January 17, 2011

Despite major advances in the treatment of HIV disease since the recognition of this pandemic, HIV/AIDS hits more than 33 million individuals worldwide with 7,000 daily new cases of infection.

TOULON, FRANCE, January 17, 2011 /EIN Presswire/ -- Despite major advances in the treatment of HIV disease since the recognition of this pandemic, HIV/AIDS hits more than 33 million individuals worldwide with 7,000 daily new cases of infection. The burden of treatment expense for each patient is astronomical. Universal access to HIV treatment is a red herring and is financially unsustainable. Finding a cure is the only solution to the problem that makes sense. Scientists have accomplished major advances in this direction over the last few years, but face investors disinterest and political pretence. Here, we call for the creation of a coordinated research task force for an HIV cure.

Two thirds of HIV-infected patients are living in Africa, where access to treatment is highly variable, but reaches less than 30 percent of cases.

HIV has also made a strong appearance in Asia. Prevention through education and new laws for the sex trade industry are the most common choices by the individual governments in this continent.

In Western and Central Europe, healthcare systems of each individual country are well educated and experienced in the distribution of the antiviral drugs allowing those infected to get longer and healthier lives. But the financial burden is huge. Tax collections are down because of the sluggish world economy so the cost to each individual country that provides the treatment is growing and financial difficulties emerge.

The United States has had mixed results with its HIV programs. In 2010, the government pledged to become more active in the prevention, treatment and education of the population to try and curb the spread of the disease. Regarding care, growing numbers of people are uninsured and access criteria are highly variable for those who are eligible to therapy.

The most common want for anyone and any country that is dealing with the spread of HIV is a cure for those infected or a vaccine to prevent it from spreading. As the expense of treating those infected with HIV is so huge, this fact alone makes an HIV cure even more critical for us to find. Estimations are as high as $25,000 per year in the United States, which is more than a lot of people's yearly salaries in that country. In France, where antiretroviral access is completely covered by the public insurance, triple-drug combinations cost between 10,000 and 15,000 euros per year per patient.

The burden usually lies on the governments of each country to foot the bill for these expensive treatment drugs, but unfortunately if everyone who needed treatment received it, it could cause an extreme financial strain on the country's economy, if it hasn't already. Universal access to HIV treatment is, actually, a red herring. Finding a cure to fight this horrific, life-shattering virus is the only solution to the problem that makes sense.

Fortunately, not all hope on finding an HIV cure is scientifically lost. In fact, we are much closer today than we have ever been before. We have already made great strides in our search for a cure by a better understanding of the mechanisms involved in HIV persistence in an infected body, the so called HIV reservoirs. But there is minor involvement of governmental and private investors; no coordinated effort and no political will, to find an HIV cure.

As scientists and doctors who have lost thousands of patients from HIV since the beginning of the epidemic, we are sick of political pretence. We need the creation of an international, multi-disciplinary agency dedicated to HIV cure research. This one must include scientists from the virology, immunology, drug development and clinical research fields with the ultimate goal of finding an HIV cure within the next decade. It is feasible, but the decisive step must be taken right now.

About us: Dr Alain Lafeuillade is chief of the department of infectious diseases at General Hospital, Toulon, France, and chair of the International Workshop on HIV Persistence, Reservoirs and Eradication Strategies since 2003. http://www.hiv-eradication.org/

Contact:

Alain Lafeuillade, MD
CHITS
Var, France
Telephone (33) 4 94616340
lafeuillade@orange.fr
http://www.hiv-eradication.org/

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Transplant Docs Change Practice After HIV/HCV Case

By Michael Smith, North American Correspondent, MedPage Today
Published: January 17, 2011
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine,
Harvard Medical School, Boston.
 
After a rare, high-profile case of HIV transmission through organ transplant, nearly a third of surgeons changed their practice, researchers reported.
 
