DENVER (Reuters) - A suspended Colorado dentist reused syringes and needles in his now-shuttered practice, potentially exposing thousands of patients to HIV and hepatitis infection, health officials warned on Friday.
The Colorado Department of Public Health and Environment sent letters to 8,000 patients of dentist Stephen Stein, urging them to seek tests for the diseases after learning of 'unsafe injection practices' at two Denver-area clinics he owned between September 1999 and June 2011.
Investigators found that Stein reused needles and syringes in several patients' intravenous lines at his oral surgery and dental implant clinics, in violation of standard medical protocol, the department said in a statement.
'This practice has been shown to transmit infections,' the statement said. It added that there had been no confirmed cases of anyone contracting the viral infections through Stein's clinics.
In the letters sent to Stein's former patients, the health department urged them to be tested for HIV, hepatitis B and hepatitis C, said Jan Stapleman, a department spokeswoman.
Stein's records were incomplete, so it is likely more people were possibly exposed than those already identified, she said.
A hot line established for Stein's patients to call was 'very busy' all day on Friday, Stapleman said.
Stein's lawyer, Victoria Lovato, said her client 'is cooperating with the state's investigation.'
Authorities said any patient who underwent any type of injection at the clinics, including sedation, might be at risk. They cautioned that if any patients of Stein tested positive for any of the viruses, there was no way to determine how they contracted the disease.
Stein's license to practice dentistry in Colorado was suspended for an unrelated matter, said Cory Everett-Lozano, spokeswoman for the state Department of Regulatory Agencies, which oversees medical licenses.
Until that probe is resolved, the reasons for Stein's current suspension are confidential, she said.
Lynn Kimbrough, a spokeswoman for the U.S. Attorney's Office in Denver, said Stein was already the target of a criminal probe for possible prescription fraud before the allegations emerged about reusing syringes. She said no criminal charges had so far been filed.
(Editing by Tim Gaynor and Peter Cooney)
This news article is brought to you by WOMEN'S SELF DEFENSE TIPS - where latest news are our top priority.
Friday, July 13, 2012
Thursday, July 12, 2012
Can HIV Prevention Be Found in a Pill?
An antiretroviral HIV drug has shown effectiveness in reducing infection risk, but the medication could put up some hurdles for physicians and health experts.
Three studies released online this week in the New England Journal of Medicine looked at the efficacy of a combination drug called Truvada (emtricitabine and tenofovir disoproxil fumarate) among heterosexuals.
Truvada is currently used as a treatment for HIV, but an FDA panel recently recommended approving the drug for preventive treatment as well.
One of the three studies followed 4,747 couples, one of whom was HIV-positive. The other partner was randomly assigned to Truvada, tenofovir (another HIV treatment) or a placebo.
The Truvada group had a 75 percent reduced risk of HIV infection compared to those who took the placebo, and those who took tenofovir had a 67 percent lower risk compared to the placebo group.
In another study, among 1,219 HIV-negative Africans, those taking Truvada were about 62 percent less likely to get the HIV infection.
But the medication, although promising, presents some challenges. A third study done among women in Africa was stopped because too many participants stopped taking the drug.
An editorial that accompanied the studies acknowledged that the studies had "complex and disparate results" and that more studies are needed to understand the potential and pitfalls of the pre-exposure prophylactic HIV treatment.
The authors of the editorial pointed out that although the studies showed no increase in risky sexual behavior or a drop in condom use, care must be taken that use of the drug doesn't indirectly encourage those behaviors.
They added that concern over how the drug is managed shouldn't take away from its promise as a preventive treatment.
What more needs to be done to prevent the spread of the HIV virus? Let us know in the comments.
Jeannine Stein, a California native, wrote about health for the Los Angeles Times. In her pursuit of a healthy lifestyle she has taken countless fitness classes, hiked in Nepal, and has gotten in a boxing ring. Email Jeannine | TakePart.com
This news article is brought to you by DESTINATION-TIPS - where latest news are our top priority.
Three studies released online this week in the New England Journal of Medicine looked at the efficacy of a combination drug called Truvada (emtricitabine and tenofovir disoproxil fumarate) among heterosexuals.
Truvada is currently used as a treatment for HIV, but an FDA panel recently recommended approving the drug for preventive treatment as well.
One of the three studies followed 4,747 couples, one of whom was HIV-positive. The other partner was randomly assigned to Truvada, tenofovir (another HIV treatment) or a placebo.
The Truvada group had a 75 percent reduced risk of HIV infection compared to those who took the placebo, and those who took tenofovir had a 67 percent lower risk compared to the placebo group.
In another study, among 1,219 HIV-negative Africans, those taking Truvada were about 62 percent less likely to get the HIV infection.
But the medication, although promising, presents some challenges. A third study done among women in Africa was stopped because too many participants stopped taking the drug.
An editorial that accompanied the studies acknowledged that the studies had "complex and disparate results" and that more studies are needed to understand the potential and pitfalls of the pre-exposure prophylactic HIV treatment.
The authors of the editorial pointed out that although the studies showed no increase in risky sexual behavior or a drop in condom use, care must be taken that use of the drug doesn't indirectly encourage those behaviors.
They added that concern over how the drug is managed shouldn't take away from its promise as a preventive treatment.
What more needs to be done to prevent the spread of the HIV virus? Let us know in the comments.
Jeannine Stein, a California native, wrote about health for the Los Angeles Times. In her pursuit of a healthy lifestyle she has taken countless fitness classes, hiked in Nepal, and has gotten in a boxing ring. Email Jeannine | TakePart.com
This news article is brought to you by DESTINATION-TIPS - where latest news are our top priority.
Circumcision ruling called threat to religion
The ruling, handed down last month by a Cologne court, has prompted widespread criticism from Jewish and Muslim groups alike, despite German government attempts to allay fears that it could lead to a national ban on circumcisions.
Despite the government's assurances, the president of the German Medical Association this week recommended that doctors cease performing circumcisions for religious reasons until the law can be clarified.
Following an emergency meeting in the German capital of some 40 rabbis from across Europe to discuss the issue, the head of the Conference of European Rabbis, Pinchas Goldschmidt, called circumcision 'the foundation' of the Jewish faith.
