July 30, 2013

Hepatitis C genotype 1 virus with low viral load and rapid virologic response to peginterferon/ribavirin obviates a protease inhibitor

Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

Viral Hepatitis

Brian L. Pearlman1,2,3,4,*, Carole Ehleben2

DOI: 10.1002/hep.26624

© 2013 by the American Association for the Study of Liver Diseases

Publication History Accepted manuscript online: 19 JUL 2013 10:11AM EST, Manuscript Accepted: 3 JUL 2013, Manuscript Revised: 12 JUN 2013 , Manuscript Received: 6 MAY 2013

Abstract

Keywords: Sustained virologic response; rapid virologic response; African American; IL-28B; boceprevir

The new standard of care for treatment-naïve patients with hepatitis C virus (HCV) genotype 1 includes triple therapy with peginterferon, ribavirin, and a protease inhibitor. However, patients who achieve a rapid virologic response after 4 weeks of peginterferon and ribavirin therapy are likely to achieve a sustained virologic response (SVR), and we hypothesized that protease inhibitor therapy may be unnecessary in these patients. Treatment-naïve, noncirrhosis patients infected with genotype-1 HCV and a low viral load at baseline were considered for inclusion (n = 233). After 4 weeks of lead-in therapy with peginterferon α-2b and ribavirin, 101 patients (48%) had a rapid virologic response (defined as undetectable levels of hepatitis C virus RNA at 4 weeks) and were eligible to participate. Patients were randomized 1:1 to 20 weeks of additional therapy with peginterferon α-2b and ribavirin (double therapy) or to 24 weeks of peginterferon α-2b, ribavirin, and boceprevir (triple therapy). There was no significant difference in rates of SVR-12 in patients treated with double versus triple therapy. This similarity persisted regardless of viral subtype (genotype 1a or 1b), interleukin (IL)−28b genotype (CC or non-CC), or ethnicity (African American versus non-Hispanic white). Conclusion: Protease inhibitor therapy could be obviated in genotype 1-infected treatment-naïve patients with low viral load at baseline who achieve undetectable viremia after 4 weeks of peginterferon/ribavirin. (Hepatology 2013;)

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Interferon-free treatment for genotype-1b hepatitis C patients: an interview with Professor Wulf Boecher, Boehringer Ingelheim

Published on July 30, 2013 at 6:32 AM

Interview conducted by April Cashin-Garbutt, BA Hons (Cantab)

Please can you give a brief introduction to genotype-1b hepatitis C and how it differs from subtype 1a?

Genotype 1 is, worldwide, the most prevalent genotype of the hepatitis C virus. It accounts for around seventy percent of all hepatitis C infections.

With the introduction of protease inhibitors, it became known that the subtypes 1a and 1b make a difference in terms of treatment response.

Subtypes 1a and 1b are genetically closely related. They share seventy to eighty percent of their genome. However, 1a turned out to be more difficult to treat than 1b, which is easier to treat.

That was also the case with the already approved protease inhibitors, and still is the case with the second generation of protease inhibitors (PIs) like faldaprevir or other second generation PIs that are in late stage development. And it applies for interferon based as well as interferon-free treatments.

image

Faldaprevir's target in viral polyprotein processing.

*Please note faldaprevir (BI 201335) is an investigational compound and not yet approved. Its safety and efficacy has not yet been fully established.

Source: Boehringer Ingelheim

Do genotypes 1a and 1b affect equal numbers of people, or is one more common than the other?

It is regionally very different. In the US, genotype 1a is more prevalent where it accounts for roughly seventy percent of genotype 1 infections.

In Europe, there is slightly more genotype 1b. So there’s roughly a sixty-forty split, with sixty percent being genotype 1b, forty percent 1a.

If you go further East the prevalence of 1b becomes nearly the only genotype 1. So in Japan, in China, and in large parts of Asia, genotype 1b is basically the vastly prevailing or the only genotype 1 subtype.

image2

Hepatitis C virus travelling in the bloodstream.

Source: Boehringer Ingelheim

Why is eliminating injectable interferon from HCV treatment regimens highly desirable?

I have been working on hepatitis C treatment for many years and it is not only subcutaneous injections that make patients uncomfortable. Interferon really makes patients sick for the whole course of treatment and with current treatments this can be as long as twenty four or forty eight weeks, so nearly one year.

