Condom Homework Increases Compliance, Comfort and Consistency

condomsA new and successful strategy for combating the spread of sexually transmitted diseases such as HIV was revealed today at the American Public Health Association’s annual meeting in Boston.

The idea is based upon the decades old premise that practice makes perfect!.

In the study entitled “A novel, self-guided, home-based intervention to improve condom use among young men who have sex with men.  The men were given a “ditty bag” full of eight different types of condoms and five different types of  lubricants, taught how to apply the condoms correctly, and then assigned homework. The men were expected to try out at least six condoms solo, paying particular attention to their own pleasure and which condoms they liked best.

The purpose of this study was to test of feasibility and efficacy of this intervention and to promote positive condom attitudes and to reduce risk behaviors.

30 volunteer subjects were recruited from a Midwestern University and its surrounding community. A pre-test questionnaire was administered.  A post-test questionnaire was given at Day 15 and an additional follow-up questionnaire at Day 45.

condom-safe-sexIt’s such a simple idea, but nobody has every structured an approach like this,” said William L. Yarber, professor in the Indiana University School of Public-Health. “These are pilot studies. But even with small samples, the results are really good. Men become more motivated to use condoms; they use them more correctly and consistently. They also appreciate learning that there are different condoms available.”

A pilot study, published in the Journal of Men’s Health in 2011, focused on heterosexual men. The new study, focuses on young men who have sex with men, or MSM.  It will be published in the Journal of American College Health, MSM aged 18 – 29 are diagnosed with HIV more than any other group, according to the Centers for Disease Control and Prevention. In fact, half of all new HIV infections in the U.S. are among MSM between the ages of 13 and 24 years. College-aged MSM are more likely than older MSM and men who only have sex with women to be infected with HIV.

This is an important group of men to reach,” says  Roberta Emetu, who coordinated the research project.  “The men who experienced this intervention became better in their condom use. They not only used them more often but used them correctly. We saw an increase in motivation to use them.”

condom_thumbs_upWhen pre-test and post-test responses were compared, significant post-intervention improvements were found for beliefs and application of condoms, self-efficacy, condom attitude, motivation to use condoms, and consistency of condom use for insertive penile-anal intercourse.

Yarber and his colleagues have documented for more than 10 years how merely wearing a condom is not enough to provide effective protection against STDs and unwanted pregnancies. Condoms need to be used correctly, yet fit-and-feel issues can result in erection difficulty, loss of sensation, removal of condoms before the intercourse episode ends, and other problems that can interfere with their correct use.

These findings suggest that this intervention could be applicable to college-aged MSM, and could be a great resource or model for other public health condom interventions.

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Stopping Herpes From Going Viral

herpes-simplex-virusOn Wednesday SRxA’s Word on Health reported on a link between memory loss and cognitive decline and the herpes virus.  Today, we bring a glimmer of hope to the 65% – 90% of people worldwide affected with either type 1 or Type 2 herpes simplex virus.

In the US alone, it’s estimated that nearly 60 percent of U.S. men and women between the ages of 14 and 49 carry the HSV-1 virus, while >16.2% are infected with herpes simplex virus type 2 (HSV-2).

HSV-2 is a lifelong and incurable infection that can cause recurrent and painful genital sores and can make those infected with the virus two-to-three times more likely to acquire HIV.

Now, according to a study just published in the Journal of the Federation of American Societies for Experimental Biology (FASEB), researchers from Albert Einstein College of Medicine of Yeshiva University have discovered a novel strategy for preventing, treating or suppressing herpes virus infections.

molecule_key_chains-We’ve essentially identified the molecular “key” that herpes viruses use to penetrate cell membranes and infect cells of the human body,” said Betsy Herold, MD of The Children’s Hospital at Montefiore.

Dr. Herold and her colleagues had previously shown that infection by the herpes viruses depends on calcium released within the cells. In this study, they found that calcium release occurs because the viruses activate a critical cell-signaling molecule called Akt [also known as Protein Kinase B (PKB) ] at the cell membrane.

As part of their investigation of Akt’s role in herpes infections, the researchers took laboratory cultures of human cell and mixed them for 15 minutes with four different drugs known to inhibit Akt. The cells were then exposed for one hour to herpes simplex virus 2.

The drugs tested were:

  • MK-2206 – an experimental drug being studied as adjunct therapy for cancer
  • Akt Inhibitor VIII
  • Miltefosine, a drug licensed for treatment of leishmaniasis and other protozoal infections
  • Perifosine, an experimental agent in phase 3 clinical trials for treatment of several cancers

STOPAll four of the drugs significantly inhibited HSV infection in each of the cell types.  Miltefosine was the most potent and reduced viral plaques by 90% in all cell types.