But the most common change was to avoid the use of high-risk donors, rather than to institute better ways of detecting the virus before transplant, according to Dorry Segev, MD, PhD, and colleagues at the Johns Hopkins University School of Medicine.

The finding, from a survey of more than 400 transplant surgeons, suggests that fear of legal or regulatory consequences -- rather than patient safety -- was driving changes in practice, Segev and colleagues reported in the January issue of Archives of Surgery.

In 2007, transplants from a single high-risk donor transmitted both HIV and hepatitis C to four organ recipients, despite negative antibody tests before the procedures. The case made national headlines, Segev and colleagues noted, and sparked a debate about informed consent and testing for HIV.

One of the issues was the use of the antibody test for HIV and hepatitis C, which in the first weeks after infection -- 22 days for HIV and 82 for hepatitis C -- cannot detect the presence of the viruses.

After the discovery of the transmission, physicians retrospectively used nucleic acid testing -- which reduces the discovery window to nine and seven days for HIV and hepatitis C, respectively -- and confirmed the donor had been infected.

To see what effect the case had, Segev and colleagues surveyed transplant surgeons across the U.S. between Jan. 17, 2008, and April 15, 2008, getting responses from 422 surgeons in current practice.

Of those, they found, 297 reported using high-risk donors, but 31.6% changed practice after the 2007 event. Specifically:

• 41.7% of those who changed decreased use of high-risk donors.
• 34.5% increased the emphasis on informed consent.
• 16.7% increased use of nucleic acid testing.
• 6% implemented a formal policy.

Surgeons who did not change were in practice longer, the researchers found -- 13.9 years versus 10.7, which was significant at P=0.002. They were also less likely to rank being sued or facing hospital pressure as disincentives (both differences significant at P≤0.001), but both groups saw the medical risks of HIV and hepatitis C in transplants as high (greater than four on a five-point scale).

In multivariate analyses of the reasons for changing practice, the researchers found that ranking the fear of being sued or hospital pressure as important disincentives was associated with higher odds of changing practice. The odds ratios were 2.26 and 2.52, respectively, and both were significant at P<0.05.

On the other hand, ranking the medical risks of HIV and hepatitis C in transplants as disincentives to high-risk donor use were not significant predictors of a change in practice overall, but did predict avoiding the use of high-risk donors. The odds ratios were 8.29 for HIV risk and 5.70 for hepatitis C risk, and both were significant at P<0.05.

Among physicians who changed practice, the researchers argued, most changes could be classified as "defensive medicine."

That finding is "worrisome," they noted, because high-risk donors contribute 8.6% of recovered organs and offer "significant survival benefit" despite a small risk of transmitting infectious disease.

The researchers cautioned that the data were self-reported, so it is possible that surgeons either over- or underreported changes to their practice following the 2007 event. It's also possible that those who responded to the survey differ from those who did not respond, they noted, although survey respondents represented 89.1% of U.S. transplant volume.

Finally, they cautioned that the survey took place after the 2007 case, so that recall bias is possible.

The researchers did not report external financial support for the study, nor did they report any relevant financial relationships.

Primary source: Archives of Surgery
Source reference:
Kucirka LM, et al "Provider response to a rare but highly publicized transmission of HIV through solid organ transplantation" Arch Surg 2011; 146(1): 41-45.

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CDC: Continued Disparities Seen in U.S. Health

By Michael Smith, North American Correspondent, MedPage Today
Published: January 16, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine,
University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
 
Health disparities among Americans continue to persist -- with higher death rates reported for babies born to black women, and poor people suffering a greater rate of illness compared with other groups -- according to a report from the CDC.
 
Among other findings, the 116-page report published in the Morbidity and Mortality Report, found that African-American babies were up to three times more likely to die in infancy than those born to members of other racial or ethnic groups, and people in lower income brackets had fewer healthy days. In addition, death rates from car crashes were twice as high for American Indians and Alaska natives compared with other groups.

