May 9, 2012

HIV–HBV Coinfection — A Global Challenge

Perspective

Athena P. Kourtis, M.D., Ph.D., M.P.H., Marc Bulterys, M.D., Ph.D., Dale J. Hu, M.D., M.P.H., and Denise J. Jamieson, M.D., M.P.H.

N Engl J Med 2012; 366:1749-1752 May 10, 2012

Human immunodeficiency virus type 1 (HIV-1) and hepatitis B virus (HBV) exact a high toll worldwide. Both can lead to chronic disease, cancer, and death, and neither can be eradicated with the use of current therapies. Antiviral drug resistance often develops after patients have received treatment for some time and is usually followed by the loss of clinical benefit. Coinfection with the two viruses exacerbates the negative effects.

Worldwide, HBV is the leading cause of chronic liver disease and a leading cause of death, accounting for up to half of all cases of cirrhosis and hepatocellular carcinoma.1 An estimated 400 million people are infected with HBV,1 with the majority of cases occurring in regions of Asia and Africa where the virus is endemic. There, up to 70% of adults show serologic evidence of current or prior infection, and 8 to 15% have chronic HBV infection.1

These staggering infection rates largely reflect a failure of maternal and child health programs. The majority of HBV infections in settings where the virus is highly endemic occur through perinatal transmission (predominant in East and Southeast Asia) or in young children, transmitted through close household contact or through medical or traditional scarification procedures (predominant in Africa).1 Perinatal HBV infection is associated with a 90% risk of chronic hepatitis B, as compared with a risk of less than 5% among adults with intact immunity.1 The risk of perinatal transmission is lower in Africa than in Asia, a disparity that could be due to a lower prevalence of hepatitis B e antigen (HBeAg) and other differences in the pathogenic characteristics of circulating HBV genotypes.1

According to the Joint United Nations Program on HIV/AIDS (UNAIDS), about 33 million people are infected with HIV worldwide, and the majority of them live in Asia and Africa. Approximately 10% of the HIV-infected population has concurrent chronic hepatitis B,2 with coinfection more common in areas of high prevalence for both viruses. In countries where the viruses are highly endemic, the rate can be as high as 25%.2

In areas where HBV is less endemic (North America, Europe, and Australia), HBV and HIV are most often acquired during adolescence or adulthood through sexual transmission or injection-drug use. The prevalence of HIV–HBV coinfection in these regions is generally less than 10% of the HIV-infected population.2 However, up to half of injection-drug users infected with HIV are coinfected with HBV. Worldwide, there may be 3 to 6 million HIV-infected people living with chronic HBV (see maps).

HIV–HBV coinfection increases the morbidity and mortality beyond those caused by either infection alone. People coinfected with HIV have higher levels of hepatitis B viremia, have progression to chronic hepatitis B that is approximately five times as fast as that among people infected with only HBV, and have a higher risk of cirrhosis and hepatocellular carcinoma.1 HIV immunosuppression can even cause the loss of hepatitis B surface antibodies and reactivation to chronic hepatitis B.1 As compared with healthy, uninfected persons, those infected with HIV — particularly the most immunocompromised — mount poorer antibody responses to HBV vaccination. Managing hepatitis B in HIV-coinfected patients is further complicated by the dual activity of several nucleoside analogues, the emergence of resistant HIV or HBV strains, the limitations of and decreased response to interferons, and the more rapid development of lamivudine-resistant HBV.2

Very few studies have addressed coinfection with HBV among HIV-infected pregnant women. Studies in Africa indicate that they are three times as likely as HIV-negative pregnant women to test positive for HBV DNA and twice as likely to test positive for HBeAg. Both higher HBV DNA levels and HBeAg expression are associated with an increased risk of an HIV-infected pregnant woman's transmitting HBV to her child.1

Vaccination of infants against hepatitis B is highly protective, reducing the risk of infection by more than 70% (the addition of hepatitis B immune globulin reduces the remaining risk by half. However, many countries with a high prevalence of HBV lack universal or timely vaccination coverage, and hepatitis B immune globulin is often unavailable or prohibitively expensive. In 2006, for example, the coverage rate for the vaccine dose at birth was only 36% in countries where the prevalence of chronic HBV infection exceeded 8%.

Even with appropriate vaccination, 5 to 15% of infants born to mothers who test positive for hepatitis B surface antigen (HBsAg) become infected. The proportion is much higher among infants whose mothers have high serum HBV DNA levels; transmission rates of 39% or higher have been noted.3 High HBV DNA levels are often seen in women with concurrent HIV infection, particularly in Southeast Asia, where HBV is highly endemic and perinatal transmission of HBV is already common.