Goldschmidt, the chief rabbi of Moscow, said that while the rabbis recognized the ruling does not set a nationwide precedent, it has raised fears among the Jewish community that members could be prosecuted if they circumcise their sons.
Goldschmidt cited France's ban on face-covering Muslim veils and Switzerland's ban on the construction of new minarets for mosques in saying the Cologne decision was part of a wider trend aimed at limiting religious traditions in largely secular Europe.
'I don't think that today there is a quasi-ban of circumcision in Germany, but it is an attack on circumcision - a big attack on circumcision - and I am here because I think that this is not only a problem for Germany but a problem for Europe,' Goldschmidt said.
'Germany is an integral part - one of the most important parts - of Europe, so we want to solve this problem here first.'
In a joint statement from Brussels earlier this week, a group of rabbis, imams and others said that they consider the ruling against circumcision 'an affront on our basic religious and human rights.'
In its decision, the court said that circumcising young boys on religious grounds amounts to bodily harm even if parents consent to the procedure.
The ruling came in the case of the circumcision of a 4-year-old Muslim boy that led to medical complications, and both German Jewish and Muslim groups have spoken out against it.
Avichai Apel, the chief rabbi of Dortmund, said he was in regular contact with Germany's bishops and imams on the issue.
'Circumcision is for us a duty, and the basis for a Jewish child to be a part of the Jewish people,' he said. 'Religious freedom is being curtailed, and that is something we cannot accept here in Germany.'
Following the decision, German Foreign Minister Guido Westerwelle was quick to offer assurances that it would not mean an end to the practice, saying 'the free exercise of religion is protected in Germany - that includes religious traditions.'
The German ambassador to Israel told lawmakers in Jerusalem on Monday that the government was looking into whether laws needed to be changed.
'For us the deadline is not tomorrow, but yesterday,' Goldschmidt said of possible changes to the law. In the meantime, however, 'we say to the Jewish community ... keep performing the brit milah, and have no fear.'
Justice Minister Sabine Leutheusser-Schnarrenberger told the Augsburger Allgemeine newspaper in an interview printed Tuesday that for her 'the best thing here would be a clear word from one of the high courts.'
'Circumcision has never been questioned in the past,' she said. 'It is about fundamental questions and different values. The question is what part of religious practice is also part of the right to physical integrity.'
This article is brought to you by MATCHMAKING.
Wednesday, July 11, 2012
HIV Drug May Prevent Bone Marrow Transplant Complication
WEDNESDAY, July 11 (HealthDay News) -- An HIV drug significantly reduced the risk of graft-versus-host disease, an all-too-common complication in blood cancer patients following bone marrow transplants, new research finds.
Bone marrow is the spongy tissue inside the bones that contains immature cells, or stem cells. In an 'allogeneic' bone marrow transplantation, also called a stem cell transplant, a patient's own stem cells and immune system are wiped out by chemotherapy and radiation. Then, the patient receives the transplant, or bone marrow, from a closely matched donor.
The treatment is used for several types of blood cancers, including lymphoma and leukemia.
But a common complication of a bone marrow transplant is graft-versus-host disease. It occurs when transplanted immune cells attack patients' healthy tissue, a complication that can be minor or life-threatening.
'Graft-versus-host disease affecting the skin, liver, gut and other organs is a dreaded complication of allogeneic stem cell transplantation either from a related or unrelated donor,' said one expert, Dr. Jasmine Zain of NYU Langone Medical Center in New York City. 'The rates are 35 percent with related donors and up to 57 percent by day 100, even in reduced-intensity transplants,' added Zain, who is director of the Bone Marrow Transplant Program and assistant professor in the division of hematologic malignancies and medical oncology at the center.
The study was conducted by a team at the University of Pennsylvania's Perelman School of Medicine and included 38 patients with several types of blood cancers. The cancers included acute myeloid leukemia, myelodysplastic syndrome, lymphoma and myelofibrosis. All of the patients were given the drugs tacrolimus and methotrexate, which suppress the immune system and are a standard treatment to prevent graft-versus-host disease.
The patients were also given a 33-day course of the HIV drug, maraviroc, beginning two days before their transplant.
None of the patients treated with maraviroc developed graft-versus-host disease in the gut or liver within the first 100 days after their transplant. The liver and gut are the most serious locations for the complication, the researchers noted.
After six months, 6 percent of these transplant patients developed severe graft-versus-host disease compared to 22 percent of a group of similar patients who weren't treated with the HIV drug.
In addition, fewer in the group given the HIV drug developed graft-versus-host disease in their liver or gut compared to those given the standard treatment.
One year following transplant, about 15 percent of patients given the HIV drug developed severe graft-versus-host disease compared to 29 percent of patients who received standard therapy.
The study was published in the July 11 edition of the New England Journal of Medicine.
Researchers explained that the HIV drug redirects these immune cells without having to suppress patients' immune systems. Because their immune systems aren't compromised by the drug, patients should be less vulnerable to infections and to a relapse of their cancer.
'It appears that our new approach allows us to prevent some patients from developing [graft-versus-host disease] by redirecting immune cells away from certain sensitive organs that they could harm,' lead study author Dr. Ran Reshef, an assistant professor in the division of hematology-oncology, said in a university news release. 'This is a novel way for us to try to decrease treatment-related complications among bone marrow transplant patients without also reducing their new immune system's ability to attack their cancer.'
More research on the effects of longer-term treatment with maraviroc is needed, they added.
For her part, Zain called the study 'innovative.'
'There was no increase in the degree of immunosuppression, which is the usual approach to prevent and treat graft-versus-host disease but comes at a cost of increased infections and disease relapse,' Zain said. 'This makes this a novel and unique approach that should be investigated in a larger trial.'
More information
The U.S. National Library of Medicine has more about bone marrow transplants.
Bone marrow is the spongy tissue inside the bones that contains immature cells, or stem cells. In an 'allogeneic' bone marrow transplantation, also called a stem cell transplant, a patient's own stem cells and immune system are wiped out by chemotherapy and radiation. Then, the patient receives the transplant, or bone marrow, from a closely matched donor.
The treatment is used for several types of blood cancers, including lymphoma and leukemia.