In a foreword to the report, CDC director Thomas Frieden, MD, said that, despite some progress, remaining health disparities are "both unacceptable and correctable."

Many of the CDC's findings are not that new or surprising.

For instance, blacks were hardest hit by the HIV/AIDS epidemic, with a 2008 prevalence of 73.7 cases per 100,000 population -- markedly higher than the 8.2 per 100,000 among whites. While the prevalence of HIV/AIDS has been steady or falling in most other ethnic and racial groups, it has been increasing among blacks -- the 2005 prevalence was 68.2 per 100,000, the researchers reported.

Binge drinking -- having five drinks at once for men and four for women -- was relatively common, mainly among the affluent and well educated, the CDC report found.

The prevalence of binge drinking rose with income and was highest among people with annual household incomes of at least $50,000. On the other hand, those in the highest income group tended to have fewer episodes of binge drinking and to drink less heavily during a single episode than those with lower incomes, the CDC reported.

Among other findings reported in the Jan. 14 MMWR:

• People in lower income brackets reported fewer average healthy days and residents of states with larger inequalities in reported number of healthy days also report fewer healthy days on average.

• Babies born to black women are between 1.5 and 3.0 times more likely to die in infancy than those born to women of other races and ethnic groups.

• Men are two to three times as likely to die in motor vehicle accidents than are women, but death rates are twice as high among American Indians and Alaska Natives -- about 43 per 100,000, compared with 23 for blacks and 21 for whites and Hispanics.

• Men are also about four times more likely to commit suicide than females -- 18.4 per 100,000 for men versus 4.8 for women.

• American Indians and Alaska Natives account for only about 1% of the total suicides and non-Hispanic whites for 18.5%, but the rate among the former is 14.6 per 100,000, comparable to the 14.4 per 100,000 among whites.

• Except for Hispanics, the rate of drug-induced deaths increased between 2003 and 2007 in all racial and ethnic groups, with the highest rate -- 15.6 per 100,000 population -- now being among non-Hispanic whites. Prescription drugs have overtaken illicit drugs as a cause of mortality.

• Men are much more likely to die from coronary heart disease than women -- at 176.5 per 100,000 versus 103.1. Black men and women are also more likely to die of both heart disease and stroke than are whites.

While wide ethnic, income, age, and gender disparities for homicide rates have been previously reported, the current report said data on individual and socioeconomic risk factors for murders were unavailable for analysis. In addition, the report noted that sufficient data were not available to assess disparities in homicide rates by certain racial/ethnic subgroups, family income, educational attainment, disability status, and sexual orientation.

The report was prepared by the CDC.

Primary source: CDC Health Disparities and Inequalities Report -- United States, 2011
Source reference:
Centers for Disease Control and Prevention "CDC health disparities and inequalities report - United States, 2011" MMWR 2011; 60(Suppl):

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Journal of Hepatology
PII: S0168-8278(11)00012-2
doi:10.1016/j.jhep.2010.12.024
© 2011 Published by Elsevier Inc.

Articles in Press

Michael Mannsa, Stefan Zeuzemb, Ajit Soodc, Yoav Luried, Markus Cornberga, Hartwig Klinkere, Peter Buggischf, Martin Rössleg, Holger Hinrichsenh, Ismail Mericani, Yaron Ilanj, Stefan Maussk, Saif Abu-Mouchl, Andryes Horbanm, Thomas H. Müllern, Christoph Welschb, Rongdean Cheno, Rab Faruqio, Lisa D. Pediconeo, Heiner Wedemeyera

Received 4 May 2010; received in revised form 3 December 2010; accepted 13 December 2010. published online 14 January 2011.
Accepted Manuscript

Abstract

Background

There is increasing interest in identifying patients with chronic hepatitis C genotype 2 or 3 infection in whom it is possible to lower the burden of therapy whilst retaining high levels of efficacy.

