Sex education reform — do it for Ryan White

By Deborah Simmons The Washington Times

Sunday, November 17, 2013

Remember Ryan White?

Diagnosed with hemophilia as a newborn in December 1971, Ryan underwent blood transfusions to stay alive and 13 years later learned he had contracted HIV from contaminated blood.

A valiant warrior, Ryan died in 1990 — but not before he made us think, rethink and then think again about what was mistakenly dubbed the “gay men’s” disease.

We could not save Ryan but we can and must save the children.

With children like Ryan being infected with the HIV virus because of ignorance and promiscuity, it’s high time we re-educate ourselves and sit down with our young children and young adults to have “the talk” — about the birds, bees and abstinence.

We’ve handed off “the talk” to public schools, and they have muddied the message.

While schools pump up the volume on teaching gender identity, making condoms easily accessible and continuing to bow to special interests’ pressure to teach “safe sex,” our young people are teetering in the shadow of death.

According to a report released a year ago, just before World AIDS Day, 13- to 24-year olds in the U.S. make up more than a quarter of new HIV infections annually.

And more than half of those youth are unaware they are HIV-positive, the report by the federal Centers for Disease Control and Prevention says.

To know a child is ill, as was the case with baby Ryan, is one thing. You take action, and do what you can to make your child healthier and keep risky behavior at bay.

What are we doing?

We are shirking our responsibility.

Instead of having the conversations with our children, we are allowing our children to learn about sex, sexual behavior and sexual identity in a school house, which is risky in and of itself because we should be our children’s primary messengers and the messages rest in our hearts and hands.

And yet again, after cutting out health education during Ryan’s lifetime and replacing it with sex education, we are being encouraged to turn our backs on our children.

An annual report released last week by D.C. Appleseed on HIV/AIDS practices and policies in the District gave the city an A in condom distribution; for education, traditional public schools got a B+ while public charter schools got a C.

Well, here we go, pressing against another World AIDS Day on Dec. 1, when reports and studies inevitably proclaim that we are making measurable progress “but “

There’s always a “but” because we are afraid to talk to and with our own doggone children.

That fear of flying endangers yet another generation of young people, youths who are being told that boys and girls are the same when we know they are not, and that having sex at a very young age OK because we and they can deal with the consequences at the foot of the bridge.

Well, Ryan had no choice, and he had no choice because we waited too late.

Think about that.

We must save our children.

Every single time you are asked to consider to sex education reform instead of health education reform think about Ryan and the HIV/AIDS rates.

And remember: HIV/AIDS is not a “gay men’s” disease; if it were, Ryan would not have died from the consequences of its infection and our children would not be contracting it at alarming rates

If all of the above sounds like I’m preaching, it is because I am — and you should be, too.

Deborah Simmons can be reached at dsimmons@washingtontimes.com

Source

HCV is for Hope, Courage, Victory.

by Opiferum

Despite the fact 60% of hepatitis C virus infections are represented by intravenous drug users, it is very unfortunate that this also too commonly translates as a group affected by hepatitis C because of sharing needles. On the contrary, as in my example, I was the unfortunate recipient of a needle-stick injury whilst practising safe injecting procedures. However, because of the fact I have a past history of intravenous drug use, my medical records of contracting the disease are always marked by the words “sharing needles”. Even though I feel this is a grossly unfair, because there is simply no proof, it is nevertheless the only way the medical field can legitimately explain one of the three ways in which I got hepatitis C. As a result, I feel at a loss to know exactly how I was re-infected for the final time, because I simply never shared needles. However, because of my past history as a intravenous drug user, the automatic assumption is that I shared needles.

Coming to terms with learning of a third hepatitis C virus infection 18-months after I ceased using intravenous drugs was, needless to say, devastating. I had undergone standard interferon and ribavirin treatment in 2007, to which end, I was very mindful never to put myself at risk in the future. After all, my initial exposure to hepatitis C was by way of a needle stick injury, not because of sharing needles. Having endured six-months of torturous (but successful) treatment that left me with a benzodiazepine dependency, the last thing I ever wanted was to go through it all again. Even though I resumed using drugs again sometime after treatment, it was never on my mind that I would get the news again that I am hepatitis C positive, simply because I never engaged with unsafe injecting practises. However, after treatment, I never felt as if I had been magically cured. I still felt lethargic, and a sense that something was still wrong. But because the PCR tests kept coming back with no viral detection after 6- to 12-months, it was concluded that the treatment had been a success. Yet, in May of 2010, the PCR test did not come back with the familiar result of “negative”. Nearly 3 years after completing treatment and 18-months after last using a needle and syringe, my worst nightmare had come true. As well, my ongoing suspicions had been confirmed: I was hepatitis C positive again. Incidentally, I was infected with exactly the same genotype (3a).

In my heart, I would like to think that I am one of the unlucky persons that have been known to show relapse after 3-years. After all, there have been studies conducted in France to indicate that this is not totally out of the question. Due to my intravenous drug user status, however, it just does not seem possible. No matter how much I try to argue, it will never be credible that I could belong to this group of late relapsers. After all, it is so often assumed that intravenous drug use must involve the sharing of needles: wrong! If I were a blood transfusion recipient, perhaps my reports of never feeling cured long after treatment would not be ignored and maybe be taken into consideration as a sign of late relapse, as opposed to receiving the instant diagnoses that I was re-infected as a result of former drug use.

Hope

In light of the above, the meaning of the hepatitis C virus has taken on a very personal meaning. With the advent of new treatment on the horizon, I now have hope. Until recently, I was absolutely adamant that I would never undergo any form of interferon treatment again. This is because the side-effects were so severe, I simply did not want to sign-up for a chance to re-live the experiences my memory can still recall, including injecting myself subcutaenously, long and paralysing episodes of depression, anxiety, lethargy and hair-loss due to anaemia, anger, frustration and isolation. The opportunity to be a part of a new generation of treatment for hepatitis C is exciting and thrilling. I would like to think that I am privileged to witness a new era in the dispensing of hepatitis C treatment, knowing how difficult it has been in the past making trips up to the hospital, just to make a pledge for treatment. In the future, I can not wait to see others with a past or present history of intravenous drug use being able to receive treatment that has so long been associated with long waits at the liver clinic, not to mention a laborious procedure that sometimes involves having to prove one’s legitimate worth for being able to receive such a wonderful opportunity to be rid of the dreaded virus. It brings me much hope to know that new treatments on the horizon will revolutionise the way in which hepatitis C is perceived, as it will finally become just another form of illness to be cured by the local doctor. Whilst it will not reduce altogether the stigma attached to intravenous drug users and hepatitis C, at least it will allow this disproportionately represented group to receive treatment in a way that is much more user-friendlier than the white walls of a sterile hospital.

Courage

Not knowing what the side-effects of a new treatment will entail, I have the opportunity to embrace courage as a means to approach the six months that are ahead of me. Already, I have the strength to confront the process of what treatment entails, namely ongoing blood-tests and the anxiety of what the results might reveal. Not knowing what each day might bring is something I am already accustomed to, as living with the hepatitis C virus, there is no way of knowing what kind of day it might be. Therefore, I am not fearful of what the side-effects of a new course of treatment might bring. After all, the desire to be free from hepatitis C is constant, like a second’s hand ticking on a big grandfather clock. Finally, I will be able to face letting go of a status that has kept me chained to a painful reminder of my past, as the ramifications of living with hepatitis C well after choosing to use drugs has been at times very difficult to accept. There are days, for example, whereby I feel resentful and regretful that I was in a situation that exposed me to the hepatitis C virus. Sometimes, I simply can not ignore the fact that if I had not used intravenous drugs, then perhaps I would not have had the last 8-years of my life affected by living with a virus that has not only affected the quality of my life, but given to me a label imbued with much stigma and discrimination. In turn, I can not only help others to be more aware of how not to react in a discriminatory manner, but live with a greater sense of awareness regarding how I can treat others better, too.