Patients feel like they have the flu, with fever, myalgia, chills, and many other symptoms. Also their neuro-cognitive function is reduced. They have low blood cell count that can lead to infections and to severe bleedings. They suffer from psychiatric side effects like severe depression. There are suicides associated with treatment with interferon.

So interferon is really a trouble-maker for patients; it makes patients sick for the duration of their treatment and it is less effective than the oral treatments that are to come. Treatment lasts longer and there is a high chance patients won’t be cured at the end. In contrast, current triple therapies the next generation triple therapies, as well as the future interferon-free treatments, offer shorter treatment duration and higher cure rates.

image3

Faldaprevir* Protease Inhibitior Mode of Action.

*Please note faldaprevir (BI 201335) is an investigational compound and not yet approved. Its safety and efficacy has not yet been fully established.

Source: Boehringer Ingelheim

How did your interferon-free combination treatment originate and what stage of development is it currently at?

It’s actually based on the knowledge of HIV and tuberculosis treatment; where by combining different oral drugs with a different mode of action it is possible to control or eliminate the virus or mycobacteria.

In HCV, we had two different mode-of-action drugs in late stage development that we combined. We had actually thought we may possibly have a forty-five percent cure rate, which would still have been a very attractive cure rate for patients without any treatment options.

Up to fifty percent of hepatitis c patients right now do not tolerate interferon or have contra-indications against interferon.

But then in our phase two studies we found out that by focusing on the easier-to-treat genotype 1b patients, eighty five to ninety five percent of patients can be cured. This makes this combination very attractive as an alternative to replace interferon-based treatments.

And with this interferon-free treatment, we are currently in phase III development.

Please can you tell us about the recent Phase IIb study into the efficacy and safety of this combination treatment?

This is our second phase IIb trial. Initially (in the SOUND-C2 trial) we tested our interferon-free treatment regimen of faldaprevir, deleobuvir and ribavirin in a large study. We had 362 patients, including patients with liver cirrhosis and all stages of liver disease.

We found that genotype 1a patients are indeed difficult to treat, achieving lower cure rates. That would have been attractive maybe three, four years ago, but not nowadays.

But in this study genotype 1b patients had a cure rate of eighty-five percent.

Then we modified the regimen. We shortened treatment from twenty eight to sixteen weeks in SOUND-C3, which is the study we just published at the Asian Pacific Liver Conference (APASL) in June.

We also dropped a so-called induction dose. So in the old regimen, we had a high dose of our polymerase inhibitor and this was not so well tolerated, as we found out.

So we dropped this, we shortened treatment and we found in genotype 1b patients ninety five percent achieved viral cure. But it turned out that in the more difficult to treat population of genotype 1a patients, only two of seventeen patients were cured. And that confirmed our decision to focus on genotype 1b patients with this regimen.

image4

Progression of liver damage caused by infection with hepatitis C.

Source: Boehringer Ingelheim

What were the results of this study and what do they indicate?

The very high cure rates of ninety five percent confirm our decision to focus on genotype 1b patients with this regimen.

We dropped genotype 1a patients from this regimen. However we are currently investigating a third compound in combination with our interferon free combination with which we strive to address genotype 1a patients.

The tolerability was very good. This was as expected from interferon-free treatment. We saw only minor effects on the red blood cells, which was due to the ribavirin component of the regimen, but we didn’t see any effects on white blood cells or platelets.

We did see mostly mild adverse events like mild rashes or nausea, which were the most common side effects.

Did any patients experience serious adverse events during the trial?

Only two patients had to discontinue treatment for adverse events and only one patient reported a serious adverse event (SAE). So overall, I think we can say that this is very good tolerability.

What serious adverse event did the patient experience?

The SAE patient was a patient who had severe dehydration. He was hospitalized to get some infusions and discontinued HCV treatment early after 6 weeks of treatment. However the condition was managed and resolved and the patient recovered completely from the event but also from his hepatitis C.

What are your plans for the future?

For genotype 1b patients we are in the middle of our phase III evaluations. We are expecting results early next year.

We have three on-going phase III trials:-

  • One in treatment-naive genotype 1b patients.
  • One in a treatment-naive population that includes interferon ineligible patients, which are patients who have contra indications to interferon based treatments. So these patients have currently no treatment option at all.
  • We have a third trial that goes to the highest unmet medical need population, which are patients with decompensated liver cirrhosis.