Methods

Treatment-naive patients with chronic hepatitis C genotype 2/3 infection were randomised to receive peginterferon alfa-2b (1.5 μg/kg/wk) for 24 weeks (group A); peginterferon alfa-2b (1.0 μg/kg/wk) for 24 weeks (group B); or peginterferon alfa-2b (1.5 μg/kg/wk) for 16 weeks (group C), each in combination with weight-based ribavirin (800–1200 mg/day). The study population comprised 2 cohorts: the Hep-Net cohort enrolled in Germany and an international cohort enrolled at study sites throughout Europe and Asia. The primary end point was sustained virological response (SVR).

Results

The study included 682 patients; 80.2% had genotype 3 infection. In the intent-to-treat population, SVR rates were 66.5%, 64.3%, and 56.6% in groups A, B, and C, and were similar in Asian and white patients. Treatment differences (A vs B and A vs C) failed to reach the predefined margin for noninferiority of −10%; and thus groups B and C failed to show noninferiority relative to group A. Among patients with undetectable HCV RNA at week 4, SVR rates were 75.3%, 75.9% and 72.4%, respectively. Relapse rates were 17.8%, 16.3%, and 29.3%, respectively. Treatment-emergent serious adverse events were highest in group A and lowest in group C, and adverse events leading to discontinuation were similar across treatment arms.

Conclusion

For patients with chronic hepatitis C genotype 2/3 infection, 24 weeks of peginterferon alfa-2b (1.5 μg/kg/wk) plus weight-based ribavirin remains a standard-of-care therapy; however, treatment for 16 weeks may be considered for patients with undetectable HCV RNA at week 4 of treatment.

Source
Dig Dis Sci. 2011 Jan 11. [Epub ahead of print]

Ho SB, Aqel B, Dieperink E, Liu S, Tetrick L, Falck-Ytter Y, Decomarmond C, Smith CI, McKee DP, Boyd W, Kulig CC, Bini EJ, Pedrosa MC.

VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA, samuel.ho2@va.gov.

Abstract

BACKGROUND: Patients with chronic hepatitis C genotype 1 (HCV-1) and difficult-to-treat characteristics respond poorly to pegylated interferon alfa and ribavirin (RBV), and could benefit from an interferon with increased activity (consensus interferon or CIFN), favorable viral kinetics from daily dosing, and a longer duration of therapy. The purpose of this pilot study was to determine the efficacy and safety of daily CIFN + RBV for initial treatment of patients with HCV-1 infection.

METHODS: Patients with difficult-to-treat characteristics (92% male, 33% African American, 78% Veterans Affairs [VA]; 67% high viral load, 59% stage 3-4 fibrosis, and mean weight of 204 lbs) were enrolled at seven VA and two community medical centers. They were randomized to daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for either 52 weeks (group A, n = 33) or 52-72 weeks (from time of viral response +48 weeks) (group B, n = 31).

RESULTS: Intention to treat analysis for treatment groups A and B demonstrated 33% (11/33) and 32% (10/31) sustained virologic response (SVR), respectively. Only 2/31 patients in group B received more than 52 weeks of treatment. The overall group demonstrated a 31% (20/64) rapid virologic response rate (RVR), 54% (34/64) end of treatment virologic response and a 33% (21/64) SVR. Patients with RVR at 4 weeks, early virologic response from 8-12 weeks, and late virologic response from 16-24 weeks demonstrated SVR of 75% (15/20), 31% (4/13), and 22% (2/9), respectively. Overall early non-protocol discontinuation occurred in 26/64 (40%) patients.

CONCLUSION: Daily CIFN and ribavirin for initial treatment of HCV-1 patients has potential for achieving a relatively high RVR rate, but discontinuations are frequent and successful use of this regimen is highly dependent on adequate patient support to maintain adherence.

PMID: 21221804 [PubMed - as supplied by publisher]

Source
Dig Dis Sci. 2011 Jan 8. [Epub ahead of print]

Al-Hamoudi W, Mohamed H, Abaalkhail F, Kamel Y, Al-Masri N, Allam N, Alqahtani S, Al-Sofayan M, Khalaf H, Al-Sebayel M, Al-Jedai A, Abdo A.

