Primrose Healthcare Provides an Innovative Calculator Tool, Giving Insight into the Costs of Hepatitis C beyond Anti-Virals First-in-industry tool for payers

PHOENIX--(BUSINESS WIRE)--Primrose Healthcare has just launched an innovative calculator tool to help health insurers and other payers uncover and better understand the total costs associated with the hepatitis C virus (HCV) within their populations. The calculator references the data and analysis from the Milliman, Inc. study, “The burden of hepatitis C virus disease in commercial and managed Medicaid populations,” and other user-input assumptions to estimate costs for a payer’s specific population.

While many payers may concentrate on managing anti-viral medication treatment costs, they may not closely focus on the underlying medical cost drivers within the population. The calculator analysis provides payers with a complete picture of typical non-antiviral treatment costs, including prevalence and key cost drivers such as stage of liver disease (i.e. chronic HCV, cirrhosis, etc.), other non-antiviral medication treatment costs and medical costs.

“Calculator analyses run to date clearly show that new medication treatments are not the only reason for high costs among the HCV populations,” said Henri Cournand, CEO of Primrose Healthcare. “Payers focused on medication costs alone are missing out on a valuable opportunity to improve health and reduce per-member-per-month costs related to managing these patients. This really comes to light when you consider that the average annual incremental non-antiviral drug medical costs for an individual with HCV are $21,888—four times higher than those without HCV.

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SNAPSHOTS —Alan Franciscus, Editor-in-Chief

This month’s (October 2015) column features a variety of studies, including treatment of people with advanced liver disease, treating people who have not achieved a cure with direct acting antiviral therapy, including people who had developed RAVs.

Article:  Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease—M Charlton et al. 

Source:  Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.

Results and Conclusions

This was a phase 2 study of 337 patients with decompensated cirrhosis with genotype 1 (332 patients) and genotype 4 (5 patients) who received 12 or 24 weeks of Harvoni plus ribavirin twice daily.  None of the patients previously treated developed resistance to sofosbuvir.  People who had been previously treated with an NS5A inhibitor were excluded from the study. 

There were two groups in the study:

•  Group A, who had NOT had a liver transplant: 59 patients with Child-Pugh class B cirrhosis and 49 patients with Child-Pugh class C  cirrhosis*
•  Group B who HAD undergone liver transplantation:  111 patients without cirrhosis, 51 patients with Child-Pugh class A cirrhosis, 52 with Child-Pugh class B cirrhosis, 9 with Child-Pugh class C cirrhosis, and 6 with fibrosing cholestatic hepatitis*

 *Child-Pugh cirrhosis scoring is a system that uses various types of blood markers and liver disease progression such as ascites to evaluate a patient to establish the severity of cirrhosis and long-term patient survival.  The classes are A, B and C with A as the less severe and C as the most severe.  Cholestatic hepatitis is bile duct blockage with fibrosis.

Group A and B had 12- and 24-week treatment arms, but cure rates were similar regardless of treatment duration.

     

 The Bottom Line

In group A (those who had not received a liver transplant), the cure rate was 86% to 89%.  In group B (transplant group) the people who did not have cirrhosis or Class A cirrhosis—the cure rate was 96% to 98%.  Furthermore, in group B with class B cirrhosis (compensated) the cure rate was 85% to 88%, and those with class C cirrhosis (moderate impairment) achieved 60% to 75% cure rates. The people who had fibrosing cholestatic hepatitis achieved 100% cure rates.  There were 13 patients (4%) who discontinued treatment.  Ten patients died in the trial.  The deaths were mainly attributed to complications from hepatic decompensation or end-stage liver disease.

Editorial Comment

In the past, people with these types of severe disease progression have been very difficult to cure or even treat, but now with these ‘miracle’ drugs many people now have a second chance at life.  Now if we could just get these drugs to everyone with hepatitis C before this stage, we would eliminate the need to treat at these stages of disease severity. 