Additional approaches are needed to protect children of infected mothers. For example, the use of antiviral therapy in pregnant women with high HBV loads has been examined in a few small studies and has shown promise in decreasing perinatal transmission3; this strategy appears to be cost-effective and should be explored further.4 Women coinfected with HIV would be good candidates for this preventive approach.

Even in areas with historically low rates of HBV, challenges exist. In the United States, the number of HBV-infected pregnant women is probably underestimated, with current methods relying on the expectation that certain ethnic groups are at high risk. In Europe, there is no consistent policy of testing women for HBV infection during pregnancy; some countries rely on assessment of “risk factors” alone. Immigration patterns in Europe and North America suggest that HBV prevalence will vary by region.

There are a number of unanswered questions about disease pathogenesis in coinfected persons and the management of HIV–HBV coinfection, especially in pregnant women. Pregnancy itself can trigger elevations of liver enzymes. The administration, during pregnancy, of antiretroviral prophylaxis containing one agent with anti-HBV activity may be associated with later development of HBV resistance. For pregnant women who, to prevent perinatal HIV transmission, take antiretroviral prophylaxis containing one or two agents with anti-HBV activity, the safety of stopping treatment after delivery is unknown. The administration of antiretrovirals without HBV activity in coinfected pregnant women may leave their infants unprotected against HBV. Finally, infection of the infant with HIV threatens the benefits of HBV immunization for perinatal prevention.

What will it take to address this crisis? First, we must acknowledge that HBV–HIV coinfection represents a major global public health threat. Because each virus affects the other's natural history and response to therapy, HIV–HBV coinfection requires dedicated research. A willingness to rapidly implement new scientific evidence is critical. Preventing transmission of both viruses to the next generation should be a priority for health policymakers.

Ideally, all pregnant women should receive early prenatal care with voluntary HIV and HBV testing to permit timely interventions aimed at preventing perinatal transmission.5 Use of antiretroviral agents with dual antiviral activity is a promising preventive approach — one limited, however, by a paucity of data on important agents (e.g., tenofovir) regarding safety during pregnancy, for both the fetus and the mother. As regimens including tenofovir become first-line therapy for many HIV-infected people (and are used as preexposure prophylaxis for the uninfected), determining the safety of these medications during pregnancy becomes a critical research need. Evaluating the HBV viral load in HIV-infected pregnant women should be an essential step of prenatal evaluation, so that the mother's health can be managed appropriately.

Continued improvements in the coverage and timeliness of HBV vaccination and the education of clinicians about its importance should be priorities everywhere. Making such improvements will require substantial advocacy and political and financial commitment. Now is the time to provide the best care we can for coinfected people and to protect a future generation of children from the largely hidden epidemic of HBV-related liver disease, which is being further fueled by the HIV epidemic.

The opinions expressed in this article are those of the authors and do not necessarily reflect the position of the Centers for Disease Control and Prevention.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Source Information

From the Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion (A.P.K., D.J.J.), the Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (D.J.H.), and the Division of Global HIV/AIDS, Center for Global Health (M.B.), Centers for Disease Control and Prevention, Atlanta; and the CDC Global AIDS Program, Beijing, China (M.B.).

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U.S. may speed approval of "breakthrough" drugs

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Pills are seen on the production line of a pharmaceutical company in a file photo.

Credit: Reuters/Jacky Naegelen

By Anna Yukhananov

WASHINGTON | Wed May 9, 2012 2:26pm EDT

WASHINGTON (Reuters) - Experimental drugs that show a big effect early in development for treating serious or life-threatening diseases would get a faster and cheaper path to U.S. approval, under a proposal likely to become law this year.

U.S. drug regulators would be able to label such treatments "breakthrough" therapies, and work with companies to speed up clinical trials, for example by testing the drugs for a shorter time or enrolling fewer patients.

The U.S. Food and Drug Administration has said it supports the proposal, which is included in both versions of an FDA "must-pass" funding bill currently working its way through Congress and set to be passed by the end of the summer.

The plan fits with President Barack Obama's aim to foster innovation as a means of spurring job creation, and may pacify some critics who say the FDA lags European countries in approving new medicines or medical devices.

Dr. Janet Woodcock, head of the FDA's drugs center, has said the FDA needs more flexibility to bypass "business as usual" when it sees unexpected effects, or when a new medicine can greatly help patients.

"What happens when you have a breakthrough drug that shows an effect that's never been seen before?" she told reporters in March, discussing the proposal.

"If we'd done business as usual during the AIDS epidemic, we would have never controlled that epidemic," Woodcock said.

During a spike in new cases of AIDS in the early 1990s, the FDA created an "accelerated approval" process to get new AIDS drugs to the market more quickly by allowing companies to show indirect measures of how the drug helped people.

