India: Mylan Pharmaceuticals launches generic hepatitis C drug MyHep in India

NEW DELHI: Drugmaker Mylan Pharmaceuticals today launched generic Sofosbuvir tablets, indicated for the treatment of chronic hepatitis C, in the country.

US-based company's Indian arm Mylan NV has launched generic Sofosbuvir tablets in strength of 400 mg under the name MyHep in the country, it said in a statement.

"The launch of Mylan's MyHep offers hope to millions of hepatitis C patients in India who are in need of a high quality, effective and affordable treatment option." 

Read more at:
http://economictimes.indiatimes.com/articleshow/47038695.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

Cape Cod Hepatitis C rates highest in state among young people

Users of heroin and other intravenous drugs face dangers beyond addiction, prison, and overdose. Deadly blood-borne diseases, transmitted through shared needles, are rampant among IV drug users.

For the past several years, Barnstable County has led Massachusetts in the rate of new infections of Hepatitis C among people aged 15 to 25. An especially dangerous virus that attacks its host’s liver, often resulting in cirrhosis or cancer, Hepatitis C infected 344.3 of every 100,000 residents of Barnstable County in 2012, the latest year for which figures are available. The incidence rate for Plymouth, the second leading county, was 194.57.

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CDC Issues Health Advisory Concerning HIV And Hepatitis C Co-Infection Outbreaks

Outbreak of Recent HIV and HCV Infections among Persons Who Inject Drugs

This is an official

CDC HEALTH ADVISORY

Distributed via the CDC Health Alert Network
April 24, 2015, 11:00 ET (11:00 AM ET)
CDCHAN-00377

Summary

The Indiana State Department of Health (ISDH) and the Centers for Disease Control and Prevention (CDC) are investigating a large outbreak of recent human immunodeficiency virus (HIV) infections among persons who inject drugs (PWID). Many of the HIV-infected individuals in this outbreak are co-infected with hepatitis C virus (HCV). The purpose of this HAN Advisory is to alert public health departments and healthcare providers of the possibility of HIV outbreaks among PWID and to provide guidance to assist in the identification and prevention of such outbreaks.

Background

From November 2014 to January 2015, ISDH identified 11 new HIV infections in a rural southeastern county where fewer than 5 infections have been identified annually in the past. As of April 21, 2015, an on-going investigation by ISDH with assistance from CDC has identified 135 persons with newly diagnosed HIV infections in a community of 4,200 people; 84% were also HCV infected. Among 112 persons interviewed thus far, 108 (96%) injected drugs; all reported dissolving and injecting tablets of the prescription-type opioid oxymorphone (OPANA® ER) using shared drug preparation and injection equipment.¹

This HIV outbreak was first recognized by a local disease intervention specialist. In late 2014, interviews conducted with three persons newly diagnosed with HIV infections in three separate venues (i.e., an outpatient clinic, a drug rehabilitation program, during a hospitalization) indicated that two of these persons had recently injected drugs and had numerous syringe-sharing and sexual partners. Contact tracing identified eight additional HIV infections leading to the current outbreak investigation, which has demonstrated that HIV had spread recently and rapidly through the local network of PWID. Without an attentive health department, active case finding, and additional testing provided as part of this investigation, this cluster may not have been identified.

Urgent action is needed to prevent further HIV and HCV transmission in this area and to investigate and control any similar outbreaks in other communities.

Injection drug use accounts for an estimated 8%² of the approximate 50,000 annual new HIV infections in the United States.³ & HCV infection is the most common blood-borne infection in the United States and percutaneous exposure via drug-injecting equipment contaminated with HCV-infected blood is the most frequent mode of transmission. Nationally, acute HCV infections have increased 150% from 2010 to 2013,⁴ and over 70% of long-term PWID may be infected with HCV.⁵ Abuse of prescription-type opioids is increasing nationally⁶ and opioid-analgesic poisoning deaths have nearly quadrupled from 1999 through 2011.⁷ Rates of acute HCV infection are increasing, especially among young nonurban PWID, often in association with abuse of injected prescription-type opioids. These increases have been most substantial in nonurban counties east of the Mississippi River.⁸