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Article:  Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent—X Forns et al.

Source:  J Hepatol. 2015 Sep;63(3):564-72. doi: 10.1016/j.jhep.2015.04.009. Epub 2015 Apr 18.

Results and Conclusions

There were 79 HCV genotype 1 patients in the study. 

• Sixty-six patients who had been previously treated patients with an NS3/4A protease inhibitor but had not been cured. 
• Of the 13 remaining patients, 12 had discontinued treatment due to side-effect(s). 
• Thirty-four patients had NS3 resistance-associated variants (RAVs), and eight patients had NS5A RAVs. 
• Eight patients treated with the combination of grazoprevir and elbasvir plus ribavirin twice daily.

 The Bottom Line

The overall cure rates were 96% (76 of 79 patients)—this included 93% (63 of 66 patients) of the genotype 1a, one hundred percent of the patients (43 of 43 patients) who DID NOT have RAVs achieved a cure.  Ninety-one percent of those who DID have NS3 RAV’s were cured and 75% (6 of 8 patients) of those who had NS5A RAVs were cured.  Of those with cirrhosis 94% were cured with this combination. 

Editorial Comment

The addition of ribavirin to grazoprevir and elbasvir works to help cure resistance-associated variants in people who have been previously treated but who have not been cured.  It is also good strategy to treat other negative predictors to current  medications.

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Article:  Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens—D Wyles et al.  

Source:  Hepatology. 2015 Jun;61(6):1793-7. doi: 10.1002/hep.27814. Epub 2015 Apr 27.

Results and Conclusions

There were 51 genotype 1 patients enrolled in the study (Note: one patient was incorrectly typed as genotype 1, but was subsequently correctly genotyped as genotype 3).  All of the patients in this trial were previously treated with a sofosbuvir containing regimes in Gilead’s phase 1 or phase 2 studies.  The treatment duration in this study was 12 weeks. 

Breaking it down by type of prior type of non-response:

• 25 pts (49%) had previously received sofosbuvir plus pegylated interferon plus ribavirin
• 20 pts (39%) had previously received sofosbuvir plus ribavirin
• 5 pts (10%) received sofosbuvir (sugar pill/placebo) plus pegylated interferon and ribavirin
• 1 pt (2%) received GS-0938 only fourteen patients (27%) had compensated cirrhosis.

 The Bottom Line

The total number of patients who achieved a cure was 98% (50 of 51 patients).  Among those who had received a prior course of sofosbuvir 98% (44 of 45) were cured.  The only patient who did not achieve a cure was the patient who was originally misdiagnosed as a genotype 1. 

The most common side effects were fatigue, headache and diarrhea.  The patients in this trial are considered some the most difficult to treat—those who have not achieved a cure with a previous course of a direct acting antiviral medication, those with cirrhosis, and people with resistant antiviral variants (RAVs). 

Editorial Comment

The addition of ledipasvir and ribavirin to sofosbuvir increased the cure rates to 100% for genotype 1.  Excellent results!  This is a good strategy with another type of direct acting antiviral to stop the virus from replicating and escaping.

Gilead, Merck, AbbVie, Janssen, and Achillion are working on other HCV drugs that have a higher barrier to resistance to avoid the development of resistance and to work for people who are not responding to the current medications.

NYU Researchers Find Development of Serious Liver Damage in Mid- to Late-adulthood Among People Who Inject Drugs with Untreated Chronic Hepatitis C Infection

October 5, 2015
N-56 2015-16

Few people who inject drugs are engaged in needed care for chronic HCV infection; Early engagement in treatment needs to be a policy priority for these individuals

The Hepatitis C virus (HCV) infection is a chronic blood-borne viral infection that affects an estimated 160 million people, or 2-3% of the population world-wide. Alarmingly, chronic HCV infection accounts for one-quarter of the cases of cirrhosis and hepatocellular carcinoma (HCC). If HCV is left untreated, chronic liver disease will occur in 60–70% of the cases, cirrhosis in 5–20% of the cases, and 1–5% will die from decompensated cirrhosis or HCC.