Jeff Allen, executive director of Friends of Cancer Research, said the time was right for another avenue to speed innovative treatments to patients.

Allen said new understanding of human biology and of diseases meant companies could create more effective drugs, but with fewer side effects, because they would be more targeted to specific patients or disease types.

He said a good example was Roche Holding AG's skin cancer drug Zelboraf, approved last year; people taking the pill were 63 percent less likely to die from melanoma than people on standard chemotherapy.

There was also Pfizer Inc's targeted lung cancer drug Xalkori, which could shrink or eliminate tumors in 10 to 12 months for people with a specific genetic mutation.

"The most promising drugs show an effect early," Allen said. "(But) there's a mentality among drug developers or FDA reviewers that you have to go through this multi-step approach" to get a drug to market.

"We're hoping to encourage getting away from that," he said.

Allen said the FDA would retain its power to require companies to do post-approval studies, or withdraw drugs from the market if initial evidence of benefit was not shown in follow-up trials.

(Reporting by Anna Yukhananov)

Source

Four Bad Actors Cause Most Infection-Related Cancer

From Medscape Medical News > Oncology

Nick Mulcahy

May 8, 2012 — Three types of viruses and 1 bacterium cause the vast majority of the new cases of cancer worldwide that are attributable to infections, according to a new study of global data.

The study found that in 2008 there were 12.7 million new cases of cancer worldwide, including 2 million that were related to infections. Helicobacter pylori, hepatitis B and C viruses (HBV and HCV), and human papillomaviruses (HPV) were responsible for 1.9 million of those infection-related cases.

Most of these new cases were gastric, liver, and cervix uteri cancers, according to study authors, who are from the International Agency for Research on Cancer in Lyon, France.

Their study is published online in the May 8 issue of LancetOncology.

The study authors, led by Catherine de Martel, MD, PhD, point out that the situation is largely remediable.

"Application of existing public-health methods for infection prevention, such as vaccination, safer injection practice, [and] antimicrobial treatments, could have a substantial effect on future burden of cancer worldwide," they write, referring to prevention measures for HBV and strains of HPV, HCV, and H pylori, respectively.

An expert not involved with the study emphasized the value of vaccination.

"Since effective and relatively low-cost vaccines for HPV and HBV are available, increasing vaccine coverage should be a priority for health systems in high-burden countries," writes Goodarz Danaei, MD, ScD, in an accompanying comment. He is from the Harvard School of Public Health in Boston, Massachusetts.

However, neither the study authors nor Dr. Danaei say where the funds will come from for this important prevention work.

The study indicates that less developed countries were 3 times as likely as more developed countries to have infection-related cancers.

The authors report that, in 2008, 1 in 6 (16%) new cases of cancer were related to infection. "This fraction was higher in less-developed countries (22.9%) than in more-developed countries (7.4%), and varied from 3.3% in Australia and New Zealand to 32.7% in sub-Saharan Africa," they note.

Dr. Danaei put the problem of infection-related cancers into a larger epidemiologic context.

"The estimated attributable fraction for all infections combined was 16.1% — by comparison, in 2004 WHO estimated the attributable fraction for the combined effect of 9 lifestyle and environmental risk factors as 35%," he writes, referring to smoking, drinking alcohol, excess weight, and other factors.

The authors report that cervical cancer accounted for about 50% of the infection-related burden of cancer in women, and liver and gastric cancers accounted for about 80% of the burden in men.

Cancers and Infections

de Martel and her colleagues did a systemic analysis to estimate the proportion of cancers that could be tied to infection globally and in 8 regions by calculating the population-attributable fractions. This refers to the proportion of new cancer cases in a population that could have been prevented by an intervention on a specific exposure.

They used data from a number of sources, including GLOBOCAN statistics on incidence estimates for 27 cancers in 184 countries.

Cancers and Their Associated Infectious Agents Covered in the Study

Cancer Associated Infectious Agents
Stomach H pylori
Liver HBV, HCV, Opisthorchis viverrini, Clonorchis sinensis
Cervix uteri HPV with or without HIV
Anogenital (penile, vulva, vagina, anus) HPV with or without HIV
Nasopharynx Epstein-Barr virus (EBV)
Oropharynx HPV with or without tobacco or alcohol use
Kaposi's sarcoma Human herpes virus type 8 with or without HIV
Non-Hodgkin's lymphoma H pylori, EBV with or without HIV, HCV, human T-cell lymphotropic virus type 1
Hodgkin's lymphoma EBV with or without HIV
Bladder Schistosoma haematobium

HIV was not listed as primary infectious agent because it causes cancer through immunosuppression, and is thus is considered a cofactor.

