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In This Issue:
Lucinda K. Porter, RN
Disability & Benefits: How Private Are My Medical Records?
Jacques Chambers, CLU
HealthWise: The Power of Support Groups
Lucinda K. Porter, RN
HCV Advocate Eblast
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HCV Snapshots: EASL 2012
—Lucinda K. Porter, RN
There were many exciting presentations at the 2012 meeting of the European Association for the Study of the Liver (EASL), including eight all oral, interferon-free regimens in clinical testing to treat chronic hepatitis C virus infection (HCV). This month’s HCV Snapshots looks at some of these Phase 2 studies. There were also some excellent studies using regimens that included peginterferon. In short, the future for HCV patients looks bright.
Important note: The research results presented here were gathered from conference posters and presentations, representing part of the story. There are many factors that influence treatment outcomes–such as the number of patients in the study, patient demographics (weight, age, ethnicity), and study design (inclusion criteria, placebo vs. open label, etc.)–to name a few. Unless and until these studies are published in a peer-reviewed journal, these data and conclusions are considered preliminary.
A huge thank you to Jules Levin of NATAP for his constant presence and commentary on the latest research.
For more information about these and other presentations, visit www.hcvadvocate.org/news/EASL_2012.html
Poster: Once Daily GS-7977 Plus Ribavirin in HCV Genotypes 1-3: The ELECTRON Trial – Gane E, Stedman C, Hyland R, et al.
Gilead Sciences’ GS-7977 is a polymerase inhibitor specifically developed to treat HCV. This research studied safety and efficacy of GS-7977 in a variety of situations:
Treatment-naïve genotype (GT)1 patients treated for 12 weeks with GS-7977 + ribavirin (RBV) (25 subjects–88% GT1a) Results: 88% of treatment-naïve GT1 patients had non-detectable virus 4 weeks after the end of treatment
Treatment-naïve GT3 patients treated with GS-7977 + RBV + peginterferon (PEG) for 8 weeks (10 subjects). Results: 100% of treatment-naïve GT3 patients had non-detectable virus 12 weeks after the end of treatment
Prior null responder GT1 patients treated for 12 weeks with GS-7977 + RBV (10 subjects). Results: Only 1 of 10 subjects had non-detectable virus 4 weeks after the end of treatment
Previously treated GT 2/3 patients treated for 12 weeks with GS-7977 + RBV (25 subjects). Results: 80% of treatment-naïve GT 2/3 patients had non-detectable virus 4 weeks after the end of treatment
GS-7977 was well-tolerated and showed a favorable safety profile. The majority of side effects occurred in the arm that used PEG. No virologic breakthrough occurred in any arm, suggesting a high barrier to resistance.
Editorial Comment: These data are exciting but small. Also, we need to see at least 24 weeks of follow-up data to see how durable these response rates are. An all-oral, 12-week HCV treatment with low risk of resistance is a fabulous regimen to hope for, and perhaps we will know more soon as Phase 3 studies have begun for GS-7977.
Poster: A 12-Week Interferon-Free Regimen of ABT-450/r + ABT-333 + Ribavirin Achieved SVR12 in More Than 90% of Treatment-Naïve HCV Genotype-1-Infected Subjects and 47% of Previous Non-Responders – Poordad F, Lawitz E, Kowdley K, et al.
This study assessed the safety and tolerability of Abbott test compounds: ABT-450/r (an HCV protease inhibitor with ritonavir) and ABT-333 (a polymerase inhibitor) tested with ribavirin. There were 3 arms. Arm 1 (19 subjects) and 2 (14 subjects) included treatment-naïve subjects with 2 different dosing regimens. Arm 3 had 17 prior non-responders. Treatment was for 12 weeks and the follow-up period was 24 weeks.
93-95% of treatment-naïve subjects achieved SVR; 100% of non-CC IL28B subjects achieved SVR. 47% of previous non-responders achieved SVR. Generally, side effects were well tolerated. One subject was discontinued early due to adverse events; four others had severe adverse events but completed the study. These events were high bilirubin, fatigue, pain, and vomiting.
Editorial Comment: These data are small but the 24-week SVR data is incredibly encouraging.
Poster: A 12-Week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naïve HCV IL28B-CC Genotype-1-Infected Subjects –Lawitz E, Poordad F, Kowdley K, et al.
