Tattoos drawing attention

Note:  the article discusses the risk of tattoos and hepatitis C, but as this articles points out that it is a transmission route in unsafe settings--NOT in commercial settings were safety is being carefully followed.

Tattooing, once a fringe, minority pursuit, is going mainstream in Dunedin, local tattoo artists say, with everyone from law students to nurses inking their skin.

But, the council says as legitimate operations flourish, there has been a spike in tattooing of the underground, backyard variety, too.

There were eight registered tattoo studios in Dunedin, but many more illegal operators were working out of private homes, with no training, risky hygiene practices and cheap tools and ink, Dunedin City Council Environmental Health and Animal Services manager Ros MacGill said.

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Visit our Tattoo Blog HERE

Cherokee Nation Working to Eliminate Hepatitis C

The Cherokee Nation is on a mission to eliminate Hepatitis C, which officials call an epidemic.

According to the Centers for Disease Control and Prevention, the highest increase in Hepatitis C incidence from 2000 to 2013 was among Native Americans.

Dr. Jorge Mera oversees Cherokee Nation Health Services’ infectious diseases division. He said the first step is screening everyone age 20–69 for Hepatitis C, even though two out of three Americans with the disease were born between 1945 and 1965.

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Study suggests unprecedented 3-week hepatitis C cure

Yet another stunning victory in the drug battle against the liver-damaging hepatitis C virus (HCV) may be in the offing: A small study suggests it may be possible to cure some people of their infections in as few as 3 weeks.

Fresh on the heels of recent approvals of four new combinations of HCV drugs that clear infections of many different types of the virus in about 3 months, a team led by hepatologist George Lau of the Humanity & Healthy GI and Liver Centre in Hong Kong, China, has mixed and matched various compounds to see whether they could further shorten the route to a cure. Following 3 weeks of treatment, 18 HCV infected people given three different combinations of drugs met the standard definition of being cured—at 12 weeks after treatment began, they had no signs of HCV’s genetic material, RNA, in their blood on standard tests. The researchers plan to present this data publicly for the first time at a scientific conference known as The Liver Meeting in 2 weeks.

Until the new HCV drugs emerged, infected people required treatment for 8 months, and the therapies often failed and had severe side effects. Now, standard treatment protocol calls for taking HCV drugs for just 12 weeks. Cutting that treatment time even more dramatically is “really, really intriguing” says Shyam Kottilil, an HCV researcher at the Institute of Human Virology in Baltimore, Maryland. And if the results hold, it could slash the overall treatment cost of $100,000 required by the most popular drugs used for the 12-week treatment. Kottilil’s own study of a 4-week treatment—which tested different drug combinations on a different patient population—had only a 40% cure rate in the 50 participants. (That study is in press at Annals of Internal Medicine.)

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Findings about WWII-Era Spread of Hepatitis C Could Inform Future Prevention Efforts

The breakneck pace of clinical research means that, by necessity, there is little time to assess the past. But research published earlier this year in the Journal of Virology on the origins of the Hepatitis C virus (HCV) shows that such examination is not a morbid trip down memory lane, but rather can deliver key insights into current prevention efforts.   

The study, from researchers at the University of Glasgow, dates the beginnings of HCV to the 1940s and says it most likely arrived through the mass treatment of soldiers in field hospitals across the country during WWII. Under circumstances of war, hastily organized and overwhelmed care units meant that HCV was easily spread easily between soldiers as their injuries were treated.   

Using statistical analysis to examine the transmission dynamics, the researchers say, can help provide a basis for identifying HCV transmission hotspots. They posit that a more comprehensive understanding of exactly how hepatitis C virus is transmitted during times of significant spread could facilitate public health initiatives to reduce the prevalence of HCV in people who contract it through intravenous drug use.

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Article: Hepatitis B Virus Reactivation During Successful Treatment of Hepatitis C Virus with Sofosbuvir and Simeprevi

This article is being re-posted from a previous newsletter.  I have been hearing from patients who have been inquiring about treatment with a DAA and who are also co-infected with chronic hepatitis B.  People co-infected with HCV and HBV should make their medical providers aware that their chronic hepatitis B should be monitored on a regular basis.  The article below recommends that people being treated with a DAA should be monitored every 2 weeks.  -Alan

Snapshots - Alan Franciscus

Article:  Hepatitis B Virus Reactivation During Successful Treatment of Hepatitis C Virus with Sofosbuvir and Simeprevir—J. M. Collins et. Al
  Source:  Clinical Infectious Diseases Advance Access

Results and Conclusions: This was a case report of two individuals with hepatitis C. 

