Friday, July 3, 2015

TGIF- July Weekly Rewind of Hepatitis C News And Updates Around The Web

TGIF- Weekly Rewind of Hepatitis C News and Updates 

It's Friday folks, the end of another week of work and the start of the holiday weekend.

Happy Forth of July!

Here is a look back at this weeks headlines with updates around the web and a bit of today's news.

Today Gilead announced Harvoni ® was approved by Japan's Mininstry of Health, read the press release here.

Japan's Ministry of Health, Labour and Welfare Approves Gilead's Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved by the MHLW under the trade name Sovaldi® in March 2015. Harvoni is indicated for the suppression of viremia in patients with genotype 1 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis, with a treatment duration of 12 weeks.
Continue reading...

Speaking of fireworks, a study published in the July edition of Hepatology reported adding ribavirin to ledipasvir and sofosbuvir did not significantly increase SVR:
Adding the antiviral drug ribavirin to the fixed-dose combination of viral inhibtor ledipasvir and nucleotide inhibitor sofosbuvir offered no better result than ledipasvir/sofosbuvir alone, says a study led by Saleh Alqahtani, M.D., and Mark Sulkowski, M.D., of the Johns Hopkins University School of Medicine. In fact, say the study’s authors, the ribavirin combination was associated with a higher rate of adverse events.
Click here to read a quick overview of the study...

Elsewhere: 
Bangladesh's Beximco launches copy of Sovaldi
One tablet will cost Tk 600 in Bangladesh, and the total cost of the therapy would be Tk 50,400 for a 12-week course compared to the whooping Tk 67 lakh in developed countries

China rejected patent linked to Gilead hepatitis C drug
China has rejected a Gilead Sciences Inc patent application related to its costly hepatitis C drug, a U.S. advocacy group said, adding the move may lead to other countries to consider rejecting patents for the controversial treatment.

AbbVie's HOLKIRA™ PAK Now Reimbursed in Ontario
Following the positive CDR recommendation announcement, Ontario is the second province to reimburse HOLKIRA PAK on its public formulary through its Exceptional Access Program (EAP) as of June 29, 20152. In Ontario, HOLKIRA PAK will be covered under the following EAP criteria: for treatment-naïve and treatment-experienced adult patients with GT1 chronic HCV infection, with compensated cirrhosis.

Holkira Pak is a combination of dasabuvir, ombitasvir and paritaprevir boosted with ritonavir. Ombitasvir, paritaprevir and ritonavir are co-formulated into one tablet that is taken once per day. Dasabuvir is a separate tablet that is taken twice per day. Holkira Pak may be prescribed with ribavirin. Holkira Pak appears to have few side effects. Common side effects are generally mild and include fatigue, headache, weakness and nausea. Hep C treatment can cure a person from Hep C. However, a person could become infected again, read more @ Catie 

 Of Interest
Updates @ NATAP
Viekira Pak - AbbVie hepatitis C cocktail succeeds in late-stage study
- 3b Results in Genotype 1b Chronic Hepatitis C Patients with Compensated Liver Cirrhosis
- 100 percent SVR(12) rate achieved with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin(1)

Updates Around The Web
We begin with "HCV Virtual Patient" an easy to follow case by case video CME over at "ViralEd." Cases 1-4 include a look at HCV re-treatment, current treatment options for various HCV genotypes, HCV recurrence after liver transplantation, and treatment in HCV/HIV co-infection. Follow "ViralEd on Twitter "or visit "ViralEd" for future launch dates. I am patiently waiting for ViralEd to release Case 5; HCV Genotype 3, Previous Failure. 

"HCV Advocate" has just published their "July Newsletter." Check out an overview of liver toxic herbs, part 2 of a two-part series discussing pain associated with hepatitis C, and long term treatment outcomes and the benefits of achieving an SVR. 

As always "hepmag.com" has a group of talented bloggers who share their personal story about living with HCV, view all updates, here and news updates, here. 

Gilead Controversy
The controversy over Gilead Sciences hepatitis C treatments was in the media again this week when it was announced that; Public Health Groups Sued The FDA For Disclosure of Clinical Trial Data for Costly Hep C Drugs. Read a great commentary over at the WSJ. 

Medicaid
Medicaid has come under much scrutiny in recent months because of Medicaid reimbursement restrictions for newer hepatitis C medications. A study in "Annals Of Internal Medicine." offers insight into how the program works.

 July 1
Two studies published online June 29 in the Annals of Internal Medicine examine how states are deciding which Medicaid patients will get sofosbuvir, the $1000-per-pill treatment for hepatitis C that has a 90% cure rate.

The authors of both studies find restrictions vary tremendously across states' Medicaid fee-for-service programs and often differ with guidelines set out by professional associations. One study says the restrictions violate the federal Medicaid law.

 June 29
(Reuters Health) - State-run insurance programs for the poor may be putting up illegal barriers that prevent people with hepatitis C from getting a new treatment, a new study suggests.

California Caps What Patients Pay For Pricey Drugs. Will Other States Follow?

Links
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.

Veterans Waiting for HCV Therapy
One year after VA scandal, veterans wait to be treated for everything from Hepatitis C to post-traumatic stress
VA’s leadership attributed the growing wait times to soaring demand from veterans for medical services, brought on by the opening of new centers and a combination of aging Vietnam veterans seeking care, the return of younger veterans from Iraq and Afghanistan and the exploding demand for new and costly treatments for Hepatitis C.
Continue reading......

July 1
Vietnam era veteran carries battle cry of hepatitis C

June 30
If you’re in a long-term monogamous relationship of at least 5-10 years, though, the risk of getting hep C through vaginal sex is “extremely low,” Wang says.

A recent study in the journal Hepatology shows that the chance someone will spread the virus to a partner this way is 0.07% per year, or 1 in 190,000 sexual contacts.

“The majority of couples in my clinic -- people who are married or partnered for a long time -- do not use condoms,” says hepatologist Andrew J. Muir, MD, an associate professor of medicine at Duke University Medical Center.. “The key is to have a comfortable sex life. You need to have a conversation and make that person feel comfortable.”

Tips to Deal With Hepatitis C Fatigue
By John Donovan
WebMD Feature
Reviewed by Lisa B. Bernstein, MD
When you have hepatitis C, being tired -- really tired -- can be a fact of life. But there are ways you can boost your energy.

Here, three people who have experience with fatigue from the disease share their tips...

That's all folks, check back later for more updates.

Tina
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