By contrast, cells not pre-treated with the Akt inhibitors were readily infected on exposure to the virus.

For people infected with herpes, the drug acyclovir helps prevent herpes outbreaks from recurring and lowers the risk of transmitting the infection to others,” said Dr. Herold. “But some people have herpes infections that don’t respond to acyclovir, and unfortunately there is no effective vaccine. So new approaches for suppressing and treating herpes infections are badly needed, and our findings indicate that inhibiting Akt should be a useful therapeutic strategy to pursue.”

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Which Is Worse, Hepatitis B or Hepatitis C?

Chronic hepatitis B and chronic hepatitis C, while caused by different viruses are clinically indistinguishable. Both affect the liver and both are potentially fatal.  Over years or decades, chronic HBV and HCV infection can progress to severe liver diseases including cirrhosisliver cancer, and ultimately end-stage liver failure.

However, until now, few head-to-head comparisons of clinical outcomes have been attempted.

So, we were really interested to read a new study published in the Journal of Clinical Infectious Diseases.  This study is the first in which the effects of hepatitis B and hepatitis C virus infections were compared in a relatively homogeneous population.

Researchers from Johns Hopkins, led by Oluwaseun Falade-Nwulia, studied almost 7,000 American men included in the large Multicenter AIDS Cohort Study (MACS) prospective database of men who have sex with men.

Approximately 5% of participants entered the study with each type of chronic hepatitis.  At the end of an 8 year follow-up, all-cause mortality was similar in both groups, but liver-related mortality was significantly higher for those with chronic hepatitis B infections. This finding held true for both HIV-negative and HIV-positive participants, including those who were severely immune-compromised.

Excluding the few men in the study who underwent treatment for hepatitis C, infection did not change the pattern. However, liver-related deaths among participants who were co-infected with hepatitis B and HIV and who were enrolled after 2002 were markedly lower than among those who were enrolled earlier, possibly reflecting use of newer antiviral drugs that are active against both HIV and hepatitis B virus.

These results are worth noting for a number of reasons.  First, they underscore the need for expansion of HBV screening and vaccination to protect against HBV infection. Second, they suggest individuals co-infected with HIV/HBV should be treated with dually active drugs.

And lastly, despite the recent surge of public health advertisements that have brought hepatitis C screening and treatment into the public eye, clinicians should remember that hepatitis B is still out there, and that effective oral treatment can save lives.

It’s here! HIV Prevention in a Pill

An estimated 1.2 million Americans are currently living with HIV. Despite the availability of condoms and HIV education, the incidence rate has remained steady over the past two decades with approximately 50,000 new infections occurring each year. 23% of these new cases occur among women and 61% occur among men who have sex with men.

In the 80′s and early 90′s, HIV was viewed as a life-threatening disease. In some parts of the world, it still is. And while medical advances, along with the availability of 30 or so approved HIV drugs, mean its now a chronic disease, rather than a killer disease – what we’ve all been waiting for is a drug to prevent it.

Now, this week, after decades of anticipation, the FDA  approved Truvada – an HIV combination pill for pre-exposure prophylaxis.  Truvada is the first drug that has been approved to combat HIV among uninfected individuals who are believed to be at high risk of acquiring the virus. Analysts estimate that the drug will cost $450 a year in the U.S.

In a study sponsored by the National Institutes of Health, Truvada was shown to significantly reduce the risk of HIV infection in 42% of HIV-negative gay and bisexual men and transgender women. In another, the risk was lowered in 75% of heterosexual couples in which one partner was HIV positive and the other was not.

The data clearly demonstrate that Truvada, as pre-exposure prophylaxis, is effective at reducing the risk of HIV infection acquired through sexual exposure,” said Connie Celum, a professor of global health and medicine at the University of Washington and lead investigator of the second study.

As part of the approval, the FDA has stipulated that patients must test negative for HIV and that education guides must be distributed to healthcare providers and patients. And the manufacturer – Gilead must conduct a post-approval trial looking at levels of drug adherence, adverse events, resistance and pregnancy outcomes for women who become pregnant while taking Truvada.

The approval of Truvada comes after a long-running debate among AIDS activists. To some, FDA approval offers much-needed assistance in containing the disease. To others, it raises the possibility of creating resistant strains of HIV due to widespread use, just as we saw in the 1960’s with antibiotics, which would then undermine the effectiveness of Truvada.

While the approval may be a cause of celebration for many, some have blasted the decision. “The FDA’s approval of Gilead’s Truvada as a form of HIV prevention today without any requirement for HIV testing is completely reckless and a move that will ultimately set back years of HIV prevention efforts,” says AIDS Health Foundation president Michael Weinstein. “The FDA’s move today is negligence bordering on the equivalence of malpractice, which will sadly result in new infections, drug resistance and serious side effects among many, many people.”

