Should children with suspected meningitis be given antibiotics before transfer to hospital?

Several European countries advise doctors in primary care to do this, but the evidence is conflicting, with some studies suggesting benefit and others suggesting harm. Two papers in this week’s BMJ add to this uncertainty.

One shows that children who are given antibiotics before admission to hospital are more likely to die on reaching hospital. The other – a review of all the current evidence – cannot conclude whether or not pre-hospital antibiotics improve survival.

In the first study, UK researchers analysed 158 children diagnosed with suspected meningococcal disease by a general practitioner before admission to hospital. Two thirds were given parenteral (injected) penicillin, in accordance with national guidelines.

The children who were given penicillin were more likely to die than those who were not given penicillin.

However, the children who received penicillin also had more severe disease on reaching hospital. So, although a harmful effect of penicillin cannot be excluded, a more likely explanation for the higher mortality is that there is a strong bias towards giving penicillin to the most severely ill children, conclude the authors.

In the second paper, an international group of researchers reviewed evidence from 14 studies and found that oral antibiotics given before hospital admission were associated with reduced mortality. Results for parenteral antibiotics were inconsistent, though the data suggest that they might have a beneficial effect when a substantial proportion of patients is treated.

Once again, it is suggested that bias linked to illness severity may explain these results. For example, doctors are likely to prescribe oral antibiotics only in patients with milder disease.

“We cannot conclude from this review whether or not antibiotics given before admission have an effect on case fatality, though the data are consistent with benefit when a substantial proportion of cases are treated,” they write.

So, should doctors change their practice in light of these findings? Probably not, says Duncan Keeley, a general practitioner in an accompanying editorial. But frontline practitioners will be keen to hear a view from the Meningitis Research Foundation once it has considered their implications.

Meanwhile, further analysis of the data is crucial, and we should also remember the contributions general practitioners can make, including educating parents, early diagnosis, and rapid transfer to hospital with optimum supportive care, he writes. These measures may be more important for improving survival than administering parenteral penicillin in the community.

Parenteral penicillin for children with meningococcal disease before hospital admission: Case-control study; BMJ Volume 332, pp 1295-7

Emma Dickinson
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The number of AIDS cases among women are increasing in Kentucky, with women accounting for almost one-quarter of people diagnosed annually with the disease in the state, the AP/Kentucky Post reports. The proportion of new AIDS cases diagnosed among women increased from none in 1982 to 24% of cases in 2003 and 21% of cases in 2004, according to the AP/Post. Heterosexual intercourse is the most common means of HIV transmission among women in Kentucky, the AP/Post reports. More than 400 women in the state are living with AIDS, and black women have an AIDS prevalence that is almost 19 times higher than white women. According to the AP/Post, black women are at an increased risk of HIV transmission because of higher rates of intravenous drug use or because they are more likely to have male partners who have been in prison, where HIV/AIDS prevalence rates are higher than among the general population. Black women also are more likely than white women to have low income levels or lack access to health care, meaning that they might wait longer to receive an HIV test, according to the AP/Post. Although some people have said that Kentucky has not conducted adequate HIV prevention efforts, state health officials have said that they are beginning to address the spread of HIV among women in the state. According to Vicki Johnson, an AIDS coordinator for the Kentucky Cabinet for Health and Family Services, the state has a budget of $1 million for HIV prevention efforts, but plans to develop a media campaign aimed at educating women about HIV/AIDS did not materialize. “We can do much better, and I think we’re going to be doing that in the near future,” Johnson said, adding, “Unfortunately, it’s going to come down to funding.” According to the AP/Post, state health officials plan to launch an initiative aimed to encourage black women to engage in healthy sexual relationships (AP/Kentucky Post, 12/4).

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

Officials in Papua New Guinea on Wednesday reported that a woman had been burnt alive at the stake after reportedly being accused of witchcraft, which often is linked to AIDS-related deaths in the country, AFP/Arab Times reports (AFP/Arab Times, 1/7). Papua New Guinea’s Post Courier reports that there was speculation the woman was practicing sorcery or adultery, or had transmitted HIV to one of the suspects (Muri, Post Courier, 1/7). According to AFP/Arab Times, reports in recent years of women being tortured and killed after being accused of witchcraft have been linked with increasing AIDS-related deaths in the country. Witchcraft often is cited as the cause of death among some young people that village residents “have seen as otherwise inexplicable,” AFP/Arab Times reports (AFP/Arab Times, 1/7).

