Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

For more information on how to use this blog, the HCV drug pipeline, and for more information on HCV clinical trials
click here

Be sure to check out our other blogs: The HBV Advocate Blog and Hepatitis & Tattoos.


Alan Franciscus

Editor-in-Chief

HCV Advocate



Monday, May 4, 2015

Fifth patient dosed with 'one-shot' drug in HCV trial

The fifth and final patient in the phase 1/2a clinical trial of TT-034, a ddRNAi-based therapeutic to treat hepatitis C virus infection, has been dosed, according to a news release from Benitec Biopharma Limited.

The phase 1/2 clinical trial being conducted at the Duke Clinical Research Unit of Duke Clinical Research Institute is an open-label dose escalation study that evaluates the safety and activity of single doses of TT-034 (Benitec), a potential treatment for HCV with a single-dose administration, in patients with chronic HCV genotype 1 infection who have failed previous treatments, according to the Duke Clinical Research Unit website. The trial consists of 14 patients in five sequential dose cohorts.

Patients in cohort two received an increased dose of TT-034 that was a half-log higher than patients dosed in the first cohort, according to the release. The dose level was still below the concentration expected to inhibit HCV viral replication, according to the release.

Read more...

Australia: 'Like night and day' – calls for federal government to approve new Hep C drugs

Advocates in Canberra have called on the government to urgently subsidise new, advanced treatments for hepatitis C, saying each month they delay about 50 people die from the condition.

The Pharmaceutical Benefits Advisory Committee recommended on April 24 that three new antiviral medications, designed to treat hepatitis C, be considered for addition to the Pharmaceutical Benefits Scheme.

Canberra Alliance for Harm Minimisation and Advocacy manager Sione Crawford, who lives with hepatitis C, said the difference between the new and old drugs was like "night and day".

Read more...

Patients First: Overview – Preparing for Treatment: Part 2, by Alan Franciscus, Editor-in-Chief

Part 2 of this article discusses Medical Tests, Medications and Side Effect Management, among other things.

Medical Tests:
There may be tests your medical provider will order before you start treatment:
  • Pregnancy test—If ribavirin is part of your treatment you will need to verify that you are not pregnant before starting treatment.  This is also true if you are a female partner of a male patient starting treatment.
  • HCV-RNA or viral load test—This is used to confirm active infection and as a baseline test. 
  • Genotype test—This test determines the strain of hepatitis C—there are seven genotypes.  Genotype 1 is the most common followed by genotype 2 and 3.  Genotype information is used to determine what HCV treatment to take and for how long to take it.
  • Baseline tests—These include a variety of tests, such as a complete blood count (CBC), diabetes, thyroid and liver tests.  Your general health will be assessed, especially if you are older than 40 or 50 years old or at risk for various medical problems. 
  • Medical and dental procedures—In some cases, it may be a good idea to have any serious medical, and dental procedures completed well in advance prior to beginning HCV therapy.  If the medical or dental procedure is not severe, you may be able to postpone it until after treatment, so your body has a chance to recover from treatment. Discuss this with your doctor.
  • Immunizations—You can be immunized while on treatment.
  • Anxiety—Current therapy can cause anxiety and though uncommon, depression. Talk with your medical provider if you are concerned about this.  Medication can provides relief relatively quickly. 
Medications
HCV treatment consists of pills.  Talk to your medical provider about how and when to take them.  Be prepared—ask your medical provider ahead of time if you miss a dose, when you should take the next dose.  If you plan on traveling, make a copy of your prescriptions to take with you. 
You may have to use a specialty/mail order pharmacy, rather than a brick and mortar pharmacy like Walgreens or CVS.  They both have similar services:
  • Specialty pharmacies ship to your home or office.  With a regular pharmacy you control where and when to pick up the prescription.
  • Both can offer support services—nurses, websites and other services to help manage your therapy.
  • Both can remind you when to re-order or will automatically refill orders.
Side Effect Management
A favorable treatment outcome is associated with your ability to stay on the prescribed dose of medication for the entire duration of treatment.  In addition, completion of treatment goes hand in hand with good side effect management—this means treating the side effects before they become worse.  For more information about side effect management see the Resource section at the end of this article. 

Treatment side effects are usually temporary and should gradually fade away after treatment is completed.  This may take weeks or months; rarely up to a year. 

The most common side effects of current therapy are fatigue, headache, nausea, diarrhea, and insomnia.  However, it is important to know that not everyone has these particular side effects, and most people do not have severe side effects.  In clinical trials for current therapies, less than 1% of individuals had side effects that required discontinuation of treatment.

Preparing Your Body
HCV treatment is a process that requires getting the mind and body ready and in shape.  Alcohol, especially in large quantities, can accelerate HCV disease progression.  Some insurance companies and medical providers are denying HCV treatment to people who consume alcohol and drugs, including medical marijuana.  You may be required to abstain from alcohol and drugs for 6 months and attend a 12-step program.  Talk to your medical provider about any concerns or questions. 