The first two trials also include patients with compensated liver cirrhosis, but the third trial really addresses the late stage liver cirrhosis, or decompensated liver cirrhosis. These are patients that will die if they do not receive a liver transplant. All studies are on-going as we speak.

Our trials are comprehensively designed and address the real-world patients that physicians see every day in clinical practice. Through robust science, our goal is to provide a safe and highly effective interferon-free treatment for genotype-1b patients.

How do you think the future of genotype-1b hepatitis C treatments will progress?

From a patient and a prescriber or physician’s perspective, the future is very bright.

There are several companies and there will be several regimens available to physicians to pick the best treatment option for a given patient.

There are many factors that need to be considered when prescribing HCV treatments, so there will be no one-size-fits-all approach. In the future individualized treatment will become a reality. Physicians will be able to pick the best treatment option for a given patient depending on:-

  • the virus genotype and patient genetics
  • on individual patient conditions
  • age
  • gender
  • co-morbidities
  • co-medications

Everything will play into this and there will be several interferon-free treatment options that can be really tailored individually to a given patient.

It is exactly our strategy to provide tailored therapy which is optimal for specific patient populations. I think this is where we believe we will excel in.

The treatment landscape will become more complex. In the past, we had only to pick between prescribing pegylated interferon for twenty four, or forty eight weeks, and ribavirin in eight hundred, one thousand or twelve hundred milligrams. This was very easy, no drug-drug interactions.

The future looks like it will be more individualized, with physicians choosing which regimen to provide based on the individual patient’s profile. But this is in fact a luxury situation and a great opportunity.

Where can readers find more information?

Readers can find more information on Boehringer Ingelheim at: http://www.boehringer-ingelheim.com/

Readers can also find more information on HCV at: http://www.newshome.com/

About Professor Wulf Boecher

Wulf trained and worked more than 15 years at Mainz University Hospital in Germany as a Gastroenterologist/ Hepatologist and Infectious Diseases Specialist, where he lectures as an Associate Professor for Internal Medicine.

His main scientific focus has been immune pathogenesis and new treatments of HBV, HCV and HIV infection.

Wulf joined Boehringer Ingelheim for the clinical development of new HCV treatments in 2007 and currently holds the position of Associate Therapeutic Area Head Virology.

Source

Sign-on letter to Gilead about sofosbuvir/ Pétition adressée a Gilead sur le sofosbuvir

Request for sign-ons/ Appel à signatures

Sign-on letter to Gilead about sofosbuvir/ Pétition adressée a Gilead sur le sofosbuvir

publication: 28 juillet 2013

The TRT-5 and the CHV are requesting individual and organizational sign-ons to a letter urging Gilead to provide early access to sofosbuvir for people with the most urgent need / Le TRT-5 et le CHV sollicitent des signatures individuelles ou d’organisations pour une pétition demandant à Gilead de donner un accès précoce au sofosbuvir aux personnes qui en ont le besoin le plus urgent.

SIGN-ON LETTER TO GILEAD - 26th JULY 2013

Version française ci-dessous

GILEAD REFUSES ACCESS TO TREATMENT TO SERIOUSLY ILL HEPATITIS C PATIENTS

People living with HCV who are in an urgent need of new treatments should get an early access to compounds that are in nearing approval, and therefore not yet on the market. In France, there is an early access system, called ATU (Temporary Authorization of Use), to allow for early access to potentially life-saving drugs.

The French national regulation agency ANSM (Agence Nationale de Sécurité du Médicament) has granted many name-based temporary authorizations of use (ATU) for sofosbuvir, a compound from Gilead that is nearing approval, for transplanted people, people awaiting a liver transplant and cirrhotic patients with no other treatment options since the drug appears to be safe and effective for these populations.

But Gilead has refused to provide sofosbuvir to some of the people with the most urgent need : patients with late-stage cirrhosis (Child-Pugh B or C).

For their refusal, Gilead argued that it would be unfair to provide access only to patients in France. We do not accept this reason.

Gilead filed a European marketing application for sofosbuvir in April 2013. Although there are patients throughout Europe who need early access to sofosbuvir, many other countries do not have the legal or regulatory framework to provide early access. If Gilead provides sofosbuvir in France, where the system already exists, it will pave the way for desperately ill patients and their advocates in other countries to gain access. A European initiative could allow early access programs without delaying the provision of sofosbuvir in the countries with adequate regulatory and medical agencies.

It is cruel to withhold potentially life-saving treatment from the patients who meet the clinical criteria for being most likely to benefit from it, or die without it.

