La FDA aprueba Technivie para el tratamiento de la hepatitis crónica de genotipo 4

La Administración de Alimentos y Medicamentos (FDA) de los Estados Unidos aprobó el día de hoy Technivie (ombitasvir, paritaprevir y ritonavir) para su uso en combinación con ribavirina para el tratamiento de las infecciones del virus de la hepatitis C (VHC) de genotipo 4 en pacientes sin cicatrización y funcionamiento deficiente del hígado (cirrosis).

Technivie en combinación con ribavirina es el primer medicamento que ha demostrado seguridad y eficacia para tratar infecciones con el VHC de genotipo 4 sin la necesidad de la coadministración de interferón, un medicamento aprobado por la FDA también utilizado para tratar la infección del VHC.

“La aprobación del día de hoy proporciona la primera opción de tratamiento para los pacientes con infecciones del VHC de genotipo 4 que no requiere el uso de interferón”, señaló el Dr. Edward Cox, director de la Oficina de Productos Antimicrobianos del Centro de Evaluación e Investigación de Medicamentos de la FDA.

La hepatitis C es una enfermedad viral que causa inflamación del hígado que puede dar lugar a una disminución de la función hepática o insufic

iencia hepática. La mayoría de las personas infectadas con el VHC no presentan síntomas de la enfermedad hasta que los daños en el hígado son evidentes, lo cual puede tardar varios años. Algunas personas con infección crónica del VHC desarrollan cirrosis a lo largo de varios años, que puede dar lugar a complicaciones como sangramiento, ictericia (coloración amarillenta de la piel), acumulación de líquido abdominal, infecciones o cáncer hepático. Según los Centros para el Control y la Prevención de Enfermedades (CDC), alrededor de 2.7 millones de estadounidenses están infectados con el VHC, de los cuales el genotipo 4 es uno de los menos comunes.

La seguridad y la eficacia de Technivie con ribavirina se evaluaron en estudios clínicos de 135 participantes con infecciones con el VHC de genotipo 4 sin cirrosis. Noventa y un participantes recibieron Technivie con ribavirina una vez al día por 12 semanas. Cuarenta y cuatro participantes recibieron Technivie sin ribavirina por 12 semanas. Los estudios se diseñaron para medir si el virus de la hepatitis C de un participante ya no se detectaba en la sangre luego de 12 semanas de finalizar el tratamiento (respuesta virológica sostenida), lo que indica que la infección por el VHC del participante se ha curado.

Los resultados demostraron que el 100 por ciento de  los participantes que recibieron Technivie con ribavirina lograron una respuesta virológica sostenida. De aquellos que recibieron Technivie sin ribavirina, el 91 por ciento lograron una respuesta virológica sostenida. 

La información de seguridad estuvo disponible para los 316 participantes con VHC tratados con la dosis recomendada de Technivie en combinación con otros medicamentos anti VHC en los estudios clínicos. Los tres medicamentos incluidos en Technivie también están incluidos en Viekira Pak, aprobado previamente para el tratamiento de la infección del VHC de genotipo 1. La información de seguridad adicional para estos medicamentos estuvo disponible en los estudios clínicos de Viekira Pak. Los efectos secundarios más frecuentes de Technivie con ribavirin fueron: fatiga, debilidad (astenia), náuseas, insomnio, picazón (prurito) y otras reacciones de la piel.

Technivie se acompaña de una advertencia que alerta a los pacientes y proveedores de salud que elevaciones de las enzimas hepáticas por encima de cinco veces el límite superior de la normalidad ocurrieron en aproximadamente el 1 por ciento de los participantes de los estudios clínicos. Las elevaciones ocurrieron más frecuentemente en mujeres que tomaban anticonceptivos que contienen etinilestradiol. Los anticonceptivos que contienen etinilestradiol deben suspenderse antes de iniciar Technivie. Deben realizarse pruebas de laboratorio de la función hepática durante las primeras cuatro semanas de iniciar el tratamiento y posteriormente cuando estén indicadas clínicamente.