Light to moderate exercise is recommended for most people with hepatitis C.  Check in with your medical provider before starting any exercise program.  Before beginning treatment, slowly build up to a comfortable level.  There are many ways to get exercise such as walking, yoga, and dancing to name a few.

Birth Control
If ribavirin is part of HCV treatment:
Women of childbearing age, their partners and female partners of male patients taking ribavirin must practice two forms of reliable contraception during to 6 months post-treatment.

It is essential that pregnancy be avoided throughout treatment and for six months after treatment has ended.  The guidelines are to use two reliable forms of birth control.  Reliable means using medically accepted contraceptive methods and using them correctly.  Whatever you choose, know how to use the method correctly.  Also, notice the word two.  This means that if you use two forms of birth control and one fails, then you have back-up protection.  If you or your partner needs information about birth control, talk to your medical provider or family planning center. 

Pill Containers/ Calendars
It is important to remember to take the pills every day.  The makers of HCV drugs make it very easy, but no one is perfect.  Plan ahead—get a calendar.  Mark off the day when you take the pill(s).  This can be a great motivation to know that you have completed one day of treatment, and you can look forward to the end of treatment and hopefully a cure. 

A Final Word
It is important to set a goal before treatment.  Why do you want to be treated?  Write them down and refer to them while on treatment.  It is an excellent way to stay motivated.  Just remember that, even though, the cure rates are very high not everyone can be cured at this time.   Planning ahead and staying the course will give you the best opportunity to be cured, and that is really all you can do.

Resources: Patient Assistance Programs

For Part 1 of this article click here

http://hcvadvocate.org/news/newsLetter/2015/advocate0515.html#2

Mid-Mo Health Expo offers free health screenings

COLUMBIA — When the Missouri Hepatitis C Alliance held the inaugural Mid-Mo Health Expo last year at the Parkade Center, organizers envisioned a small health education fair for the community.

But when word got out that Boone Hospital Center was providing free health screenings, dozens came out to take advantage of the offer.

Sixty-seven participants received more than 300 screenings, said Aaron Boone, a development manager for the Missouri Hepatitis C Alliance.

Read more...

Friday, May 1, 2015

Joint Pain a Major Issue in Chronic HCV Infection

Smoking increases risk of arthralgias in hepatitis C.

Patient-reported joint pain is prevalent in those with chronic monoinfection with hepatitis C virus (HCV) or monoinfection with immunodeficiency virus (HIV), as well as in patients with HIV/HCV coinfection, according to a study published online in BMC Musculoskeletal Disorders on April 19, 2015. But chronic HCV patients report more arthralgia.

The study, led by Alexis R. Ogdie, MD, a rheumatologist at the University of Pennsylvania in Philadelphia, found that chronically HCV-monoinfected patients more frequently reported arthralgias compared with HIV/HCV-coinfected or HIV-monoinfected persons.

Joint pain was more commonly reported in HCV-monoinfected than HIV/HCV-coinfected (71% versus 56%; P=0.038) and HIV-monoinfected patients (71% versus 50%; P=0.035).

Read more...

Implementing the Nation’s First State Hepatitis C Testing Law

As the first state hepatitis C testing law in the nation progresses into its second year of implementation, the New York State Department of Health (NYSDOH) is taking steps to educate both healthcare providers and consumers about the importance of HCV screening for individuals born between 1945 and 1965 (often referred to as the “Baby Boomers”) and New York’s related law requiring that healthcare providers offer a one-time HCV screening to patients in this birth cohort as part of routine primary care. Here is an overview of the activities that the NYSDOH has been engaged in to implement and evaluate the new law.

The Law

The NYS Hepatitis C Testing Law was signed into law by the governor on October 23, 2013 and implemented effective January 1, 2014.  This new law mirrors the Centers for Disease Control and Prevention’s (CDC) 2012 expanded hepatitis C virus (HCV) screening recommendations, requiring healthcare providers in the state to offer a one-time HCV screening test to all persons born between 1945 and 1965, and is similar to the 2010 NYS HIV Testing Law .  The law was enacted to increase HCV testing and ensure timely diagnosis and linkage to care.

The two key provisions of the NYS Hepatitis C Testing Law  are:

- See more at: https://blog.aids.gov/2015/05/implementing-the-nations-first-state-hepatitis-c-testing-law.html#sthash.LmYhdAYZ.dpuf

A physician's lesson on hepatitis C

One of a physician’s responsibilities is to stay in tune with the new updates in medicine. A few years ago, I attended a class about hepatitis C. We have made some great advances in the treatment for hepatitis C, but we need to find those who have the infection first.

In this class, the instructor said that patients with hepatitis C may present without symptoms and have a slightly-elevated liver function test on some occasions, then return to normal. Obviously, this makes hepatitis C very elusive and easy to miss. Here is my lesson on hepatitis C.

Read more...