FDA Warnings Not Heeded Equally

By Kristina Fiore, Staff Writer, MedPage Today
Published: January 23, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

The attention paid to FDA notices about drug risks appears to be highly variable, with some notices having a wide impact and others garnering a delayed response or none at all, researchers found.

In a review of the literature, serious adverse event warnings appeared to be most heeded of all FDA communications, but response still varied depending on the drug, Caleb Alexander, MD, of the University of Chicago, and colleagues reported in Medical Care.

For instance, use of rosiglitazone (Avandia) fell tremendously after an FDA warning about cardiovascular events associated with use of the drug

On the other hand, cautioning against the use of long-acting beta-agonists (LABAs) without inhaled controller medications didn't impact the use of those drugs in asthma, the researchers found.

"We will need a better understanding of how to make [FDA risk communications] work, and where they can go wrong," Alexander said in a statement. "And we will need more and better studies of the successes and failures of this process."

To assess the full impact of FDA risk communications on the use of drugs and other outcomes, the researchers looked at 49 studies, published between 1990 and 2010, that evaluated the success of these notices.

They divided the notices into four categories:

• Warnings about serious adverse events
• Recommendations against use in specific subpopulations
• Prevention of drug-drug interactions
• Calls for increased lab or clinical monitoring

Warnings about potential serious adverse events with specific drugs were associated with large drops in use of those agents, but the impact varied by drug, as seen with rosiglitazone versus LABAs, the researchers found.

Notices about use of drugs for certain populations tended to spill over into others, they reported. For instance, a warning about antidepressant use in children and adolescents led to declines in their use among adults as well.

"As with other public policies, FDA communications have the potential for unintended consequences," they wrote.

They also found that warnings about drug-drug interactions appeared to take a long time to be put into practice. Several studies found the largest declines in cisapride (Propulsid) co-prescribing happened only after a third FDA warning, and the greatest drop in terfenadine (Seldane) co-prescribing didn't occur until 18 months after the initial notice.

Finally, there was no evidence that practitioners heeded recommendations about increased monitoring, though some may have done so transiently, Alexander and colleagues found.

Rates of glucose testing for patients on antipsychotics, for example, went unchanged after the FDA advised keeping watch for hyperlipidemia and diabetes, while rates of liver enzyme monitoring after a black box warning for troglitazone (Rezulin) increased slightly after FDA warnings, but waned again over time.

Studies that assessed provider attitudes about FDA communications generally found high levels of clinician awareness of warnings and label changes.

The researchers concluded that based on settings where incident and prevalent use were examined, notices are adopted more quickly for new patients rather than those continuing on their medication.

They also said the findings suggest that "warnings will be most effective in cases where they are specific, where acceptable alternatives are available, and where the messaging is reinforced over time."

They called for more research on factors associated with fast and sustained responses to risk communications, and continued work on characterizing the effects of advisories and warnings on a variety of behaviors "to enhance the science of risk communication regarding prescription drugs."

The study was limited by the heterogeneity of the included analyses and because regulatory advisories have a level of complexity that may not be fully captured by the studies.

The researchers reported no conflicts of interest.

Primary source: Medical Care
Source reference:
Dusetzina SB, et al "Impact of FDA drug risk communications on healthcare utilization and health behaviors: A systematic review" Med Care 2011.

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Experimental hepatitis C vaccine tested

Published on Monday 23 January 2012 23:44

“An early clinical trial of a hepatitis C vaccine has shown ‘promising’ results,” BBC News has today reported.

This story is based on a clinical trial that tested the dosage and safety of a newly developed vaccine against the hepatitis C virus. Researchers developed a vaccine by inserting small pieces of DNA from a hepatitis C virus into a rare form of the virus that causes the common cold. When faced with a vaccine like this, the body should mount an immune response and ‘remember’ the virus so that it can respond swiftly to any potential infections in the future. The researchers found that cells indicating immunity to the virus were present for a year in 41 healthy people who were vaccinated. This suggests that the immune system was prepared to respond if faced with the virus. None of the people involved with the study experienced significant side effects.

