drugs are off-patent now and very cheap, so they are the frontline treatment" in developing countries. According to Samaras, "There are drugs on the market which do not have these side effects, but they are not yet on" Australia's pharmaceutical benefits programs and are "too expensive for most people. The primary concern is to optimize viral suppression, that is reduce the virus load in the body, to minimize its effects." She added that physicians should ensure that their HIV-positive patients are regularly screened for diabetes (Benson, Sydney Morning Herald, 11/18).
Katherine Samaras -- lead author of the study, which was published in the journal Obesity -- said the findings indicate that older antiretrovirals, still commonly used in Australia, can give many HIV-positive patients the same level of heart disease risk seen in obese people with sedentary lifestyles. The Herald also reports the study found that antiretrovirals can cause fat cells to create inflammatory molecules promoting certain diseases. Samaras said, "When fat cells are healthy, they help maintain our metabolism, but if they become too large or are affected by drugs, such as HIV medications, they can produce" numerous chemicals linked to heart disease. She added, "We also have the problem that the older drugs are off-patent now and very cheap, so they are the frontline treatment" in developing countries. According to Samaras, "There are drugs on the market which do not have these side effects, but they are not yet on" Australia's pharmaceutical benefits programs and are "too expensive for most people. The primary concern is to optimize viral suppression, that is reduce the virus load in the body, to minimize its effects." She added that physicians should ensure that their HIV-positive patients are regularly screened for diabetes (Benson, Sydney Morning Herald, 11/18).
Friday, November 14, 2008
Bone Marrow Transplant Eradicates AIDS in Patient
An American man who suffered from AIDS appears to have been cured of the disease 20 months after receiving a targeted bone marrow transplant normally used to fight leukemia, his doctors said.
While researchers, and the doctors themselves, caution that the case might be no more than a fluke, others say it may inspire a greater interest in gene therapy to fight the disease that claims two million lives each year. The virus has infected 33 million people worldwide.
Dr. Gero Huetter said his 42-year-old patient, an American living in Berlin who was not identified, had been infected with the AIDS virus for more than a decade. But 20 months after undergoing a transplant of genetically selected bone marrow, he no longer shows signs of carrying the virus.
"We waited every day for a bad reading," Huetter said.
It has not come. Researchers at Berlin's Charite hospital and medical school say tests on his bone marrow, blood and other organ tissues have all been clean.
However, Dr. Andrew Badley, director of the HIV and immunology research lab at the Mayo Clinic in Rochester, Minn., said those tests have probably not been extensive enough.
"A lot more scrutiny from a lot of different biological samples would be required to say it's not present," Badley said.
Eradicating AIDS?
This isn't the first time marrow transplants have been attempted for treating AIDS or HIV infection. In 1999, an article in the journal Medical Hypotheses reviewed the results of 32 attempts reported between 1982 and 1996. In two cases, HIV was apparently eradicated, the review reported.
Huetter's patient was under treatment at Charite for both AIDS and leukemia, which developed unrelated to HIV.
As Huetter — who is a hematologist, not an HIV specialist — prepared to treat the patient's leukemia with a bone marrow transplant, he recalled that some people carry a genetic mutation that seems to make them resistant to HIV infection. If the mutation, called Delta 32, is inherited from both parents, it prevents HIV from attaching itself to cells by blocking CCR5, a receptor that acts as a kind of gateway.
"I read it in 1996, coincidentally," Huetter told reporters at the medical school. "I remembered it and thought it might work."
Roughly one in 1,000 Europeans and Americans have inherited the mutation from both parents, and Huetter set out to find one such person among donors that matched the patient's marrow type. Out of a pool of 80 suitable donors, the 61st person tested carried the proper mutation.
Before the transplant, the patient endured powerful drugs and radiation to kill off his own infected bone marrow cells and disable his immune system — a treatment fatal to between 20 and 30 per cent of recipients.
He was also taken off the potent drugs used to treat his AIDS. Huetter's team feared that the drugs might interfere with the new marrow cells' survival. They risked lowering his defences in the hopes that the new mutated cells would reject the virus on their own.