This small study enrolled 11 non-cirrhotic, treatment-naïve HCV GT1 subjects with host IL28B “CC” genotype from multiple ethnic backgrounds. The objectives were to assess the safety and tolerability of Abbott test drugs: ABT-450/r (an HCV protease inhibitor with ritonavir) and ABT-072(a polymerase inhibitor) plus ribavirin for 12 weeks.
Although everyone responded to treatment, one subject relapsed post-therapy at week 8, and another at week 36. There were no other relapses 48 weeks post-therapy. The regimen was well-tolerated with mild adverse events.
Editorial Comment: This very small study is encouraging except for the disturbing fact that a subject relapsed 36 weeks after treatment. Need more information before drawing conclusions, but may imply that we need longer follow-up from these clinical trials to evaluate durability of SVR.
Poster: SVR4 and SVR12 with an Interferon-Free Regimen of BI 201335 and BI 207127, +/- Ribavirin, in Treatment-Naïve Patients with Chronic Genotype-1 HCV Infection: Interim Results of SOUND-C2 – Zeuzem S, Soriano V, Assehlah T, et al.
This study of safety and tolerability of Boehringer Ingelheim’s BI 201335 (a protease inhibitor) and BI 207127 (a polymerase inhibitor), with and without ribavirin, enrolled 362 GT1 treatment-naïve cirrhotic subjects. They were randomized into five arms with varying regimens of doses, combinations, and durations.
Up to 43% of GT1a and 71% of GT1b subjects achieved SVR. Treatment was well-tolerated, with less than 10% discontinuing due to side effects.
Editorial Comment: These are good sample sizes for Phase 2 data, although a larger sample is still needed to determine efficacy. An interferon-free treatment that is effective for HCV patients with cirrhosis is a high priority and these test compounds are worth keeping a close watch on.
Poster: Dual Oral Therapy with NS5A Inhibitor Daclatasvir (BMS-790052) and NS3 Protease Inhibitor Asunaprevir (BMS-650032) in HCV Genotype 1b-Infected Null Responders or Patients Ineligible/Intolerant to Peginterferon/Ribavirin – Suzuki F, Ikeda K, Toyota J, et al.
This study enrolled 21 previous non-responders and 22 patients who were previously ineligible/intolerant to PEG/RBV. Safety and tolerability of Bristol-Myers Squibb’s daclatasvir (NS5A inhibitor) and asunaprevir (a protease inhibitor) was tested.
The overall SVR rate was 77%. Although generally well- tolerated (fewer side effects than with PEG/IFN), 5 patients had 6 serious adverse events, with 3 early discontinuations; 3 subjects developed resistance.
Editorial Comment: Although this is a small sample size, these data are encouraging as they target a difficult to treat population.
Poster: All-Oral Combination of Investigational Hepatitis C Compounds Daclatasvir and GS-7977 Achieved Sustained Virologic Response (SVR4) in 100% of Genotype 1 and 91% of Genotype 2 and 3 Treatment-Naïve Patients in Phase II Study – Sulkowski M, Gardiner D, Lawitz E, et al.
This study assessed the safety and tolerability of Bristol-Myers Squibb’s daclatasvir (NS5A inhibitor) and Gilead’s GS-7977 (a polymerase inhibitor). There were six study arms, two using RBV along with GS-7977 and daclatasvir.
In the GT1 treatment groups, 100% (44 subjects) had non-detectable virus 4 weeks after the end of treatment
In the genotypes 2 and 3 treatment groups, 91% (40/44) had non-detectable virus 4 weeks after the end of treatment
The medications were well-tolerated, with mild side effects including fatigue, headache and nausea. No one terminated treatment because of side effects.
Editorial Comment: These data intrigued me. Again, the numbers are small and we need to see 24 weeks of follow-up data to assess durability of these response rates. There are rumblings of difficulties between the two pharmaceutical companies, which may impede further research. A number of variables, too vast to discuss here, complicate the issue. For interesting reading, check out Nathan Sadeghi-Nejad’s The Street
Final Note: Data using alisporivir (a cyclophilin inhibitor) was presented, but research is on-hold due to death of a subject and risk of pancreatitis.
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Disability & Benefits: How Private Are My Medical Records?