This was an early-stage clinical trial designed to test the safety of the vaccine rather than whether it could prevent infections. Extensive further research will now be needed to determine effectiveness, particularly whether or not it can prevent hepatitis C infections in real-life settings. Given the complexities of testing and development, it is likely to take many years before any such vaccine could enter clinical use.

Where did the story come from?

The study was carried out by researchers from the Universities of Oxford and Birmingham, and from institutions throughout Italy. The research was funded by the European Union, the UK Medical Research Council, the Wellcome Trust, the UK National Institute for Health Research and the US National Institutes of Health.

The study was published in the journal Science Translational Medicine.

The media reported on this study appropriately, with both the BBC and the Daily Mirror emphasising the early nature of the research and the fact that the possibility of a working vaccine is still several years away.

What kind of research was this?

This was a phase I clinical trial that tested the safety and tolerability of a new vaccine intended to prevent infection with the hepatitis C virus. The virus primarily affects the liver, causing inflammation and damage to the organ. It can lead to severe liver scarring (cirrhosis) and liver cancer. There are currently no vaccines available to protect against infection with hepatitis C, and treatments vary in effectiveness depending upon the specific strain of the virus causing the infection.

The Health Protection Agency estimates that more than 200,000 people have the disease in the UK, and that many carry the virus without knowing it. Approximately 20% of people infected with the virus have a natural immunity to it and will clear the virus within the first six months after infection, before the disease is considered to be chronic. Among those who develop chronic hepatitis C, most can clear the infection with the help of drugs, although not all respond to treatment and some remain chronically infected. As a blood-borne virus, it is particularly common among intravenous (IV) drug users.

The development of an effective vaccine would be invaluable, as the World Health Organization estimates that around 130-170 million people around the world have chronic hepatitis C, and therefore could pass the infection on. Certain countries are also reported to have very high rates of hepatitis C, with around 22% of the Egyptian population having a chronic infection.

Phase I clinical trials are conducted in small groups of healthy individuals, and are designed to test the safety and tolerability of new drugs and therapies. They are not designed to test the effectiveness of new treatments, although the results are used to determine the dosing regimen that should be used in future studies. Such small, early studies are required before larger, longer-term research can be conducted to assess the effectiveness of the therapy.

What did the research involve?

The researchers made the vaccine by inserting small pieces of DNA from the hepatitis C virus into a rare form of the virus that causes the common cold. They injected 41 healthy volunteers with the vaccine, and collected data on any side effects, as well as the scale and duration of the immune response. Two rounds of the vaccine were given – an initial priming dose and a subsequent boosting dose four weeks later.

They first conducted ‘dose-escalation’ studies to determine the size of vaccine dose that produced an optimal immune response. The researchers divided the volunteers into groups of four or five people, with each group being given a different dose of the vaccine. They assessed the immune response and tolerability of the vaccine at each of these increasing doses.

The researchers also assessed, in laboratory experiments, whether the immune responses would hold against different strains of the hepatitis C virus, including the strain most commonly affecting European IV drug users (a group that is at highest risk of hepatitis C infection in the UK). To do this they took a blood sample from the study participants, challenged the blood cells with proteins found in different strains of the virus, and analysed the immune response. This was done using laboratory tests. No participants were exposed to these viruses.

What were the basic results?

The researchers found that there were no serious side effects associated with the vaccine. They observed mild side effects that increased at higher doses, but they were short lived.

The researchers determined an optimal dose for the vaccine, and found that the immune response elicited by this dose was similar to that seen in people who have a natural immunity to the hepatitis C virus. They were able to detect this immune response up to a year after vaccination.

They found that the vaccine elicited an immune system response to multiple hepatitis C strains, including the strain that is most common to European IV drug users. The immune response to this strain was, however, approximately only 20% of the response seen to the strain used in the vaccine. Despite this lower response level, this was still higher than the response seen in control subjects not given the vaccine. This indicates that the vaccine did in fact produce some immune response against a common European strain of the virus.