Technivie y Viekira Park están comercializados por AbbVie Inc. con sede en North Chicago, Illinois.

Para obtener más información:

• FDA: Medicamentos aprobados: Preguntas y respuestas (en inglés)
• FDA: Innovación de medicamento (en inglés)
• FDA: ¿Que hay de nuevo en la FDA en Hepatitis? (en inglés)
• CDC: Hepatitis C: Información para el público

La FDA, una agencia del Departamento de Salud y Servicios Sociales de los EE. UU. protege la salud pública asegurando la protección, eficacia y seguridad de los medicamentos tanto veterinarios como para los seres humanos, las vacunas y otros productos biológicos destinados al uso en seres humanos, así como de los dispositivos médicos. La agencia también es responsable de la protección y seguridad de nuestro suministro nacional de alimentos, los cosméticos, los suplementos dietéticos, los productos que emiten radiación electrónica, así como de la regulación de los productos de tabaco.

 http://www.fda.gov/NewsEvents/Newsroom/ComunicadosdePrensa/ucm455906.htm

Organizations in California Launch Campaign to Encourage Primary Care Clinicians to Screen Patients for Hepatitis C

FOR IMMEDIATE RELEASE

Media Contacts:

Ryan Clary National Viral Hepatitis Roundtable 202-407-2391 rclary@nvhr.org

Shelly Rodrigues, CAE, FACEHP California Academy of Family Physicians 415-345-8667, ext 228 srodrigues@familydocs.org

In Honor of World Hepatitis Day Organizations in California Launch Campaign to Encourage Primary Care Clinicians to Screen Patients for Hepatitis C

(San Francisco, CA, July 28, 2015) – Today the California Academy of Family Physicians, California Hepatitis Alliance (a program of Project Inform) and the National Viral Hepatitis Roundtable launch the “California Hepatitis C Clinicians’ Honor Roll” campaign. The Honor Roll recognizes clinicians who sign a pledge to screen their adult patients for hepatitis C in accordance with the United States Preventive Services Task Force (USPSTF) guidelines. To view the USPSTF hepatitis C screening guidelines, visit: http://www.uspreventiveservicestaskforce.org/uspstf/uspshepc.htm

According to the California Department of Public Health, 750,000 Californians are living with hepatitis C. Because this contagious liver disease often remains asymptomatic for years and many providers and patients commonly overlook testing, the vast majority of individuals are unaware that they are infected.

Karen Smith, MD, MPH, Director of the California Department of Public Health notes, “The best tools we have to reduce the human and economic costs of hepatitis C in California are to prevent new infections, screen people at risk, and link those who are infected to care.”

The USPSTF recommends hepatitis C screening for:

• Adults born between 1945 through 1965
• Anyone with past or current history of injecting drugs
• Anyone who received a blood transfusion before 1992
• Long-term hemodialysis patients
• Anyone born to a mother infected with hepatitis C
• Anyone with a history of incarceration
• Anyone with past or current history of intranasal drug use (snorting drugs)
• Anyone who has received a tattoo from an unregulated source
• Anyone with other percutaneous exposures to blood

“Hepatitis C is a devastating disease.  Unfortunately, the majority of people with hepatitis C do not even know they are infected,” states Ron Chapman, MD, MPH, family physician and past director and state health officer for the California Department of Public Health. ”Family doctors, primary care, and other physicians and care team members have a critical role to play to identify these people and save their lives.”

Hepatitis C is the leading cause of catastrophic liver damage, cirrhosis, liver cancer, and liver transplants, and hepatocellular carcinoma is the fastest growing cancer in the United States. While the virus remain undetected, causing potentially life-threatening liver damage, individuals can unknowingly transmit the disease to others. California clinicians can stop this silent epidemic.

This Honor Roll campaign is conducted in partnership with the California Academy of Physician Assistants Foundation, California Department of Public Health, California Medical Association Foundation, Network of Ethnic Physician Organizations and San Francisco Medical Society.