Researchers with the Australian Center for Independent Studies in 2007 released a report that found that many women were being accused of practicing witchcraft to cause AIDS-related deaths among young people and, as a result, the women were tortured or murdered. The report estimated that there had been 500 such attacks in the previous year. According to a 2007 United Nations report, Papua New Guinea accounts for 90% of HIV cases in the Oceania region. High levels of sexual violence against women and inadequate access to sex education has contributed to the spread of the virus, according to the U.N. report. An estimated 60,000 people in the country were living with HIV in 2005 (Kaiser Daily HIV/AIDS Report, 7/25/07).

According to Reuters, women in Papua New Guinea’s Highlands often are blamed for spreading HIV, killed for having extramarital affairs and accused of practicing sorcery. Witnesses reported that the woman was between ages 16 and 20 (Perry, Reuters, 1/6).

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On the 20th anniversary of World AIDS Day on Dec. 1, advocates worldwide discussed numerous challenges facing HIV prevention efforts and called on governments to follow through on pledges to support HIV/AIDS care, prevention and treatment, AFP/Yahoo! News reports. The organizers of World AIDS Day 2008 — which focuses on the themes of leadership, self-responsibility and advocacy — said that many people in developing countries still lack access to affordable and effective HIV/AIDS treatment and that people who are resistant to first-line drugs require even more costly medications. “We have effective treatments,” Jean-Francois Delfraissy, head of the French National Research Agency on AIDS and Viral Hepatitis, said, adding, “We have no other choice than to offer [drugs] to all those who need them” (Courcol, AFP/Yahoo! News, 11/29).

In addition, the International AIDS Society ahead of World AIDS Day called on the Group of Eight industrialized nations to sustain its commitment to providing universal access to antiretroviral treatment by 2010. IAS said the G8 had pledged $22.2 billion for global HIV programs between 2008 and 2010, which is 36% of the UNAIDS-estimated $61 billion needed for HIV/AIDS efforts during this time period. According to AFP/Google, three million people had access to antiretrovirals by the end of 2007, but this number is still two-thirds short of the target of achieving universal access by 2010 (AFP/Google, 11/28).

UNAIDS Releases Report Ahead of World AIDS Day
In related news, UNAIDS on Friday released a report that offers perspectives on how and why current HIV transmissions are occurring. The report recommends that countries expand efforts to address HIV/AIDS by adopting flexible prevention policies that combine numerous approaches. The report also recommends targeting the highest-risk populations, such as injection drug users and men who have sex with men. Karen Stanecki, senior advisor for UNAIDS, said the “message” of the report “is that countries need to tailor their prevention programs to the epidemics in their own specific countries.” Stanecki added that UNAIDS recommends “a combination-prevention process” because “one prevention program isn’t going to do it all” (Bryant, VOA News, 11/28)

During a Friday press briefing on the report, Peter Piot, outgoing UNAIDS executive director, said an improved understanding about the history and current challenges of HIV/AIDS could “help prevent the next 1,000 infections in each community.” He added that it could “make money for [HIV/AIDS] work more effectively and help put forward a long-term and sustainable [HIV/AIDS] response.” Piot said there is “no single magic bullet for HIV prevention,” adding that health officials “can choose wisely from the known prevention options available so that they can reinforce and complement each other.” Paul De Lay — UNAIDS director of evidence, monitoring and policy — said that “combination prevention” strategies can include behavioral, biomedical and structural approaches to HIV/AIDS treatment. Behavioral approaches could include the promotion of condom use and discouragement of multiple sexual partners, and biomedical approaches could include male circumcision or antiretroviral treatment to prevent mother-to-child HIV transmission. “The epidemic is constantly changing,” De Lay said, adding that HIV incidence must be analyzed “at regular intervals” (AFP/Google, 11/28).

The report is available online (.pdf).

De Lay Urges Governments To Sustain HIV/AIDS Funding
Global HIV prevalence could increase if governments and international aid organizations reduce funding for HIV prevention programs because of the current economic situation, De Lay said. According to De Lay, governments must sustain funding levels or there could be a “resurgence” in HIV cases during the next four or five years, “and we won’t be able to scale up the treatment that is clearly going to be needed.” Although treatment programs currently reach almost four million HIV-positive people, 9.7 million people are still in need of antiretroviral medications, De Lay said.

According to De Lay, antiretroviral medication is becoming less expensive and easier to take. He added that integrase inhibitors — a new class of drugs that includes Merck’s antiretroviral Isentress — “will continue to improve patients’ response and make it easier and easier to take the drug regimens.” De Lay said that clinical trials for integrase inhibitors will examine how the drugs function in combination drug regimens and reduce the number of pills needed. The new drug regimens could be rolled in “probably about a year to two years,” De Lay said (Nebehay, Reuters, 11/28).