Victory

It is a battle to live with hepatitis C, so it will feel like a victory to survive another course of treatment that will (hopefully) be successful. Modestly, I remain hopeful that treatment will be a success, as after all, I already know too well that nothing is guaranteed. Afterwards, I will be able to look back and know that I conquered coping with a disease that has influenced my life, from controlling the amount of energy I have each day, to instilling the fear of developing cirrhosis of the liver one day if I do not manage to clear the virus by way of treatment. As each day passes, I know it is one closer to reclaiming my health and future, even though it has been a long journey. Finally, it will be a relief someday to admit that I am no longer hepatitis C positive, but it will also mean having to explain how that could be possible, considering the widespread misconception is that the virus is not medically treatable. No matter what amount of disbelief I may encounter, it will nevertheless remain a personal victory to

have come this far. Whilst people may take their lives for granted every day, I know that as a person living with the hepatitis C virus, the complete opposite is true. Rather, each day is treasured, as the meaning of life and the gravity of our existence takes on a different kind of significance, simply because of a virus that can give to us much hope, courage and victory: hepatitis C.

Incorrect Perceptions About Sexual Versus Injection Hepatitis C Transmission Risk among Couples May Contribute to Unsafe Injecting Practices

The majority of hepatitis C virus (HCV) transmissions occur via injection drug use (IDU). The risk of sexual transmission of HCV among HIV-uninfected heterosexual couples is believed to be very low. There is limited information about how people with IDU perceive the risk of HCV transmission via heterosexual sexual activity. This qualitative study examined how perceptions of risk among this population affected practices. Researchers conducted in-depth interviews with 37 adults who had used injection drugs within the past 30 days.

• Of the total sample, 15 (41%) were HCV-positive, 10 (27%) were female, 28 (76%) were Caucasian, and the mean age was 40 (range 23–57). Heroin was the primary drug of choice 25 (68%) followed by crack and heroin mix 12 (32%).
• The majority of participants who were, or had been, in long-term heterosexual relationships reported needle and syringe sharing with their regular sexual partner.
• Many participants believed that sexual transmission risk was equivalent to drug risk. This narrative of “risk equivalence” was frequently used to justify needle and syringe sharing practices among partners who were already having unprotected sex.

Comments:

This study highlights a gap in knowledge about HCV transmission among people with IDU. The authors suggest that HCV prevention programs that “add on” safer sex messages may do more harm than good by perpetuating risk equivalence beliefs that foster dismissal of safer injecting practices among those practicing unprotected sex. While it is speculative whether more accurate messages about sexual transmission risk would impact injecting behaviors in couples, this study does provide an interesting new framework for understanding risk behaviors among people with IDU.Judith Tsui, MD, MPH

Reference:

Harris M, Rhodes T. Injecting practices in sexual partnerships: Hepatitis C transmission potentials in a “risk equivalence” framework. Drug Alcohol Depend. 2013; 132(3):617–623.

Source

SIMEPREVIR ADMINISTRADO UNA VEZ AL DÍA DEMUESTRA UNA ALTA RESPUESTA VIROLÓGICA SOSTENIDA EN PACIENTES NO TRATADOS PREVIAMENTE Y PACIENTES PRETRATADOS CON HEPATITIS C CRÓNICA GENOTIPO 1

Madrid, Nov. 12, 2013 – Janssen R&D Ireland (Janssen) ha anunciado la presentación de nuevos datos de simeprevir, -un inhibidor de proteasa (IP) frente al virus de la hepatitis C-. Estos datos hacen referencia a simeprevir (TMC435) en el tratamiento del genotipo 1 del virus de la hepatitis C crónica (VHC), para pacientes no tratados previamente (naïve) y pretratados, en adultos con enfermedades hepáticas compensadas. Según el análisis de los estudios de la Fase 3 QUEST-1 y QUEST-2 en pacientes no tratados previamente y el estudio de la Fase 3 PROMISE en pacientes con recaída previa, la eficacia de simeprevir ha sido observada en pacientes con VHC considerados de difícil tratamiento, incluyendo pacientes con el genotipo IL28B TT y F4 en la escala METAVIR.

El virus de la hepatitis C crónica es una problema en EMEA, donde aproximadamente 15 millones de personas conviven con la enfermedad (1). Muchos pacientes que conviven con la hepatitis C crónica necesitan tratamiento y el genotipo del virus normalmente determina como de eficaz será el tratamiento (2).

“Los pacientes con determinados requerimientos y características pueden ser más propensos a la recaída después de un primer tratamiento”, asegura el Dr. Ira Jacobson, investigador de los ensayos clínicos de simeprevir, jefe de la División de Gastroenterología y Hepatología en Estados Unidos. “La amplitud de los datos de simeprevir presentados en la Reunión Anual de la Asociación Americana para el Estudio de Enfermedades Hepáticas (AASLD), refuerzan el potencial de simeprevir como una opción de tratamiento efectiva en diferentes perfiles de pacientes, incluyendo aquellos considerados de difícil tratamiento, y ofrecerá una importante ayuda para los especialistas una vez que simeprevir sea aprobado”.

El 24 de octubre, el Comité Asesor de Medicamentos Antivirales de la FDA votó de forma unánime (19-0) para recomendar a la FDA la aprobación de simeprevir 150mg una vez al día en combinación con interferón pegilado y ribavirina, para el tratamiento en pacientes adultos con el virus de la hepatitis C crónica de genotipo 1 con enfermedad hepática compensada.

En Abril de 2013 se envió una petición de Autorización de Marketing a la Agencia Europea del Medicamento solicitando la aprobación de simeprevir para el tratamiento del genotipo 1 o genotipo 4 crónico de la VHC. Simeprevir fue aprobado en Japón en septiembre de 2013 para el tratamiento del genotipo 1 VHC. Simeprevir también ha sido estudiado en diversos regímenes libres de interferón utilizando combinaciones seleccionadas de agentes antivirales de acción directa con diferentes mecanismos de acción.

Análisis combinado de QUEST-1 y QUEST-2 confirma el beneficio clínico de Simeprevir en subpoblaciones de pacientes (Abstract 1122)

En la Fase 3 del estudio QUEST-1 y QUEST-2, en tratamiento con simeprevir junto con interferón pegilado y ribavirina, un 80% de los pacientes no tratados previamente alcanzaron el endpoint primario, la Respuesta Virológica Sostenida a las 12 semanas del tratamiento (RVS12), comparado con el 50% en pacientes tratados con placebo junto a interferón pegilado y ribavirina. El análisis, que incluye a pacientes considerados de difícil tratamiento, señaló que un 61% de los pacientes con el genotipo IL28B TT, un 60% de los pacientes con F4 en la escala METAVIR y un 75% de pacientes con genotipo 1a del virus de la hepatitis C crónica tratados con simeprevir, combinado con interferón pegilado y ribavirina, alcanzaron RVS12, comparado con el 21%, 34% y 47% de los pacientes que recibieron placebo, interferón pegilado y ribavirina.