The first case was a 55 yo man who was coinfected with hepatitis B and hepatitis C genotype 1a.  He had been previously treated with pegylated interferon plus ribavirin but did not achieve a cure.  He was started on sofosbuvir and simeprevir.  After week 4 he was HCV undetectable, but at week 7 he started to have severe liver symptoms (AST of 1792 IU/L, ALT of 1495 IU/L, total bilirubin of 12.2 mg/dl and INR of 1.96) and his hepatitis B viral load rose to 22 million.  His other tests (antinuclear antibody, ferritin, a-fetoprotein, etc.) were also abnormal.

The HCV treatment was discontinued, and hepatitis B treatment (tenofovir/emtricitabine) was started and the hepatitis B viral load subsequently decreased to less than 20 IU/mL.  The hepatitis B treatment was continued for ongoing hepatitis B suppression.

The second case was a 57 yo man with HCV genotype 1a.  He had been treated for HCV with pegylated interferon plus ribavirin but had not been cured. He was positive for the hepatitis B virus, but the hepatitis B viral load was below the level of detection (20 IU/mL).  He was started on HCV treatment—sofosbuvir and simeprevir and his HCV and hepatitis B viral loads were monitored every two weeks.  After two weeks, his HCV viral load was undetectable and his hepatitis B viral load increased to 353 IU/mL.  After four weeks of HCV treatment, HCV was still undetectable, but the hepatitis B viral load increased to 11,255 IU/mL.  The liver function tests were normal, and there were no other signs of liver disease.  The patient remained on sofosbuvir/simeprevir treatment.  Tenofovir was added to the HCV treatment regime to treat hepatitis B. 

The Bottom Line:  The reactivation of HBV in people who were coinfected with HBV and HCV was rare in the days of pegylated interferon based therapies.  This was most likely because PEG works against HBV whereas the new HCV direct acting antivirals do not have antiviral properties that will suppress hepatitis B while treating HCV.   

Editorial Comment:  A couple of important points:

• Everyone with hepatitis C should be tested for hepatitis B (and A), and if not previously infected should be vaccinated.
• People who are chronically infected with HBV and HCV who are being treated with the direct-acting antiviral medications (Harvoni or Viekira Pak) and monitored very closely—every two weeks as listed in the second study—for HBV flares and treated for chronic HBV as needed. 

THE FIVE Clinical Trials – What Patients Need To Know —By Alan Franciscus

THE FIVE: Clinical Trials – What Patients Need To Know
—By Alan Franciscus

In this month’s The Five column, I will provide a simple overview of clinical trials, the pluses and minuses of participating in a clinical study and information about how to find clinical trials your area. I hope this article will help our readers who are interested in participating in a clinical trial to make an educated decision. '

1.  Phases of Clinical Trials – Clinical trials begin with pre-clinical studies conducted in test tubes or animals.  If the results are positive the drugs can move through different phases—1 through 3—and a possibly 4th phase.  A brief recap of the 4 phases is listed below

• Phase 1 studies usually include healthy people, but can include persons with the particular disorder that the study drug is being tested to treat.  The primary reason for phase 1 studies is to establish the safety of the study drug.  Another important part of a phase 1 study is to find the dose that combines the highest effectiveness with the lowest rate of side effects.  (generally 20 to 80 people are recruited for phase 1 trials),    

• Phase 2 only includes people who have the disorder or disease that the investigational drug is being tested in to find the efficacy—also called effectiveness.  In some phase 2 studies the study drug may be compared to a current drug approved by the Food and Drug Administration (FDA) or a placebo drug (sugar pill).  Additional safety and side effect information is also  obtained.  (generally 100 to 300 people are recruited for phase 2 studies), 

• Phase 3 is similar to phase 2 clinical trials but have a larger patient population.  They also compare the study drug to other medicines to treat the same disorder or disease—usually the current standard of care drugs—and in different patient populations.  Since the patient population is much larger the effectiveness, side effect information and other information obtained is more realistic data compared to the information obtained in phase 1 and 2 studies.  (up to 1,000 or more people).