So is this a watershed moment in the battle against HIV or not?  Let us know what you think.

Scientific Breakthrough of the Year

Happy New Year!

Earlier this month Hollywood announced it’s nominations for the 69th Golden Globe Awards. Among the movies in the running for best motion picture are The Descendants, The Help and War Horse.

While we will have to wait until January 15th to learn the actual winner, we already know who won the 2011 ScienceBreakthrough of the Year”.   This title went to a team of researchers, who demonstrated that HIV treatment with antiretroviral drugs  can actually prevent transmission of the virus from an infected person to his or her uninfected partner.

Their clinical research showed that early initiation of antiretroviral  therapy in people infected with HIV reduces transmission of the virus to their partners by 96%. The findings end a longstanding debate over whether treatment of HIV-infected individuals can provide a double benefit by treating the virus in individual patients while simultaneously cutting transmission rates.

The results were called “astounding” by Anthony Fauci, the government’s top HIV researcher. Others have called them a “game changer” because of the near 100 percent efficacy of the intervention.

It’s wonderful for this trial to be recognized,” says Susan H. Eshleman, M.D., Ph.D., a professor of pathology at the Johns Hopkins University School of Medicine and head of the HIV Prevention Trials Network, which supported the trial. “This research moves the field of HIV prevention science forward, leading us on a path toward curbing the HIV epidemic. It provides a new direction for HIV prevention research and is beginning to shape public health policy.”

SRxA’s Word on Health is delighted to bring you such great news to start the New Year. If you have any health related stories you’d like to share, we’d love to hear from you.

Looking back at 30 years of HIV

June 5, 1981. The U.S. Centers for Disease Control and Prevention issued its first warning about a rare pneumonia called pneumocystis circulating among a small group of young gay men. Unrealized at the time, it was the official beginning of the HIV/AIDS epidemic.

In October 1981 I met and cared for my first AIDS patient, while a student at the Middlesex Hospital, London, UK.  Almost thirty years later, I remember him as if it were yesterday.  He was a 32 year old family doctor, who had a busy practice helping a poor and homeless community in London’s Kings Cross.  He wasn’t in it for the money or the glory, he just wanted to make a difference in people’s lives. He wasn’t promiscuous either. He had only one lover during his all too short life. Unfortunately that partner had a one night stand while visiting friends in San Francisco, and although he didn’t become sick, “George” did.

When I first met him he had just been diagnosed with pneumocystis carinii pneumonia (PCP) a rare opportunistic infection.  And although the underlying immunodeficiency disease had not yet been identified or named, the press was already buzzing with stories of a “gay plague”.

Sadly, back then there were no medications and care was largely palliative. Essentially patients were given a terminal diagnosis and without exception they died quickly.  In the beginning, we didn’t even know it was a viral infection. However, at least this meant we could care for “George” without the Haz Mat protection suits that we were later forced to wear, by naïve, but well-meaning infection control officials.

I was with him when he died and it was calm and dignified although the disease had taken its toll and he was no longer recognizable as the vibrant young man in the photograph on his bedside locker. Sadly, his friends and family were not there. In those early days the stigma associated with the disease was too great. His family didn’t even know that he was gay. I heard later that his partner had told “George’s” mother that he’d died from cancer.

In the thirty years that have passed since the first CDC warning, millions of lives have been touched by AIDS and much has happened in the fight against it,  yet we still don’t have a vaccine to prevent it or a definitive cure.

Since AZT, the first antiretroviral drug, was introduced in 1987, and particularly since the commencement of treatment through a regime involving a cocktail of drugs- so-called highly active antiretrovial therapy (HAART)- in 1996, outcomes have improved so much that HIV is no longer regarded as a death sentence.

Instead, with the initiation of- and adherence to- the right treatment, HIV is viewed as a chronic but manageable condition.

What does the future hold?

Today there are 33 million people living with HIV/ AIDS , so HIV must remain a global health funding priority. The new head of the International AIDS Society, Bertrand Audoin, has called for investment, both scientific and financial, in pursuing a cure for HIV. Audoin, however, acknowledges that any cure could be 25 years away. On-going research is investigating potential HIV vaccine candidates, as well as microbicides that may allow HIV negative people to protect themselves from the virus. There is also compelling evidence emerging that early initiation of treatment can play a role in curbing the onward transmission of the virus, the concept of treatment as prevention.

Still, the key message remains one of prevention. Even the advances in treatment, and the increased availability of medication, do not address the fact that for every person who starts treatment, two more are newly infected with HIV. Basic HIV education is vital for the prevention of transmission in all its forms, enabling those who do not have HIV to protect themselves from infection.

“George” this blog’s for you. You may not have lived long enough to fulfill all your dreams, but you certainly made a difference to my life.