Entre los pacientes portadores del polimorfismo del genotipo 1a Q80K al inicio del estudio, el 58% de los pacientes tratados con simeprevir combinado con interferón pegilado y ribavirina alcanzaron RVS12, frente al 52% de los pacientes tratados con placebo en combinación con interferón pegilado y ribavirina, pero la diferencia no fue estadísticamente significativa. El 3% de los pacientes tratados con simeprevir interrumpieron el tratamiento debido a eventos adversos, comparado con el 2% de los pacientes tratados con placebo.

El análisis PROMISE completa los datos de eficacia de simeprevir en subpoblaciones de pacientes (Abstract 1092)

El estudio PROMISE, “pivotal” fase III, se llevó a cabo en pacientes que anteriormente habían experimentado una recaída después del anterior tratamiento basado en la terapia interferón pegilado. El 79% de los pacientes del brazo de simeprevir con interferón pegilado y ribavirina alcanzaron endpoint primario de RVS12 en comparación al 37% de los pacientes del grupo placebo con interferón pegilado y ribavirina.

En este subanálisis, entre pacientes considerados de difícil tratamiento, el 65% de los paciente con el genotipo IL28B TT, el 74% de los pacientes con el nivel F4 de la escala METAVIR y el 70% de los pacientes con genotipo 1a VHC tratados con simeprevir combinado con interferón pegilado y ribavirina alcanzaron RVS12 comparado con el 19%, 26% y 28% de pacientes que tomaban placebo junto a interferón pegilado y ribavirina, respectivamente.

Entre los pacientes con genotipo 1a y polimorfismo basal Q80K, el 47% de los pacientes tratados con simeprevir, interferón pegilado y ribavirina alcanzaron RVS12, comparado con el 30% de los pacientes tratados con placebo, interferón pegilado y ribavirina. Los efectos adversos más comunes en pacientes tratados con simeprevir combinado con interferón pegilado y ribavirina en las primeras 12 semanas fueron fatiga, dolor de cabeza y síntomas pseudogripales.

“Los datos presentados en la AASLD aportan nuevas evidencias de la eficacia de simeprevir en pacientes de difícil tratamiento”, ha asegurado María Beumont, Medical Lead de simeprevir en Janssen. “Después del reciente voto positivo de la semana pasada, por parte del Comité Asesor de Medicamentos Anitivirales de la FDA, que recomendaba la aprobación de simeprevir, esperamos que simeprevir pueda estar disponible para pacientes que conviven con VHC crónica y necesitan tratamiento en el corto plazo, mientras que continuamos evaluando el papel de simeprevir como parte de diferentes combinaciones para el tratamiento de la VHC”.

Sobre Simeprevir
Simeprevir (TMC435) es una nueva generación de inhibidor de proteasa NS3/4A desarrollado conjuntamente con Janssen R&D Ireland y Medivir AB, actualmente en Fase III de desarrollo. Simeprevir trabaja bloqueando la enzima proteasa que permite al VHC replicarse en las células huéspedes. Hasta la fecha, más de 3.700 pacientes han sido tratados con simeprevir en ensayos clínicos.

Janssen Therapeutics EMEA, es una división de Janssen Pharmaceutica NV y tiene los derechos de comercialización de simeprevir en Europa, Oriente Medio y África. Medivir AB lo comercializará en los Países Nórdicos.

En octubre, Janssen Pharmaceuticals, Inc. adquirió, procedente de GlaxoSmithKline plc, el nuevo compuesto de investigación GSK2336805, un complejo inhibidor NS5a en Fase 2 de desarrollo para el tratamiento de VHC crónica. Desde su adquisición, el compuesto pasó a denominarse JNJ-56914845. Janssen Pharmaceuticals planea iniciar los estudios en Fase 2 para evaluar el uso de JNJ-56914845 en combinaciones libres de interferón con simeprevir y TMC647055, el inhibidor no nucleósido de polimerasa, para el tratamiento de VHC crónica en pacientes adultos con enfermedad hepática compensada.

Para más información sobre los ensayos clínicos de simeprevir, por favor visita:
https://www.clinicaltrialsregister.eu o www.clinicaltrials.gov

Sobre la hepatitis C
El virus de la hepatitis C es un enfermedad infecciosa del hígado de transmisión sanguínea que afecta aproximadamente a 150 millones de personas en todo el mundo y causa 350.000 muertes anualmente (2). Sólo en la Europa el ratio de incidencia es de 8.7 por 100.000 y conlleva 86.000 muertes anuales (1).

Cuando no se trata, el virus de la hepatitis C puede causar graves daños al hígado incluyendo cirrosis. Además, el VHC puede incrementar el riesgo de desarrollar complicaciones de cirrosis, que pueden incluir un fallo hepático. Es la principal causa de cáncer primario de hígado en Europa (3).

Referencias

1. Oficina Regional de Europa de la organización mundial de la Salud. Datos y estadísticas de hepatitis. http://www.euro.who.int/en/health-topics/communicable-diseases/hepatitis/data-and-statistics. Último acceso en Octubre 2013.

2. Centro de medios de la OMS: Hepatitis C Fact Sheet No. 164; Julio 2013.
http://www.who.int/mediacentre/factsheets/fs164/en/. Último acceso en Octubre 2013.

3. Asociación Europea para el estudio del Hígado. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. Journal of Hepatology 2011;55:245–264

acceso.com  14-11-13  Janssen   Nota de prensa

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Translation

SIMEPREVIR ADMINISTERED ONCE DAILY DEMONSTRATED HIGH SUSTAINED VIROLOGICAL RESPONSE IN PREVIOUSLY UNTREATED PATIENTS AND PATIENTS PRETREATED WITH CHRONIC HEPATITIS C GENOTYPE 1

Madrid, Nov. 12, 2013 - Janssen R & D Ireland (Janssen) today announced the presentation of new data from simeprevir ,-a protease inhibitor (PI) against virusHepatitis C -. These data refer to simeprevir (TMC435) in the treatment of Genotype 1 virushepatitis C chronic (HCV) for previously untreated patients (naïve) and pretreated in adults with compensated liver disease. According to the analysis of the Phase 3 studies QUEST-1 and QUEST-2 in treatment-naïve patients and Phase 3 study in patients with relapsed PROMISE prior simeprevir efficiency has been observed in HCV patients considered difficult treatment, including patients with IL28B genotype TT and the METAVIR F4.

virusHepatitis C is a chronic problem in EMEA, where approximately 15 million people living with the disease (1). Many patients living withhepatitis C chronic need treatment and genotype of the virus usually determines how effective the treatment (2).

"Patients with certain requirements and characteristics may be more likely to relapse after initial treatment," said Dr. Ira Jacobson, researcher simeprevir clinical trials, head of the Division of Gastroenterology and Hepatology in the United States. "The breadth of simeprevir data presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), reinforce the potential of simeprevir as an effective treatment option in different patient profiles, including those considered difficult to treat and provide an important support for the specialists once approved simeprevir ".

On 24 October, the Antiviral Drugs Advisory Committee of the FDA voted unanimously (19-0) to recommend FDA approval of simeprevir 150mg once daily in combination with pegylated interferon and ribavirin treatment in patients adults virus hepatitis C genotype 1 chronic compensated liver disease.

In April 2013 a petition was sent to Marketing Authorization European Medicines Agency seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic HCV. Simeprevir was approved in Japan in September 2013 for the treatment of genotype 1 HCV. Simeprevir also been studied in various interferon free regimens using selected combinations of direct-acting antiviral agents with different mechanisms of action.