The study was supported by funding from the Fondation Innovations en Infectiologie and the Bill & Melinda Gates Foundation.

Lancet Oncol. Published online May 8, 2012. Abstract, Comment

Source

From Morbidity & Mortality Weekly Report

45 States, 2008-2010

Laura Kann, PhD; Nancy Brener, PhD; Timothy McManus, MS; Howell Wechsler, EdD

Posted: 05/09/2012; Morbidity & Mortality Weekly Report. 2012;61(13):222-228. © 2012 Centers for Disease Control and Prevention (CDC)

Abstract and Introduction
Introduction

In the United States, 46% of high school students have had sexual intercourse and potentially are at risk for human immunodeficiency virus (HIV) infection, other sexually transmitted diseases (STDs), and pregnancy.[1] The National HIV/AIDS Strategy for the United States recommends educating young persons about HIV before they begin engaging in behaviors that place them at risk for HIV infection.[2] The Community Preventive Services Task Force (CPSTF) also recommends risk reduction interventions to prevent HIV, other STDs, and pregnancy among adolescents.[3] To estimate changes in the percentage of secondary schools that teach specific HIV, other STD, and pregnancy risk reduction topics, a key intervention consistent with those supported by the National HIV/AIDS Strategy and CPSTF,[2,3] CDC analyzed 2008 and 2010 School Health Profiles data for public secondary schools in 45 states. This report summarizes the results of those analyses, which indicated that in 2010, compared with 2008, the percentage of secondary schools teaching 11 topics on HIV, other STD, and pregnancy prevention in a required course in grades 6, 7, or 8 was significantly lower in 11 states and significantly higher in none; the percentage of secondary schools teaching eight topics in a required course in grades 9, 10, 11, or 12 was significantly lower in one state and significantly higher in two states; and the percentage of secondary schools teaching three condom-related topics in a required course in grades 9, 10, 11, or 12 was significantly lower in eight states and significantly higher in three states. Secondary schools can increase efforts to teach all age-appropriate HIV, other STD, and pregnancy prevention topics to help reduce risk behaviors among students.

School Health Profiles surveys have been conducted biennially since 1996 to assess school health practices in the United States.* States, territories, large urban school districts, and tribal governments participate in the surveys, either selecting systematic, equal-probability samples of their secondary schools (middle schools, junior high schools, and high schools with one or more of grades 6–12), or selecting all public secondary schools within their jurisdiction.§ Self-administered questionnaires are sent to the principal and lead health education teacher at each selected school and returned to the agency conducting the survey. Lead health education teachers are asked questions regarding the content of required instruction related to HIV, other STD, and pregnancy prevention. Data are included in this report only if the state provided appropriate documentation of methods and had a school response rate ≥70% for both the 2008 and 2010 surveys. Across states included in this report, school response rates ranged from 70% to 93% (median: 73%) in 2008 and from 70% to 86% (median: 73%) in 2010. The number of lead health education teachers who participated, by state, ranged from 71 to 472 (median: 245) in 2008 and from 65 to 677 (median: 249) in 2010. Participation in School Health Profiles is confidential and voluntary. Follow-up telephone calls, e-mails, and written reminders are used to encourage participation. For states that use a sample-based method, results are weighted to reflect the likelihood of schools being selected and to adjust for differing patterns of nonresponse. For states that conduct a census, results are weighted to adjust for differing patterns of nonresponse.

This report includes data from 45 states that provided weighted School Health Profiles data in 2008 and 2010.** For each of these states, three composite measures were created to determine the percentage of schools that taught 1) all 11 topics listed in the questionnaire in a required course in grades 6, 7, or 8; 2) all eight topics listed in the questionnaire in a required course in grades 9, 10, 11, or 12; and 3) all three condom-related topics listed in the questionnaire in a required course in grades 9, 10, 11, or 12. These topics reflect the knowledge and skills that are the focus of interventions shown to be effective in reducing risk that CPSTF and others use as a basis for their recommendations about interventions for adolescents.[3–6] For each state, the percentages of schools that taught individual topics and the composite measurements are reported. Significant (p<0.05) differences between results from 2008 and 2010 were determined by t-test. Statistical software was used to account for the sample design and unequal weights.