Recommendations for Health Departments

• Review the most recent sources of data on HIV diagnoses, HCV diagnoses (acute as well as past or present), overdose deaths, admissions for drug treatment, and drug arrests. Attributes of communities at risk for unrecognized clusters of HIV and HCV infection include the following:
  • Recent increases in the:
    • Number of HIV infections attributed to injection drug use,
    • Number of HCV infections, particularly among persons aged < 35 years;
  • High rates of injection drug use and especially prescription-type opioid abuse, drug-related overdose, drug treatment admission, or drug arrests.
• Ensure complete contact tracing for all new HIV diagnoses and testing of all contacts for HIV and HCV infection.
• Ensure persons actively injecting drugs or at high-risk of drug injection (e.g., participating in drug substitution programs, receiving substance abuse counseling or treatment, recently or currently incarcerated) have access to integrated prevention services,⁹ and specifically:
  • Are tested regularly for HIV and HCV infection (consider more frequent testing based on frequency of injection drug usage or sharing of injection equipment);
  • If diagnosed with HIV or HCV infection:
    • Are rapidly linked to care and treatment services;
  • If actively injecting drugs:
    • Have access to medication-assisted therapy (e.g., opioid substitution therapy) as well as other substance abuse services, if not already engaged,
    • Are counseled not to share needles and syringes or drug preparation equipment (e.g., cookers, water, filters),
    • Have access to sterile injection equipment from a reliable source.
  • If not HIV infected but actively injecting drugs:
    • Are referred for consideration of HIV pre-exposure prophylaxis¹⁰ and if potentially exposed within the past 72 hours (e.g., shared drug preparation or injection equipment with a known or potentially HIV-infected person) HIV post-exposure prophylaxis^11,12
• Remind venues that may encounter unrecognized infections, such as emergency departments and community-based clinical practices (e.g., family medicine, general medicine, prenatal care) of the importance of routine opt-out HIV testing as well as HCV testing per current recommendations^13-15
• Local health departments should notify their state health department and CDC of any suspected clusters of recent HIV or HCV infection.

Recommendations for Healthcare Providers

• Ensure all persons diagnosed with HCV infection are tested for HIV infection,¹⁶ and that all persons diagnosed with HIV infection are tested for HCV infection.¹⁷
• Ensure persons receiving treatment for HIV and/or HCV infection adhere to prescribed therapy and are engaged in ongoing care.
• Encourage HIV and HCV testing of syringe-sharing and sexual partners of persons diagnosed with either infection.
• Report all newly diagnosed HIV and HCV infections to the health department.
• For all persons with substance abuse problems:
  • Refer them for medication-assisted treatment (e.g., opioid substitution therapy) and counseling services,
  • Use effective treatments (e.g., methadone, buprenorphine), as appropriately indicated.
• For any persons for whom opioids are under consideration for pain management:
  • Discuss the risks and benefits of all pain treatment options, including ones that do not involve prescription analgesics.
  • Note that long-term opioid therapy is not associated with reduced chronic pain.¹⁸
• Contact the state or local health department to report suspected clusters of recent HIV or HCV infection.

For more information:

• AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report/hcv-testing-and-linkage-care
• Centers for Disease Control and Prevention. Integrated Prevention Services for HIV Infection, Viral Hepatitis, Sexually Transmitted Diseases, and Tuberculosis for Persons Who Use Drugs Illicitly: Summary Guidance from CDC and the U.S. Department of Health and Human Services. 2012: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6105a1.htm?s_cid=rr6105a1_w.
• Centers for Disease Control and Prevention. HIV and Injection Drug Use fact sheet. (http://www.cdc.gov/hiv/pdf/g-l/cdc-hiv-idu-fact-sheet.pdf
• Centers for Disease Control and Prevention. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. 2006; http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm.
• Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. http://dx.doi.org/10.15620/cdc.23447
• Centers for Disease Control and Prevention. Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. May 10 2013;62(18):362-365.
• Centers for Disease Control and Prevention. MMWR Integrated Services Report. (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6105a1.htm?s_cid=rr6105a1_w)
• Centers for Disease Control and Prevention. HIV and Injection Drug Use fact sheet. (http://www.cdc.gov/hiv/pdf/g-l/cdc-hiv-idu-fact-sheet.pdf)
• US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States - 2014 clinical practice guideline. 2014; http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf.
• Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. 2015; http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.