For more information about the Honor Roll campaign, visit http://www.familydocs.org/world-hepatitis-c-day-july-28

###

The California Academy of Family Physicians (CAFP) is the only organization solely dedicated to advancing the specialty of family medicine in the state. Since 1948, CAFP has championed the cause of family physicians and their patients. CAFP is critically important to primary care. With a strong collective voice of more than 9,200 family physician, family medicine resident and medical student members, the CAFP is the largest primary care medical society in California and the largest chapter of the American Academy of Family Physicians. We focus on family physicians’ professional challenges and health policy concerns through advocacy and education to expand access to high-quality and cost-effective patient care for California. We are committed to helping family physicians improve their everyday practice lives by offering affordable evidence-based continuing medical education, providing cost-saving practice management resources, delivering practical approaches to practice transformation, and fostering opportunities to promote the family medicine specialty and ensure a strong and healthy primary care pipeline. For more information about CAFP, visit www.familydocs.org.

Founded in 2006, the California Hepatitis Alliance (CalHEP), a program of Project Inform (www.projectinform.org), is an alliance of more than 100 organizations dedicated to reducing the scope and consequences of the hepatitis B and C epidemics, which disproportionately affect California’s ethnic communities and the socioeconomically underserved. CalHEP includes among its membership public health organizations, community-based organizations, clinics and health care agencies, county hepatitis task forces, and others committed to viral hepatitis prevention, care, advocacy, and education. Committed to culturally competent public education and awareness, CalHEP’s work focuses on advocating for sound policies; promoting evidence-based education; and broadening access to services.  For more information about CalHEP, visit www.calhep.org.

The National Viral Hepatitis Roundtable (NVHR) is a broad coalition working to fight, and ultimately end, the hepatitis B and hepatitis C epidemics. We seek an aggressive response from policymakers, public health officials, medical and health care providers, the media, and the general public through our advocacy, education, and technical assistance. NVHR believes an end to the hepatitis B and C epidemics is within our reach and can be achieved through addressing stigma and health disparities, removing barriers to prevention, care and treatment, and ensuring respect and compassion for all affected communities. For more information about NVHR, visit www.nvhr.org.

Source: http://us5.campaign-archive1.com/?u=9dd22df1cf3a741391755d010&id=7928f2321c&e=227fe74971
 

Tennessee Dept. of Health issues public health advisory on hepatitis C epidemic

"The rate of acute Hepatitis C cases in Tennessee has more than tripled in the last seven years, and the steadily increasing number of cases may only represent “the tip of the iceberg” of the state’s Hepatitis-C epidemic, according to TDH Commissioner John Dreyzehner, MD, MPH."

NASHVILLE (WATE) – The Tennessee Department of Health is issuing a public health advisory urging residents to increase their awareness about hepatitis C, a life-threatening disease spread by direct contact with blood from an infected person.

The Knox County Health Department says it’s important to know all the risk factors. Within the last year there’s been an increase of testing for the virus at the health department. Director Dr. Martha Buchanan says her staff will be looking at that data and determining what can be done.

“The best protection you have is knowledge and knowing what behaviors and what things put you at risk,” said Buchanan.

Read more...

Weekly Special Topic: Advocates & Activists Needed!

Advocates & Activists Needed!

World Hepatitis Day is approaching - What Can YOU do to help raise the level of awareness of viral hepatitis:

Read more...

 

World Hepatitis Day: July 28, 2015

July 28, 2015

400 MILLION PEOPLE IS 400 MILLION TOO MANY

Worldwide 400 million people are living with hepatitis B or C. Every year 1.4 million people die from viral hepatitis and yet all of these deaths could be prevented. With better awareness and understanding of how we can prevent hepatitis we can eliminate this disease and save 4,000 lives a day.

Learn more and get involved here

A New Powerful HCV Health Tool, by Alan Franciscus, Editor-in-Chief

Originally published July 1, 2015

In this age of technology, hepatitis C finally has it is own App!  This technology is brought to you by Help-4-Hep which provides peer-to-peer counselling services for people with hepatitis C.  It is available on the internet and mobile devices.