Promise of gene therapy
Anthony Fauci, director of the National Institute of Allergy and Infections Diseases in the U.S., said the procedure was too costly and too dangerous to employ as a first-line cure. But he said it could inspire researchers to pursue gene therapy as a means to block or suppress HIV.
"It helps prove the concept that if somehow you can block the expression of CCR5, maybe by gene therapy, you might be able to inhibit the ability of the virus to replicate," Fauci said.
David Roth, a professor of epidemiology and international public health at the London School of Hygiene and Tropical Medicine, said gene therapy as cheap and effective as current drug treatments is in very early stages of development.
"That's a long way down the line, because there may be other negative things that go with that mutation that we don't know about."
For the patient in Berlin, the lack of a clear understanding of exactly why his AIDS has disappeared means his future is far from certain.
"The virus is wily," Huetter said. "There could always be a resurgence."
While researchers, and the doctors themselves, caution that the case might be no more than a fluke, others say it may inspire a greater interest in gene therapy to fight the disease that claims two million lives each year. The virus has infected 33 million people worldwide.
Dr. Gero Huetter said his 42-year-old patient, an American living in Berlin who was not identified, had been infected with the AIDS virus for more than a decade. But 20 months after undergoing a transplant of genetically selected bone marrow, he no longer shows signs of carrying the virus.
"We waited every day for a bad reading," Huetter said.
It has not come. Researchers at Berlin's Charite hospital and medical school say tests on his bone marrow, blood and other organ tissues have all been clean.
However, Dr. Andrew Badley, director of the HIV and immunology research lab at the Mayo Clinic in Rochester, Minn., said those tests have probably not been extensive enough.
"A lot more scrutiny from a lot of different biological samples would be required to say it's not present," Badley said.
Eradicating AIDS?
This isn't the first time marrow transplants have been attempted for treating AIDS or HIV infection. In 1999, an article in the journal Medical Hypotheses reviewed the results of 32 attempts reported between 1982 and 1996. In two cases, HIV was apparently eradicated, the review reported.
Huetter's patient was under treatment at Charite for both AIDS and leukemia, which developed unrelated to HIV.
As Huetter — who is a hematologist, not an HIV specialist — prepared to treat the patient's leukemia with a bone marrow transplant, he recalled that some people carry a genetic mutation that seems to make them resistant to HIV infection. If the mutation, called Delta 32, is inherited from both parents, it prevents HIV from attaching itself to cells by blocking CCR5, a receptor that acts as a kind of gateway.
"I read it in 1996, coincidentally," Huetter told reporters at the medical school. "I remembered it and thought it might work."
Roughly one in 1,000 Europeans and Americans have inherited the mutation from both parents, and Huetter set out to find one such person among donors that matched the patient's marrow type. Out of a pool of 80 suitable donors, the 61st person tested carried the proper mutation.
Before the transplant, the patient endured powerful drugs and radiation to kill off his own infected bone marrow cells and disable his immune system — a treatment fatal to between 20 and 30 per cent of recipients.
He was also taken off the potent drugs used to treat his AIDS. Huetter's team feared that the drugs might interfere with the new marrow cells' survival. They risked lowering his defences in the hopes that the new mutated cells would reject the virus on their own.
Promise of gene therapy
Anthony Fauci, director of the National Institute of Allergy and Infections Diseases in the U.S., said the procedure was too costly and too dangerous to employ as a first-line cure. But he said it could inspire researchers to pursue gene therapy as a means to block or suppress HIV.
"It helps prove the concept that if somehow you can block the expression of CCR5, maybe by gene therapy, you might be able to inhibit the ability of the virus to replicate," Fauci said.
David Roth, a professor of epidemiology and international public health at the London School of Hygiene and Tropical Medicine, said gene therapy as cheap and effective as current drug treatments is in very early stages of development.
"That's a long way down the line, because there may be other negative things that go with that mutation that we don't know about."