How did the researchers interpret the results?

The researchers say that this study indicates that the vaccine can induce a sustained immune response to the hepatitis C virus, and that further clinical studies into its use as a preventative and therapeutic agent are needed. The next step, they say, is to test it in a setting where exposure to the hepatitis C virus is common, such as in IV drug users, which could help test whether the immunisation is an effective vaccine.

Conclusion

This was a small, early-stage human study into a new vaccine against the hepatitis C virus. While such research is required to determine the safety profile of a new therapy, little information on the effectiveness of the vaccine can be gleaned from the study.

Phase I clinical trials are designed to determine the optimal dose of a new therapy, and to assess the safety and tolerability of treatments. This study shows that the developed vaccine is well tolerated and safe to use, and the preliminary results indicate that the immune response may be similar to that of people with a natural immunity to the virus.

In addition to the small study size and the focus on safety and not effectiveness, there are other practical limitations to the study that should be considered before it is concluded that a preventative vaccine against hepatitis C will be available, even in the next several years:

• Further research is needed to determine whether the vaccine will be effective over a longer period than a year.
• The researchers say that the specific strain of the hepatitis C virus used in the vaccine is common in the US, but that it is not the most common strain in the UK. This may limit how useful any future vaccine is in this country.
• The researchers point out that there are difficulties surrounding the design and execution of future trials, as the virus is common to specific subgroups of people. Future trials will need to be conducted in high-risk groups in whom the predominant virus strain is the same as the strain used to develop the vaccine.

All in all, this was an important initial study into the development of a vaccine against a virus that is difficult to detect and treat. As this was an early-stage study, it will be several years before it could potentially result in an available vaccine.

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New Hepatitis C Regimen Stimulates Changes in Therapy Management

Costly protease inhibitors work well in many patients, but call for careful monitoring

Thomas Reinke

Contributing Editor

In less than a year, two new protease inhibitors — telaprevir (Incivek) and boceprevir (Victrelis) — have changed the standard of care for hepatitis C by introducing a new mechanism of action, but their significance goes beyond that.

They are the first new medications for the disease in 10 years and they have brought dramatic improvements in outcomes by knocking out this infection in many more patients, including previous poor responders. They have also complicated care by adding a third agent to the previous standard regimen of two agents.

The new agents are examples of how therapy management for new and costly medications is moving from traditional utilization and outcomes management to more sophisticated strategies. The focus on adherence and medication possession rates is giving way to patient selection criteria and close monitoring of clinical results.

Approximately 3.9 million people in the United States have chronic hepatitis C virus (HCV) infection, and about 5,000 acute cases surface annually.

Boceprevir and telaprevir are direct-acting agents that block the growth of viruses by directly disrupting essential viral functions. They were approved only as supplements to the previous standard treatment, a combination of ribavirin (Rebetol, Copegus) plus peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron).

Both are also approved only for use in one subset of patients: genotype 1 patients. HCV has at least 6 genotypes and 50 different subtypes, with genotype 1 being the most common.

In trials, the new drugs increased cure rates, known as sustained viral response (SVR) rates, by 30 to 40 percentage points over control groups receiving peginterferon and ribavirin. SVR means that no HCV is detected in the blood.

For telaprevir in one study, a SVR at 24 weeks was achieved in 75 percent of patients, compared with 44 percent for control patients. For boceprevir, in one study the success rate for triple therapy was 66 percent, compared with 38 percent for control patients.

Based on these results, the American Association for the Study of Liver Diseases updated its clinical guidelines to recommend triple therapy with a protease inhibitor, interferon, and ribavirin as the standard of treatment for hepatitis C.

“The hope for improved outcomes produced an immediate demand for these medications,” says David Lassen, PharmD, chief clinical officer of Prime Therapeutics, a pharmacy benefit manager. “Previously the utilization of medications used to treat hepatitis C was on the decline, causing an overall decrease in the pharmacy cost trend over time. With the entrance of these two new agents, we have seen a significant increase in drug trend driven by increased use and cost.”