References

1. Spiller MW, Broz D, Wejnert C, Nerlander L, Paz-Bailey G. HIV Infection and HIV-Associated Behaviors Among Persons Who Inject Drugs - 20 Cities, United States, 2012. MMWR Morb Mortal Wkly Rep. Mar 20 2015;64(10):270-275.
2. Centers for Disease Control and Prevention. HIV Surveillance Report, 2013; vol. 25. http://www.cdc.gov/hiv/library/reports/surveillance/, last accessed April 22, 2015.
3. Prejean J, Song R, Hernandez A, et al. Estimated HIV incidence in the United States, 2006-2009. PLoS ONE. 2011;6(8):e17502.
4. Hagan H, Des Jarlais DC, Stern R, et al. HCV synthesis project: preliminary analyses of HCV prevalence in relation to age and duration of injection. The International journal on drug policy. Oct 2007;18(5):341-351.
5. Maxwell JC. The prescription drug epidemic in the United States: a perfect storm. Drug and alcohol review. May 2011;30(3):264-270.
6. Chen LH HH, Warner M. Drug-poisoning deaths involving opioid analgesics: United States, 1999–2011. NCHS data brief, no 166. Hyattsville, MD: National Center for Health Statistics. 2014.
7. Suryaprasad AG, White JZ, Xu F, et al. Emerging epidemic of hepatitis C virus infections among young nonurban persons who inject drugs in the United States, 2006-2012. Clin Infect Dis. Nov 15 2014;59(10):1411-1419.
8. Centers for Disease Control and Prevention. Integrated prevention services for HIV infection, viral hepatitis, sexually transmitted diseases, and tuberculosis for persons who use drugs illicitly: summary guidance from CDC and the U.S. Department of Health and Human Services. MMWR Recomm Rep. Nov 9 2012;61(Rr-5):1-40.
9. US Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States - 2014 clinical practice guideline. 2014; http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf.
10. Centers for Disease Control and Prevention. Antiretroviral Postexposure Prophylaxis After Sexual, Injection-Drug Use, or Other Nonoccupational Exposure to HIV in the United States Recommendations from the U.S. Department of Health and Human Services. 2005; http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5402a1.htm.
11. Kuhar DT, Henderson DK, Struble KA, et al. Updated US Public Health Service guidelines for the management of occupational exposures to human immunodeficiency virus and recommendations for postexposure prophylaxis. Infection control and hospital epidemiology. Sep 2013;34(9):875-892.
12. Centers for Disease Control and Prevention. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. 2006; http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm. Accessed April 22, 2015.
13. Centers for Disease Control and Prevention and Association of Public Health Laboratories. Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. http://dx.doi.org/10.15620/cdc.23447. Accessed April 22, 2015.
14. Centers for Disease Control and Prevention. Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. May 10 2013;62(18):362-365.
15. AASLD/IDSA/IAS–USA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report/hcv-testing-and-linkage-care. Accessed April 22, 2015.
16. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. 2015; http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed April 22, 2015.
17. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. 2015; http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed April 22, 2015.
18. Chou R, Turner JA, Devine EB, et al. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. Feb 17 2015;162(4):276-286.

The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national and international organizations.

Department of Health and Human Services

HAN Message Types

• Health Alert: Conveys the highest level of importance; warrants immediate action or attention. Example: HAN00001
• Health Advisory: Provides important information for a specific incident or situation; may not require immediate action. Example: HAN00346
• Health Update: Provides updated information regarding an incident or situation; unlikely to require immediate action. Example: HAN00342
• Info Service: Provides general information that is not necessarily considered to be of an emergent nature. Example: HAN00345

###
This message was distributed to state and local health officers, state and local epidemiologists, state and local laboratory directors, public information officers, HAN coordinators, and clinician organizations.
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Source: http://emergency.cdc.gov/han/han00377.asp

Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection

• Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection
• Merck Remains on Track to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in First Half of 2015

 VIENNA--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentations of data from the company’s ongoing C-EDGE pivotal Phase 3 clinical trial program evaluating the investigational once-daily tablet grazoprevir/elbasvir (100mg/50mg) in patients with or without cirrhosis who are infected with chronic hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6).1 Patients in both the HCV infected, treatment-naïve (C-EDGE TN), and HIV/HCV co-infected, treatment-naïve (C-EDGE CO-INFXN) trials treated for 12 weeks achieved rates of sustained virologic response 12 weeks after the completion of treatment (SVR12) of 95 percent (299/316 and 207/218, respectively). In addition, HCV infected, treatment-experienced patients (C-EDGE TE) treated with or without ribavirin (RBV) for 12 weeks achieved SVR12 rates of 94 percent (98/104) and 92 percent (97/105), respectively, and those treated for 16 weeks achieved SVR12 rates of 97 percent (103/106) and 92 percent (97/105), respectively. These data were presented at The International Liver CongressTM 2015 – the 50th annual congress of the European Association for the Study of the Liver (Abstract #G07, E-Poster P0886 and E-Poster P0887). A paper detailing the findings of C-EDGE TN was published online in the Annals of Internal Medicine today.