For the patient in Berlin, the lack of a clear understanding of exactly why his AIDS has disappeared means his future is far from certain.
"The virus is wily," Huetter said. "There could always be a resurgence."
Monday, November 10, 2008
Global Financial Crisis Could Adversely Effect AIDS Funding
The current global financial crisis could harm HIV/AIDS funding and increase the factors that make people vulnerable to the disease, UNAIDS Executive Director Peter Piot said on Tuesday during an event at the Center for Strategic and International Studies, CQ HealthBeat reports. According to Piot, as rising food and energy costs drive more people into poverty worldwide, the factors that drive the spread of HIV also could increase. "That must have an impact on the spread of HIV, although it's not so clear," he said, adding that it is certain that low-income countries will be more affected by and vulnerable to the financial crisis when it comes to providing HIV/AIDS treatment. For example, 100% of the cost to provide 50,000 HIV-positive people in Rwanda with antiretroviral drugs at the end of last year was paid by donors -- such as the Global Fund To Fight AIDS, Tuberculosis and Malaria and the President's Emergency Plan for AIDS Relief -- according to Piot. He added that Brazil receives no donor funding to provide similar treatment services to its HIV-positive citizens.
Countries likely will not feel the effects of the financial crisis on HIV/AIDS "in the next six or 12 months because of commitments that have been made in better times," Piot said, adding that he wonders if it will be possible to continue enrolling 700,000 to one million people in drug treatment programs over the next few years. "If not, deaths will go up again, deaths from AIDS, no doubt about it," he said, adding, "We estimate that even if (funding) continues at the same level, deaths will go up to about three million per year by 2011."
Piot also praised the Bush administration and Congress for continuing PEPFAR, which he said is an "unprecedented program that has saved millions of lives." Piot added, "It is quite rare in international development that you can count so easily, you can measure, the impact of actions, and yet this has been the case when it comes to what PEPFAR has done, and it's unprecedented in international development." In addition, Piot commended President Bush and Secretary of State Condoleezza Rice for their comments at the recent White House summit on international development about how the U.S. should not reduce aid. "I hope that the next president will follow along the same lines," Piot said.
Jennifer Kates -- vice president and director of HIV policy at the Kaiser Family Foundation -- said it is difficult to assess how the financial crisis will affect future funding levels. "How the financial crisis plays into that, we still don't know," she said.
Piot will leave his position at UNAIDS at the end of the year to head the new Institute for Global Health at Imperial College London (Vadala, CQ HealthBeat, 10/28).
Recession proof your medicine cabinet today by switching to generic AIDS drugs. Visit www.aids-drugs-online.com
Countries likely will not feel the effects of the financial crisis on HIV/AIDS "in the next six or 12 months because of commitments that have been made in better times," Piot said, adding that he wonders if it will be possible to continue enrolling 700,000 to one million people in drug treatment programs over the next few years. "If not, deaths will go up again, deaths from AIDS, no doubt about it," he said, adding, "We estimate that even if (funding) continues at the same level, deaths will go up to about three million per year by 2011."
Piot also praised the Bush administration and Congress for continuing PEPFAR, which he said is an "unprecedented program that has saved millions of lives." Piot added, "It is quite rare in international development that you can count so easily, you can measure, the impact of actions, and yet this has been the case when it comes to what PEPFAR has done, and it's unprecedented in international development." In addition, Piot commended President Bush and Secretary of State Condoleezza Rice for their comments at the recent White House summit on international development about how the U.S. should not reduce aid. "I hope that the next president will follow along the same lines," Piot said.
Jennifer Kates -- vice president and director of HIV policy at the Kaiser Family Foundation -- said it is difficult to assess how the financial crisis will affect future funding levels. "How the financial crisis plays into that, we still don't know," she said.
Piot will leave his position at UNAIDS at the end of the year to head the new Institute for Global Health at Imperial College London (Vadala, CQ HealthBeat, 10/28).