Doubling the cost of HCV management

An article in the November 2011 issue of the Journal of Managed Care Pharmacy by Prime’s pharmacy experts says that the new regimen will more than double the cost of HCV management. Telaprevir costs $49,200 for its 12-week regimen. The required peginterferon and ribavirin add $17,175 for 24 weeks and $34,349 for 48 weeks of therapy.

Boceprevir costs $26,410 for a 24-week duration and $35,213 for 32 weeks. Peginterferon and ribavirin add $20,037 or $34,349 to the total.

Complexities

The protease inhibitors add to the complexity of treatment for hepatitis C. Poor response and anemia were problems with the previous peginterferon-ribavirin regimen.

Anemia has increased significantly with the new agents. In studies of telaprevir it increased from 17 percent to 36 percent, and in studies of boceprevir it increased from 20–30 percent to 45–50 percent. The increased anemia may stimulate more frequent therapy with erythropoiesis-stimulating agents, further driving up costs.

The new agents have many drug interactions, including conflicts with statins, and there are new side effects, such as the skin rash that is associated with telaprevir. This is in addition to flu-like symptoms that are associated with peginterferon.

There are other implications for the new medications. Both have demonstrated success and are approved for use in poor responders, so the demand for the new agents may spike until this cohort is resolved.

The new regimen requires monitoring of viral loads at specific points, and there are parameters for discontinuing therapy when treatment is futile.

Lassen says that Prime Therapeutics planned ahead to be able to handle the protease inhibitors. “In anticipation of the approvals we took a step back to revise our management strategies to be sure we could capitalize on the value of these medications in an evidence-based manner,” he says.

Prime Therapeutics made significant changes in its utilization and therapy management activities. It expanded the patient-specific data it captures. For initial authorizations, it asks about comorbidities such as HIV/AIDS and about the extent of liver disease. It also asks about previous treatments with protease inhibitors for HCV.

For renewing authorizations, the company is going further. “We are looking at the viral load component to ensure that the therapy is on track because some of the patients are not naïve to treatment,” says Lassen. Providers are asked to report the specific HCV RNA levels from lab tests at 4 or 12 weeks, depending on which new drug is being used.

While Prime, like other PBMs and even health plans, is interested in capturing more clinical data to improve its quality and cost management, Lassen emphasizes that this has to be done appropriately. “We were careful and thoughtful in our approach. Any request for additional information as part of prior authorization or utilization management can have a negative impact on providers.”

He adds: “It is also important that requests like lab results as part of renewals do not interrupt therapy. There can be legitimate delays in getting tests done, and we make it a point to provide continued coverage while tests are being arranged.”

For health plans

The protease inhibitors are game changers in the treatment of hepatitis C — the first new medications in 10 years with a new mechanism of action.

“Triple therapy is complex, “Lassen says. “Patients cannot be switched to a different agent once a course of therapy is started, and it is critical that therapy be completed. Up front, you need a clear set of criteria for patient selection, and then there needs to be close monitoring and a clear set of supportive care activities as patients move through therapy.”

How well did that new drug work?

Health plans and PBMs are collecting more patient-specific clinical data as part of their prior-authorization and therapy management. These data are increasingly important in ensuring the appropriate use of new, more complex, targeted medications.

The questions below are asked by Prime Therapeutics, a pharmacy benefit manager owned by several Blue Cross Blue Shield plans, when a renewal authorization is being considered for telaprevir (Incivek) and boceprevir (Victrelis). HCV RNA results indicate the level of hepatitis C infection and the progress of therapy.

The questions are taken from the prior-authorization form used by Blue Cross Blue Shield of Texas.

Source

Study finds the love of a dog or cat helps women cope with HIV/AIDS

January 23, 2012

A spoonful of medicine goes down a lot easier if there is a dog or cat around. Having pets is helpful for women living with HIV/AIDS and managing their chronic illness, according to a new study from the Frances Payne Bolton School of Nursing at Case Western Reserve University.