Compared with 2008, the percentage of schools in 2010 in which all 11 topics were taught in a required course in grades 6–8 was significantly lower in 11 states and significantly higher in no state (Table 1). The percentage of schools in which all eight topics were taught in a required course in grades 9–12 was significantly lower in one state and significantly higher in two states (Table 2). Additionally, the percentage of schools in which all three condom-related topics were taught in a required course in grades 9–12 was significantly lower in eight states and significantly higher in three states (Table 3). Among the 45 states in 2010, the percentage of schools that taught all 11 topics in grades 6, 7, or 8 ranged from 12.6% (Arizona) to 66.3% (New York) (median: 43.3%), the percentage of schools that taught all eight topics in grades 9–12 ranged from 45.3% (Alaska) to 96.4% (New Jersey) (median: 80.3%), and the percentage of schools that taught all three condom-related topics in grades 9–12 ranged from 11.3% (Utah) to 93.1% (Delaware) (median: 58.1%).

For five of the 11 topics (Table 1), the percentage of schools teaching the topic in a required course in grades 6–8 increased significantly in no state, and for the remaining six topics, the percentage increased significantly in one state. Conversely, the percentage of schools teaching any one topic decreased significantly in one to 10 states. The percentage of schools teaching how HIV and other STDs are diagnosed and treated decreased significantly in 10 states, as did the percentage teaching health consequences of HIV, other STDs, and pregnancy. The percentage of schools teaching how to prevent HIV, other STDs, and pregnancy decreased significantly in nine states.

For five of the eight topics (Table 2), the percentage of schools teaching the topic in a required course in grades 9–12 increased significantly in no state; for two topics, the percentage increased significantly in one state; and for the remaining two topics, the percentage increased significantly in two states. Conversely, the percentage of schools teaching any one topic decreased significantly in one to four states. The relationship among HIV, other STDs, and pregnancy was the one topic that showed significant decreases in the percentage of schools teaching it in four states. No state showed a significant increase, and one to seven states showed a significant decrease in the percentage of schools teaching any of the three condom-related topics in any of grades 9–12 (Table 3). The percentage of schools teaching how to obtain condoms decreased significantly in seven states.

* Additional information and questionnaires are available at http://www.cdc.gov/healthyyouth/profiles.
Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Florida, Indiana, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, and Wisconsin.
§ Delaware, Hawaii, Idaho, Maine, Massachusetts, Montana, Nevada, New Hampshire, Rhode Island, South Carolina, Utah, Vermont, and Wyoming.
In 2008, lead health education teachers were asked, "During this school year, did teachers in this school teach each of the following HIV, STD, or pregnancy prevention topics in a required course for students in any of grades 6, 7, or 8?" for a list of 11 topics (Table 1) (e.g., how HIV and other STDs are diagnosed and treated; how to prevent HIV, other STDs, and pregnancy; and the benefits of being sexually abstinent). Respondents were instructed to mark "yes" or "no" for each topic or "not applicable" if their school did not include grades 6, 7, or 8. Teachers also were asked the same question for grades 9–12 for a list of eight topics (Table 2) that repeated some of the 11 topics and added others (e.g., the relationship between alcohol and other drug use and risk for HIV, other STDs, and pregnancy), and three condom-related topics (Table 3). In 2010, lead health education teachers were asked, "During this school year, did teachers in your school teach each of the following HIV, STD, or pregnancy prevention topics in a required course for students in each of the grade spans below?" The topics, grade spans, and possible responses were the same as those specified in 2008.
** Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.

Editorial Note

CPSTF recommends group-based comprehensive risk reduction interventions delivered to adolescents, in schools or communities, to promote behaviors that prevent or reduce the risk for HIV, other STDs, and pregnancy. This recommendation is based on evidence of effectiveness in reducing engagement in any sexual activity, frequency of sexual activity, number of partners, and frequency of unprotected sexual activity, and in increasing the self-reported use of protection against STDs and pregnancy.[3]

Although a median of 90% of all public secondary schools across the 45 states in this report taught HIV prevention in a required course during 2010,[7] the findings indicate that little progress was made in increasing the number of specific topics covered as part of HIV, other STD, and pregnancy prevention education during 2008–2010. The percentage of secondary schools that taught all HIV, other STD, and pregnancy prevention topics in a required course also varied widely across states. Further research is needed to understand determinants of the number of specific HIV, other STD, and pregnancy prevention topics taught in secondary schools.