—Jacques Chambers, CLU
People who are dealing with a serious, chronic infection such as HCV are concerned about their health and what the future holds for them. They are also concerned about the privacy of their medical records. “Who can learn about my infection?” “How easy is it to get a look at my medical records?” “If my insurance comes through my employer, can my employer see what claims have been submitted and what they were for?” “Can I lose my job if they know of my condition?”
Fortunately, some of the strictest laws regarding confidentiality of information are directed at the protection of the privacy of medical records. Virtually all states have their own statutes regarding limits on the accessibility of an individual’s medical records. Even the American Medical Association (AMA) Code of Ethics emphasizes the importance of confidentiality of medical records. In 1996, with the passage of the Health Insurance Portability and Accountability Act (HIPAA), the confidentiality of medical records was further strengthened nationwide.
Of course, that’s not the end of the story. Laws are fine, especially laws such as HIPAA that have fairly severe penalties for non-compliance. However, humans have control over medical records and humans have flaws, which can result in unauthorized release of medical records. Fortunately, it has been kept to a minimum, and you are an important part of keeping them confidential.
But first, let’s get the legal issues out of the way and take a look at HIPAA and see just what it does about medical confidentiality. The Department of Health and Human Services (HHS) implemented its requirements under what it called the Privacy Rule. Enforcement of the Privacy Rule is handled by the HHS Office for Civil Rights (OCR).
HIPAA directly applies to:
Health Plans – All health plans, whether individual or group, including health, dental, vision, Health Maintenance Organizations (HMOs), Medicare, Medicaid, Medicare Advantage Plans, Medicare supplement (Medigap) plans and long term care plans.
Health Care Providers – Every health care provider who electronically transmits health information is a covered entity, including institutional providers such as hospitals or nursing homes, and providers of medical or health services, such as doctors, dentists, or pharmacists.
Health Care ClearingHouses – These are groups that are ancillary to health care providers that process information such as billing services, and health management information systems and other medical support services.
HIPAA protects “individually identifiable health information,” which it calls “protected health information (PHI)” and includes:
Information your doctors and other health care providers enter into your medical record;
Any conversations you have with your health care providers;
All information your health insurer has in their records; and,
Billing information about you in your providers’ records.
Even without a current, HIPAA-approved authorization to release protected health information signed by you, there are occasions where such information can be released:
Medical treatment to other medical providers treating you or for medical consultations about your course of treatment, although there are special restrictions on the release of psychotherapy notes;
With your informal permission to your family, relatives, friends or other persons whom you identify; or,
Public interest or public benefit such as public health activities, victims of mistreatment, medical oversight activities, judicial proceedings, law enforcement purposes, research, and other essential government functions.
Workers’ Compensation information when required by state law.
Generally, however, you, the patient, must sign a HIPAA-approved authorization to release protected health information before a physician can release your records to insurance companies, Social Security and others you may designate. The law specifies what must be in such a release and virtually all medical services use a version of one.
There are three main areas where people are most concerned about the release of their medical records.
Medical records and your credit report
People are often concerned about whether medical bills can show up on your credit report, and the answer is yes they can. Medical bills are like any other debt, and nonpayment by either you or your insurance company can be reported to the credit bureaus. HIPAA itself permitted the report to include not only the amount of the unpaid bill, but the name and address of the medical provider owed. But the names of the providers could give clues to the type of medical treatment and condition.
However, changes to the Fair Credit Reporting Act, prohibit revealing the medical provider’s name, address or telephone number, so only the size of the debt is shown on credit reports. Therefore, the only information that can be disclosed to a credit bureau is: your name and address, your date of birth, your Social Security number, payment history, and account number.
An interesting aside: Over half of all collections on credit reports are for unpaid medical bills.
Another needless concern is that the government has a database or other mechanism that collects your medical information. There is no mandate which obligates doctors and other medical providers to provide such information. For government entities that may need your medical information, such as the Social Security Administration, they have their own HIPAA-approved authorization you must sign before they can obtain it.
Note: State law may permit that medical records due to on-the-job injuries be required to be submitted for workers’ compensation claims.
Your employer and your medical records
The largest concern, by far, is what an employer can access, especially if your health insurance comes through your employment. Obviously, the employer has a right to see enrollment and disenrollment information from the insurer. In addition, if requested by the employer (or union or other plan sponsor), the employer has a right to “Summary Health Information,” primarily for the purpose of obtaining bids for the insurance plan or to amend the plan. That information summarizes claims history, claims expenses, or types of claims experience of the individuals covered in the plan, provided that the information is stripped of all individual identifiers other than the five-digit zip code.