Recession proof your medicine cabinet today by switching to generic AIDS drugs. Visit www.aids-drugs-online.com
ARV Therapy Should Start Earlier
People living with HIV should begin antiretroviral treatments earlier than what current guidelines recommend, according to a large new study presented on Sunday, the AP/Yahoo! News reports. According to the AP/Yahoo! News, current guidelines by the International AIDS Society-USA and the government recommend that patients who are not showing symptoms of the virus delay treatment until their CD4 T-cell counts drop below 350 per milliliter of blood.
Physicians traditionally have delayed antiretroviral treatment for HIV patients to avoid the treatment's side effects, which can include heart and cholesterol problems, diarrhea, nausea and other conditions. Robert Schooley, infectious disease chief at the University of California-San Diego, said, "There was this thinking, maybe the drugs were worse than the disease. If you could wait as long as you possibly could wait, you would have fewer side effects."
The new study, however, shows that a treatment delay can nearly double the risk of death in the next few years. The study's findings were reported at a conference held by the American Society of Microbiology and the Infectious Diseases Society of America. The National Institute of Allergy and Infectious Diseases helped provide funding for the study (Marchione, AP/Yahoo! News, 10/26).
For the study, researchers led by Mari Kitahata of the University of Washington examined information in the International Epidemiology Databases to Evaluate AIDS, a global network of HIV clinics from 1996 to 2005. Researchers looked at records for 8,374 healthy HIV patients with CD4 counts of 351 to 500 who had never taken highly active antiretroviral treatments. Thirty percent of the patients began antiretroviral treatment, and the remainder delayed treatment until their CD4 counts dropped below 350. The study shows that the patients who delayed treatments were 71% more likely to die during the course of the study period than those who began treatments early (Reuters, 10/26).
Schooley, who helped write the current guidelines for AIDS treatments and acts as a consultant for several companies that make antiretroviral drugs, said the new study and others like it "have all shown the same thing -- that we were starting too late" and need to continue treatments when they have been started. "The data are rather compelling that the risk of death appears to be higher if you wait than if you treat," Anthony Fauci, director of NIAID, said (AP/Yahoo! News, 10/26). He added that treatment guidelines committees are "certainly going to look hard at these data next time they meet" (Sternberg, USA Today, 10/27).
Physicians traditionally have delayed antiretroviral treatment for HIV patients to avoid the treatment's side effects, which can include heart and cholesterol problems, diarrhea, nausea and other conditions. Robert Schooley, infectious disease chief at the University of California-San Diego, said, "There was this thinking, maybe the drugs were worse than the disease. If you could wait as long as you possibly could wait, you would have fewer side effects."
The new study, however, shows that a treatment delay can nearly double the risk of death in the next few years. The study's findings were reported at a conference held by the American Society of Microbiology and the Infectious Diseases Society of America. The National Institute of Allergy and Infectious Diseases helped provide funding for the study (Marchione, AP/Yahoo! News, 10/26).
For the study, researchers led by Mari Kitahata of the University of Washington examined information in the International Epidemiology Databases to Evaluate AIDS, a global network of HIV clinics from 1996 to 2005. Researchers looked at records for 8,374 healthy HIV patients with CD4 counts of 351 to 500 who had never taken highly active antiretroviral treatments. Thirty percent of the patients began antiretroviral treatment, and the remainder delayed treatment until their CD4 counts dropped below 350. The study shows that the patients who delayed treatments were 71% more likely to die during the course of the study period than those who began treatments early (Reuters, 10/26).
Schooley, who helped write the current guidelines for AIDS treatments and acts as a consultant for several companies that make antiretroviral drugs, said the new study and others like it "have all shown the same thing -- that we were starting too late" and need to continue treatments when they have been started. "The data are rather compelling that the risk of death appears to be higher if you wait than if you treat," Anthony Fauci, director of NIAID, said (AP/Yahoo! News, 10/26). He added that treatment guidelines committees are "certainly going to look hard at these data next time they meet" (Sternberg, USA Today, 10/27).