In addition, Gilead has much to gain by providing sofosbuvir through early access programs. Scientific data can be collected in patients with the most urgent need, who are also likely to be the first to receive the drug when it will be approved. Data from early access programs can be used to determine the safest and most effective way to treat HCV in people who need it most. For example, the CUPIC study (French ANRS) provided critical information on which cirrhotic patients were most likely to benefit—or be harmed by —boceprevir or telaprevir-based regimens.

If Gilead refuses to study sofosbuvir in « real life » cohorts, the opportunity to minimize harm and maximize benefits is lost.

Therefore, we ask Gilead to provide sofosbuvir NOW, for the people with urgent need, including patients with late-stage cirrhosis (Child-Pugh B or C), among whom people living with HIV or other illnesses.

To sign the letter, please go to change.org

PÉTITION ADRESSÉE À GILEAD - 26 JUILLET 2013

GILEAD REFUSE DE DONNER UN TRAITEMENT A DES PERSONNES GRAVEMENT MALADES DE L’HÉPATITE C

Les personnes vivant avec une hépatite C et dont l’état de santé présente une urgence doivent pouvoir bénéficier des médicaments en cours de développement et proches de leur mise sur le marché. Pour cela, il existe en France un dispositif appelé Autorisations Temporaires d’Utilisation (ATU), qui permet l’accès précoce à des médicaments susceptible de sauver des vies.

L’Agence Nationale de Sécurité du Médicament (ANSM) a accordé des ATU de sofosbuvir, une molécule développée par Gilead proche de sa mise sur le marché, à des personnes transplantées, des personnes en attente de transplantation et des personnes cirrhotiques en impasse thérapeutique. Le sofosbuvir apparaît comme sûr et efficace chez ces populations de patients.

Mais Gilead refuse de donner la molécule à certains des patients qui en ont un besoin urgent : les patients avec une cirrhose avancée (score Child-Pugh B ou C). Cet antiviral du virus de l’hépatite C leur est refusé par Gilead au motif de l’équité entre les pays européens. Nous n’acceptons pas cette justification.

Gilead a déposé une demande européenne de mise sur le marché pour le sofosbuvir en avril 2013. Bien que des patients aient besoin d’un accès précoce au sofobuvir partout en Europe, de nombreux autres pays ne possèdent pas le cadre légal ou réglementaire nécessaire. Si Gilead met le sofosbuvir à disposition en France, où le système existe déjà, cela ouvrira une voie pour obtenir l’accès précoce aux malades très avancés et aux associations de défense des patients d’autres pays d’Europe. Une initiative européenne pourrait permettre la mise en place de programmes d’accès précoce à l’échelle européenne, sans retarder la mise à disposition du sofosbuvir dans les pays ayant déjà les structures médicales et administratives adéquates.

Il est cruel de bloquer des traitements susceptibles de sauver des vies lorsque les personnes auxquelles ils sont refusés présentent des critères cliniques qui montrent qu’elles ont une très forte probabilité d’en retirer un bénéfice, ou de mourir sans.

De plus, Gilead a beaucoup à gagner en fournissant le sofosbuvir par le biais de programmes d’accès précoce. Des données scientifiques peuvent ainsi être collectées chez des patients qui en ont un besoin urgent, dont il est probable qu’ils seront aussi les premiers à recevoir le produit quand il sera approuvé.

Les données issues de programmes d’accès précoce (ou compassionnel) peuvent être utilisées pour déterminer les façons les plus sûres et les plus efficaces de traiter le VHC chez les personnes qui ont le plus besoin d’un traitement. Par exemple, la cohorte ANRS CUPIC a fourni des informations essentielles pour comprendre quels patients cirrhotiques étaient les plus susceptibles d’aller mieux- ou moins bien – avec des traitements basés sur le boceprevir ou le telaprevir.

Si Gilead refuse d’étudier le sofosbuvir « dans la vraie vie », l’occasion est perdue de minimiser les dommages et de maximiser les bénéfices.

C’est pourquoi nous demandons à Gilead de donner le sofosbuvir MAINTENANT aux personnes qui en ont le besoin le plus urgent, y compris celles avec une cirrhose avancée (Child-Pugh B ou C), parmi lesquelles certaines vivent avec le VIH ou une autre maladie.