Employers are unable to learn who had what claim and what it was for. If an employer should attempt to acquire more detailed information from the insurer, a HIPAA-approved authorization to release information is required.
However, large employers don’t buy health “insurance.” They self-fund; they pay the medical claims themselves. Whether they hire an outside claims administrator or pay the claims in-house, all of the documents and records are legally owned by the employer. An employer that is also the insurer of the health plan is a “hybrid entity” under HIPAA. Hybrid entities are required to:
Give notice of privacy procedures in writing to everyone covered;
Have a written policy restricting the use of health information;
Appoint a privacy officer and train all staff; and,
Erect “firewalls” between the portion of the company that handles the health claims and the portion that does not.
Experience since HIPAA’s inception indicates that employers are willing and even eager to build strong firewalls. They not only protect your medical information, they also protect the employer from claims of discrimination on the basis of medical condition or expenses incurred.
HIPAA also gives you rights as well. Health insurers and health providers covered under HIPAA must give you the right to:
Receive a notice explaining how your medical records can be used;
Ask to review and obtain a copy of your medical records;
Add any correction to your health information;
File a complaint with your health care provider, your health insurer, or the federal government.
HIPAA provides for both civil money penalties as well as criminal penalties for improperly disclosing individually identifiable health information. Criminal penalties can result in fines of up to $250,000, or even higher, and up to ten years imprisonment for wrongful conduct involving false pretenses, intent to sell, or for malicious harm. Criminal sanctions are enforced by the US Department of Justice.
HIPAA goes to great lengths to protect your medical information, however, laws are only perfect when abided by totally, which does not always happen in the real world. Perhaps, you remember when personnel at a major Los Angeles medical center accessed celebrity medical records to market them to tabloids. They were all terminated or severely disciplined.
In another case, a hospital, attempting to respond to charges against a complaining patient, released the patient’s medical records to journalists and sent an email about her treatment to the 785 hospital employees. Another clear violation of HIPAA that was punished.
While these are unlikely events, especially if you aren’t a celebrity, HIPAA is unable to stop all gossip and speculation about medical conditions. It is also unable to control the most likely source of that medical information. That is the patient him or herself, the family, and the friends in whom the patient confided. The majority of claims that an employer illegally obtained your medical information usually result in a finding that the patient herself confided information to a close co-worker or two who promised not to pass it on.
For more information on HIPAA, see: www.hhs.gov/ocr/privacy
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HEALTHWISE: The Power of Support Groups
—Lucinda K. Porter, RN
“It takes community to maintain a human.”
- Earon Davis
This newsletter and the Hepatitis C Support Project (HCSP) exist because Alan Franciscus wanted to attend a support group following a diagnosis of chronic hepatitis C virus infection (HCV). Living in the San Francisco Bay Area in the 1990’s, Alan was aware of health-based support groups for people with HIV and breast cancer. Yet, there were none for people with HCV—the most common blood borne virus in the U.S.
Recognizing the need, Alan started an HCV support group, and then another, and the rest, is as the saying goes, history. Alan’s need for support led to so much more, bringing to mind words by Demosthenes, “Small opportunities are often the beginning of great enterprises.”
Support groups are still the backbone of the HCSP. In April, Alan posted two new guides—the Hepatitis C Support Group Handbook and Hepatitis C Support Group Lessons, published by HCSP and Vertex. These two manuals are breathtakingly informative. After reading them I thought, “Everyone who is newly diagnosed, HCV caregivers, and others wanting to know more about this disease would benefit from the Lessons publication. It reads like a gentle, reassuring voice whispering, “There is hope.”
Support groups work. They may sound touchy-feely, but a good group empowers people to make choices about their health by providing solid information and insight on how to live with their disease. The potential value of support groups is not just theoretical—there is evidence for it.
In the 1970’s and 80’s, Harvard-trained psychiatrist David Spiegel became interested in the emotional aspect of illness, specifically cancer. He could see the advantages of using the mind to assist people with aspects of their illness. However, Spiegel was uncomfortable with claims made in alternative medicine about the power of positive thinking.
Spiegel decided to put the issue of “mind-body” to rest by proving that giving positive emotional support would have no effect on the course of disease. He collected data from a research project conducted at Stanford, where Spiegel had co-facilitated a breast cancer support group.