"We think this finding about pets can apply to women managing other chronic illnesses," said Allison R. Webel, instructor of nursing and lead author of the article, "The Relationship Between Social Roles and Self-Management Behavior in Women Living with HIV/AIDS," which appears in the online journal Women's Health Issues.

Webel set out to better understand how women manage their HIV/AIDS and stay on track to take their medications, follow doctors' orders and live healthy lifestyles. She conducted 12 focus groups with 48 women to find out what they did to stay healthy. The women had an average age of 42, about 90 percent had children, and more than half were single.

During the focus groups, six predominant social roles emerged that helped and hindered these women in managing their illness: pet owner, mother/grandmother, faith believer, advocate, stigmatized patient, and employee. All roles had a positive impact except stigmatized patient, which prevented women from revealing their illness and seeking out appropriate supports.

"Much information is available about the impact of work and family roles, but little is known about other social roles that women assume," Webel said.

Being a pet owner was an important surprise, added Webel, who collaborated with co-author Patricia Higgins, a professor of nursing at Case Western Reserve University.

"Pets—primarily dogs—gave these women a sense of support and pleasure," Webel said.

When discussing the effect their pets have on their lives, the women weighed in. "She's going to be right there when I'm hurting," a cat owner said. Another said: "Dogs know when you're in a bad mood…she knows that I'm sick, and everywhere I go, she goes. She wants to protect me."

The human and animal bond in healing and therapy is being recognized, Webel said, as more animals are visiting nursing homes to connect to people with dementia or hospitals to visit children with long hospital stays.

Being a pet owner is just one social aspect of these women's lives. "We found the social context in which this self-management happens is important," Webel said.

Another strong role to emerge was advocate. Participants wanted to give back and help stop others from engaging in activities that might make them sick, the researchers report.

While roles as mothers and workers are well documented, "less-defined social roles also have a positive impact on self-management of their chronic illness," Webel said.

Provided by Case Western Reserve University (news : web)

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High Prevalence of Hep B in Cambodia: Doctor

Monday, 23 January 2012

Soeung Sophat, VOA Khmer | Washington, DC

Hepatitis B, a disease that attacks the liver, has high prevalence in Cambodia, but there are now a number of drugs to treat it, a US doctor said Thursday.

Taing Tek Hong, a Florida-based physician, told “Hello VOA” that the US Food and Drug Administration has approved the following drugs to treat hepatitis B: Interferon alpha-2b, Peg Interferon alfa-2a, Lamivudine (Epivir-HBV), Adefovir (Hepsera), Entecavir (Baraclude), Telbivudine (Tyzeka), Tenofovir (Viread).

In 2002, as many as 13 percent of Cambodian blood donors tested positive for the antigen of the Hepatitis-B virus, he said. Another study showed prevalence of around 12 percent for people aged 20 to 35.

Chronic infection affects most infants, around a third of infected children below age five and around 6 percent of anyone affected age six and above, he said. Chronic infection leads to death in around 15 percent to 25 percent of patients, he said.

“Hepatitis B can be transmitted by sexual contact, sharing of needles and syringes contaminated with infected blood, accidental needle sticks, or mother to child,” Taing Tek Hong said. “Risk factors include unprotected sex with more than one partner, unprotected sex with someone who’s infected with HBV, having a sexually transmitted infection, such as gonorrhea or chlamydia, men who have sexual contact with other men, and sharing needles during IV-drug use.”

Other risks include living in a household with someone with a chronic infection, working where exposure to blood is common, receiving dialysis or traveling to regions like Africa, Central and Southeast Asia and Eastern Europe, he said.

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Your liver is for life - so treat it well

Vicky Fenton and Dr Alexander Grimson

As the Love Your Liver roadshow hits the streets of the UK health correspondent Rachel Allen finds out why liver disease – one of the UK’s biggest killers – is rising each year.