Combined analysis of QUEST-1 and QUEST-2 confirms the clinical benefit in patient subpopulations Simeprevir (Abstract 1122)

In Phase 3 study QUEST-1 and QUEST-2 in treatment simeprevir with pegylated interferon and ribavirin, 80% of previously untreated patients achieved the primary endpoint, Sustained Virologic Response at 12 weeks of treatment ( SVR12) compared with 50% in placebo-treated patients with pegylated interferon and ribavirin. The analysis, which included patients considered difficult to treat, said that 61% of patients with the IL28B genotype TT, 60% of patients with the METAVIR F4 and 75% of patients with genotype 1a virus the hepatitis C treated with simeprevir chronic, combined with pegylated interferon and ribavirin achieved SVR12, compared to 21%, 34% and 47% of patients receiving placebo, pegylated interferon and ribavirin.

Among patients with genotype 1a polymorphism Q80K at baseline, 58% of patients treated with simeprevir combined with pegylated interferon and ribavirin achieved SVR12, compared to 52% of patients treated with placebo in combination with pegylated interferon and ribavirin , but the difference was not statistically significant. The 3% simeprevir treated patients discontinued treatment due to adverse events, compared with 2% of patients treated with placebo.

Full PROMISE analysis of efficacy data simeprevir in subpopulations of patients (Abstract 1092)

The PROMISE study, "pivotal" Phase III was conducted in patients who had previously relapsed after previous treatment based on pegylated interferon therapy. The 79% of patients simeprevir arm with pegylated interferon and ribavirin achieved SVR12 primary endpoint compared to 37% of patients in the placebo group with pegylated interferon and ribavirin.

In this subanalysis, among patients considered difficult treatment, 65% of patients with genotype TT IL28B, 74% of patients with the level of the METAVIR F4 and 70% of patients treated with HCV genotype 1a simeprevir combined with pegylated interferon and ribavirin achieved SVR12 compared to 19%, 26% and 28% of patients taking placebo with pegylated interferon and ribavirin, respectively.

Among patients with genotype 1a and basal polymorphism Q80K, 47% of patients treated with simeprevir, pegylated interferon and ribavirin achieved SVR12, versus 30% of placebo-treated patients, pegylated interferon and ribavirin. The most common adverse events in patients treated with simeprevir combined with pegylated interferon and ribavirin in the first 12 weeks were fatigue, headache and flu-like symptoms.

"The data presented at AASLD provide new evidence of the effectiveness of simeprevir in difficult to treat patients", said Maria Beumont, Medical Lead of simeprevir in Janssen. "After the recent positive vote last week by the Anitivirales Drugs Advisory Committee of the FDA, which recommended approval of simeprevir, expect simeprevir may be available to patients living with chronic HCV and need treatment in the short term while continuing to evaluate the role of simeprevir as part of different combinations for the treatment of HCV. "

About Simeprevir
Simeprevir (TMC435) is a new generation of NS3/4A protease inhibitor jointly developed with Janssen R & D Ireland and Medivir AB, currently in Phase III development.Simeprevir works by blocking the protease enzyme allows the HCV replication in the host cells. To date, over 3,700 patients have been treated with simeprevir in clinical trials.

Therapeutics Janssen EMEA, a division of Janssen Pharmaceutica NV and has marketing rights simeprevir in Europe, Middle East and Africa. Medivir AB will market in the Nordic countries.

In October, Janssen Pharmaceuticals, Inc. acquired from GlaxoSmithKline plc, the new compound GSK2336805 research, a complex NS5A inhibitor development in Phase 2 for treating chronic HCV. Since its acquisition, renamed compound JNJ-56914845. Janssen Pharmaceuticals plans to initiate Phase 2 studies to evaluate the use of JNJ-56914845 in interferon-free combinations with simeprevir and TMC647055, the non-nucleoside polymerase inhibitor, for the treatment of chronic hepatitis C in adult patients with compensated liver disease.

For more information about clinical trials simeprevir, please visit:
www.clinicaltrials.gov https://www.clinicaltrialsregister.eu  or

On Hepatitis C virus

Hepatitis C is an infectious blood-borne liver that affects approximately 150 million people worldwide and causes 350,000 deaths annually (2). Only in Europe the incidence rate is 8.7 per 100,000 and 86,000 associated deaths annually (1).

When untreated, the virus Hepatitis C can cause severe liver damage including cirrhosis . Furthermore, HCV can increase the risk of developing complications cirrhosis , which may include liver failure. It is the leading cause of primary liver cancer in Europe (3).

References

1. Regional Office for Europe of the World Health Organization. Data and Statistics hepatitis. http://www.euro.who.int/en/health-topics/communicable-diseases/hepatitis/data-and-statistics. Last accessed October 2013.

Two. Media Center WHO:Hepatitis C Fact Sheet No. 164, July 2013.
http://www.who.int/mediacentre/factsheets/fs164/en/. Last accessed October 2013.

Three. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management ofhepatitis C virus infection. Journal of Hepatology 2011, 55:245-264

Janssen acceso.com Press Release 11/14/13

Source

Also See: Simeprevir Administered Once Daily as Part of Combination Therapy Demonstrates Sustained Virologic Response in Treatment-Naive and Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients

BOEHRINGER INGELHEIM REFUERZA SU CARTERA DE FÁRMACOS PARA HEPATITIS C EN REGÍMENES DE TRATAMIENTO SIN INTERFERÓN GRACIAS A PROMETEDORES DATOS DE FASE II

Sant Cugat del Vallès, 15 de noviembre de 2013 –

Boehringer Ingelheim ha dado a conocer datos intermedios de un estudio en fase II en el que el 100% de los pacientes tratados con un régimen basado en faldaprevir*, deleobuvir*, PPI-668* y ribavirina presentaron niveles indetectables del virus de hepatitis C al finalizar las 12 semanas de duración del tratamiento. El análisis del periodo de seguimiento tras 4 semanas después de haber finalizado el tratamiento combinado indicó que el 75% de ellos continuaba con niveles indetectables de virus (SVR4).

Este estudio, desarrollado en colaboración con Presidio Pharmaceuticals, se ha presentado en la reciente 64ª Reunión Anual de la Sociedad Americana para el Estudio de Enfermedades Hepáticas (AASLD).

Cabe destacar además otros datos del estudio que muestran que el 100% de los pacientes tratados con un régimen sin ribavirina obtiene niveles de virus menores al nivel inferior de cuantificación en la semana 4 (1). Por esto, se ha concluido que la seguridad y la tolerabilidad parecen ser mejores en este grupo tratado sin ribavirina que en los grupos que recibieron ribavirina.

“Estos resultados intermedios refuerzan las evidencias disponibles favorables a faldaprevir* como tratamiento eficaz para una variada población de pacientes con hepatitis C de genotipo 1, incluidos aquellos de difícil tratamiento. El estudio se halla todavía en una fase inicial, pero los primeros resultados son prometedores,” ha afirmado el Profesor Klaus Dugi, vicepresidente corporativo sénior de Medicina de Boehringer Ingelheim.

“Estos datos aportan nuevas pruebas de las posibilidades de faldaprevir* como futura base de regímenes de tratamiento sin interferón. Nuestros estudios pivotales  HCVerso® que investigan el régimen basado en faldaprevir*, deleobuvir* y ribavirina sin interferón se hallan actualmente en fase III de desarrollo.Esperamos con gran interés los resultados finales de ambos estudios que se conocerán en el segundo trimestre del próximo año”.