Gastroenterology Unit (59), Department of Medicine, College of Medicine, King Saud University, PO Box 2925, Riyadh, 11461, Saudi Arabia, walhamoudi@gmail.com.

Abstract

BACKGROUND: Hepatitis C virus (HCV) recurrence after liver transplantation (LT) is universal and tends to be more aggressive. Data on post-transplant HCV genotype 4 treatment is scarce. The aim of this study is to assess the safety and efficacy of pegylated interferon alpha-2a (PEG-IFN) in combination with ribavirin in the treatment of recurrent HCV genotype 4 after LT.

METHODS: Twenty-five patients infected with HCV genotype 4 were treated with PEG-IFN alpha-2a at a dose of 180 μg/week in addition to 800 mg/day of ribavirin (the dose was adjusted within the tolerated range of 400-1,200 mg). Pretreatment liver biopsies were obtained from all patients. Biochemical and virological markers were assessed before, during, and after treatment.

RESULTS: Twenty-two patients (88%) achieved an early virological response (EVR) (12 patients tested negative for HCV-RNA). Fifteen (60%) and 14 patients (56%) achieved an end of treatment virological response (ETVR) and a sustained virological response (SVR), respectively. Five patients had advanced pretreatment liver fibrosis. Pretreatment ALT was elevated in 24 patients (96%). The most common adverse effects were flu-like symptoms and cytopenia. Eighteen patients (72%) required erythropoietin alpha and/or granulocyte-colony stimulating factor as a supportive measure. One patient developed severe rejection complicated by sepsis, renal failure, and death. Other adverse effects included depression, mild rejection, impotence, itching, and vitiligo.

CONCLUSIONS: Post-transplant treatment with pegylated interferon alpha-2a and ribavirin achieved SVR in 56% of liver transplant recipients with chronic HCV genotype 4 infection. The combination was relatively safe and exhibited a low rate of treatment withdrawal.

PMID: 21221800 [PubMed - as supplied by publisher]

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New Hope For Hepatitis C, An Often Hidden Disease

Jan. 17, 2011

HEALTHBEAT: New Drugs Take Aim At Hepatitis C, Spur Debate On Whether To Test Baby Boomers

(AP) WASHINGTON (AP) - There's new hope for an overlooked epidemic: Two powerful drugs are nearing the market that promise to help cure many more people of liver-attacking hepatitis C - even though most who have the simmering infection don't know it yet.

Surprisingly, two-thirds of hepatitis C sufferers are thought to be baby boomers who've harbored since their younger, perhaps wilder, years a virus that can take two or three decades to do its damage.

What could be a treatment revolution is spurring the government to consider if it's time to start screening aging baby boomers for hepatitis C, just like they get various cancer checks.

"We're entering a whole new era of therapy," says Dr. John Ward, hepatitis chief at the Centers for Disease Control and Prevention. "We really want to begin that clarion call for action for this population who's at risk."

Today's two-drug treatment for hepatitis C cures only about 40 percent of people with the most common variety of the virus, and causes some grueling side effects. Now major studies show that adding a new drug -either Vertex Pharmaceuticals' telaprevir or Merck & Co.'s boceprevir - can boost those cure rates as high as 75 percent. And they allow some people to cut treatment time in half, to six months, thus lessening how long they must deal with those side effects.

If the Food and Drug Administration approves the drugs - a decision widely expected this summer - they would be the first that work by directly targeting the hepatitis C virus. Specialists draw comparisons to the early 1990s when potent combination therapies emerged to treat AIDS. Many recently diagnosed patients are postponing therapy to await these new drug cocktails in hopes of a better chance at a faster cure, says Dr. Paul Pockros, hepatology chief at the Scripps Clinic in La Jolla, Calif., who helped test telaprevir.