Pour signer la pétition, merci d’aller sur change.org


TRT-5 : Actions Traitements, Act Up-Paris, Act Up-Sud Ouest, AIDES, ARCAT, Dessine-Moi Un Mouton, Nova Dona, Sida Info Service, SolEnSi

CHV : Actif Santé, Actions Traitements, ARCAT, Association Française des Hémophiles (AFH), ASUD, CIGaLes, Nova Dona, Sida Info Service / Hépatites Info Service, SOS Hépatites, Transhépate

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Activists demand cheaper Hepatitis C drugs

The Jakarta Post, Jakarta | National | Tue, July 30 2013, 2:24 PM

A group of 14 non-governmental organizations running a campaign titled “People living with HIV/AIDS (ODHA) have a right to health” signed an online petition urging a drug manufacturer to offer Hepatitis C drugs at lower prices.

The petition launched via public campaign platform change.org is aimed at urging Roche Indonesia to immediately cut the prices of Hepatitis C drugs, the patent of which belongs to it parent Swiss multinational pharmaceuticals company.

In Indonesia, the official figure of people with Hepatitis C is estimated at 7 million, although the actual figure is likely higher due to low the awareness of the need to have a Hepatitis C test. The high cost of the test aggravates the problem.

For people living with HIV/AIDS, Hepatitis C infection has become a particular source of concern because co-infection of HIV and hepatitis C virus (HCV) exacerbates their condition and can lead to death.

The campaign’s public campaigner, Ayu Oktariani, said many ODHA managed to survive and were still healthy because the government provided HIV-infected people with anti-retroviral drugs for free.

“But ODHA co-infected with Hepatitis C makes their life expectancy lower because in Indonesia, Hepatitis C medication is costly,” said Ayu in a statement made available to The Jakarta Post, on Tuesday.

Currently, Hepatitis C medication costs around Rp 25 million (US$2,425) per month, with medication until recovery costing more than Rp 250 million per patient.

“The role of our government in regulating the trade of pharmaceuticals is still very weak. As a result, multinational companies can set the prices of drugs as they like,” said Indonesia AIDS Coalition executive director Aditya Wardhana. (ebf)

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Prices of treatment are killing patients with hepatitis C - a protest action in Russia

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29/07/2013

On 24 July 2013 a protest action was carried out in Moscow in front of the Ministry of health of Russia. Activists of the "Patients’ control" came to officials with the requirement to force manufacturers of hepatitis C drugs to decrease prices. The protest took place under the slogans: "There are 5 million people with hepatitis C in Russia", "Treatment costs 500,000 rubles", "Prices Roche and Merck are killing us", "Force Roche and Merck to lower prices".

The same day activists of the "Patients’ control" held pickets at the offices of pharmaceutical companies Roche and Merck and sent letters to them demanding price reductions for hepatitis C treatment.

The prices of the main component of HCV treatment - pegylated interferon – are constantly high for the last 15 years. There are only two major manufacturers of pegylated interferons in the world - Roche and Merck.

“As for today 5 million people are affected by hepatitis C in Russia. Not everyone can afford Hepatitis C treatment. People are getting into debt, sometimes they are forced to sell their homes to buy treatment. We have repeatedly asked the manufacturers to lower prices, but haven’t received any reply. Our last hope - that the new composition of the Ministry of Health will hear us and will take drastic measures to ensure affordable treatment - namely, force companies to decrease prices”, - says Andrey Skvortsov, leader of “Patients’ control” movement.

"Hepatitis C is curable", - says Alexei Mikhailov, activist. "If we cure all people the epidemic would stop. If prices are reduced the state could provide treatment to more people, save the budget and, thus, more people could afford to buy life-saving drugs".

Russia is not the only country where activists call on the manufacturers of pegylated interferon to cut prices. In anticipation the International Hepatitis Day similar events take place or will take place in Ukraine, Georgia, Armenia, India, Thailand, Moldova, Latvia, the United States and other countries.

For information:

The average price of hepatitis C treatment (48 weeks of pegylated interferon in combination with ribavirin) in the commercial market in Russia is more than half a million of rubles (~$15.000) while the drugs do not always allow the patient to fully recover from a virus and have a number of serious side effects.

Because of the very high cost of HCV treatment the state provides with treatment an extremely small number of patients: according to the independent patients monitoring, the federal program in 2012 covered less than 4,000 patients.