“Patients with co-morbidities and varying treatment experiences represent important segments of the chronic hepatitis C population in need of additional innovative treatment options,” said Dr. Eric Lawitz, vice president, scientific and research development, The Texas Liver Institute and clinical professor of medicine, The University of Texas Health Science Center, San Antonio. “These findings are important because they demonstrate that a single pill of grazoprevir/elbasvir taken once-daily achieved consistently high rates of SVR12 in the patient populations studied.”

Summary of SVR12 findings: C-EDGE TN, C-EDGE CO-INFXN, C-EDGE TE

C-EDGE TN

C-EDGE CO-INFXN

C-EDGE TE

Without RBV (n=316)

Without RBV (n=218)

Without RBV (n=105)

With RBV (n=104)

Without RBV (n=105)

With RBV (n=106)

Duration

12 weeks

12 weeks

12 weeks

12 weeks

16 weeks

16 weeks

All Patients:

95%

95%

92%

94%

92%

97%

SVR12

(299/316)

(207/218)

(97/105)

(98/104)

(97/105)

(103/106)

Cirrhotic

97%

100%

89%

89%

92%

100%

(68/70)

(35/35)

(33/37)

(31/35)

(35/38)

(37/37)

Non-cirrhotic

94%

94%

94%

97%

93%

96%

(231/246)

(172/183)

(64/68)

(67/69)

(62/67)

(66/69)

Genotype 1a

92%

94%

90%

93%

94%

95%

(144/157)

(136/144)

(55/61)

(56/60)

(45/48)

(55/58)

Genotype 1b or

other Genotype

99%

96%

100%

97%

96%

100%

1

(129/131)

(43/45)

(35/35)

(28/29)

(46/48)

(38/38)

Genotype 4

100%

96%

78%

93%

60%

100%

(18/18)

(27/28)

(7/9)

(14/15)

(3/5)

(8/8)

Genotype 6

80%

100%

75%

100%

(8/10)

(1/1)

N/A

N/A

(3/4)

(2/2)

“At Merck, we continue to build upon our clinical experience using grazoprevir/elbasvir across diverse populations of patients infected with chronic hepatitis C virus,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “We remain on track to submit a New Drug Application with the U.S. Food and Drug Administration in the first half of 2015.”

C-EDGE TN Overview and Additional Findings
C-EDGE TN is a randomized, blinded, placebo-controlled trial evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks. Patients were randomized to an immediate treatment group that received grazoprevir/elbasvir for 12 weeks or to a deferred treatment group that received placebo for 12 weeks, were followed for an additional four weeks, and then received open label grazoprevir/elbasvir for the next 12 weeks. The primary efficacy analysis included those patients who received immediate treatment with grazoprevir/elbasvir or placebo. Of the 316 patients who received immediate treatment with grazoprevir/elbasvir, 50 percent were infected with GT1a, 42 percent with GT1b, six percent with GT4 and three percent with GT6. Overall, 22 percent of patients had liver cirrhosis.

In this study, virologic failure occurred in 13 patients (4%) in the immediate treatment group, including one virologic breakthrough and 12 virologic relapses. Serious adverse events occurred in nine (3%) and three (3%) patients in the immediate treatment and corresponding placebo arms, respectively; none were considered drug-related. The most common adverse events reported (greater than 5% incidence) in the immediate treatment and corresponding placebo groups, were headache (17%, 18%), fatigue (16%, 17%), nausea (9%, 8%) and arthralgia (6%, 6%), respectively.

C-EDGE CO-INFXN Overview and Additional Findings
C-EDGE CO-INFXN is an open label, single-arm study evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 and HIV who received therapy for 12 weeks. Of the 218 patients enrolled in the trial, 66 percent were infected with HCV GT1a, 21 percent with GT1b or other GT1, 13 percent with GT4, and one percent with GT6. Overall, 16 percent of patients had liver cirrhosis.
In this study, virologic failure occurred in seven patients (3%), including six virologic relapses and one reinfection. There were no reported drug-related serious adverse events. The most common (greater than 5% incidence) adverse events reported were fatigue (13%), headache (12%) and nausea (9%).

C-EDGE TE Overview and Additional Findings
C-EDGE TE is a randomized study evaluating the efficacy and safety of once-daily grazoprevir/elbasvir with or without twice-daily RBV in treatment-experienced (prior null response, partial response or relapse with peg-interferon/RBV) patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks or 16 weeks.

12 week arms
 Of the 209 patients randomized to the 12 week arms, 105 patients received grazoprevir/elbasvir only and 104 patients received grazoprevir/elbasvir plus RBV. Patients in the grazoprevir/elbasvir only arm comprised 58 percent GT1a, 33 percent GT1b or other GT1 and nine percent GT4. Overall, 35 percent had liver cirrhosis. Among the 104 patients receiving grazoprevir/elbasvir plus RBV, 58 percent were infected with chronic HCV GT1a, 28 percent GT1b or other GT1, and 14 percent GT4. Overall, 34 percent had liver cirrhosis.

