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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Canada: Multiple Provinces Align to Provide Public Funding for Harvoni™, the First Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C Virus Infection

-- Reimbursement of Harvoni Within Five Months of Health Canada Notice of Compliance Brings Patients Earlier Opportunity for a Cure --

MISSISSAUGA, Ontario, Mar 24, 2015 (BUSINESS WIRE) -- Gilead Sciences Canada, Inc. (Gilead Canada) today announced that multiple provinces will provide public access to Harvoni™ (ledipasvir/sofosbuvir), the first once-daily, single tablet regimen for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults. In Canada, it is estimated that more than 250,000 Canadians are living with chronic HCV infection, with thousands of new cases diagnosed each year.1 Genotype 1 infection represents an estimated 65 per cent of patient cases.2

Public reimbursement comes after a positive recommendation from the Common Drug Review, and as a result of a productive collaboration between Gilead Canada and the Pan-Canadian Pharmaceutical Alliance (pCPA) to ensure participating provinces are able to provide timely access to patients in need of curative treatment. This review, co-led by the BC Ministry of Health and the Ontario Ministry of Health and Long-Term Care, resulted in an agreement with member provinces to fund the innovative therapy for patients.

“We have been waiting for an innovative therapy like Harvoni since interferon was first used to treat the disease,” said Dr. Alnoor Ramji, Clinical Associate Professor of Medicine (Gastroenterology and Hepatology), University of British Columbia. “This is a transformative, interferon-free therapy, with a combination of high cure rates, good tolerability and simplicity of treatment. Harvoni provides patients with the confidence to commit to therapy and a very high probability to achieve a cure.”

Current treatments include interferon and ribavirin that often exclude patients from treatment or lead to early discontinuation of treatment due to associated side effects. Harvoni represents a significant advance in the treatment of genotype 1 HCV infection, the most prevalent genotype in Canada. Harvoni is the only once-daily, single tablet regimen that offers cure rates between 94 and 99 per cent, eliminates the need for interferon and ribavirin, and shortens the duration of treatment to as little as eight weeks for many patients. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL. Recently, the Canadian Association for the Study of the Liver updated the Canadian consensus guidelines on the management of hepatitis C and recommended Harvoni as first-line therapy for all genotype 1 patients.

“Today’s announcement recognizes the significant health-system and societal benefits associated with curing this disease and preventing its complications,” said Dr. Paul Marotta, Associate Professor, University of Western Ontario and with London Health Sciences Centre. “Access to Harvoni will help us confront this serious public health issue and start formulating longer-term solutions that may prove relevant to the hepatitis C disease elimination efforts across Canada.”

In a recent article, “Burden of disease and cost of chronic hepatitis C virus infection in Canada,” (Canadian Journal of Gastroenterology and Hepatology), leading Canadian hepatitis C specialists highlighted an expected 205 per cent increase in cases of liver cancer, a 160 per cent increase in liver-related deaths, and a 60 per cent increase in total healthcare costs over the next 20 years.2 Recently, the article was recognized with a scientific award for its groundbreaking research in Canada.
In addition to Harvoni, Gilead Canada’s Sovaldi® (sofosbuvir) has also been listed for public reimbursement for chronic HCV genotypes 1, 2 and 3 infection in multiple provinces.

“We live in an era of rapid evolution in the treatment of chronic hepatitis C infection, and Gilead Canada is pleased that our collaboration with the pCPA has allowed multiple provinces to recognize the clinical value of Harvoni as a simple, well tolerated and curative therapy for patients living with genotype 1 HCV,” said Edward Gudaitis, General Manager, Gilead Sciences Canada, Inc. “Gilead Canada will continue to work closely with all provinces and territories to bring this cost-effective, once-daily treatment to patients across Canada.”

Read complete press release here

Canada: B.C Parmacare to cover Sovaldi and Harvoni

Sovaldi and Harvoni now covered by Pharmacare in BC

VICTORIA – British Columbia is providing public drug plan coverage of two new, often curative, hepatitis C drugs effective March 24, 2015, announced Minister of Health Terry Lake today.

People with hepatitis C will be able to apply tomorrow for coverage under B.C.’s PharmaCare program of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir). These new medications cure about 90% or more of people treated; are easier to take; involve a much shorter course of treatment; and have fewer side effects than older drugs.

“These two new drugs can utterly change the lives of people with hepatitis C for the better,” said B.C. Health Minister Terry Lake. “These drugs represent a significant advance in the treatment of chronic hepatitis C, and more British Columbians affected by this virus now have significantly better odds of becoming free of the disease.”

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India: Portal to create awareness on Hepatitis C launched

Hyderabad, March 23:  Asian Institute of Gastroenterology (AIG) has launched a portal to create awareness on Hepatitis C.

This was formally launched by E S L Narasimhan, Governor, Andhra Pradesh and Telangana, at a function here on Monday.

Speaking on the occasion, D Nageshwar Reddy, Chairman of AIG, said out of an estimated 150 million people affected by Hepatitis C in the world, 15 million were from India.

See also:  Most Hepatitis C affected untreated in India

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