A Big “Clap” for the FDA

Sexually transmitted diseases (STDs) have always been a bit of a taboo subject.  Especially it seems among the FDA.   In a joint initiative with the Federal Trade Commission (FTC), the Agency has just sent warning letters to more than a dozen companies selling non-prescription products that claim to treat STD’s such as herpes, chlamydia, genital warts, HIV, and AIDS.

Despite names such as Medavir, Herpaflor, Never An Outbreak and C-Cure, the FDA says that none of the products have been proven to prevent, treat or cure any disease.  In fact, say FDA scientists, the products are a public health hazard because patients could waste time taking them and delay seeking medical care.

A full list of the companies and products involved can be found here.

These products, sold both online and in retail outlets, often claim to be supported by research. A website for Medavir, made claims the product “has been proven effective in several official university research studies, including an official FDA trial.”

Similarly, Arenvy Laboratories’ website for ImmuneGlory touts the product as “the ultimate herpes outbreak solution” and claims the product “strengthens your immune system so that herpes or cold sores have nowhere to hide.”

However, the Agency says that is has never approved any non-prescription products for sexually transmitted diseases.  Drugs are available for herpes, chlamydia, HIV and other diseases, but only via prescription.

These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available,” said Deborah Autor, FDA Director of Drug Compliance.

Companies cited by the FDA will have 15 days to take their products off the market. If they do not, the agency can take legal action, including seizing products and taking company officials to court.

Additionally, under the FTC Act it is illegal to make such unsubstantiated treatment claims.

These companies are on notice that advertising health benefits that are not supported by rigorous scientific evidence violates the FTC Act,” said David Vladeck, Director of the FTC’s Bureau of Consumer Protection. “They also should know that health scams that endanger public health will not be tolerated.”

While we wait with baited breath to see if the companies will comply, Word on Health cautions its readers that appropriate treatment of STDs can only occur under the supervision of a health care professional.

Nonprofits Calls on America to Expand Health Research

Policymakers and public health experts from across the globe gathered on Capitol Hill this week to call on the United States to bolster its commitment to fighting the deadly diseases that afflict the developing world.

Organized by the Global Health Technologies Coalition, the briefing featured a panel discussion in which participants explained how vaccines, drugs, diagnostics, and devices can catalyze improvements in a country’s health infrastructure. Panelists also examined how the U.S. can assure that residents of the developing world have a voice in the development and use of new health tools.

“Thanks to U.S. investment and innovation, undeniable progress has been made in preventing, diagnosing, and treating conditions like HIV/AIDS, malaria, tuberculosis, and other neglected tropical diseases,” said Jana Armstrong, Executive Director of the Drugs for Neglected Diseases initiative North America, “But the fight against infectious disease is by no means won. American leaders in both the public and private sectors must recommit to this fight.”

Word on Health agrees, but wonders why the pharmaceutical and biotech industry wasn’t invited to the party. The Global Business Coalition on HIV/AIDs, Malaria and Tuberculosis (GBC) was created to turn business assets into disease-fighting assets and has been pivotal in joining the corporate sector, governments and civil society together in common cause. Many pharmaceutical and biotech companies are members of GBC and have done outstanding work in this area. If you work for one of them, we’d love to hear from you.

A banana a day keeps HIV away?

Yes, you read that right, and no, this isn’t our attempt at an early April Fool’s day story.  Your favorite fruit really might be even healthier for you than you thought.

Scientists have discovered that bananas may hold the key to preventing sexual transmission of HIV. Researchers from the University of Michigan Medical School have shown that a chemical found in bananas is better at preventing HIV than two current synthetic anti-HIV drugs.

The miracle substance is called BanLec, a type of lectin.

BanLec, works by binding to the sugar-rich envelope that encases the HIV virus and blocks its entry into the body.  BanLec could therefore be incorporated into a vaginal ointment and could be self-applied before sexual contact.  Researchers believe it would be much cheaper to produce and distribute than most current anti-retroviral medications which require the production of synthetic components.

One thing’s for sure: new ways of stopping the transmission of HIV are desperately needed. “HIV is still rampant in the U.S. and the explosion in poorer countries continues to be a problem” said study senior author Professor David Marvovitz, M.D.

Condoms are effective, but they are often used incorrectly or inconsistently.

Although clinical use of BanLec is probably years away, researchers believe that even modest success could save millions of lives. They estimate that if as little as 20% of the “at risk” population used a drug that is only 60 percent effective against HIV, it could still prevent up to 2.5 million infections over the course of three years.

It’s been more than two decades since HIV and AIDS began sweeping the globe, during which time hundreds of billions of dollars have been spent on research and the elusive hunt for a vaccine or a cure.  Who’d have thought  that the answer may have been literally hanging in front of us all this time?