Investigación de régimen de tratamiento con y sin ribavirina:

Este estudio de fase II en curso investiga los efectos del régimen con y sin ribavirina durante 12 semanas de duración en 36 pacientes con infección de VHC con genotipo 1a, uno de los tipos más difíciles de curar. Como dato adicional cabe destacar que más de la mitad de los pacientes participantes tenía mutaciones previas del VHC. Éstas incluyen la variante Q80K, muy frecuente en los pacientes con infección por el genotipo 1a y que se asocia a una menor respuesta a algunos inhibidores de la proteasa del VHC. Hay que destacar que los 12 participantes en el estudio que son portadores de mutaciones Q80K previas están respondiendo bien al tratamiento basado en faldaprevir sin interferón (1). En términos generales, los acontecimientos adversos observados en este estudio, como exantemas cutáneos y efectos secundarios gastrointestinales fueron leves a moderados, con una incidencia similar a lo observado en estudios anteriores de faldaprevir* y deleobuvir*.

Un enfoque personalizado de la hepatitis C

La variedad de pacientes estudiados en el programa de estudios de la hepatitis C desarrollado por Boehringer Ingelheim es el reflejo de la población que los profesionales de la salud tratan, y de la que forman parte pacientes con tipos de virus de hepatitis C difíciles de curar. “La gran diversidad de pacientes con hepatitis C, debido sobre todo a factores personales y a las variantes existentes del virus, pone de manifiesto la importancia de utilizar una estrategia terapéutica personalizada,” ha señalado Graham Foster, profesor de Hepatología en Queen Mary”s Hospital, Londres.

“Existe una diferencia notable entre los genotipos del VHC. Por ejemplo, los genotipos 1a y 1b sólo comparten el 75% del material genético, lo que representa un porcentaje menor de similitud genética que la compartida por los humanos y algunos animales. Estos pacientes muestran grados diferentes de daño hepático que pueden exigir cambios en el enfoque del tratamiento. Dada la gran variabilidad de la enfermedad y del virus, es probable que cada paciente necesite una evaluación personalizada y un tratamiento adecuado basado en dicha evaluación.”

Resumen del programa de estudios del VHC de Boehringer Ingelheim

El programa de estudios clínicos de la hepatitis C de Boehringer Ingelheim incluye una gran variedad de pacientes con infección por el genotipo 1. Este programa investiga tres regímenes que incluyen faldaprevir* como medicamento de base.

Sobre la hepatitis C

La hepatitis C es una enfermedad infecciosa de transmisión hemática causada por el virus de la hepatitis C, que vive y se replica en el hígado. La hepatitis C es una de las principales causas de hepatopatía crónica, cáncer de hígado y trasplante de este órgano (7). La hepatitis C crónica es uno de los principales problemas de salud pública y una de las enfermedades infecciosas con mayor prevalencia en todo el mundo, que afecta a unos 170 millones de personas (8) diagnosticándose entre 3 y 4 millones de casos nuevos cada año (9) Es habitual que los pacientes con hepatitis C permanezcan sin diagnosticar debido a los síntomas inespecíficos iniciales de la enfermedad. Por este motivo, un gran número de pacientes acude por primera vez al médico cuando experimenta síntomas o ya tiene una hepatopatía (10). Los pacientes con hepatopatía avanzada son difíciles de curar y, sin embargo, son los que tienen una mayor necesidad de tratamientos más eficaces y mejor tolerados. De los pacientes con hepatitis C crónica, el 20 % desarrollará cirrosis hepática, de los cuales entre el 2 % y el 5 % morirán cada año (11). Las hepatopatías en estadío avanzado debidas a hepatitis C constituyen actualmente la principal causa de trasplante de hígado en el mundo occidental (11).

Sobre Boehringer Ingelheim en la hepatitis C

Mediante una labor científica pionera, Boehringer Ingelheim se esfuerza por encontrar respuestas a los retos más apremiantes a los que aún tienen que enfrentarse las diversas poblaciones de pacientes con hepatitis C. El programa de ensayos clínicos de la empresa sobre la hepatitis B, con su diseño exhaustivo, incluye a una gran variedad de pacientes, entre ellos, los que presentan los tipos del VHC cuya curación plantea los mayores retos y que los médicos ven diariamente en la práctica clínica. Boehringer Ingelheim está desarrollando faldaprevir*, un potente inhibidor de la proteasa de segunda generación, en combinaciones con y sin interferón. Como parte del compromiso a largo plazo de Boehringer Ingelheim en dar respuesta a los retos de la hepatitis C, la empresa está evaluando también otras combinaciones de compuestos en investigación para la hepatitis C que actúan de diferentes formas. La reciente colaboración de Boehringer Ingelheim con Presidio Pharmaceuticals, Inc. en un estudio clínico de fase II que investiga una combinación completamente oral que no contiene ni interferón ni ribavirina forma parte de las investigaciones continuas de la compañía para descubrir y desarrollar opciones innovadoras para el tratamiento del VHC.

Sobre Boehringer Ingelheim

El grupo Boehringer Ingelheim figura entre las 20 compañías farmacéuticas mayores del mundo. Con sede en Ingelheim, Alemania, trabaja globalmente con 140 filiales y cuenta con más de 46.000 colaboradores. Desde su fundación en 1885, esta empresa de propiedad familiar ha estado comprometida con la investigación, el desarrollo, la producción y la comercialización de nuevos medicamentos de alto valor terapéutico para la medicina humana y veterinaria. La responsabilidad social es un elemento central en la cultura de Boehringer Ingelheim. La participación en proyectos sociales, la preocupación por sus colaboradores y sus familias y proporcionar igualdad de oportunidades a todos ellos constituyen la base de sus operaciones en todo el mundo. La cooperación y el respeto mutuos, así como la protección del medio ambiente y la sostenibilidad son factores intrínsecos en todas las actividades de Boehringer Ingelheim. En 2012, Boehringer Ingelheim consiguió unas ventas netas de unos 14.700 millones de euros. El gasto en I D en el segmento de Prescription Medicines supuso el 22,5 % de sus ventas netas.

Sobre Presidio Pharmaceuticals en VHC

Presidio Pharmaceuticals, Inc. es una compañía farmacéutica clínica con sede en San Francisco (Estados Unidos) centrada en el descubrimiento y desarrollo de una terapia oral pan-genotípica para pacientes con VHC. Actualmente, los esfuerzos se centran en nuevos inhibidores para los genes NS5A y NS5B del VHC. En estudios clínicos anteriores en voluntarios sanos y pacientes con infección por VHC, PPI-668 ha estado bien tolerada hasta la fecha, sin efectos adversos serios o severos y sin ningún patrón aparente de efectos secundarios clínicos o anormalidades de laboratorio. PPI-668 logra unas concentraciones de plasma lo suficientemente altas para inhibir parte de las variantes resistentes preexistentes y alcanza niveles de estado estacionario tras una única toma. En un estudio clínico de monoterapia PPI-668 en pacientes GT1 con infección VHC, se consiguió una reducción de la carga viral de 3,5 a 3.7 log 10 VHC en 1-2 días. La actividad también se observó en los pacientes infectados por el VHC GT3.El inhibidor NS5B de Presidio, PPI-383, es un Nuevo inhibidor pan-genotípico no nucleósido con potencial para inhibir todos los principales genotipos de VHC. Este compuesto se encuentra actualmente en estudio en fase1 en sujetos sanos. Para más información, visita www.presidiopharma.com

Para más información:

Más información sobre la compañía: http://www.boehringer-ingelheim.es

CONTACTO: Hill Knowlton Strategies Alba Carid/Mónica Navas Email: alba.carid@hkstrategies.com / monica.navas@hkstrategies .com Telf.: 93 410 82 63 * Faldaprevir, deleobuvir y PPI668 son compuestos en investigación y no están autorizados todavía para el uso clínico. Por lo tanto, su seguridad y eficacia aún no están totalmente establecidas. ^RVS12 = respuesta viral sostenida 12 semanas después de completar el tratamiento, también conocida como curación viral

Referencias:

1. Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting®, the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1- 5 November, 2013.