HIV, other STD, and pregnancy prevention education in grades 6–8 is particularly important because most students in those grades are not yet sexually active.[1,2] HIV, other STD, and pregnancy prevention education that is taught before most young persons engage in risk behaviors, and that includes information on the benefits of abstinence and delaying or limiting sexual activity, can prevent behaviors that might lead to HIV infection, other STDs, and pregnancy.[2]

Because many students become sexually active during high school,[1] HIV, other STD, and pregnancy prevention education in these grades also is critically important.[2] HIV, other STD, and pregnancy prevention education that includes information on condom efficacy, the importance of using condoms consistently and correctly, and how to obtain condoms taught to those who might decide to be or are sexually active also can prevent behaviors that might lead to HIV infection, other STDs, and pregnancy.[4–6]

HIV prevention education also can address misconceptions about how HIV is transmitted.[2] A 2011 public opinion poll indicated that 20% of persons aged 18–29 years believe incorrectly that a person can become infected with HIV by sharing a drinking glass, or are unsure whether the statement is true or false.[8]

The findings in this report are subject to at least three limitations. First, these data apply only to public secondary schools and, therefore, do not reflect practices at private schools or elementary schools. Second, these data were self-reported by lead health education teachers or their designees, and the accuracy of their description of the HIV, other STD, and pregnancy prevention topics taught in required courses was not verified by other sources. Finally, the effect of changes between 2008 and 2010 in the percentage of secondary schools in a state that taught HIV, other STD, and pregnancy prevention topics varies by the number of students attending public schools in the state during those years. States with fewer students would have less of a nationwide impact.

HIV prevention education supports strategies required to achieve the National HIV/AIDS Strategy goal of lowering the annual number of new HIV infections by 25% by 2015.[2] Families, the media, and community organizations, including faith-based organizations, can play a role in providing HIV, other STD, and pregnancy prevention education. However, schools are in a unique position to provide HIV, other STD, and pregnancy prevention education to young persons because almost all school-aged youths in the United States attend school.[9] School policies can provide critical support for implementation of comprehensive HIV, other STD, and pregnancy prevention education in secondary schools.[10]

References
  1. CDC. Youth risk behavior surveillance—United States, 2009. MMWR 2010;59(No. SS-5).
  2. Office of National AIDS Policy. National HIV/AIDS Strategy for the United States. Washington, DC: The White House; 2010. Available at http://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf. Accessed December 9, 2011.
  3. CDC. Guide to community preventive services. Prevention of HIV/AIDS, other STIs and pregnancy: interventions for adolescents. Atlanta, GA: US Department of Health and Human Services, CDC; 2010. Available at http://www.thecommunityguide.org/hiv/riskreduction.html. Accessed March 28, 2012.
  4. CDC. Health Education Curriculum Analysis Tool (HECAT). Atlanta, GA: US Department of Health and Human Services, CDC; 2009. Available at http://www.cdc.gov/healthyyouth/hecat. Accessed December 13, 2011.
  5. Kirby D, Laris BA, Rolleri L. Sex and HIV education programs for youth: their impact and important characteristics. Scotts Valley, CA: ETR Associates; 2006. Available at http://www.etr.org/recapp/documents/programs/sexhivedprogs.pdf. Accessed December 13, 2011.
  6. Kirby D, Coyle K, Alton F, Rolleri L, Robin L. Reducing adolescent sexual risk: a theoretical guide for developing and adapting curriculum-based programs. Scotts Valley, CA: ETR Associates; 2011. Available at http://pub.etr.org/upfiles/reducing_adolescent_sexual_risk.pdf. Accessed December 13, 2011.
  7. Brener ND, Demissie Z, Foti K, et al. School Health Profiles 2010: characteristics of health programs among secondary schools in selected U.S. sites. Atlanta, GA: US Department of Health and Human Services, CDC; 2011. Available at http://www.cdc.gov/healthyyouth/profiles/2010/profiles_report.pdf. Accessed December 9, 2011.
  8. Kaiser Family Foundation. HIV/AIDS at 30: a public opinion perspective. Menlo Park, CA: Kaiser Family Foundation; 2011. Available at http://www.kff.org/kaiserpolls/upload/8186.pdf. Accessed December 9, 2011.
  9. Snyder TD, Dillow SA. Table 7. Percentage of the population 3 to 34 years old enrolled in school, by age group: selected years, 1940 through 2009. In: Digest of education statistics 2010. Washington, DC: US Department of Education, National Center for Education Statistics, Institute of Education Sciences; 2011. Available at http://nces.ed.gov/programs/digest/d10/tables/dt10_007.asp?referrer=report. Accessed December 9, 2011.
  10. National Association of State Boards of Education. Someone at school has AIDS: a complete guide to education policies concerning HIV infection. Alexandria, VA: National Association of State Boards of Education; 2001.
Sidebar
What is Already Known on this Topic?

Schools provide a unique setting for reaching most youths nationwide with information they can use to prevent human immunodeficiency virus (HIV) infection, other sexually transmitted diseases, and pregnancy.

What is Added by this Report?

In 2010, compared with 2008, the percentage of public secondary schools in 45 states teaching specific HIV, other sexually transmitted disease (STD), and pregnancy prevention topics in required courses generally did not increase, and percentages teaching all topics varied widely across these states.