PEPFAR Meets Target of Treating 2M HIV-Positive People, Official Says
President Bush on Monday is expected to announce that the President’s Emergency Plan for AIDS Relief has met its target of treating two million HIV-positive people by the end of the year, White House spokesperson Dana Perino said in a statement, AFP/Google reports. According to Perino, PEPFAR by Sept. 30 had supported the provision of antiretrovirals for more than 2.1 million people living with HIV, including more than two million people in sub-Saharan Africa. She added that about 9.7 million HIV-positive people — including almost four million children — in the 15 countries targeted by PEPFAR had received “compassionate care” by that date. In addition, PEPFAR has helped prevent MTCT for almost 240,000 infants, Perino said.

Perino said that PEPFAR is “the largest commitment by any nation to combat a single disease,” adding that about 50,000 people in sub-Saharan Africa had access to antiretroviral medication before Bush launched PEPFAR in 2003. Bush in July 2008 signed legislation that reauthorized PEPFAR at $48 billion. According to AFP/Google, Bush and first lady Laura Bush on Monday plan to join the Rev. Rick Warren in a forum discussing the fight against HIV/AIDS AFP/Google, 11/30).

French First Lady Bruni-Sarkozy Named Global Fund Ambassador
French first lady Carla Bruni-Sarkozy on Monday will be named the first ambassador for the Global Fund To Fight AIDS, Tuberculosis and Malaria and said that she plans to use the position to promote awareness of MTCT. Bruni-Sarkozy, whose brother died of AIDS-related causes in 2006, said she is “very sensitive to the issue of [HIV/AIDS]” and plans to “put all of the media coverage” directed towards her “to the service of a useful cause.” She added that she will make herself “available to all those who are working on the ground” with the Global Fund and would like to “communicate directly” with women and children affected by the disease. Michel Kazatchkine, executive director of the Global Fund, said Bruni-Sarkozy will be a powerful “advocate” for preventing MTCT by raising awareness on the need for more programs and additional information for pregnant women (Landry, AFP/Tocqueville Connection, 11/30).

Some Experts Question Funding Levels for HIV/AIDS Programs
Some health experts are “growing more outspoken” in their argument that global efforts against HIV/AIDS have expended significant resources and funding while other health needs are not being met, the AP/Arizona Daily Star reports. Jeremy Shiffman, who studies health spending at Syracuse University, said HIV/AIDS is “a terrible humanitarian tragedy, but it’s just one of many terrible humanitarian tragedies.” Roger England of Health Systems Workshop said in an article published earlier this year that the “global HIV industry is too big and out of control,” adding that he believes UNAIDS should be disbanded. According to England, eliminating UNAIDS would allow $200 million to be spent on other health challenges, such as pneumonia. The Global Health Council reports that HIV/AIDS programs account for 80% of U.S. funding for health and population issues.

De Lay said that although it is valid to question health spending priorities, progress in treating HIV/AIDS is recent and the disease is not yet under control. “To suddenly pull the rug out from underneath” the fight against HIV/AIDS “would be disastrous,” De Lay said. In addition, many advocates argue that funding for HIV/AIDS helps strengthen health systems by providing basic services. Margaret Chan, director-general of the World Health Organization, said, “We cannot afford, in this time of crisis, to squander our investments” (Cheng, AP/Arizona Daily Star, 12/1).

Reports, Initiatives
The Kaiser Family Foundation on Wednesday announced several new media productions developed in coordination with partner organizations.
BET: As part of BET and the Kaiser Family Foundation’s Rap-It-Up partnership, BET will air a television show titled “Are You Positive?” confronting the stigma surrounding HIV/AIDS in the black community.

MTV: As part of MTV’s ongoing campaign with the Kaiser Family Foundation titled “It’s Your (Sex) Life,” MTV will dedicate all on-air promotion time between Nov. 24 and Dec. 1 to public service announcements promoting safer sex and HIV testing. MTV also will run “on-screen takeovers” on Dec. 1 during programming to refer viewers to additional IYSL resources. MTV on Dec. 1 also will air a documentary titled “The Diary of Kelly Rowland” describing the recent travels of singer Kelly Rowland to Kenya, South Africa, Tanzania and around the U.S. to meet with young people affected by HIV/AIDS.

Univision: Univision on Dec. 8 will devote a special episode of “The Cristina Show” to promoting awareness of the impact of HIV/AIDS on the Hispanic community. The program will feature Hispanics living with HIV and their families, many of whom are currently profiled in the campaign “Soy … (I am…)” launched this fall by Univision and the Kaiser Family Foundation.

