AIDS Specialist Advocates Sweeping Approach to Battle Against Hepatitis C

Could hepatitis C be the next communicable disease to come under a targeted attack in B.C.?

It will be if HIV/AIDS expert Dr. Julio Montaner has his way.

Montaner said Tuesday that even if the virus is eradicated among baby boomers, that won’t stop its continued spread.

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USA-Lack of Insurance Bars Some from Hepatitis C Treatment

Survey data from 2001 to 2010 show that lack of insurance kept some people with hepatitis C virus from getting treatment.

Recently, more effective and well-tolerated drugs have been developed to treat hepatitis C, removing many of the discouraging side effects of older drugs. The infection is curable and transmission can be prevented, researchers write in the American Journal of Gastroenterology.

But for the more than three million people in the U.S. who have chronic liver disease from hepatitis C, there are still two important barriers to getting treatment, said lead author Dr. Ivo Ditah from the Mayo Clinic in Rochester, Minnesota.

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UK-Prime Minister Apologizes for Tainted Blood Scandal That Infected Thousands in '70s, '80s

LONDON— British Prime Minister David Cameron on Wednesday apologized to thousands of patients who were infected from contaminated blood during the 1970s and 1980s.

Tainted government blood products and transfusions infected an estimated 2,500 people with the hepatitis C virus and HIV from 1970 to 1991. The scandal has been called the worst treatment disaster in the history of Britain's public health care system.

Cameron's apology came after a six-year official inquiry was completed. The probe said more should have been done to screen blood and donors in the early 1990s, and that the collection of blood from prisoners should have stopped earlier.

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Cipla launches generic Hepatitis C drug Hepcvir

Cipla, on Wednesday, announced the launch of generic drug Sofosbuvir for treating chronic Hepatitis C under the brand name Hepcvir.

“Following the non-exclusive licensing agreement signed with Gilead Sciences in September last to manufacture and market chronic Hepatitis C medicines, Cipla is now all set to make the drug Sofosbuvir available to Indian patients in a week’s time,” the company said in a statement.

“Cipla has always brought accessible and affordable medicines to fight against diseases like AIDS and Hepatitis B; hence, Cipla has made it a priority to bring Hepcvir to patients in India as well as the other developing nations,” Cipla Managing Director and Global CEO Subhanu Saxena said.

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Canada-Ontario decision to cover costly hepatitis C drug a lifesaver, doctor says

Ottawa liver specialist Dr. Curtis Cooper is calling Ontario’s decision to pay for new treatments that can cure hepatitis C a “landmark event” that will change the lives of thousands of people with the disease.

Cooper, director of The Ottawa Hospital and Regional Hepatitis Program, sees thousands of hepatitis C patients, many of whom will benefit from the new drug therapy now that it is covered by the province.

“This is going to mean the difference between health or illness and death,” for many patients, he said.

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FDA MedWatch: Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone

AUDIENCE: Cardiology, Infectious Disease, Gastroenterology, Pharmacy

ISSUE: FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. FDA is adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. FDA is recommending that health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as the investigational drug daclatasvir or Olysio (simeprevir), with amiodarone.

FDA review of submitted postmarketing adverse event reports found that patients can develop a serious and life-threatening symptomatic bradycardia when either Harvoni or Sovaldi combined with another direct-acting antiviral is taken together with amiodarone. The reports included the death of one patient due to cardiac arrest and three patients requiring placement of a pacemaker to regulate their heart rhythms. The other patients recovered after discontinuing either the hepatitis C drugs or amiodarone, or both (see Data Summary). The cause of these events could not be determined. FDA will continue to monitor Harvoni and Sovaldi for risks of serious symptomatic bradycardia and further investigate the reason why the use of amiodarone with these hepatitis C drugs led to the heart-related events.

BACKGROUND: For a Data Summary and additional recommendations for health professionals and patients, see the FDA Drug Safety Communication.

RECOMMENDATION: Health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone. However, in cases where alternative treatment options are unavailable, FDA recommends heart monitoring in an inpatient hospital setting for the first 48 hours. Subsequently, monitoring in a doctor’s office or self-monitoring of the heart rate should be done every day through at least the first 2 weeks of treatment.

Due to the long half-life of amiodarone, patients discontinuing amiodarone just prior to starting Harvoni, or Sovaldi in combination with another direct-acting antiviral, should also undergo similar cardiac monitoring as outlined above.

Patients taking either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone should seek medical attention right away if they experience signs or symptoms of symptomatic bradycardia such as:

• Near-fainting or fainting
• Dizziness or light-headedness
• Malaise
• Weakness
• Excessive tiredness
• Shortness of breath
• Chest pains
• Confusion or memory problems

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439662.htm

Cannabis use lowers risk for insulin resistance in patients with HIV/HCV

Among patients coinfected with HIV and hepatitis C, cannabis use reduced the risk for insulin resistance, according to researchers from INSERM in France.

“This is the first longitudinal study documenting the relationship between the reduced risk of insulin resistance and cannabis use in a population particularly concerned by insulin resistance risk,” the researchers wrote in Clinical Infectious Diseases. “The results found were robust as they were confirmed in three sensitivity analyses, one of [these] also including patients with diabetes.”

M. Patrizia Carrieri, PhD, and colleagues evaluated data from the ANRS HEPAVIH CO-13 cohort, which included patients in France coinfected with HIV and HCV. The data included patient information obtained from self-administered questionnaires, such as HIV and HCV testing, HIV-related symptoms, coffee consumption and drug and alcohol use in the previous month. The questionnaires were completed every 12 months for 60 months.

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