But a common complication of a bone marrow transplant is graft-versus-host disease. It occurs when transplanted immune cells attack patients' healthy tissue, a complication that can be minor or life-threatening.
'Graft-versus-host disease affecting the skin, liver, gut and other organs is a dreaded complication of allogeneic stem cell transplantation either from a related or unrelated donor,' said one expert, Dr. Jasmine Zain of NYU Langone Medical Center in New York City. 'The rates are 35 percent with related donors and up to 57 percent by day 100, even in reduced-intensity transplants,' added Zain, who is director of the Bone Marrow Transplant Program and assistant professor in the division of hematologic malignancies and medical oncology at the center.
The study was conducted by a team at the University of Pennsylvania's Perelman School of Medicine and included 38 patients with several types of blood cancers. The cancers included acute myeloid leukemia, myelodysplastic syndrome, lymphoma and myelofibrosis. All of the patients were given the drugs tacrolimus and methotrexate, which suppress the immune system and are a standard treatment to prevent graft-versus-host disease.
The patients were also given a 33-day course of the HIV drug, maraviroc, beginning two days before their transplant.
None of the patients treated with maraviroc developed graft-versus-host disease in the gut or liver within the first 100 days after their transplant. The liver and gut are the most serious locations for the complication, the researchers noted.
After six months, 6 percent of these transplant patients developed severe graft-versus-host disease compared to 22 percent of a group of similar patients who weren't treated with the HIV drug.
In addition, fewer in the group given the HIV drug developed graft-versus-host disease in their liver or gut compared to those given the standard treatment.
One year following transplant, about 15 percent of patients given the HIV drug developed severe graft-versus-host disease compared to 29 percent of patients who received standard therapy.
The study was published in the July 11 edition of the New England Journal of Medicine.
Researchers explained that the HIV drug redirects these immune cells without having to suppress patients' immune systems. Because their immune systems aren't compromised by the drug, patients should be less vulnerable to infections and to a relapse of their cancer.
'It appears that our new approach allows us to prevent some patients from developing [graft-versus-host disease] by redirecting immune cells away from certain sensitive organs that they could harm,' lead study author Dr. Ran Reshef, an assistant professor in the division of hematology-oncology, said in a university news release. 'This is a novel way for us to try to decrease treatment-related complications among bone marrow transplant patients without also reducing their new immune system's ability to attack their cancer.'
More research on the effects of longer-term treatment with maraviroc is needed, they added.
For her part, Zain called the study 'innovative.'
'There was no increase in the degree of immunosuppression, which is the usual approach to prevent and treat graft-versus-host disease but comes at a cost of increased infections and disease relapse,' Zain said. 'This makes this a novel and unique approach that should be investigated in a larger trial.'
More information
The U.S. National Library of Medicine has more about bone marrow transplants.
Studies Show Value of AIDS Drugs as Prevention
WEDNESDAY, July 11 (HealthDay News) -- Researchers have released the final results of two studies that suggest AIDS drugs can prevent exposed people in Africa from getting infected with HIV by their sexual partners. However, another study indicates that it's a tough job to convince African women who aren't at the highest risk to take preventive medications.
In the big picture, the studies show that 'we have a new HIV-prevention strategy, one that's quite powerful but also depends on adherence,' said Dr. Jared Baeten, an associate professor of global health at the University of Washington, in Seattle. 'The next step is figuring out how to motivate people to take it.'
The studies appeared online July 11 in the New England Journal of Medicine.
The general findings of the studies have been previously released, but only now has the research become available in a medical journal after going through a peer-review process.
Two studies offer promising details about the potential for the drugs to prevent -- although not all the time -- the transmission of HIV to heterosexual men and women from their infected partners.
One study in Kenya and Uganda looked at heterosexual couples -- almost all married -- in which one person was infected with HIV, the virus that causes AIDS. The uninfected partners were randomly assigned to take an inactive placebo or a once-daily dose of the drug tenofovir (Viread) or a tenofovir-emtricitabine combination (Truvada) for up to three years. Nearly 5,000 people completed the study.
Those who took Truvada had a 75 percent lower risk of becoming infected with HIV compared to those who received a placebo. The risk was 67 percent lower in those who took Viread compared to a placebo. Even in those who got the placebo, the overall risk of getting infected was low: 52 of 1,468, or a little more than 3 percent, did so.
Truvada treatment in the United States costs several thousand dollars a year, Baeten said, but the discounted price can be as cheap as 25 cents a day in Africa. The drug, which stops the AIDS virus from reproducing in people who are infected, appears to do the same thing in uninfected people who are exposed to the virus, he said. In their cases, the virus doesn't already have a foothold in the body so it dies off.
In this study, 10 percent or less of those who took the drugs reported side effects such as fatigue, diarrhea and nausea, and only in the first month.
The second study of 1,219 HIV-negative adults in Botswana looked at Truvada versus a placebo. Comparing the 33 participants who became infected during the trial -- nine people in the drug group and 24 people on a placebo -- the study found those who took Truvada were 62 percent less likely to become infected with HIV.
In this study, significant loss of bone mineral density was a side effect for participants receiving the drug, compared to those on a placebo.
Another study, in Kenya, South Africa and Tanzania, assigned 2,120 women at higher risk of HIV infection to receive Truvada or a placebo. However, there wasn't much difference in HIV infection rates between the two groups -- about 5 percent in both became infected.
Baeten explained the finding, saying many women stopped taking the drug, which prevented an accurate assessment of its effectiveness.
The next step in research into the use of the drugs to prevent infection is to 'figure out how to make them work in the real world, outside of an intensive research setting,' Baeten said. In the United States, for example, researchers are studying their use in gay men who are at high risk for infection.
As for condoms, another major player in HIV prevention, Baeten said the prevention drugs will add to their level of security or provide some protection in cases where people can't use condoms.
In an editorial accompanying the studies, two experts stressed that medications should never be viewed as a substitute for the condom.
'Although no evidence of increased risky sexual behavior or decreased condom usage was reported in these studies, we must ensure that pre-exposure prophylaxis does not indirectly encourage such behavior,' wrote Dr. Myron Cohen of the University of North Carolina at Chapel Hill and Dr. Lindsey Baden of Brigham and Women's Hospital, Boston.