Regional media partners of the Global Media AIDS Initiative — a project conceived and run by the Kaiser Family Foundation with support by the United Nations to mobilize media around the world in response to HIV/AIDS — also announced new programs in observance of World AIDS Day. Summaries appear below.

African Broadcast Media Partnership Against HIV/AIDS: ABMP will launch a new series of public service announcements under its “Imagine an HIV-Free Generation … It Begins With YOU” campaign, which uses soccer to promote healthy lifestyles and responsible choices.

Asia Broadcasting Union: In partnership with the Asia-Pacific Media AIDS Initiative, ABU will offer rights-free television programs on HIV/AIDS to broadcasters in the region.

Caribbean Broadcast Media Partnership on HIV/AIDS: CBMP’s public information campaign, “LIVE UP. Love. Protect. Respect,” will air a special World AIDS Day edition of the television magazine program (Kaiser Family Foundation release, 11/26).

In addition, several other HIV/AIDS organizations announced new initiatives. Summaries appear below.

AIDS Healthcare Foundation: AHF hosted a 24-hour marathon of no-cost, rapid HIV testing from Nov. 29 – Nov. 30 in Hollywood, Calif. The testing program is part of AHF’s “One Million Tests” campaign, which is a coalition of organizations collaborating to provide one million no-cost HIV tests in conjunction with World AIDS Day (AHF release, 11/27).

Global Fund: The Global Fund on Friday announced that programs supported by the fund helped provide treatment for two million HIV-positive people, an increase of 43% from the previous year (Global Fund release, 12/1).

Broadcast Coverage
NPR’s “Weekend Edition Sunday”: The program on Sunday examined HIV among children and teenagers. The segment includes comments from Khadijah Tribble, executive director of Pediatric AIDS/HIV Care in Washington, D.C., and an HIV-positive teenager and her grandmother (Chang, “Weekend Edition Sunday,” NPR, 11/30). Audio of the segment is available online.

CNN’s “International Correspondents”: The program on Friday examined the challenges faced by journalists who cover HIV/AIDS. The segment includes comments from Larry Altman, medical correspondent for the New York Times; Sarah Boseley, health editor for London’s Guardian; and photojournalist Gideon Mendel (Newton, “International Correspondents,” CNN, 11/28). Video of the segment is available online.
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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The Anniston Star on Wednesday examined an almost $1 million Department of Housing and Urban Development grant awarded to the Health Services Center in Hobson City, Ala., which is the area’s only HIV/AIDS clinic. The not-for-profit center has provided transitional housing for people living with HIV/AIDS and their families in 14 counties since 2005, and the $997,838 grant from the HUD’s Housing Opportunities for Persons with AIDS program will go toward purchasing permanent housing units and supporting the existing units already owned by the clinic, the Star reports. Rita Flegel, housing program coordinator for the center, said the clinic owns three units in nearby Oxford that will be used for permanent housing. She added that the center hopes to use the grant money to purchase two more units in Anniston and one in Gadsden for a total of six units. She said that housing “is health care” and is the “basis of everything. If you don’t have a place to sleep at night, it doesn’t really matter if you’re taking your medications or not.”

The clinic said it will also use the grant to continue funding its Permanent Housing Plus program, which helps clients pay short-term rent, mortgage and utility bills. Flegel said that the clinic has “many working clients who are struggling to pay for the typical housing costs and cost of daily living — just like so many people today.” She added that additional costs for HIV/AIDS medications and illness-related absences from work can cause them to “run into a financial crisis quickly.” Flegel said the grant “will help those people with a month of rent or a utility bill to help them get through the crisis.”

Prior to the new grant, the Health Services Center’s housing program was funded through a separate HUD grant, which helped 21 clinic clients receive funding for short-term transitional housing. The Star reports that 77% of the clients who left the transitional housing had moved into stable housing arrangements. Cindy Yarbrough, director of HUD’s Birmingham field office, said that the clinic was awarded the new grant based on this “impressive” success rate and its previous record of effectively using HUD grant money. She said the clinic “demonstrated a need … [and] a good program. Their past funding has been carried out wisely, and they’ve been good stewards of that funding.”

The Star reports that Health Services Center was one of nine national HIV/AIDS housing programs to receive HOPWA grants, which totaled almost $10 million and included programs in larger metropolitan areas such as Dallas, Chicago, Los Angeles and New York. Flegel said that Hobson City’s inclusion among the agencies awarded grants “shows that the need here is just as great.” She added that the issues the grant will address are “HIV and homelessness combined,” which will “provide a tremendous service not only for our clients but for the entire community.”