2. Wyles, D. L. Perspective: Beyond Telaprevir and Boceprevir: Resistance and New Agents for Hepatitis C Virus Infection. Drug Resistance in HCV 2012; 20(4):139-145

3. FDA Antiviral Drugs Adviosory Committee Meeting: Background Package for NDA 205123, Simeprevir (TMC435). 2013 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371623.pdf [last accessed 24/10/2013]

4. World Health Organisation. Hepatitis C. 2002 http://www.who.int/csr/disease/hepatitis/Hepc.pdf [Last accessed on 21/10/13]

5. Centers for Disease Control and Prevention (2012) Hepatitis C available at: http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseases-related-to-travel/hepatitis-c.htm [Last accessed on 21/10/13]

6. World Health Organisation. Hepatitis C Fact Sheet. Updated July 2012 http://www.who.int/mediacentre/factsheets/fs164/en/index.html [Last accessed on 21/10/13]

7. Chen S.L., Morgan T.R. The Natural History of Hepatitis C Virus (HCV) Infection. Int J Med Sci 2006; 3:47-52. Available from http://www.medsci.org/v03p0047.htm [Last accessed on 21/10/13]

8. Soriano, Vincent et al. New Therapies for Hepatitis C Virus Infection. Clinical Infectious Disease, February 2009

 http://www.denoticias.es

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Translation

BOEHRINGER INGELHEIM STRENGTHENS ITS PORTFOLIO OF DRUGS FOR HEPATITIS C IN INTERFERON-FREE TREATMENT REGIMENS BY PROMISING PHASE II DATA

Sant Cugat del Vallès, November 15, 2013??

Boehringer Ingelheim has announced Interim data from a phase II study in which 100% of patients treated with a regimen based on faldaprevir *, deleobuvir *, PPI-668 * and ribavirin had undetectable levels of virushepatitis C at the end of the 12 weeks of treatment. The analysis of the follow-up period after 4 weeks after completion of the combined treatment indicated that 75% of them remained with undetectable virus (SVR4).

This study, developed in collaboration with Presidio Pharmaceuticals, has been presented at the recent 64th Annual Meeting of the American Society for the Study of Liver Diseases (AASLD).

Also include other data from the study show that 100% of patients treated with a regimen without ribavirin virus levels obtained under the lower level of quantification at week 4 (1). Therefore, it was concluded that the safety and tolerability appear to be better at this without ribavirin-treated group than in the groups receiving ribavirin.

"These results reinforce the evidence available intermediate pro faldaprevir * as an effective treatment for a diverse population of patients with hepatitis C genotype 1, including those difficult to treat. The study is still at an early stage, but early results are promising, "said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.

"These data provide further evidence of the potential for future base faldaprevir * as treatment regimens without interferon. HCVerso ® Our pivotal studies investigating faldaprevir based regimen *, deleobuvir * without interferon and ribavirin are currently in phase III development . We look forward to the final results of both studies are expected in the second quarter of next year. "

Research treatment regimen with or without ribavirin :

This phase II study in progress investigates the effects of the system with and without ribavirin for 12 weeks in 36 patients with HCV infection with genotype 1a, one of the most difficult to cure. As additional data should be noted that most of the Half of the patients enrolled had previous HCV mutations. These include the variant Q80K very common in patients with genotype 1a infection and is associated with a lower response to some inhibitors of HCV protease. Note that the 12 participants in the study who carry mutations previous Q80K are responding well to treatment based on faldaprevir without interferon (1). Overall, adverse events observed in this study, such as skin rashes and gastrointestinal side effects were mild to moderate, with an incidence similar to that observed in previous studies deleobuvir faldaprevir * and *.

A personalized approach Hepatitis C

The variety of patients studied in the curriculum of the hepatitis C developed by Boehringer Ingelheim is a reflection of population health professionals treat, and patients who are part of virus types hepatitis C difficult to cure. "The wide variety of patients withhepatitis C , mainly due to personal factors and the existing variants of the virus, highlights the importance of using a personalized treatment strategy, "said Graham Foster, Professor of Hepatology at Queen Mary 's Hospital, London.

"There is a significant difference between genotypes of HCV. For example, genotypes 1a and 1b share only 75% of genetic material, which represents a smaller percentage of the shared genetic similarity to humans, and animals. These patients show varying degrees of liver damage that may require changes in the treatment approach. Given the great variability of the disease and the virus, it is likely that each patient needs a personalized assessment and appropriate treatment based on that assessment. "

Summary curriculum Boehringer Ingelheim HCV

The program of clinical studies hepatitis C from Boehringer Ingelheim includes a variety of patients with genotype 1 infection. This program investigates three regimens including medication faldaprevir * as base.

On Hepatitis C

The Hepatitis C is a blood-borne infectious disease caused by virushepatitis C , who lives and replicates in the liver. TheHepatitis C is a leading cause of chronic liver disease, and liver cancerTransplantation of this body (7). TheHepatitis C Chronic is a major public health problem and one of the most prevalent infectious diseases worldwide, affecting about 170 million people (8) diagnosed between 3 and 4 million new cases each year (9 ) is common in patients withhepatitis C remain undiagnosed due to nonspecific symptoms of the disease. For this reason, a large number of first-time patients see the doctor when you experience symptoms or already have liver disease (10). Patients with advanced liver are difficult to cure and, however, are those with a greater need for more effective treatments and better tolerated. Of the patients withhepatitis C chronic, 20% will developcirrhosis of the liver, of which between 2% and 5% each year die (11). The advanced-stage liver disease due tohepatitis C are currently the leading cause oftransplant liver in the Western world (11).

Boehringer Ingelheim on the Hepatitis C

By pioneering scientific work, Boehringer Ingelheim strives to find answers to the most pressing challenges that still face various patient populations hepatitis C . The clinical trial program of the company on thehepatitis B , with its comprehensive design, includes a variety of patients, including those with HCV types whose recovery poses the greatest challenges and that doctors see every day in clinical practice. Boehringer Ingelheim is developing faldaprevir *, a potent protease inhibitor second generation, in combinations with and without interferon. As part of the long term commitment of Boehringer Ingelheim in responding to the challenges ofhepatitis C , the company is also evaluating other combinations of investigational compounds for thehepatitis C which act in different ways. The recent collaboration with Presidio Boehringer Ingelheim Pharmaceuticals, Inc. a Phase II clinical study investigating a fully oral combination containing neither interferon nor ribavirin is part of the company's continuing research to discover and develop innovative treatment options HCV.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the top 20 pharmaceutical companies in the world. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and has more than 46,000 employees. Since its founding in 1885, the family-owned company has been committed to the research, development, production and marketing of new drugs of high therapeutic value for human and veterinary medicine. Social responsibility is a key element in the culture of Boehringer Ingelheim.Involvement in social projects, caring for their employees and their families, and providing equal opportunities to all of them form the basis of its operations worldwide.Cooperation and mutual respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim activities. In 2012, Boehringer Ingelheim achieved net sales of about 14,700 million euros. Spending on R & D segment Prescription Medicines accounted for 22.5% of net sales.