They added that more research is needed to properly assess who stands to benefit most from these drug regimens, the best timing and dosage, as well as any potential side effects from long-term use.
More information
For more about AIDS, visit the U.S. National Library of Medicine.
This news article is brought to you by OUTDOORS - where latest news are our top priority.
In the big picture, the studies show that 'we have a new HIV-prevention strategy, one that's quite powerful but also depends on adherence,' said Dr. Jared Baeten, an associate professor of global health at the University of Washington, in Seattle. 'The next step is figuring out how to motivate people to take it.'
The studies appeared online July 11 in the New England Journal of Medicine.
The general findings of the studies have been previously released, but only now has the research become available in a medical journal after going through a peer-review process.
Two studies offer promising details about the potential for the drugs to prevent -- although not all the time -- the transmission of HIV to heterosexual men and women from their infected partners.
One study in Kenya and Uganda looked at heterosexual couples -- almost all married -- in which one person was infected with HIV, the virus that causes AIDS. The uninfected partners were randomly assigned to take an inactive placebo or a once-daily dose of the drug tenofovir (Viread) or a tenofovir-emtricitabine combination (Truvada) for up to three years. Nearly 5,000 people completed the study.
Those who took Truvada had a 75 percent lower risk of becoming infected with HIV compared to those who received a placebo. The risk was 67 percent lower in those who took Viread compared to a placebo. Even in those who got the placebo, the overall risk of getting infected was low: 52 of 1,468, or a little more than 3 percent, did so.
Truvada treatment in the United States costs several thousand dollars a year, Baeten said, but the discounted price can be as cheap as 25 cents a day in Africa. The drug, which stops the AIDS virus from reproducing in people who are infected, appears to do the same thing in uninfected people who are exposed to the virus, he said. In their cases, the virus doesn't already have a foothold in the body so it dies off.
In this study, 10 percent or less of those who took the drugs reported side effects such as fatigue, diarrhea and nausea, and only in the first month.
The second study of 1,219 HIV-negative adults in Botswana looked at Truvada versus a placebo. Comparing the 33 participants who became infected during the trial -- nine people in the drug group and 24 people on a placebo -- the study found those who took Truvada were 62 percent less likely to become infected with HIV.
In this study, significant loss of bone mineral density was a side effect for participants receiving the drug, compared to those on a placebo.
Another study, in Kenya, South Africa and Tanzania, assigned 2,120 women at higher risk of HIV infection to receive Truvada or a placebo. However, there wasn't much difference in HIV infection rates between the two groups -- about 5 percent in both became infected.
Baeten explained the finding, saying many women stopped taking the drug, which prevented an accurate assessment of its effectiveness.
The next step in research into the use of the drugs to prevent infection is to 'figure out how to make them work in the real world, outside of an intensive research setting,' Baeten said. In the United States, for example, researchers are studying their use in gay men who are at high risk for infection.
As for condoms, another major player in HIV prevention, Baeten said the prevention drugs will add to their level of security or provide some protection in cases where people can't use condoms.
In an editorial accompanying the studies, two experts stressed that medications should never be viewed as a substitute for the condom.
'Although no evidence of increased risky sexual behavior or decreased condom usage was reported in these studies, we must ensure that pre-exposure prophylaxis does not indirectly encourage such behavior,' wrote Dr. Myron Cohen of the University of North Carolina at Chapel Hill and Dr. Lindsey Baden of Brigham and Women's Hospital, Boston.
They added that more research is needed to properly assess who stands to benefit most from these drug regimens, the best timing and dosage, as well as any potential side effects from long-term use.
More information
For more about AIDS, visit the U.S. National Library of Medicine.
This news article is brought to you by OUTDOORS - where latest news are our top priority.
Pills to prevent HIV raise many questions: studies
The findings of three major studies in Africa, published in the New England Journal of Medicine, raise many questions about which groups would likely benefit and how to manage such treatments in the future, doctors said.
The approach is known as pre-exposure prophylaxis, or PrEP, in which healthy people take antiretroviral drugs -- the kind used to treat people with HIV -- in order to prevent getting the virus during sex with HIV-infected partners.
One study detailed in the journal which included heterosexual couples -- each with one HIV-positive partner, one HIV-negative -- showed a 67 to 75 percent reduced risk of getting HIV among uninfected partners taking the drugs.
The study, known as Partners PrEP, ran from 2008 to 2010 in Kenya and Uganda and included more than 4,700 couples. It randomly assigned the HIV-negative partners to once-daily tenofovir, a combination of tenofovir-emtricitabine, or a placebo.
Both treatments showed 'significant' and a 'similar magnitude' of protection for both men and women, the study said.
Adherence to the drug regimen was also high in this study, with 82 percent of samples from randomly selected participants showing detectable drug levels, and study authors estimating an overall 92 percent adherence rate.
Another study detailed in the journal however was stopped early in April 2011 because the group receiving the drug did not show any better level of protection than the group taking the sugar pill.
That study, known as FEM-PrEP, was a randomized trial of 2,120 women in Kenya, South Africa and Tanzania.
Thirty-three women taking the drug became infected with HIV, compared to 35 taking the placebo.
The study also showed a much lower rate of adherence to the medication regimen (40 percent) and a much higher rate of reported side effects such as nausea, vomiting and kidney or liver abnormalities.
Since many of the women in the study reported viewing themselves at low-risk for acquiring HIV, this may have contributed to their failure to take the drug regularly, the study authors said.
A third study, called TDF-2, enrolled 1,219 men and women in Botswana, and showed that pre-exposure prophylaxis had an efficacy rate of about 62 percent in sexually active heterosexual adults.
Previous studies on men who have sex with men have shown that the approach could reduce transmission of HIV by 44 percent overall, though much higher success rates were seen in men who took the pills most regularly.
'Why the results differ across the various studies reported to date is unclear,' said an accompanying editorial by Myron Cohen from the University of North Carolina and Lindsey Baden of Brigham and Women's Hospital in Boston.
Learning more through future study is important because PrEP is increasingly being seen as a part of an integrated HIV prevention approach, they wrote.
Also, an advisory panel to the US Food and Drug Administration earlier this year recommended approving the first ever pill for HIV prevention. A decision is expected in September.
