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Alan Franciscus

Editor-in-Chief

HCV Advocate



Monday, May 4, 2015

India: Mylan launches hepatitis-C Sovaldi tablets in India

HYDERABAD: Pharma giant Mylan NV today said its subsidiary Mylan Pharmaceuticals has launched Gilead Sciences' Sovaldi (sofosbuvir 400mg tablets) in the country.

Sovaldi is used for the treatment of chronic hepatitis-C infection as a component of a combination anti-viral treatment.

It is estimated that around 12 million people are chronically infected with hepatitis-C in India, Mylan said in a release.

In February this year, Gilead appointed Mylan as its exclusive distributor of Sovaldi in India.

Read more at: http://economictimes.indiatimes.com/articleshow/47148108.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst


Entering Leg 2 of syringe exchange triathlon

With law enacted, implementation adheres to prescribed steps

Indiana is about to legalize syringe exchange. This herculean bipartisan effort, led by Rep. Ed Clere, R-New Albany, enacted evidence-based public health policy in a state with a long-starved public health system.

As triathlons go, the syringe exchange legislative process was a tough first leg that will be followed by a second leg of policy implementation and a final leg of impact evaluation. We are now at T1 – that transition between Legs 1 and 2. And Leg 2 will be challenging.

Syringe exchange is part of a comprehensive public health effort to reduce HIV and hepatitis C among drug-injecting populations. Programs “exchange” sterile for used syringes, and link participants to screening and treatment for Hepatitis C and HIV, as well as substance abuse treatment. Studies over the past 30 years have demonstrated their effectiveness at reducing hepatitis C and HIV.

Read more...

Egypt: Locally manufactured Sovaldi to be released soon

CAIRO: The Egyptian market will receive a new batch of the hepatitis C treatment medication Sovaldi next June after being manufactured locally, Youm 7 reported Sunday.

Pharmed Healthcare Executive Director, Mohamed Mabrouk, said that his firm will deliver 500,000 bottles after being manufactured with local chemical materials.

“This step will give the Egyptian market an unprecedented motive,” he said.

Read more...

Pakistan: Every 10th Pakistani suffering from hepatitis

LAHORE - Every 10th person in the country is suffering from one type of hepatitis or the other and the viral infection varies in severity from a self-limited condition with total recovery to a life-threatening or lifelong disease.

Over 20 million people in Pakistan are infected with hepatitis B and C virus including around 15 million with C and five million with B and the disease is swelling at an alarming rate, medical experts say.

“Owing to lack of preventive measures and treatment facilities, hepatitis prevalence in Pakistan is the highest on the globe.
  • Every 10th person is infected with hepatitis.
  • Over 1.
  • 5 lakh hepatitis patients die annually.
  • As such over 400 people are losing life to hepatitis every day.
  • Every year, over 1.
  • 5 lakh Hepatitis patients are added to the existing patient load,” said senior consultant and Principal Gujranwala Medical College Prof Aftab Mohsan.
 Read more...

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