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Assessment of health-related quality of life predicts the outcome of pegylated interferon and ribavirin therapy for chronic hepatitis C

J Gastroenterol Hepatol. 2013 Jul 22. doi: 10.1111/jgh.12337. [Epub ahead of print]

Matsushita H, Ikeda F, Iwasaki Y, Seki H, Nanba S, Takeuchi Y, Moritou Y, Yasunaka T, Onishi H, Miyake Y, Takaki A, Nouso K, Yamamoto K.

Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama.

Abstract

BACKGROUND: Chronic infection with hepatitis C virus (HCV) decreases health-related quality of life (HRQOL). The present study was planned to investigate the impact of HRQOL of patients with chronic hepatitis C (CHC) on the outcomes of therapy with pegylated interferon and ribavirin, in addition to IL28B polymorphisms.

METHODS: The present study enrolled 228 CHC patients, and assessed their HRQOLs prospectively with the 36-item short-form health survey.

RESULTS: The patients with chronic hepatitis C have lower physical HRQOL status than the general population (P = 0.037, the Z test). The patients with advanced liver diseases exhibited further decreases in HRQOL (P = 0.036, Spearman's rank correlation coefficient). The score of total HRQOL was significantly lower in the group with sustained virological response (SVR) to the therapy with pegylated interferon and ribavirin than the non-SVR group (P = 0.031, the Mann-Whitney U test), with significantly lower scores of mental component and its comprising subscales in the SVR group. Stepwise multivariate logistic regression analysis showed that low HRQOL score ≤400 points was significantly associated with SVR (odds ratio = 2.4, P = 0.013), independently from high platelet counts, low HCV RNA, favorable SNP type of IL28B, and HCV serotype 2. The patients with low HRQOL score will had significantly less decrease in HRQOL score by 4 weeks of the treatment than those with high HRQOL score at baseline (P = 0.0045).

CONCLUSIONS: HRQOL is one of the significant predictor of the outcomes of therapy with pegylated interferon and ribavirin independently from IL28B polymorphism.

This article is protected by copyright. All rights reserved.

KEYWORDS: Interferon, QOL, and HCV

PMID: 23869873 [PubMed - as supplied by publisher]

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Telaprevir safe, effective among older patients with chronic HCV

Provided by Healio

Furusyo N. J Hepatol. 2013;59:205-212.

July 30, 2013

Advanced age did not impact the efficacy of triple therapy with pegylated interferon, ribavirin and telaprevir among patients with hepatitis C genotype 1b in a recent study.

In a prospective study, researchers evaluated 120 patients with chronic hepatitis C genotype 1b, including 64 participants aged older than 60 years. All patients received peginterferon alfa-2b, ribavirin and telaprevir for 12 weeks, then 12 weeks of peginterferon and ribavirin. During prior therapy 53.3% of participants had relapsed, 22.5% were treatment-naive, 20.8% were prior nonresponders and 3.3% had an unknown prior response.

Undetectable HCV RNA (rapid virological response) was observed at 4 weeks in 73.4% of older patients and 73.2% of patients aged younger than 60 years. Sustained virological response at 24 weeks post-treatment occurred similarly between groups: 76.6% of older patients vs. 83.9% of younger patients (P=.314 for difference). Investigators said SVR was more common among all patients with the IL28B TT allele (89.4% of older and 91.9% of younger patients vs. 41.2% and 68.4% among those without; P<.05 for both comparisons).

Multivariate analysis indicated associations between SVR and RVR (OR=7.498; 95% CI, 1.014-65.42) and IL28B TT genotype (OR=14.93; 95% CI, 1.6-142.9), as well as prior nonresponse (OR=8.403; 95% CI, 1.025-66.667), among older patients. Independent associations with RVR and TT genotype also were noted among younger patients.

Treatment discontinuation for adverse events occurred in 12.5% of all cases. Hemoglobin decreases for levels of 100 g/L or more were observed in 41.1% of younger and 9.4% of older patients; between 85 g/L and 100 g/L in 25% and 40.6%, and less than 85 g/L was present in 33.9% and 50% of younger and older patients, respectively (P=.0006).

“This study shows there is no impact by age on the virological outcome of TVR-based triple therapy for HCV genotype 1b chronic hepatitis C,” the researchers concluded. “We found that older patients achieve a better virological outcome by TVR-based triple therapy than with the traditional dual therapy. IL28B genotyping and EVR indicate the potential to achieve an SVR in these difficult-to-treat older patients.”

Disclosure: The researchers report no relevant financial disclosures.

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