In the grazoprevir/elbasvir only and grazoprevir/elbasvir plus RBV arms, six patients in each arm (6%) were reported to have virologic relapse. No patients were reported to have virologic breakthrough or rebound. Serious adverse events were reported in four patients in the grazoprevir/elbasvir only arm (4%) and three patients in the grazoprevir/elbasvir plus RBV arm (3%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (19%, 27%), headache (21%, 20%) and nausea (9%, 14%).

16 week arms
Of the 211 patients enrolled in the 16 week arms, 105 patients received grazoprevir/elbasvir only and 106 patients received grazoprevir/elbasvir plus RBV. In the grazoprevir/elbasvir only arm, 46 percent were infected with chronic HCV GT1a, 46 percent with GT1b or other GT1, five percent with GT4 and four percent with GT6. Overall, 36 percent of patients had liver cirrhosis. Among those in the grazoprevir/elbasvir plus RBV arm, 55 percent were infected with chronic HCV GT1a, 36 percent with GT1b or other GT1, eight percent with GT4, and two percent with GT6. Overall, 35 percent had liver cirrhosis.

Among the patients receiving grazoprevir/elbasvir only, three patients (3%) were reported to have virologic breakthrough or rebound and four patients (4%) were reported to have virologic relapse. No virologic failures occurred in patients receiving grazoprevir/elbasvir plus RBV. Serious adverse events were reported in three patients in the grazoprevir/elbasvir only arm (3%) and four patients in the grazoprevir/elbasvir plus RBV arm (4%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (16%, 30%), headache (19%, 19%) and nausea (4%,17%).

About the C-EDGE Program
C-EDGE is the Phase 3 clinical development program for Merck’s investigational HCV treatment grazoprevir/elbasvir comprising five studies with more than 1,700 patients across more than 25 countries. These studies are evaluating grazoprevir/elbasvir in multiple genotypes (GT1, 4 and 6) and diverse patient populations, including difficult-to-treat patients such as: treatment-experienced, patients with cirrhosis, HIV/HCV co-infection, advanced chronic kidney disease, inherited blood disorders, and those receiving opiate substitution therapies.

Read complete press release here...

Merck oral hepatitis C regimen shows 95 pct cure rate

(Reuters) - Merck and Co Inc presented trial results on Friday showing that a once-daily combination of two experimental pills cured 95 percent of previously untreated hepatitis C patients after 12 weeks.

The trial included patients infected with the most common form of the liver-destroying virus, genotype 1, along with less common genotypes 4 and 6. It also involved patients with and without liver cirrhosis.

Cure rates, defined as sustained virologic response 12 weeks after treatment, were 92 percent for patients with genotype 1a; 99 percent for genotype 1b; 100 percent for genotype 4; and 80 percent for genotype 6. Cures were achieved in 97 percent of cirrhotic patients and 94 percent of non-cirrhotic patients.

Read more...

EU regulators warn against combining hepatitis C drugs with amiodarone

(Reuters) - European health regulators warned on Friday against using Gilead Sciences Inc's and Bristol-Myers Squibb Co's hepatitis C medicines along with amiodarone, a drug used to regulate the heartbeat of people with heart rhythm disorders.

The European Medicines Agency said there is a risk of severe bradycardia, or heart block, when Gilead's drug Harvoni or a combination of Gilead's Sovaldi and Bristol-Myers' Daklinza are used in patients who are also taking amiodarone. (bit.ly/1HvQg8n)

The agency's committee for medicinal products for human use recommended that amiodarone only be used in patients taking these hepatitis C medicines if other anti-arrhythmics cannot be administered.

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Canada: Williams Lake gets Hepatitis C clinic

Waiting times for people in the Cariboo seeking treatment to cure Hepatitis C will be shorter now that a new clinic has opened in Williams Lake.

Every month Dr. Alexandra King and clinical research nurse Shawn Sharma will run the clinic for a few days out of the Atwood Clinic in co-operation with local family doctor Jolien Steyl, who already runs an HIV-Aids clinic.

“As a family doctor it’s been a nightmare getting patients treated,” Steyl said. “They either have to travel really far or they don’t get started on treatment because the waiting lists are long.”

King and Sharma work at the Vancouver Infectious Diseases Centre (VIDC) where King  is an internal medicine specialist.

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