The good news for us is that Spiegel was wrong; his research revealed the exact opposite.
“…Dr. Spiegel was troubled by the assertion that you could “wish-away-your-illnesses.”…In the 1980’s his well-designed study of women with breast cancer shocked the medical community. Those in support groups lived on average twice as long as those who had not been in a group – an 18-month extension. (Published in The Lancet, 1989) However, the group model emphasized confronting cancer and death rather than “wishing it away.” The focus was on living better, not on living longer.”1
Somewhat stunned, Spiegel conducted further research and concluded:
Support groups can improve quality of life – reduce anxiety and depression, increase coping skills, and help symptom management
A thorough understanding of illness affects physical and psychosocial factors that affect response to treatment and resistance to disease progression
The most effective techniques involve facing the illness directly
There is no evidence that these techniques will cure an illness, but there is evidence that they may prolong life with cancer, heart disease, and other chronic diseases.2
I am a huge fan of support groups, especially for those who are going through HCV treatment. In this era of short medical appointments, support groups provide an opportunity for participants to share tips with each other. Further, patients who have personal experience with treatment bring perspective and a streetwise expertise that is highly valuable to those who are newly diagnosed or in treatment.
There are different kinds of groups, such as those we physically attend versus web-based groups. Groups may be education-oriented, providing literature, speakers, and other forms of information, while some focus primarily on providing emotional support to their members.
My preference is for groups that offer something for everyone, built on a solid foundation of reliable information. We are all different, and a strictly educational group might not meet the needs of someone who is reeling from a recent HCV diagnosis. On the other hand, a group that focuses strictly on feelings will not help anyone looking for facts and resources.
Some support groups are better than others are, whether the format is online or community-based. Groups may be positive and upbeat, while others may be unnecessarily negative. The quality of a support group is influenced by its leadership as well as its regular members. Try a group a few times, and if it doesn’t feel supportive, look for another one.
If you live in an area without an HCV support group, either start one or join an online group. There are many web-based hepatitis C support groups and chat rooms. The benefit of Internet support groups is that there are so many of them that if you don’t like one group, you can easily find another. Another plus is that you don’t need to reveal your identity in order to participate and you can wear your pajamas to meetings.
Web-based support groups have characteristics that may be both useful and harmful. They are more anonymous than in-person groups, so this makes it easier for people to say things that they might not say in face-to-face discussions. Open communication can foster genuine compassion, which is a good thing, but it can also lead people to say whatever is on their minds – without thinking it through – and that can lead to comments perceived as tactless or even hurtful.
Another problem with electronic conversations is that there is no body language. Communication is more than the spoken word; it involves gestures, facial expression and other body language, all of which are missing online. When we read words on a page, we hear the message in our own voice, adding meaning and interpretation from our own perspective that perhaps wasn’t intended by the “speaker.”
The immediacy of the Internet has an up and a downside. The upside is that you may get immediate feedback. The downside is that when we speak in a group, there is a delay in conversation as we listen to others. This helps us think before we speak. This delay doesn’t necessarily occur in chat rooms. It is easy to type out a quick response without thinking about it, and then hit the send key. Practice restraint if you are involved in an emotional conversation on the Internet. Don’t press the reply button for 24 hours, giving you a chance to review your message before sending it. You can also ask someone you trust to read what you wrote before you send it.
Here are some tips for locating a group:
Talk to your medical provider. Some providers offer groups exclusively for their patients and don’t advertise to the general public.
Ask those with HCV if they are aware of any local support groups.
Look online for listings of community support groups (a few resources are listed below).
Search for web-based support groups on Facebook, YahooGroups, Google, etc. There are groups on Delphi Forums www.delphiforums.com
If you don’t feel like you need support, perhaps you can give support. There are wonderful benefits to being able to walk with others through the ups and downs of living with HCV. When Alan started an HCV support group, he did not know it would change his life, and the lives of so many others. Oliver Wendell Holmes wrote, “Man’s mind, once stretched by a new idea, never regains its original dimensions.” Keep this in mind if you are thinking about starting or attending a support group; you just might end up changing the world.
Lucinda Porter, RN is the author of Free from Hepatitis C
Links to organizations that list community-based HCV support groups:
1 Spiegel, David Living Beyond Limits Fawcett Columbine 1993
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