About Presidio Pharmaceuticals in HCV

Presidio Pharmaceuticals, Inc. is a clinical pharmaceutical company based in San Francisco (USA) focused on the discovery and development of a pan-genotypic oral therapy for patients with HCV. Currently, efforts are focused on new inhibitors for NS5A and NS5B genes of HCV. In previous trials in healthy volunteers and patients with HCV infection, PPI-668 has been well tolerated to date, no serious or severe adverse effects and without any apparent pattern of side effects clinical or laboratory abnormalities. PPI-668 plasma concentrations achieved high enough to inhibit part of pre-existing resistant variants and reaches steady state levels after a single dose.In a clinical study of PPI-668 monotherapy in patients with HCV infection GT1, found a reduction in viral load of 3.5 to 3.7 log 10 HCV in 1-2 days. Activity was also observed in patients infected with HCV NS5B inhibitor GT3.El Presidio, PPI-383, is a new pan-genotypic inhibitor nucleoside with no potential to inhibit all major genotypes of HCV. This compound is currently in phase 1 study in healthy subjects. For more information, visit www.presidiopharma.com

For more information:

More information about the company: http://www.boehringer-ingelheim.es

CONTACT: Hill Knowlton Strategies Alba Carid / Monica Navas Email: alba.carid @ hkstrategies.com / monica.navas @ hkstrategies. Com Tel: 93 410 82 63 * Faldaprevir, deleobuvir and PPI668 are investigational compounds and not approved yet for clinical use. Therefore, safety and efficacy are not yet fully established. ^ SVR12 = sustained viral response 12 weeks after completing treatment, also known as viral cure

References:

1. Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, With and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at The Liver Meeting ®, the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), 1-5 November, 2013.

Two. Wyles, DL Perspective: Beyond Telaprevir and Boceprevir: Resistance and New Agents forHepatitis C Virus Infection. Drug Resistance in HCV 2012, 20 (4) :139-145

Three. FDA Antiviral Drugs Adviosory Committee Meeting: Background Package for NDA 205123, Simeprevir (TMC435). 2013 [Last accessed 24/10/2013]

April. World Health Organisation.Hepatitis C . 2002 http://www.who.int/csr/disease/hepatitis/Hepc.pdf [Last accessed on 10.21.13]

May. Centers for Disease Control and Prevention (2012)Hepatitis C available at: [Last accessed on 10.21.13]

June. World Health Organisation.Hepatitis C Fact Sheet. Updated July 2012 http://www.who.int/mediacentre/factsheets/fs164/en/index.html [Last accessed on 10.21.13]

July. Chen SL, Morgan TR The Natural History ofHepatitis C Virus (HCV) Infection. Int J Med Sci 2006; 3:47-52. Available from http://www.medsci.org/v03p0047.htm [Last accessed on 10.21.13]

August. Soriano, Vincent et al. New Therapies forHepatitis C Virus Infection. Clinical Infectious Disease, February 2009

 http://www.denoticias.es

Source

Also See: Boehringer Ingelheim's interferon-free hepatitis C treatment portfolio strengthened by promising Phase II data

Gran parte de la población argentina desconoce la hepatitis C y su posibilidad de diagnóstico ---- (Much of Argentina's population unknown hepatitis C and its diagnostic possibility)

“La vedette de este año ha sido el virus C y las nuevas estrategias terapéuticas, con las drogas ya disponibles y las que están en plan de empezar a utilizarse a nivel mundial”, afirmó el Dr.Cairo en referencia a las novedades del actual congreso AASLD.

JCA Actualizado lunes 4 noviembre 2013 20:27:00 hs

Fernando Cairo, Director Médico del Instituto Buenos Aires, Subjefe de Transplante Hepático del Hospital El Cruce y staff de Transplante Hepático en el Hospital Británico de Buenos Aires, explicó que estas nuevas estrategias, como la triple terapia o las nuevas drogas que se esperan, permiten que el incremento de la tasa de respuesta viral sea “significativo”.

Según el especialista, el problema actual de la Argentina se basa en tres puntos:

• La falta de conocimiento por parte de la población general del acceso al diagnóstico. “Desconocen la enfermedad y la posibilidad de acceder al diagnóstico”, aseguró Cairo.
• “Los médicos generalistas, que reciben al mayor porcentaje de la población en general, son los que deberían estimular a la población a realizarse estudios de diagnóstico para la detección precoz de la hepatitis C”, apuntó doctor.
• La accesibilidad del tratamiento. "Las nuevas drogas actuales como boceprevir o telaprevir, que se incorporan a las terapias ya conocidas como el interferon pegilado más la ribavirina, hoy en día, en pacientes que no tienen cobertura social o una prepaga, es difícil de ofrecer como tratamiento. Si bien es la política del Ministerio de Salud de la Nación que se pueda ofrecer esta terapéutica, todavía no la tenemos. En el ámbito privado el acceso es más factible".

Cairo alertó que en la Argentina “aproximadamente el 1,5% de la población puede estar infectada con el virus de la hepatitis C, pero sólo un tercio, o sea, 300.000 personas conocen la enfermedad”.

“Como médicos debemos estimular el diagnóstico precoz, para detectarla cuando el daño a nivel hepático todavía no es severo, ofrecerles tratamiento y prevenir la aparición de cirrosis o cáncer de hígado, que son las principales complicaciones”, concluyó Cairo.

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Translation

Much of Argentina's population unknown hepatitis C and its diagnostic possibility

"The star of this year was the hepatitis C virus and new therapeutic strategies with drugs already available and those that are used to start plan globally," said Dr.Cairo in reference to current news from Congress AASLD.

JCA Updated Monday November 4, 2013 20:27:00 PM

Fernando Cairo, Medical Director of the Institute Buenos Aires, Deputy Chief of Liver Transplant Hospital staff Crossing Liver Transplant and the British Hospital of Buenos Aires, said that these new strategies, such as triple therapy or new drugs that are expected to allow that increased viral response rate is 'significant'.

According to him, the current problem of Argentina is based on three points:

• The lack of awareness by the general population access to diagnosis. "Unaware of the disease and the possibility of access to diagnosis," said Cairo.
• "General practitioners, who receive the largest percentage of the general population are those that should encourage people to diagnostic studies performed for early detection of hepatitis C," said Dr..
• Accessibility of treatment. "The current and new drugs boceprevir or telaprevir, which are incorporated to therapies already known as pegylated interferon plus ribavirin, today, in patients who have no social or prepaid coverage, it is difficult to provide such treatment. Though is the policy of the Ministry of Health of the Nation that can offer this therapy, yet we do not. In the private sector access is more feasible. "

Cairo warned that in Argentina "approximately 1.5% of the population may be infected with hepatitis C, but only one third, ie, 300,000 people know about the disease."

"As physicians we must encourage early diagnosis, to detect when the liver damage is not yet severe, provide treatment and prevent the onset of cirrhosis or liver cancer, which are the main complications," he said Cairo.

Source

Krokodil (a potent substitute for heroin) Could Be Spreading Across U.S. ---- GRAPHIC VIDEO

Posted: 11/17/2013 11:56 am EST

Sat Nov 16 10:46:12 PST 2013

Krokodil: Has exotic ’flesh-eating’ drug come to Arizona?
WARNING: Graphic video and photos

It’s a deadly drug with an exotic name. Krokodil is a potent substitute for heroine and it literally has been eating people alive. Now there are concerns that Arizona could be the epicenter of krokodil’s U.S. invasion. view full article

Krokodil could be spreading.

Arizona may be the "epicenter" of the drug's possible uprising in the U.S., according to a story published on Saturday by AZ Family.

In September, at least two possible cases of the drug were reported by Banner Good Samaritan Poison Control Center in Phoenix.