Therefore, doctors need to consider how to manage such an approach with patients, the authors said.
Questions to consider include which populations are best suited, when to start and stop treatment, how to avoid the risk of drug resistance, what long-term side effects may include, and how to make sure the treatment does not encourage risky behavior such as unprotected sex.
'Concern about the management of pre-exposure prophylaxis of HIV infection should not detract from the potential importance of the intervention,' Cohen and Baden wrote.
'The health care provider who recommends pre-exposure prophylaxis needs a management plan that recognizes the effects of the intervention on the patient's sexual behavior, safety and well-being as well as the ramifications of the intervention for the health of the public.'
GSK's HIV drug beats Gilead market leader in study
Dolutegravir, which could reach the market late next year, belongs to a novel class of drugs known as integrase inhibitors that fight HIV/AIDS by blocking the virus causing the disease from entering cells.
It should help British group GSK rejuvenate its HIV/AIDS business - an area it used to dominate but where it has fallen behind rivals, notably U.S.-based Gilead.
The stakes are high with Atripla, the leading HIV/AIDS treatment in the United States, raking in sales of $3.2 billion last year.
Dolutegravir's impressive result may also make a spin-off of GSK's HIV/AIDS business ViiV Healthcare more likely, analysts said. ViiV is currently run as a joint venture with Pfizer, with Britain's biggest drugmaker holding an 85 percent stake.
Dolutegravir's success against Atripla, taken as a single tablet, may impress clinicians as Gilead's own new Quad pill, which also contains an integrase inhibitor, only matched Atripla.
In the latest Phase III study, 88 percent of patients taking a regimen of dolutegravir plus two older drugs for 48 weeks had their virus suppressed against 81 percent for those on Atripla, GSK and Shionogi said on Wednesday.
The superior efficacy was driven by the fact that more patients taking Atripla dropped out of treatment, with 10 percent of those on the Gilead drug stopping due to side effects against 2 percent in the dolutegravir arm.
The result was the second positive final-stage clinical read-out for dolutegravir, following encouraging results against U.S. company Merck & Co's rival Isentress in April.
Two further Phase III trials are expected to report results by the end of the year and dolutegravir could potentially be filed for approval with regulators before the end of 2012, a company spokesman said.
That means the medicine may reach the market before the end of 2013, ramping up competition in the HIV/AIDS market.
GSK shares were up 0.7 percent by 1150 GMT, while Gilead was down 2 percent in pre-market Nasdaq trading.
GSK'S 40 PCT SHARE
Dolutegravir is viewed by analysts as a potential multibillion-dollar-a-year seller, as its once-daily dosing is likely to be attractive to patients. However, the financial gain to GSK will be diluted by its deals with Shionogi and Pfizer.
Income from the medicine will be shared 50:50 between ViiV and Shionogi, so GSK will receive only just over 40 percent after taking account of Pfizer's minority stake in ViiV.
The creation of ViiV in 2009 marked an unusual drug industry collaboration because of the way in which it pooled GSK and Pfizer's HIV/AIDS operations into a new business. There have been doubts, however, as to whether the joint venture would have a viable future, given uncertainty about its new drug pipeline.
The impressive results with dolutegravir will lay some of those worries to rest.
Mark Schoenebaum, an analyst at ISI Group, said the latest data was 'a bit better than expected', although it might not be enough to drive big shifts away from Gilead's drugs.
Citi analysts also noted that concerns remained about the cardiovascular safety of Epzicom, one of the older drugs used with dolutegravir.
Still, the findings are clearly an overall plus for GSK's HIV unit and could help make it a viable standalone business.
'Today's news may prompt further market discussion of a possible spin-off of ViiV as dolutegravir is much the most important pipeline product for this venture,' Deutsche Bank analysts said in a note.
GSK Chief Executive Andrew Witty said last year he had no immediate plans to spin off ViiV but was 'open-minded' about the unit's long-term future.
Merck's Isentress, which had sales of $1.4 billion last year, is currently the only integrase inhibitor approved by regulators, although Gilead's Quad pill containing its integrase inhibitor elvitegravir was recommended by a U.S. expert panel in May.
(Editing by Jon Loades-Carter)
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Tuesday, July 10, 2012
Teens' Lifestyle Choices Affect Their Blood Pressure
TUESDAY, July 10 (HealthDay News) -- Teen girls who use birth control pills and teen boys who drink alcohol are at increased risk for elevated blood pressure, according to a new study.
The risk is also greater among teens of both sexes who have a high salt intake and those with a higher body mass index (BMI), which is a measure of body fat based on weight and height. High blood pressure (hypertension) increases the chances of heart disease and stroke.
Researchers looked at blood pressure, alcohol consumption, smoking, physical activity levels, prescription medicine use and eating habits among nearly 1,800 teens in Australia.
About 24 percent of the teens had pre-hypertension or hypertension, including 34 percent of those who were overweight and 38 percent of those who were obese.
Average systolic blood pressure (top number in a reading) among boys in the study was 9 mmHg higher than in girls in general. Among boys, systolic blood pressure was significantly associated with salt intake, alcohol consumption and BMI.
Regular physical activity was associated with lower diastolic (bottom number) blood pressure.
The use of birth control pills was significantly associated with higher blood pressure in girls. The average systolic blood pressure of girls who used birth control pills was 3.3 mmHg higher than in those who didn't use this form of contraception, and blood pressure was even higher in girls who used birth control pills and also had higher BMI readings.
Alcohol consumption did not affect blood pressure in girls, according to the study, which was published July 10 in the European Journal of Preventive Cardiology.
The major differences in blood pressure found between teens with healthy and less healthy lifestyles could have a significant impact on their risk for heart disease and stroke in adulthood, the researchers said.
'Adolescents need to be aware that a lifestyle which predisposes to fatness, high salt intake and alcohol consumption may lead to adverse health consequences in adult life. The effects are additive and already associated with hypertension. Moreover, teenage girls taking oral contraceptives should be advised about regular blood pressure monitoring,' study author Dr. Chi Le-Ha, of the Royal Perth Hospital, said in a journal news release.
More information
The U.S. National Heart, Lung, and Blood Institute has more about high blood pressure.