THE biggest misconception of liver disease (cirrhosis) is that it is automatically associated with alcohol abuse.

Of course alcohol is the biggest culprit – accounting for 35 per cent of all cases – but it can also develop from hepatitis viruses (25 per cent of all cases), non-alcoholic fatty liver disease, which is linked to obesity (20 per cent), autoimmune liver diseases (10 per cent) and genetic disorders and other rare causes, also 10 per cent.

Obesity is the other big offender – something which people often forget about despite the number of health problems it leads to.

In a bid to combat the rising numbers of cirrhosis cases, which lead to 4,000 deaths a year, The British Liver trust has launched a Love Your Liver Campaign for January – the first of its kind.

Dr Alexander Gimson is a consultant physician and hepatologist at the Liver Unit at Addenbrooke’s and he’s keen to emphasise the importance of taking care of your liver.

He said: “Cirrhosis is the name given by doctors to a certain pattern of scarring within the liver which eventually damages the liver’s functions, which progressively fail over a number of years and may eventually be fatal.

“Compared to most other major conditions like heart disease and cancer, liver disease continues to be a major cause of death in this country.

“It’s increasing, whereas the number of people dying from heart disease and cancer is getting less and less.

“Also, deaths from liver disease continue to rise in this country in contrast to reductions in Europe.

“People need to be aware that obesity causes liver disease, not just alcohol abuse.

“Obesity is prevalent in about one in five of the population and that can be associated with diabetes and, less well known, with cirrhosis.”

And some people are afflicted with liver disease due to rare genetic conditions – like Vicky Fenton.

The 34-year-old mother-of-two was diagnosed with primary sclerosing cholangitis (PSC), an autoimmune liver disease, as a child.

In autoimmune diseases the patient’s own immune system starts to attack their organs – in some cases the liver, resulting in inflammation and eventually cirrhosis.

She said: “It’s quite rare and more common in middle-aged men but I was critically ill when I was just 12 before I was diagnosed.

“I became really tired and got really itchy skin, which is one of the main symptoms, and I went quite yellow as well.

“I was put in isolation in Addenbrooke’s because doctors didn’t know what it was, as it was so rare.

“It was Dr Gimson who diagnosed me and has treated me ever since.

“They put me on loads of different sorts of medication at the time and gave me lots of blood transfusion and told me that one day I would need a transplant.

“I was well for years after that really. They told me I might not have children but I went on to have two daughters.

“I only went into hospital a couple of times but when I hit 30 my health started to deteriorate and I was getting more and more tired.

“I’m quite an energetic, vibrant person but I was just tired all the time.”

Vicky was put on the organ donor list in September 2010 and had a 70 per cent chance of dying within a year.

Dr Gimson said: “Everyone who goes on the transplant list has a 0 per cent chance of surviving five years without one. Some will die in the first year.”

Vicky, of Cambridge, said: “I couldn’t receive the initial liver that I was offered in December 2010 as I had started to show signs of pneumonia. It was quite difficult because I was really ill and you usually only get one chance to get a donor organ.

“It’s a really strange time, you are always waiting for the phone to ring but you are scared of having the operation at the same time. You can never relax.

“You have to think about what is going to happen to your children if you are not around and make plans in case you are not.”

However, she received a call on June 15 last year asking her to go to the hospital as another organ had become available.

She said: “I remember shaking uncontrollably. I felt relief and excitement but as I was going into theatre I kept crying uncontrollably and apologising.”

She had a long road to recovery, spending six weeks in hospital, and her body rejected the organ twice, despite being on high levels of immunosuppressant drugs.

One of the first things she did on leaving the hospital was go to the seaside with her daughters Lola, 7 and Poppy, 5.

Vicky is just one of many grateful patients who has been given a new lease of life and is passionate about making people aware of organ donation to reduce the shortage.

She said: “I just enjoy life now and live in the moment. Just enjoying being a mum and running round the park with my kids is wonderful.”