What are the Implications for Public Health Practice?

To help reduce HIV-, other STD-, and pregnancy-related risk behaviors among students, secondary schools can increase efforts to teach all age-appropriate HIV, other STD, and pregnancy prevention topics.

Source

A Potential Game Changer in the Fight Against HIV/AIDS

Sean Cahill Director of Health Policy Research, The Fenway Institute

Posted: 05/09/2012 4:11 pm

Imagine what it would mean to have a medication that would make it harder for HIV to enter a person's body. Tomorrow, May 10, may lead to just such a turning point in the fight against HIV/AIDS. On this date the U.S. Food and Drug Administration will review a supplemental new drug application for emtricitabine/tenofovir disoproxil fumarate (FTC-TDF) to reduce the risk of acquiring HIV in men and women by pre-exposure prophylaxis (PrEP), offered as part of a comprehensive HIV-prevention package including risk reduction counseling.

Before Westerners go to some African countries, they take malarial drugs as a preventive strategy. PrEP works much the same way: HIV treatment medications are taken to make it harder for HIV to enter the body.

PrEP has shown efficacy with men who have sex with men (MSM) and heterosexual women and men. Biomedical prevention interventions such as PrEP have great potential, especially if coupled with traditional prevention approaches such as condom use, expanded testing, and linkage to treatment and care. Modeling demonstrates the most effective deployment of PrEP will be in combination with scaled-up HIV treatment of people who are known to be HIV-positive, as this was shown to reduce infections.

The FDA's Antiviral Drugs Advisory Committee will consider and vote on whether to recommend approving FTC-TDF for PrEP with MSM, serodiscordant couples, and others at risk of HIV through sexual activity. The FDA is expected to issue a final decision in mid-June.

We are hopeful that the full dossier of submitted PrEP research, based on multiple clinical trials with a number of different populations vulnerable to HIV, can lead to a responsible regulatory and marketing plan that allows for safe use in the populations that may benefit most from this innovative development. If the FDA approves the additional indication of the use of tenofovir-emtricitabine for PrEP, health programs and individuals will have improved choices to address one of the administration's domestic health priorities, and save lives.

Some have raised concerns about PrEP related to potential side effects, risk compensation (the idea that people will stop using condoms if PrEP becomes available), and drug resistance. However, reviews of five major clinical trials involving about 6,000 participants by the Forum for Collaborative HIV Research found no greater risk of side effects, no risk compensation, and no clinically significant development of drug resistance in participants.

Recent press coverage has emphasized the cost of FTC-TDF. Last year the Centers for Disease Control and Prevention estimated the medications would cost $8,030 per person per year. While the cost of PrEP in the U.S. would be substantial, private insurers and state Medicaid departments are open to providing coverage. Low-cost generic medications could enable access in low-income countries. The prioritization of highly vulnerable populations could increase the cost-effectiveness of PrEP. Providing PrEP is also much less expensive than treating someone for HIV over the course of a lifetime. Recent modeling of PrEP implementation coupled with scaled-up treatment (focusing on MSM in San Francisco, the general adult population in Botswana, and serodiscordant couples in South Africa) predicts that PrEP could significantly reduce HIV incidence and prevalence, saving health care costs and lost economic productivity.

We therefore urge the FDA to approve the application of Gilead Sciences Inc.'s supplemental new drug application for emtricitabine/tenofovir disoproxil fumarate for reducing the risk of acquiring HIV by means of pre-exposure prophylaxis (PrEP) offered as part of a comprehensive prevention package including risk reduction counseling.

We believe that if the FDA looks closely at the science, it will see the merit of allowing PrEP to be added to our toolkit to prevent HIV infections. We must deploy new tools to prevent new infections, which are affecting 50,000 Americans each year and more than 2 million people worldwide, most in Africa. PrEP combined with sustained behavioral interventions and medical care to maintain adherence could help us finally begin to turn the tide with this virus.

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(Credit: istockphoto)

May 9, 2012 10:11 AM

By Ryan Jaslow

(CBS News) Treatable infections lead to two million cancer cases each year worldwide, a new study suggests. Out of 7.5 million people who died of cancer across the world in 2008, about 1.5 million were due to preventable and treatable infections such as human papillomavirus (HPV) and hepatitis C (HCV).

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"Infections with certain viruses, bacteria, and parasites are one of the biggest and preventable causes of cancer worldwide," study authors Dr. Catherine de Martel and Dr. Martyn Plummer, scientists from the International Agency for Research on Cancer, France, said in a written statement. "Application of existing public-health methods for infection prevention, such as vaccination, safer injection practice, or antimicrobial treatments, could have a substantial effect on future burden of cancer worldwide."