This article is sponsored by medical case study.
The risk is also greater among teens of both sexes who have a high salt intake and those with a higher body mass index (BMI), which is a measure of body fat based on weight and height. High blood pressure (hypertension) increases the chances of heart disease and stroke.
Researchers looked at blood pressure, alcohol consumption, smoking, physical activity levels, prescription medicine use and eating habits among nearly 1,800 teens in Australia.
About 24 percent of the teens had pre-hypertension or hypertension, including 34 percent of those who were overweight and 38 percent of those who were obese.
Average systolic blood pressure (top number in a reading) among boys in the study was 9 mmHg higher than in girls in general. Among boys, systolic blood pressure was significantly associated with salt intake, alcohol consumption and BMI.
Regular physical activity was associated with lower diastolic (bottom number) blood pressure.
The use of birth control pills was significantly associated with higher blood pressure in girls. The average systolic blood pressure of girls who used birth control pills was 3.3 mmHg higher than in those who didn't use this form of contraception, and blood pressure was even higher in girls who used birth control pills and also had higher BMI readings.
Alcohol consumption did not affect blood pressure in girls, according to the study, which was published July 10 in the European Journal of Preventive Cardiology.
The major differences in blood pressure found between teens with healthy and less healthy lifestyles could have a significant impact on their risk for heart disease and stroke in adulthood, the researchers said.
'Adolescents need to be aware that a lifestyle which predisposes to fatness, high salt intake and alcohol consumption may lead to adverse health consequences in adult life. The effects are additive and already associated with hypertension. Moreover, teenage girls taking oral contraceptives should be advised about regular blood pressure monitoring,' study author Dr. Chi Le-Ha, of the Royal Perth Hospital, said in a journal news release.
More information
The U.S. National Heart, Lung, and Blood Institute has more about high blood pressure.
This article is sponsored by medical case study.
Monday, July 9, 2012
HPV Vaccine Reducing Infections, Even Among Unvaccinated: Study
MONDAY, July 9 (HealthDay News) -- Even among unvaccinated girls and young women, the human papillomavirus vaccine is reducing infections of certain strains of the virus known to cause genital warts and cervical cancer, new research finds.
The study is among the first to show signs that the human papillomavirus (HPV) vaccine not only prevents infections, but it can also promote herd protection -- a decrease in infections among the unimmunized thanks to lower rates of infections among other people in their community who might otherwise be transmitting the disease.
HPV is the most common sexually transmitted infection in the United States, and is thought to be the leading cause of cervical cancer. Certain strains of the virus can cause other health problems as well, including other genital cancers, anal cancer, head and neck cancers, and genital warts, experts say.
The study involved two groups of women aged 13 to 26 who had already had sexual contact and who were seen at two primary-care clinics in Cincinnati, one of which was a teen health center.
One group was seen at the clinic in 2006 or 2007, before the HPV vaccine, which protects against four strains of HPV, was widely available. The second group was seen in 2009 or 2010, after the vaccines were widely available.
About 60 percent of the latter group had received the vaccine.
Participants filled out a questionnaire with demographic information and information about their sexual activity, and were tested for 37 strains of HPV. The vaccine protects against four common strains of HPV that are known to cause warts or cancer. The strains include types 6 and 11, which cause almost all genital warts, and types 16 and 18, which cause about 70 percent of cervical cancers and 90 percent of anal cancers, said study author Dr. Jessica Kahn, associate professor of pediatrics at Cincinnati Children's Hospital Medical Center.
From 2006 to 2010, the prevalence of these four strains decreased by about 60 percent, from about 32 percent to 13 percent.
Among the vaccinated, rates of HPV infection fell from 32 percent to 10 percent -- a 70 percent drop. Perhaps even more dramatic, rates of infection among the unvaccinated fell from 30 percent to 15 percent -- a 50 percent drop.
'This is a first look at how the vaccine is working in a real-world setting,' Kahn said. 'We were very encouraged to find the rates of HPV fell so dramatically, especially because the girls in the study already had sexual contact, some had more than one sexual partner and some only had one dose to be considered vaccinated.'
'That's what you get in the real world,' she continued. 'You get vaccinated girls who have already had sex, who aren't compliant with the vaccine. It's a messy sample, not the clean sample you get in a clinical trial.'
Although encouraging, Kahn noted, the findings may not be applicable nationally. Most participants in the study were low-income black women, many with Medicaid insurance, and all were drawn from two primary-care centers in the same city.
The study, funded by the U.S. National Institutes of Health, is published online July 9 in the journal Pediatrics.
The U.S. Food and Drug administration has approved two HPV vaccines -- Gardasil and Cervarix. The girls in the study were given Gardasil, which protects against four HPV strains; Cervarix prevents two HPV types.
'If girls are getting vaccinated, they are not spreading HPV to male partners, who then don't spread it to other female partners,' Kahn explained.
Although the prevalence of the four main strains of HPV fell, the overall rate of HPV infection remained 'extremely high,' according to the study. Infection by any strain actually increased from 61 percent to 76 percent during the study's two time periods. Researchers said this highlights the need for vaccines, some of which are under development, that also protect from other strains of HPV.
Dr. Walter Orenstein, a member of the American Academy of Pediatrics' committee on infectious diseases and associate director of the Emory Vaccine Center in Atlanta, said the findings strongly suggest the beginnings of herd immunity against HPV.
'It's too early to be definitive, but there is a very strong suggestion that this vaccine not only protects the [people who received the vaccine] but protects the community as well,' Orenstein said.
The U.S. Advisory Committee on Immunization Practices recommends that girls and boys get vaccines against HPV at age 11 or 12, before they've had sexual contact, or up until age 26 if they missed that window. The vaccine is given in three doses, each two months apart. Orenstein urged parents to follow the recommend schedule.
'This is a vaccine that can protect against cancer. It's important to vaccinate at the recommended ages, before there is sexual debut,' Orenstein said. 'Not only can vaccines protect individuals, but the more individuals who are vaccinated, the more likely the overall community is protected as well.'
More information
The U.S. Centers for Disease Control and Prevention has more on vaccination schedules.
This article is brought to you by SINGLES.