Other potential cases have appeared in Illinois, Ohio and Oklahoma, though, as the Daily Beast notes, confirmed cases are much harder to come by.

Physicians who spoke with the online news outlet said the more likely culprit for the flesh rotting symptoms are dirty needles that infect heroin users with HIV, Hepatitis and Methicillin-resistant Staphylococcus aureus. This can lead to "gangrenous skin, deep abscesses, and loss of limbs."

But, as Raw Story reported this week, two doctors from Missouri told the American Journal of Medicine that they treated a patient last year "whose skin was rotted away from using krokodil." That report marks the first official case of the drug making its way to America, according to KTVI.

Source

A simple rule to personalize standard dual therapy across all genotypes in naive chronic hepatitis C patients: The TT4 randomized trial

Digestive and Liver Disease

Available online 13 November 2013

In Press, Corrected Proof — Note to users

Liver, Pancreas and Biliary Tract

Simona Francioso^a,  Cristiana Almerighi^a, Paolo Forte^b, Franco Bandiera^c,  Lorenzo Nosotti^d,  Raffaella Lionetti^e, Gloria Taliani^f, Maria Rosaria Piras^g, Maria Laura Ponti^g, Giustino Parruti^h, Francesco Di Candiloⁱ, Silvia Gentile^a, Paola Piccolo^a, Angela Salso^a, Francesca Riccobelli^a, Sara Renzi^b, Maria Antonella Longo^e, Marzia Montalbano^e, Salvatore Zaru^c, Elisa Biliotti^f, Francesco Di Masi^h, Francesco Santopaolo^a, Mario Angelico^a

a Hepatology and Liver Transplantation Unit, Department of Experimental Medicine and Surgery, Tor Vergata University, Rome, Italy
b G. Careggi Hospital, University of Florence, Italy
c SS Annunziata Hospital, Sassari, Italy
d National Institute for Health Migration and Poverty (NIHMP), Rome, Italy
e National Institute of Infectious Diseases, L. Spallanzani Hospital, Rome, Italy
f Department of Infectious and Tropical Diseases, Sapienza University, Rome, Italy
g G. Brotzu Hospital, Cagliari, Italy
h Ospedale Civile, Pescara, Italy
i S.M. Misericordia Hospital, Perugia, Italy

Abstract

Background Rapid and early virological responses to peginterferon-alpha and ribavirin are predictive of sustained virological response (SVR) in hepatitis C virus (HCV) infection. We aimed at finding a simple rule to determine the shortest duration of dual therapy for all HCV genotypes, obtained by multiplying time to Initial Viral Response, IVR (first undetectable HCV-RNA) by 4 (Tailored Therapy-4, or TT4).

Method 267 naïve HCV-infected patients with compensated liver disease were randomized (2:1) to the TT4 (n = 180) or current standard-of-care (SoC, n = 87) and received peginterferon-alpha plus ribavirin. Patients with HCV-RNA decrease ≤2 log₁₀ at week 12 or detectable HCV-RNA at week 24 discontinued treatment.

Results Both groups had comparable baseline characteristics, SVR rates were similar in the whole population (60.6% vs. 60.9%) and within each genotype subgroup (G1: 46.6% vs. 55.6%; G2: 90.2% vs. 94.4%; G3: 74.1% vs. 58.3%; G4: 45.8% vs. 33.3%). Relapse rate was higher in G1-TT4 than G1-SoC. Treatment duration in SVR patients was shorter in TT4 compared to SoC, both overall [25 ± 15 vs. 36 ± 12.1 weeks], and for subgroups: G1 [35.3 ± 16.7 vs. 47.3 ± 2.6 weeks], G2 [18.3 ± 7.5 vs. 24 ± 2.8 weeks], G3 [15.2 ± 8.7 vs. 22.8 ± 3 weeks] and G4 [26.9 ± 13 vs. 48 weeks].

Conclusions In HCV-naive patients, TT4-rule treatment yields similar SVR rates compared to SoC but with shorter treatment duration and remarkable cost reduction.

Keywords HCV treatment; Dual therapy; Pegylated interferon; Ribavirin; Rapid viral response; Response-guided therapy; Individualized therapy

Source

We need to talk about hepatitis C

By Professor Gregory Dore

Updated 1 hour 0 minutes ago

PHOTO: Lou Reed's death may raise awareness of the challenges of living with hepatitis C. (AFP: Jose Jordan)

The death of musician Lou Reed from liver cancer may raise awareness of the challenges of living with hepatitis C, but more work needs to be done to make sure treatments are widely available, writes Professor Gregory Dore.

In a moving, intimate tribute to Lou Reed in the current issue of Rolling Stone, his partner Laurie Anderson writes with gratitude and love of their shared joys of artistic endeavour, their embrace of life and learning and of Reed's power and grace, even in the face of death.

She also writes, in an awareness-raising matter-of-fact manner, of the challenges of living with hepatitis C, the chronic liver disease that led to his liver cancer, a liver transplant, and ultimately his death from complications.

He was sick for the last couple of years, first from treatments of interferon, a vile but sometimes effective series of injections that treats hepatitis C and comes with lots of nasty side effects.

Last spring, at the last minute, he received a liver transplant, which seemed to work perfectly, and he almost instantly regained his health and energy. Then that, too, began to fail, and there was no way out.

— Laurie Anderson, writing about Lou Reed in Rolling Stone

One of the greatest challenges faced by people living with hepatitis C, their partners and families, is discussing the illness openly.

Although, Reed, a founding member of The Velvet Underground, did not shy away from his own personal history, the stigma associated with the alignment of hepatitis C infection and injecting drug use is so profound that people often hide their status, even from their family and friends.

For most people with hepatitis C there is no fame or fortune to dilute fears of being harshly judged.

Consequently, even in consultations with health care professionals many people with hepatitis C are reluctant to acknowledge past injecting drug use, often due to their previous experiences of discrimination.

Such stigma and discrimination are major barriers to advancing the public health response to hepatitis C at both the individual and population levels.

The mobilisation of advocacy to address the rising burden of infection and deaths from HIV in the 1980s was supported by the effective community-based endeavours of the gay rights movement of the 1970s.

In contrast, former or current injecting drug users are generally reluctant to identify with this part of their lives, despite often having strong social networks related to such shared experiences.

The illicit nature of injecting drug use has also clearly influenced community attitudes and impeded the overall public health response to hepatitis C, despite a well-developed strategic governmental response, particularly in New South Wales.

Change, however, is imminent. Within the next few years, the treatment of hepatitis C should be transformed from the relatively prolonged (6 to 12 months), arduous, and often ineffective interferon-based injectable therapy that Reed endured, to an oral once daily "direct-acting antiviral" therapy with limited side effects.

Even more remarkably, based on preliminary clinical trials, the cure rate with these new hepatitis C regimens should be greater than 90 per cent, with treatment only required every three months.

But, to enable people living with hepatitis C to benefit from what could be one of the great clinical advances in recent decades, treatment programs must be within reach.

This means challenging stigma and discrimination now and raising community awareness to support people with hepatitis C to seek treatment, as well as making sure that treatment is widely available.

I have had the opportunity to care for people with hepatitis C in hospitals, methadone clinics and community-based clinics; such diverse care environments reflect the great diversity of those living with the illness.

The Perfect Day that we are striving for in hepatitis C would be one in which the 230,000 people living with chronic hepatitis C in Australia have the opportunity to fully benefit from approaching advances in treatment and care.

Professor Gregory Dore is head of the Viral Hepatitis Clinical Research program at the University of New South Wales's Kirby Institute for infection and immunity in society. View his full profile here.

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