For the study, researchers calculated the proportion of cancers caused by infections by reviewing statistics on 27 types of cancer from 184 countries. They found 16 percent of all cancers worldwide were infection-related, with rates about three times higher in developing countries. For example, 3.3 percent of cancers in Australia and New Zealand were infection related, while 32.7 percent in sub-Saharan Africa were due to infectious agents. The four main infections associated with cancer were HPV, hepatitis B and C, and Helicobacter pylori (which infects the stomach). Those four infections in particular are responsible for an estimated 1.9 million cancer cases each year, including gastric, liver and cervical cancers.

In women, cervical cancer accounted for 50 percent of the infection-related cancers; in men, liver and gastric cancers accounted for more than 80 percent of cancers caused by infections. The study is published in the May 9 issue of The Lancet Oncology.

"One thing that infection-associated cancers have in common is that a chronic infection is required," Plummer told Fox News. "It takes decades for an infection to progress to cancer."

In an accompanying editorial in the same journal, Dr. Goodarz Danaei, an assistant professor of global health at Harvard School of Public Medicine in Boston wrote, "Since effective and relatively low-cost vaccines for HPV and HBV are available, increasing coverage should be a priority for health systems in high-burden countries."

The HPV vaccine is recommended for all 11 or 12 year old girls, and women who did not receive it during that time can get it until they are 26. In February of this year, the CDC also recommended the shot for all males between the ages of 11 and 21, HealthPop reported.

Dr. Otis Brawley, chief medical officer of the American Cancer Society, who was not involved with the research, told CNN,"The more people you vaccinate, male and female, the more likely you are to get a population that doesn't have the disease."

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ACH

May 9, 2012

Structurally Distinct NS5A Inhibitor Displays Potent Preclinical Activity Against Commonly Observed Resistant Variants

NEW HAVEN, Conn., May 9, 2012 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that it has begun dosing ACH-3102 in a Phase 1 clinical trial. ACH-3102 is Achillion's second generation pan-genotypic NS5A inhibitor being investigated for the treatment of chronic hepatitis C virus (HCV) infection.

ACH-3102 is a structurally distinct small molecule compound that has demonstrated potent inhibition of the NS5A protein across all genotypes of HCV in preclinical studies. Furthermore, the unique chemical structure of ACH-3102 has resulted in enhanced potency in vitro against resistant mutants that have emerged during clinical studies with first generation NS5A inhibitors.

The randomized, double-blind, placebo-controlled Phase 1 trial will enroll approximately 96 healthy volunteers in the U.S. to investigate the safety, tolerability and pharmacokinetic profile of ACH-3102. The trial will assess dosing in single and multiple ascending oral doses for up to 28 days.

"We believe that NS5A inhibitors, in combination with protease inhibitors, will play an integral role in achieving the goal of an all-oral interferon-free treatment regimen for all segments of the HCV infected patient population," commented Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "With our continued focus on compounds with potentially best-in-class characteristics, including safety and efficacy, broad genotypic effect with once-daily dosing and enhanced resistance profiles, we hope to move ACH-3102 through Phase 1 for HCV-infected subjects and toward combination studies with ACH-1625, our Phase 2 protease inhibitor, during the third quarter of 2012."

About NS5A Inhibitors and ACH-3102

The NS5A protein is a clinically validated target that serves multiple functions at various stages of the HCV life cycle including involvement in virion production, interaction with host proteins and association with interferon-resistance. ACH-3102, Achillion's second generation NS5A inhibitor, has demonstrated potent activity against all HCV genotypes in vitro and in preclinical studies achieved additive to synergistic activity when combined with NS3 protease inhibitors, NS5B polymerase inhibitors, interferon and ribavirin. In preclinical studies, ACH-3102 demonstrated excellent potency, in the pico-molar range, against wild type HCV RNA replication, as well as potency against resistant mutants that have been identified in clinical studies.

About HCV

The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide including more than 5 million people in the United States, more than twice as widespread as HIV. Three-fourths of the global HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.

About Achillion Pharmaceuticals

Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to: the potency, safety, tolerability, effectiveness and other characteristics of Achillion's ACH-1625 and ACH-3102; Achillion's expectations regarding timing for the commencement, completion and reporting of results of clinical trials of ACH-1625 and ACH-3102; and Achillion's ability to advance a potentially best-in-class all-oral, interferon-free combination of ACH-1625 and ACH-3102. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: replicate in later clinical trials positive results found in earlier stage preclinical studies and clinical trials of ACH-1625 and ACH-3102; advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and its subsequent SEC filings.

In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law.

Source Achillion Pharmaceuticals, Inc.

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