The study is among the first to show signs that the human papillomavirus (HPV) vaccine not only prevents infections, but it can also promote herd protection -- a decrease in infections among the unimmunized thanks to lower rates of infections among other people in their community who might otherwise be transmitting the disease.
HPV is the most common sexually transmitted infection in the United States, and is thought to be the leading cause of cervical cancer. Certain strains of the virus can cause other health problems as well, including other genital cancers, anal cancer, head and neck cancers, and genital warts, experts say.
The study involved two groups of women aged 13 to 26 who had already had sexual contact and who were seen at two primary-care clinics in Cincinnati, one of which was a teen health center.
One group was seen at the clinic in 2006 or 2007, before the HPV vaccine, which protects against four strains of HPV, was widely available. The second group was seen in 2009 or 2010, after the vaccines were widely available.
About 60 percent of the latter group had received the vaccine.
Participants filled out a questionnaire with demographic information and information about their sexual activity, and were tested for 37 strains of HPV. The vaccine protects against four common strains of HPV that are known to cause warts or cancer. The strains include types 6 and 11, which cause almost all genital warts, and types 16 and 18, which cause about 70 percent of cervical cancers and 90 percent of anal cancers, said study author Dr. Jessica Kahn, associate professor of pediatrics at Cincinnati Children's Hospital Medical Center.
From 2006 to 2010, the prevalence of these four strains decreased by about 60 percent, from about 32 percent to 13 percent.
Among the vaccinated, rates of HPV infection fell from 32 percent to 10 percent -- a 70 percent drop. Perhaps even more dramatic, rates of infection among the unvaccinated fell from 30 percent to 15 percent -- a 50 percent drop.
'This is a first look at how the vaccine is working in a real-world setting,' Kahn said. 'We were very encouraged to find the rates of HPV fell so dramatically, especially because the girls in the study already had sexual contact, some had more than one sexual partner and some only had one dose to be considered vaccinated.'
'That's what you get in the real world,' she continued. 'You get vaccinated girls who have already had sex, who aren't compliant with the vaccine. It's a messy sample, not the clean sample you get in a clinical trial.'
Although encouraging, Kahn noted, the findings may not be applicable nationally. Most participants in the study were low-income black women, many with Medicaid insurance, and all were drawn from two primary-care centers in the same city.
The study, funded by the U.S. National Institutes of Health, is published online July 9 in the journal Pediatrics.
The U.S. Food and Drug administration has approved two HPV vaccines -- Gardasil and Cervarix. The girls in the study were given Gardasil, which protects against four HPV strains; Cervarix prevents two HPV types.
'If girls are getting vaccinated, they are not spreading HPV to male partners, who then don't spread it to other female partners,' Kahn explained.
Although the prevalence of the four main strains of HPV fell, the overall rate of HPV infection remained 'extremely high,' according to the study. Infection by any strain actually increased from 61 percent to 76 percent during the study's two time periods. Researchers said this highlights the need for vaccines, some of which are under development, that also protect from other strains of HPV.
Dr. Walter Orenstein, a member of the American Academy of Pediatrics' committee on infectious diseases and associate director of the Emory Vaccine Center in Atlanta, said the findings strongly suggest the beginnings of herd immunity against HPV.
'It's too early to be definitive, but there is a very strong suggestion that this vaccine not only protects the [people who received the vaccine] but protects the community as well,' Orenstein said.
The U.S. Advisory Committee on Immunization Practices recommends that girls and boys get vaccines against HPV at age 11 or 12, before they've had sexual contact, or up until age 26 if they missed that window. The vaccine is given in three doses, each two months apart. Orenstein urged parents to follow the recommend schedule.
'This is a vaccine that can protect against cancer. It's important to vaccinate at the recommended ages, before there is sexual debut,' Orenstein said. 'Not only can vaccines protect individuals, but the more individuals who are vaccinated, the more likely the overall community is protected as well.'
More information
The U.S. Centers for Disease Control and Prevention has more on vaccination schedules.
This article is brought to you by SINGLES.
Saturday, July 7, 2012
New optimism about stemming spread of AIDS virus
Yet more than 20,000 international HIV researchers and activists will gather in the nation's capital later this month with a sense of optimism not seen in many years - hope that it finally may be possible to dramatically stem the spread of the AIDS virus.
'We want to make sure we don't overpromise,' Dr. Anthony Fauci, the National Institutes of Health's infectious disease chief, told The Associated Press. But, he said, 'I think we are at a turning point.'
The big new focus is on trying to get more people with HIV treated early, when they're first infected, instead of waiting until they're weakened or sick, as the world largely has done until now. Staying healthier also makes them less likely to infect others.
That's a tall order. But studies over the past two years have shown what Fauci calls 'striking, sometimes breathtaking results,' in preventing people at high risk of HIV from getting it in some of the hardest-hit countries, using this treatment-as-prevention and some other protections.
Now, as the International AIDS Conference returns to the U.S. for the first time in 22 years, the question is whether the world will come up with the money and the know-how to put the best combinations of protections into practice, for AIDS-ravaged poor countries and hot spots in developed nations as well.
'We have the tools to make it happen,' said Dr. Elly Katabira, president of the International AIDS Society, which organizes the world's largest HIV conference, set for July 22-27. He points to strides already in Botswana and Rwanda in increasing access to AIDS drugs.
But Fauci cautioned that moving those tools into everyday life is 'a daunting challenge,' given the costs of medications and the difficulty in getting people to take them for years despite poverty and other competing health and social problems.
In the U.S., part of that challenge is complacency. Despite 50,000 new HIV infections here every year, an AP-GfK poll finds that very few people in the United States worry about getting the virus.
Also, HIV increasingly is an epidemic of the poor, minorities and urban areas such as the District of Columbia, where the rate of infection rivals some developing countries. The conference will spotlight this city's aggressive steps to fight back: A massive effort to find the undiagnosed, with routine testing in some hospitals, testing vans that roam the streets, even free tests at a Department of Motor Vehicles office, and then rapidly getting those patients into care.
'These are the true champions,' Dr. Mohammed Akhter, director of the city's health department, said of patients who faithfully take their medication. 'They're also protecting their community.'