According to the Star, the housing provided by the clinic is connected to intensive support service centers, providing clients access to medical care and case management. Flegel said the main goal of the program is to help people living with HIV become financially independent. “We want to help them learn how to live on their own,” she said, adding that the grant “isn’t going to bring in the needy people. The needy people are already here” (Buckner, Anniston Star, 12/10).

An HUD press release about its recent grants is available online.

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

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Abbott Laboratories on Friday agreed to lower the price of its antiretroviral drug Kaletra in Brazil, and the Brazilian government dropped its threat to break the patent on the drug to begin producing a low-cost, generic version of the medication,… Reuters reports (Khalip, Reuters, 7/8). The agreement between Abbott and Brazil’s Ministry of Health will keep the government’s annual expenses on Kaletra at current levels for the next six years, even though the government expects to provide the drug to as many as three times the number of patients now receiving the drug under the country’s National STD/AIDS Programme (Abboud, Wall Street Journal, 7/11). However, Abbott said no per-capsule price of Kaletra is specified in the deal (Reuters, 7/8). The agreement also guarantees the Brazilian government access to a new version of Kaletra, called Meltrex, if the drug is approved by FDA (Benson, New York Times, 7/9). The Brazilian government last month announced that it would break Abbott’s patent on Kaletra unless the company lowered the drug’s price 42% to $1.17 per pill. Outgoing Brazilian Health Minister Humberto Costa on June 24 informed Abbott of the country’s ultimatum regarding Kaletra, saying that under the World Trade Organization’s intellectual property agreement, governments can approve the domestic production of generic versions of patented drugs during emergency public health situations if they fail to reach an agreement with the patent holder (Kaiser Daily HIV/AIDS Report, 7/8). The National STD/AIDS Programme provides antiretrovirals at no cost to all HIV-positive people in the country who need them. The program ignores all patents issued before 1997. The government over the past three years repeatedly has said it might break patents in order to negotiate price reductions with pharmaceutical companies (Kaiser Daily HIV/AIDS Report, 6/27).

Abbott, Brazilian Officials’ Comments
Abbott spokesperson Melissa Brotz said, “We’re pleased to have reached an agreement that expanded access to Kaletra for Brazilian patients and preserved our intellectual property rights, which Abbott was not willing to negotiate” (Reuters, 7/8). She added, “Throughout this process, we were mindful of the importance of the outcome of this issue, which has implications beyond our company and our industry for all innovators” (Japsen, Chicago Tribune, 7/9). Brazil’s health ministry in a statement said the price reduction will save the government $18 million in 2006 and up to $259 million over the next six years. The ministry said 23,400 HIV-positive people in the country are taking Kaletra but that about 60,000 could be taking the drug in six years. The ministry statement also said Abbott will start transferring technology to make the drug at the Brazilian laboratory FarManguinhos in 2009. However, Brotz said, “Abbott will not start transferring technology in 2009. We will begin the transfer prior to 2015, which is when the patent expires, but Brazil will not be able to manufacture the drug before the patent expires” (Reuters, 7/8).

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

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In many poor countries, mothers with HIV face a stark choice: to nurse their infants, and risk passing on HIV through their breast milk – or to formula feed, and deprive their infants of much of the natural immunity needed to protect against fatal diseases of early infancy. Now, two studies supported by the National Institutes of Health offer insights into preventing early death and HIV infection among breastfeeding infants of mothers with HIV in these countries.

The studies were published online in the New England Journal of Medicine and will appear in the publication’s print edition on July 10.

One study was supported in large part by NIH, with additional funding by the Centers for Disease Control and Prevention and the United States Agency for International Development. That study found no benefit for infants born to mothers with HIV from abrupt cessation of breastfeeding after the first four months of life. In addition, this study found no difference in HIV infection rates or in death rates by age 2 among infants abruptly weaned off all breast milk at four months versus those who breast fed until later in infancy. In fact, for one group of infants, those infected with HIV, abrupt cessation of breastfeeding resulted in an increased death rate.

The other study, co-sponsored by the NIH and the Centers for Disease Control and Prevention, found that it was possible to greatly reduce the risk of HIV infection in breast-feeding infants by treating them with an extended anti-HIV regimen. The treatment consisted of the anti HIV drug nevirapine, alone or in combination with the drug zidovudine, during the first 14 weeks of life.

“In poor countries where sanitation is a problem, exclusive breastfeeding appears to confer the greatest benefits to infant health and survival, even in mothers with HIV” said Duane Alexander, M.D., director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the NIH institute that provided much of the support for the two studies. “Extended treatment with nevirapine greatly reduces the chances that infants will be infected with HIV through breast milk. The National Institutes of Health is now sponsoring additional studies to determine the most effective treatments to prevent the spread of HIV through breast milk.”