Even if you sign up to become an organ donor to save the lives of others your next of kin can refuse to release your organs. So both Dr Gimson and Vicky want to make sure people talk about the topic.

Vicky said: “Currently 30 per cent of the population are on the register but considering 98 per cent would accept an organ if needed that is such a low figure – the numbers should match.”

Dr Gimson said: “I think the problem is that it is a taboo subject.

“Nobody wants to talk about death and organ donation but if it is your wish to be an organ donor you should tell your next of kin because they may go against your wishes.”

For more information and to register visit www.organdonation.nhs.uk.

rachel.allen@cambridge-news.co.uk

Cirrhosis facts and figures

Cirrhosis is a certain pattern of scarring within the liver which eventually damages the liver’s functions, which fail over a number of years and may eventually be fatal.

Every year over 4,000 people in the UK die from cirrhosis.

Around 700 people have to have a liver transplant each year to survive.

Survival after a liver transplant is good – 90 per cent are alive after one year and 75 per cent after five years.

Causes of Cirrhosis:

• Alcohol 35%
• Hepatitis viruses 25%
• Non-alcoholic fatty liver disease
• Autoimmune liver diseases 10%
• Genetic disorders and other rare causes 10%.

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Community Health Center launches new video conferencing technology

Published: Sunday, January 22, 2012; Last Updated: Monday, January 23, 2012 12:43 AM EST

By JIM SALEMI
Press Staff

MIDDLETOWN — Community Health Center unveiled a new tool Friday that will allow it to lend the expertise of CHC HIV specialist to other CHC clinics that do not have such specialists.

Called Project ECHO Hepatitis C/HIV, is a state of the art video conferencing system that allows for multiple clinics in the CHC system to link together to share expertise and information to treat HIV and Hepatitis C patients.

The purpose of the project, according to Eliza Cole, spokeswoman for CHC, is to provide specialist support and education to help primary care teams manage cases that would otherwise be referred out to specialists.

“This system will allow us to offer specialized treatment to patients across the state, many of whom do not have access to such treatment otherwise. In many communities there are few specialists willing to accept patients without insurance or with Medicaid insurance,” Dr. Marwan Haddad, Medical Director of HIV, HCV, and Buprenorphine Services for CHC.

The system was developed by the University of Mexico originally to allow for treatment of Hepatitis C and HIV in rural areas via video-conference with a specialists. With the new video conferencing technology, CHC will be able to extend treatment to six clinics in the CHC system that do not have HIV care specialists. Those clinics include Bristol, Norwalk, Waterbury, Enfield, Clinton, and New London.

CHC offers HIV and Hepatitis C treatment at its New Britain, Meriden, and Middletown clinics.

Five of those clinics without a HIV hepatitis C specialist were linked up with a five member panel of medical, behavioral and pharmaceutical experts in Middletown in a conference room at the organization’s offices on Main Street.

A large panel, flat screen monitor hung on the wall with its screen divided into six parts. A large camera on a table under the monitor was aimed at the table where the CHC staff were seated. A microphone was at the center of the table. The staff looked at patient information on their laptops as they asked questions of health care experts at CHC locations in Waterbury, New London Clinton, Norwalk and Bristol and offered advice or asked for additional information about the patient's history, medications, psychiatric conditions, if any, and their medication regimens.

For some of the cases, financial counseling and keeping the patient on their regimens and scheduled visits seemed to be discussed as much as medical conditions.

“Some patients have a hard time following up because of costs and transportation issues,” Haddad told a physician in New London via the ECHO system while discussing a patient who skipped follow up visits.

“We need to try and correct that. The first barrier to treatment is cost or lack of insurance and transportation issues,” he told his colleague.

The program will eventually allow CHC to expand access to care for other conditions, such as diabetes, asthma and chronic pain management, Cole said.

The CHC Project ECHO Hepatitis C/HIV program is funded in part by a grant from The Mayday Fund and Vertex Pharmaceuticals Inc., in support of the ‘Hep-C Circle of Care’ program.

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