Isentress More Effective in Un-Treated Patients
Merck's antiretroviral drug Isentress suppresses levels of HIV in previously untreated patients better than the company's antiretroviral efavirenz, according to research presented Sunday at a meeting of the American Society of Microbiology and the Infectious Diseases Society of America, Reuters reports. According to Phase III clinical trial results, Isentress -- known generically as raltegravir -- reduced HIV viral loads to undetectable levels in 86% of patients compared with 82% of patients treated with efavirenz (Fox, Reuters, 10/26).
FDA in October 2007 approved raltegravir for use by HIV-positive people who have not responded to other treatments. Raltegravir works by blocking an HIV enzyme called integrase. Integrase is one of the three enzymes necessary for HIV to replicate in the body, and integrase inhibitors stop HIV from inserting its genes into uninfected DNA (Kaiser Daily HIV/AIDS Report, 10/15/07). The agency also granted Isentress accelerated approval for use among patients who showed initial signs of resistance to existing antiretrovirals. According to Merck, up to 40% of the approximately 500,000 HIV-positive people in the U.S. receiving antiretrovirals have developed resistance to the drugs. In addition, researchers at the conference said that drug-related adverse effects were significantly fewer in patients treated with Isentress (44%) than with efavirenz (77%) (AFP/Yahoo! News, 10/26).
Robin Isaacs, executive director for infectious disease clinical research at Merck, said, "There was a desperate unmet medical need for those patients who had failed other therapies" until recent years. He added that Isentress and Pfizer's Selzentry -- also approved last year -- helped address that need, along with three other new drugs: Boehringer Ingelheim's Aptivus, and Johnson & Johnson's Prezista and Intelence. According to Isaacs, patients "have all these different options now, which they didn't before, to build new successful regimens."
According to AP/Yahoo! Finance, Pfizer at the conference also presented research from a 48-week study comparing its antiretroviral Selzentry with Bristol-Myer Squibb's antiretroviral Sustiva in a total of 417 patients also receiving GlaxoSmithKline's antiretroviral combination drug Combivir. In both groups, 68% of patients had the HIV virus reduced to undetectable levels; however, 4.2% of those who got Selzentry and 14.2% taking Sustiva stopped because of side effects (Johnson, AP/Yahoo! Finance, 10/26).
FDA in October 2007 approved raltegravir for use by HIV-positive people who have not responded to other treatments. Raltegravir works by blocking an HIV enzyme called integrase. Integrase is one of the three enzymes necessary for HIV to replicate in the body, and integrase inhibitors stop HIV from inserting its genes into uninfected DNA (Kaiser Daily HIV/AIDS Report, 10/15/07). The agency also granted Isentress accelerated approval for use among patients who showed initial signs of resistance to existing antiretrovirals. According to Merck, up to 40% of the approximately 500,000 HIV-positive people in the U.S. receiving antiretrovirals have developed resistance to the drugs. In addition, researchers at the conference said that drug-related adverse effects were significantly fewer in patients treated with Isentress (44%) than with efavirenz (77%) (AFP/Yahoo! News, 10/26).
Robin Isaacs, executive director for infectious disease clinical research at Merck, said, "There was a desperate unmet medical need for those patients who had failed other therapies" until recent years. He added that Isentress and Pfizer's Selzentry -- also approved last year -- helped address that need, along with three other new drugs: Boehringer Ingelheim's Aptivus, and Johnson & Johnson's Prezista and Intelence. According to Isaacs, patients "have all these different options now, which they didn't before, to build new successful regimens."
According to AP/Yahoo! Finance, Pfizer at the conference also presented research from a 48-week study comparing its antiretroviral Selzentry with Bristol-Myer Squibb's antiretroviral Sustiva in a total of 417 patients also receiving GlaxoSmithKline's antiretroviral combination drug Combivir. In both groups, 68% of patients had the HIV virus reduced to undetectable levels; however, 4.2% of those who got Selzentry and 14.2% taking Sustiva stopped because of side effects (Johnson, AP/Yahoo! Finance, 10/26).
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