In the developed world, mothers with HIV forego breastfeeding and formula feed their infants, said Lynne Mofenson, M.D., Chief of NICHD’s Pediatric, Adolescent and Maternal AIDS Branch, and the project officer for the two studies. But in many poor countries, there are barriers to formula feeding. Sanitation is lacking, and clean water to mix formula is often not available. Many families have difficulty affording infant formula. They also have difficulty providing enough wood or charcoal for cooking fires to boil water needed for formula.

Formula fed infants also miss out on protective antibodies – passed on through breast milk – needed to ward off the deadly infant diseases prevalent in many parts of the world. Formula feeding, also, may carry a social stigma for mothers. The practice is often seen as a tacit acknowledgement that a woman has HIV.

“Formula feeding is a hardship in many poor countries,” Dr. Mofenson said. “So the finding that it doesn’t confer any apparent benefits in resource poor settings – and may even be harmful – has important implications.”

The first of the two studies was conducted by Louise Kuhn, Mailman School of Public Health, Columbia University, New York, and colleagues from the Boston University School of Public Health, University of Zambia, and other institutions.

The study was conducted in Lusaka, Zambia. The researchers enrolled 958 women with HIV and their infants. The women consented to be randomly assigned to one of two groups. In the first, or intervention, group, 481 women were counseled to exclusively breastfeed their infants for four months, not offering any formula or other liquids. The women were advised to stop all breastfeeding when their infants were four months old. The women were also provided with formula and instructed in how to safely prepare it. In the second, or control, group, the women were advised to continue breastfeeding for as long as they chose to. Infants were tested for HIV at birth, and then periodically throughout the study, until they were 24 months of age.

In the intervention group, 69 percent of infants had stopped breastfeeding by 5 months of age. Children in the control group stopped breastfeeding at a range of ages, between 5 and 24 months of age. Only 7 percent of children in the control group had stopped breastfeeding by 5 months of age and 66 percent were still breastfeeding at 12 months of age.

The researchers found no significant differences in survival between the two groups. In the intervention group, 76.1 percent had survived to 24 months of age, versus 75.4 percent in the control group. Among infants who were still breastfeeding and uninfected at 4 months, there was also no significant difference in HIV-free survival by 24 months (83.9 percent in the intervention group, versus 80.7 percent in the control group.)

Breastfeeding appeared to improve survival among infants who were infected with HIV. Children in the intervention group who were infected with HIV at or before 4 months of age and still alive at 4 months of age had higher death rates by 24 months than did their counterparts in the control group (73.6 percent versus 54.8 percent). Causes of death were predominantly diarrheal and respiratory diseases, but also included malaria, malnutrition, measles, and injury.

The researchers were surprised to find that the proportion of new HIV infections between 4 and 24 months were not significantly different between the two groups despite differences in the time breastfeeding was stopped: 6.2 percent in the intervention group and 8.8 percent in controls. The researchers theorized that the chances of transmitting the virus may increase as a result of the weaning process. The breast swelling and infection (mastitis) that occurs when breastfeeding is sharply reduced may increase the likelihood that the virus will be transmitted in the few feedings that remain.

The second study, conducted in Blantyre, Malawi, was led by Taha E. Taha, of The Johns Hopkins University and Newton Kumwenda, of the University of Malawi College of Medicine. Among the study’s other authors were Dr. Michael Thigpen, of the CDC, and Dr. Mofenson. In a study of 3,016 infants who did not have HIV at birth, the researchers compared two extended regimens of nevirapine (NVP) to the country’s standard treatment: a single dose of NVP given to the mother during labor and to the infant at birth, with daily doses of zidovudine (ZDV) given to the infant during the first week of life.

The infants were assigned at random to one of three groups. The control group received the standard treatment. The next group (the extended NVP group) received the standard treatment plus NVP from day 8 through the 14th week of life. The final group (the extended NVP+ZDV group) received the standard treatment plus NVP and ZDV from day 8 through 14 weeks.

When they were 9 months old, 10.6 percent of infants in the standard treatment group had acquired HIV. By comparison, 5.2 percent in the extended NVP group were infected and 6.4 percent in the extended NVP+ZDV group were infected, corresponding to a 51 percent and 40 percent decrease in HIV infection, respectively. The difference in HIV infection between the two extended treatment groups was not statistically significant.

Infants in the NVP+ZDV group were more likely than infants in the other groups to experience neutropenia, a deficiency of a certain type of an infection-fighting cell. People with neutropenia may be more susceptible to infection.