The application includes everything you need to stay healthy living with hepatitis C and if undergoing treatment: 

• Appointment Calendar
• Personal Journal
• Medication Tracker
• Symptom tracker
• Weight Tracker
• Daily Moods
• HCV Lab Tracker
• Meal Tracker

This is another powerful new tool that Help-4-Hep provides nationwide.  Help-4-Hep is a non-profit, peer-to-peer helpline — 877‑HELP‑4‑HEP (877‑435‑7443) — where counselors work with patients to meet the challenges of hepatitis C head-on.  Callers talk one-to-one with a real person, typically someone who’s had hepatitis C touch their own life.  This is a fantastic service.

If you need help or know someone who needs help, please refer them to this service.  Alan

http://hcvadvocate.org/news/newsLetter/2015/advocate0715.html#5

Patients First: Antacid, Pregnancy Categories and Herbs, by Alan Franciscus, Editor-in-Chief

Originally published July 1, 2015

I was recently looking on Facebook and the topic was antacids and Proton Pump Inhibitors.  It was interesting because everyone had a different take on how and when to take them.  As a result I thought I would talk about what they are, when it is safe to take them and a couple of other common topics such as—pregnancy categories and herbal supplements. 

The current standard of care for treating hepatitis C by genotype includes: 

• Genotype 1:  Harvoni (sofosbuvir/ledipasvir) and Viekira Pak with and without ribavirin
• Genotype 2 and 3:  Sovaldi (sofosbuvir) plus ribavirin
• Genotype 4:  Sovaldi (sofosbuvir) plus pegylated interferon and ribavirin

The drugs listed above were approved by the Food and Drug Administration (FDA). The approval process went through vigorous testing that included testing to find out what type of other drugs (drug-drug interactions) affected the absorption of the HCV medicines into the blood stream.  This could change how well these drugs work and affect cure rates. This includes herbs since these can be considered a type of medicine.  It is important to remember that herbs are not regulated. 

Drug-Drug Interactions

• Harvoni/Viekira Pak: 
Proton Pump Inhibitors are drugs that work by reducing the amount of stomach acid made by glands in the lining of your stomach.  The package label specifically lists omeprazole (Priolsec)—talk with your medical provider if you take this type of medication. 

• Harvoni:
  Check with your medical provider if you take any acid reducing agents (antacids).  There are specific times you can and can not take them.  

• Herbal Supplements:
Harvoni/Sovaldi/Viekira Pak:  Do not take St. John’s wort. 

Note:  People who are taking any protease inhibitor (HIV or HCV protease inhibitor) should not take St. John’s wort).  People taking Olysio should not take the herb Milk Thistle.

 

Note:  Make sure to talk with your medical provider about any herb, supplement or medicine to make sure there is no drug-drug interaction.  For information about liver toxic herbs see this edition of the HCV Advocate newsletter. 

Pregnancy Categories
Harvoni, Sovaldi and Viekira Pak are classified as Pregnancy B drugs.  This means that there have been no studies in humans and that they should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus or if needed. 

Ribavirin is a Pregnancy X drug and as such pregnancy has to be avoided.  Women of child bearing potential and their male partners can not receive ribavirin unless they are using two forms of effective contraception during treatment with ribavirin and for six months after treatment has concluded.  Women should have a pregnancy test before starting treatment, during treatment and the six month period after treatment. 

Women are encouraged to sign up with the ribavirin registry at:  www.ribavirinpregnancyregistry.com

Comment:  If a woman is contemplating pregnancy most medical providers recommend HCV treatment first and starting a family afterwards.  Talk with your medical provider about your options. 

HCV Treatment FDA-Approved Prescribing Information:

• Harvoni (sofosbuvir/ledipasvir) FDA-Approved Prescribing Information
• Harvoni (sofosbuvir/ledipasvir) Patient Information
• Sovaldi (Sofosbuvir) FDA-Approved Prescribing Information
• VIEKIRA PAK FDA-Approved Prescribing Information
• Ribavirin Warning!

http://hcvadvocate.org/news/newsLetter/2015/advocate0715.html#4