However, the bigger impact could come if more people get tested for hepatitis C, a blood-borne virus. It's often stigmatized as a risk only to people who inject illegal drugs. But the virus could have begun festering from a blood transfusion before 1992, when testing of the blood supply began.

Lapses in infection control in health facilities still occasionally expose people today. So could even a one-time experiment with drugs way back in college, something doctors are reluctant to ask a now middle-aged, button-downed patient to reveal, says Ward.

"It cuts across every segment of society," adds Dr. Arun Sanyal of Virginia Commonwealth University, past president of the American Association for the Study of Liver Diseases. "I can tell you our hepatitis C treatment clinic is a great social equalizer."

About 3.2 million Americans, and 170 million people worldwide, have chronic hepatitis C. In the U.S., new infections have dropped dramatically - although the disease's toll is rising as people infected decades earlier reach ages where their livers start showing damage. Hepatitis C already is a leading cause of liver transplants, and it kills about 12,000 U.S. patients a year, a number expected to triple within 20 years.

Most people find out they're infected like Brian Graham of Briarcliff Manor, N.Y., during a routine check-up that spotted elevated liver enzymes. He'd never heard of hepatitis C and had no obvious risk factors. But tests showed the virus had begun to scar his liver. So over the last decade he tried three rounds of traditional treatments, with increasingly tough side effects, to no avail.

"I didn't want to die of liver disease or cancer or suffer the prospect of having to tee up for a liver transplant. Scary stuff," says Graham, now 56.

Enter the new drugs. They work by blocking an enzyme named protease that's key for the virus to reproduce. But they must be taken together with standard medications - ribavirin pills plus injections of interferon-alpha - that are thought to boost the immune system.

According to studies presented at a recent medical meeting, 67 percent to 75 percent of patients given treatment including either boceprevir or telaprevir, respectively, had what doctors call a cure. That's defined as no sign of the hepatitis C virus six months after their last dose. Importantly, only about a quarter of black patients are helped by standard therapy but adding one of the new drugs more than doubled their cure rates.

People getting their first-ever treatment did best, but the studies also found improvements in hard-to-treat patients like Graham.

"The fourth time did the trick," says Graham, who volunteered for an early telaprevir study and says he's been hepatitis-free for three years.

The new drugs do add side effects to the flulike symptoms and other complaints of existing treatment. Telaprevir's main risk is a rash that is sometimes severe, and boceprevir's is anemia.

"The future looks very bright beyond telaprevir and boceprevir," notes Dr. Fred Poordad of Cedars-Sinai Medical Center in Los Angeles, who has studied both drugs and consults for several companies. He points to additional drugs in earlier-stage testing that promise to target more types of hepatitis C and perhaps eventually allow for pill-only, interferon-free treatment.

Manufacturers haven't said how much the new drugs will add to the price of treatment that already can cost $30,000, albeit far cheaper than a liver transplant.

A stickier issue: Not everyone suffers serious liver damage and it's hard to predict who will, raising questions about exactly who needs treatment even as drug companies help push for more screening."

That's a concern, acknowledges Jeff Levi of the nonprofit Trust for America's Health, also a screening proponent. But when to treat is a doctor-patient decision, and "anyone with chronic infection you do want to be monitoring so you can intervene at the right moment," he adds.

Plus, people with hepatitis C should avoid alcohol and consider other liver-protection steps - and know how to avoid infecting others, he stresses.

Stay tuned: The CDC has begun a study at four hospitals - in New York, Detroit, Houston and Birmingham, Ala. - to see if a one-time hepatitis C test for baby boomers makes sense. Among the boomers, black men in their 50s are at particular risk. CDC plans new guidelines next year.

Meanwhile, "start that conversation" at a routine doctor's visit by asking about hepatitis C risks and testing, Ward advises boomers.

____

EDITOR's NOTE - Lauran Neergaard covers health and medical issues for The Associated Press in Washington
 
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