The study authors concluded that providing anti-HIV drugs to breastfeeding infants is a practical and effective way to reduce HIV infection. They noted that additional studies are needed to determine whether it was safe to provide anti-HIV drugs to infants for the duration of breastfeeding.

Dr. Mofenson said that one NIH-supported study, now in progress, was investigating whether anti HIV drugs could be safely given to breastfeeding infants for the first six months of life. Another NIH effort, now in the planning phase, will compare the effectiveness of infant nevirapine given to breastfeeding infants for the entire duration of breastfeeding, to the effectiveness of providing combination anti-HIV therapy to breastfeeding mothers.

###

The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute’s Web site at nichd.nih/.

The National Institutes of Health (NIH) – The Nation’s Medical Research Agency – includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih/.

Source: Robert Bock or Marianne Glass Miller

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A vascular surgical technique pioneered at UT Southwestern Medical Center and designed to replace infected aortic grafts with the body’s own veins has proved more durable and less prone to new infection than similar procedures using synthetic and cadaver grafts.

Aortic graft infections are one of the most serious complications in patients undergoing aortic grafting procedures for peripheral arterial disease (PAD) and aortic aneurysms. PAD reduces blood circulation in the pelvis and lower extremities, and aortic aneurysms result in a weakening of the aortic wall that can cause lethal rupture of the aorta, the largest artery in the body. Patients with PAD and aortic aneurysms often require surgery, and aortic grafting procedures using synthetic grafts are typically the first line of treatment.

For patients with PAD, the procedure restores blood circulation to the legs, and for patients with aneurysm, it replaces the weakened aortic wall and prevents rupture. Synthetic grafts made of Dacron, a polyester material, are placed in the aorta and femoral arteries in the abdomen and groin, which feed blood to the legs. But in about 1 percent to 2 percent of these patients, the grafts become infected a complication that causes amputation and death if left untreated.

Dr. G. Patrick Clagett, chief of vascular surgery at UT Southwestern, pioneered a technique called the neo-aortoiliac system (NAIS) that repairs these aortic-graft infections. The procedure involves removing the infected graft and replacing it with sections of femoral-popliteal veins harvested from the patient’s thighs, rather than another synthetic graft or vessels harvested from human cadavers.

In a recent study published in the Journal of Vascular Surgery, Dr. Clagett and his team reported on 187 patients at UT Southwestern treated for aortic graft infections who underwent the NAIS procedure from 1990 to 2006. It is the largest group of such patients ever studied, and the researchers found that the incidence of re-infection was lower and the procedure resulted in superior durability with much lower long-term amputation rates when compared with other operations to treat this condition.

“This operation has gained favor worldwide in the treatment of this devastating condition,” said Dr. Clagett. “Since performing the first operation here in the 1990s, we have accumulated data over the years and have found this procedure to be far superior in overall patient outcomes.”

Simply replacing the old Dacron graft with a new synthetic graft can result in devastating infection of the new one, said Dr. Clagett, who is immediate past president of the Society for Vascular Surgery. His team and others also have found that the new synthetic or cadaver grafts tend to develop clots and new blockages.

“When we use the patient’s own tissue to construct a new graft, it provides an advantage because they are less likely to form clots within the graft and less likely to develop new blockages,” Dr. Clagett said. “Patients also need fewer subsequent procedures, a common problem with the other treatments for this complication.”

He added that patients who have the NAIS procedure don’t need to be on lifelong antibiotic therapy. Because the aortic reconstruction is fashioned with the patient’s own tissue, there is no foreign material that is prone to re-infection.

Other UT Southwestern researchers who contributed to the study included Dr. J. Gregory Modrall, associate professor of surgery; Dr. R. James Valentine, professor of surgery; and Jennie Hocking, assistant professor of physician assistant studies. Dr. Ahsan Ali, a former vascular surgery fellow at UT Southwestern now at the University of Arkansas, was the lead author of the study.

Source: UT Southwestern Medical Center Continue reading →

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that it has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Prevnar 13(TM), Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM(197) Protein). Last year, the FDA granted Prevnar 13 Fast Track designation, which is designed to facilitate review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.

Prevnar 13 is designed to protect against the 13 most prevalent serotypes associated with pneumococcal disease (PD), the leading cause of vaccine-preventable death worldwide. Seven of these serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevnar(R), Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM(197) Protein) – the current global standard in PD prevention in infants and young children. The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are associated with the greatest remaining burden of invasive disease. Both Prevnar 13 and Prevnar use CRM(197) – an immunological carrier protein with a 20-year history of use in pediatric vaccines.