___
A few miles east of the Capitol and the tourist-clogged monuments, the Community Education Group's HIV testing van pulls into a parking lot in a low-income neighborhood with a particularly high infection rate. An incentive for the crowd at a nearby corner is the offer of a $10 supermarket gift card for getting tested.
Christopher Freeman, 23, is first in line. He was tested earlier this year and says showing off that official paper proclaiming him HIV-negative attracts 'the ladies.'
'Forget money, it's the best thing you can show them,' he said.
But that test was months ago, and Freeman admits he seldom uses condoms. He climbs into the van and rubs a swab over his gums. Twenty minutes later, he's back for the result: Good news - no HIV. But counselor Amanda Matthews has Freeman go through a list of the risk factors; it's education to try to keep him and his future partners safe.
'Just try to get yourself in the habit of using condoms,' she said. 'You say it's hard to use condoms but what if you do contract the virus? Then you've got to take medications every day.'
Freeman waves his new test result with a grin, and walks off with a handful of free condoms.
At a nearby bus stop, counselor Laila Patrick encounters a little resistance while handing out condoms, when a woman says that encourages sex outside of marriage.
'Stopping AIDS is everyone's business. You're looking out for the next person,' Patrick said. 'You might just want to help someone be safe.'
___
About 34 million people worldwide have HIV, including almost 1.2 million Americans. It's a very different epidemic from the last time the International AIDS Conference came to the United States, in 1990. Life-saving drugs emerged a few years later, turning HIV from a death sentence into a manageable chronic disease for people and countries that can afford the medications.
Yet for all the improvements in HIV treatment, the rate of new infections in the U.S. has held steady for about a decade. About 1 in 5 Americans with HIV don't know they have it, more than 200,000 people who unwittingly can spread the virus.
Government figures show most new U.S. infections are among gay and bisexual men, followed by heterosexual black women. Of particular concern, African-Americans account for about 14 percent of the population but 44 percent of new HIV infections.
Your ZIP code plays a role in your risk, too. Twelve cities account for more than 40 percent of the nation's AIDS cases: New York, Los Angeles, Washington, Chicago, Atlanta, Miami, Philadelphia, Houston, San Francisco, Baltimore, Dallas and San Juan, Puerto Rico. Many are concentrated in specific parts of those cities.
'Maps tell the story,' said Brown University assistant professor Amy Nunn, who is beginning a campaign that will bring a testing van door-to-door in the hardest-hit Philadelphia ZIP code.
'It's not just what you do, it's also where you live. There's just a higher chance that you will come into contact with the virus,' she explained.
___
Prospects for a vaccine are so far elusive and health disparities are widening, so why the optimism as expressed by the Obama administration's goal of getting to an AIDS-free generation?
Consider the potential strategies, to add to tried-and-true steps such as condom use and treating HIV-infected pregnant women to protect their unborn babies:
-Studies found treatment-as-prevention could lower an HIV patient's chance of spreading the virus to an uninfected sexual partner by a stunning 96 percent. In the U.S., new guidelines recommend starting treatment early rather than waiting until the immune system has weakened. Abroad, the United Nations hopes to more than double the number of patients being treated in poor countries to 15 million by 2015.
-Other studies show a longtime AIDS medication named Truvada can prevent infection, too, if taken daily by healthy people who are at risk from their infected sexual partners. The U.S. Food and Drug Administration is expected to decide by fall whether to formally approve sale of Truvada as an HIV preventive.
-A study from South Africa found a vaginal gel containing anti-AIDS medication helped protect women when their infected partners wouldn't use a condom, generating more interest in developing women-controlled protection.
-Globally, experts also stress male circumcision, to lower men's risk of heterosexually acquired HIV.
___
Testing is a key step in improving prevention. The AP-GfK poll found 57 percent of adults say they've been tested at some point, a bit higher than federal estimates, but not enough. The government recommends at least one test for adults, and that populations at higher risk get tested at least once a year.
Following those recommendations depends in part on people's concern about AIDS. The poll found just over half of Americans consider HIV as much or more of a problem now than two decades ago. But less than 20 percent are worried about getting it themselves, and even populations at higher risk don't consider HIV a big threat. Some 16 percent of black respondents said they're very worried about HIV, compared with 4 percent of whites.
'We've become complacent about HIV in America, and it's a real tragedy because hundreds of thousands of people in our own country aren't getting the care they need,' said Chris Collins of amFAR, The Foundation for AIDS Research.
The drugs can cost up to $15,000 a year in the U.S., and overall treatment costs are rising as people with HIV live longer. In developing countries, those drugs can cost less than $400 a year.
The AP-GfK Poll was conducted June 14-18 by GfK Roper Public Affairs and Corporate Communications. It involved landline and cellphone interviews with 1,007 adults nationwide. Results for the full sample have a margin of sampling error of plus or minus 4.0 percentage points.
_____
In the U.S., the government is targeting the hardest-hit communities as part of a plan to reduce HIV infections by 25 percent by 2015, said Assistant Secretary of Health Howard Koh. Work is under way to learn the best steps to get people treated early, including in cities such as Washington, where 2.7 percent of residents have HIV, roughly four times the national rate.
Washington resident Zee Turner knows it's hard to stick with care. She's had HIV for two decades, learning the news when her baby was born sick. Health workers helped mom and daughter receive then-newly emerging treatments, and they're doing well today.
'I felt that I should get out here and try to help somebody else, because somebody had to help us get into care,' said Turner, now 53 and a community health worker.
The city's latest HIV count suggests progress, with a slight decrease in new diagnoses and a majority of patients being connected with medical care. Community workers such as Turner are called to try to help people stay on treatment when other problems intervene.
'If they're on drugs, I take them to the drug program. If they need help going on Medicaid, I go with them to Medicaid,' Turner said. 'Any problem they have, I'm going to try to fix it and get them back into care.'
___
Associated Press Deputy Director of Polling Jennifer Agiesta and News Survey Specialist Dennis Junius contributed to this report.
___
Online:
International AIDS conference: http://www.aids2012.org
Poll results: http://www.ap-gfkpoll.com
HTML interactive features world map of incidents of HIV by country, explanation of increase of HIV in recent years and a chronology of the epidemic: http://hosted.ap.org/interactives/2012/hiv-aids
This article is brought to you by ONLINE DATING.
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