The pharmaceutical company will compile and review the phase 3 data and apply to the FDA for New Drug Application (NDA).  After a period of review and if appropriate the FDA will approve the medication for a particular patient population.  The FDA will also issue a package label

• Phase 4 is post-marketing studies.  These are studies that the FDA may require as part of the FDA approval process.  Phase 4 studies gather more information about the safety, effectiveness, and/or the use of the approved medication in certain patient populations

2.  Types of Studies – In clinical studies there are various types of studies including:

• Randomization means that some patients will receive the study drug and some will receive the drug that it is being compared against (an FDA approved drug) or a placebo (sugar pill), 

• Open-label means that everyone will receive the study drug,

• Prospective these are studies that look ahead look for certain outcomes.  These are studies that recruit patients to find out if the drugs in development work.

• Informed Consent – To participate in a clinical study, a document called ‘informed consent’ is filled out.  The subject/patient is required to read, understand and sign the document.  A copy is given to the subject/patient.   A study nurse is assigned to each study. It is the nurse’s responsibilities that every patient in the study understands the benefits and risks of the study.  The informed consent form should be written in language (6th grade and lower) that is simple, and easy to understand.  The sentences should be short, and non-technical. The person who is entering into a clinical trial should be encouraged to ask questions and understand every aspect of the clinical trial.  

Listed below is some general information that should be included in an informed consent form.

• The nature of the study,

• Why the candidates are being recruited for this study,

• What risks, benefits and alternatives are associated with the research, and

• What rights the subjects/patients have as research subjects.

4. Questions Patients Should Ask – If you are thinking of enrolling in a clinical trial, there are many questions you should ask yourself in order to make an informed choice:

• Do you think the study drug may be better than the current standard-of-care medications that have been approved by the FDA?  If so, why?

• What is the current phase of the trial (phase 1, 2, 3 or 4)?  

• Have you considered the possible side effects and the safety profile of the trial drugs 

• Is it too early in the clinical trial development that it may pose too many risks?

• Are your willing to take the possible risks, and side effects?

• What are the potential benefits?  

• Is the cost of the study tests covered?

• Is it an open-label study—that is, does everyone receive the study drug?

• Is it a randomized study?  If so, if you do not get the study drug are you offered the study drug at the end of the study?

• Who will be in charge of the patient care?

• Can you wait until the study drugs are FDA approved?

Note:  Remember you can drop out of a clinical trial any time you want.

5. Next Steps

There are many questions to think about before entering into a clinical trial.  Some people would like to further the knowledge about a particular disease and treatment that will help their community.  Others may want to receive medical care and treatment.  Medical care and treatment may be particularly important for many people who do not have insurance or for those who have been denied coverage.  Still others who have been treated but have not been cured may seek treatment and care through clinical trials.  All of these reasons are valid and clinical trials are a good way to explore HCV treatment and care.  However, as with any HCV treatment you do not want to rush into any decision.  It is always good to do your research and work with your medical provider to make the best possible medical decision that is the best decision for you.

Ask your medical provider and/or gastroenterologist/hepatologist about clinical trials in your area.  Many medical hospitals also conduct clinical trials.

The best website that I have found is www.clinicaltrials.govhttps://www.clinicaltrials.gov/.

Type in ‘HCV’ and away you go…

For more information:  Making sense of Hepatitis C Research and Medical Literature
http://hcvadvocate.org/hepatitis/factsheets_pdf/Making_Sense.pdfhttp://hcvadvocate.org/hepatitis/factsheets_pdf/Making_Sense.pdf

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for patients with decompensated cirrhosis.

“As the first fixed-dose combination of two pan-genotypic, direct-acting antivirals, SOF/VEL represents an important step forward in the treatment of patients with hepatitis C,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “Genotype 1 is the most prevalent form of HCV in the United States, but worldwide, more than half of people living with HCV are infected with other genotypes. SOF/VEL complements our current HCV portfolio of Sovaldi and Harvoni, offering high cure rates and the potential to simplify treatment and eliminate the need for HCV genotype testing.”

The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for SOF/VEL is supported by data from four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Those who received SOF/VEL plus RBV for 12 weeks achieved an SVR12 rate of 94 percent,while those who received SOF/VEL for 12 weeks and 24 weeks achieved SVR12 rates of 83 percent and 86 percent, respectively.

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