“We are pleased that, with this milestone, we are now one step closer to bringing Prevnar 13 to infants and children,” says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. “Prevnar, our currently available vaccine, has both proven clinical efficacy and documented effectiveness, which has resulted in a significant public health impact. Prevnar 13 builds on the scientific foundation of Prevnar and, if approved, will provide coverage for the 13 most prevalent pneumococcal serotypes associated with pneumococcal disease, including serotype 19A, which has emerged as a serious public health threat in the United States and around the world.”

The Prevnar 13 submission to the FDA includes data from 13 Phase 3 studies, involving more than 7,000 infants and young children. The Company initiated its global pediatric filings in late 2008 and, to date, has submitted regulatory applications for the 13-valent candidate vaccine in more than 40 countries worldwide. Prevnar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.

Pneumococcal Disease

Pneumococcal disease is complex and describes a group of illnesses, all of which are caused by the bacterium Streptococcus pneumoniae. PD affects both children and adults and includes invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media (middle ear infection).

Following the inclusion of Prevnar into the routine pediatric immunization schedule in the United States, there has been a 98 percent (95% CI: 97%-99%) reduction in vaccine-type IPD and a 77 percent reduction in all IPD among children younger than 5 years of age through 2005, compared with a pre-licensure baseline. In addition, the incidence of disease caused by the seven conjugate vaccine serotypes declined 55 percent (95% CI: 51%-58%) among adults 50 years of age or older, an unvaccinated group. The Centers for Disease Control and Prevention has reported an increase in the incidence of IPD due to non-vaccine serotypes in children younger than 5 years of age and in adults 40 years of age and older; it is unknown whether these effects would be observed in other populations.

Most recently, serotype 19A, which is included in the candidate vaccine, has been increasing in prevalence in many regions of the world and is frequently resistant to antibiotics. In fact, serotype 19A has emerged as the predominant invasive pneumococcal serotype in the United States.

Indication

Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM(197) Protein) is indicated for active immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine. The seven serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) are the strains that most commonly caused these serious diseases in children prior to the introduction of Prevnar. The routine vaccination schedule is 2, 4, 6, and 12 to 15 months of age.

Prevnar is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes included in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.

As with any vaccine, Prevnar may not protect all individuals receiving the vaccine from serious invasive disease cause by S. pneumoniae. This vaccine should not be used for treatment of active infection.

Important Safety Information for Prevnar

In clinical trials, the most frequently reported adverse events included injection site reactions, fever (greater than or equal to 38 degrees Celsius /100.4 degrees Fahrenheit), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.

Risks are associated with all vaccines, including Prevnar. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar does not protect 100% of children vaccinated. Immunization with Prevnar does not substitute routine diphtheria immunization.

About Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, clinical trial data are subject to differing interpretations, and the views of regulatory agencies, medical and scientific experts and others may differ from ours. There can be no assurance that our regulatory submissions for Prevnar 13 will be accepted for review by regulatory agencies or that Prevnar 13 will ever receive regulatory approval or be successfully developed and commercialized. Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by forward-looking statements include, among others, risks related to our proposed merger with Pfizer, including satisfaction of the conditions of the proposed merger on the proposed timeframe or at all, contractual restrictions on the conduct of our business included in the merger agreement, and the potential for loss of key personnel, disruption in key business activities or any impact on our relationships with third parties as a result of the announcement of the proposed merger; the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; the outcome of government investigations; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; global economic conditions; interest and currency exchange rate fluctuations and volatility in the credit and financial markets; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption “Item 1A, Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission on February 27, 2009. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Wyeth Pharmaceuticals
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View drug information on Prevnar 13. Continue reading →

HIV/AIDS prevalence rates in South Africa continue to increase and could reduce the life expectancy of South Africans from age 63 to 46, University of KwaZulu-Natal researcher Alan Whiteside said at an AIDS conference in Johannesburg, South Africa on Thursday, Xinhuanet reports. Whiteside reported that there are nearly 6.3 million South Africans living with HIV/AIDS and “most of them [do] not know it,” according to Xinhuanet. He warned that in the next two decades the impact of the virus will peak when more children become orphans as a result of the virus. He also said the effect will be felt within the country’s government, as well as throughout communities, municipalities, work places and schools. “Impact on the demographic structure is going to be greatest,” Whiteside said, adding, “The population is going to be smaller and the structure is going to be different.” Acting Gauteng province Premier Gwen Ramokgopa said that while the virus is not spreading as quickly as it was previously, prevalence rates were still increasing (Xinhuanet, 10/6).

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