In most high-income countries, such as the United States, where drug injection is the primary route of HCV transmission, the disease is concentrated among people who inject drugs (PWID). While it is estimated that 50–80% of PWID are chronically infected, fewer than 5% of PWID have received treatment.

In a new study, “Hepatitis C virus (HCV) disease progression in people who inject drugs (PWID): A systematic review and meta-analysis,” published in the International Journal of Drug Policy, a team of researchers from New York University’s Center for Drug Use and HIV Research (CDUHR) assessed existing data on the natural history of HCV among PWID. A total of twenty-one studies examined over 8500 PWID, who contributed nearly 120,000 person-years at risk, for the study of four major HCV-related outcomes included in the synthesis.

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THE FIVE: Cirrhosis —Alan Franciscus, Editor-in-Chief

This month’s column is about cirrhosis—the causes, how it develops, the symptoms and
consequences and issues about HCV treatment related to cirrhosis.
 
1.  What are the Causes of Cirrhosis?  

Cirrhosis is caused by many substances (alcohol), viruses (hepatitis B, C and D), and even by metabolic disorders (diabetes). Currently, the most common reason for liver transplantation in the United States is from complications from the hepatitis C virus.  Cirrhosis caused by hepatitis C is responsible for  more than 19,000 deaths every year.  Prior to the emergence of hepatitis C, the most common cause of cirrhosis was alcohol consumption. Fatty liver is also a common cause of cirrhosis, and it is expected to surpass the hepatitis C virus as the most common cause of cirrhosis and liver transplantation in the next two decades.

2.   How Does Cirrhosis Develop?

In the case of hepatitis C, the development of cirrhosis is a complex process of liver cells becoming damaged or destroyed by the hepatitis C virus.  Furthermore, the body’s immune system seeks out and identifies the hepatitis C virus (and the destroyed liver cell) as a foreign pathogen—attacks it and kills it.  As a result, scar tissue develops.  Usually, the liver can repair itself, but as the hepatitis C virus causes more and more damage, it overwhelms the body and the damage builds and builds.  As more scar tissue develops the damaged cells start to connect, and fibrosis develops. Over time, the scar tissue can be so extensive that it can interfere with the functioning of the liver.  This is called cirrhosis. Cirrhosis is classified into two types: compensated and decompensated. Compensated means that the liver is extensively scarred but can still perform most of its functions; decompensated means that the liver is extensively scarred and unable to perform many of the functions that keep the body healthy.  

3.  What are the Tests to Identify Cirrhosis?

There are many types of tests to find out if someone has cirrhosis.  In the past, the most common test was a liver biopsy.  The procedure requires a medical person to  insert a needle through the skin to extract a piece of liver tissue and examine it under a microscope.  The liver biopsy is still being used, but it is also being replaced by other procedures such as a Fibroscan (an imaging test), Fibrometer (combination of blood tests), and other blood tests to gauge the degree of liver damage.

There are many models used to grade and stage the degree of liver damage.  The most common is the Metavir. The Metavir has an inflammation and fibrosis scoring stage—in this article I am just listing the fibrosis stages:

• Stage F0 = no fibrosis
• Stage F1 = mild fibrosis
• Stage 2 = moderate fibrosis
• Stage 3 = bridging fibrosis
• Stage 4 = cirrhosis 

Note:  This is important to know because many insurance companies are using this system to approve or deny insurance for HCV treatment claims.

4.  What are the Symptoms and Consequences of Cirrhosis? 

In the early stages of extensive scarring—called compensated cirrhosis—the symptoms may be similar to hepatitis C—fatigue, loss of appetite, muscle and joint pain, flu-like symptoms, nausea, indigestion, headaches and many other symptoms.  As cirrhosis develops and reaches the later stages—called decompensated cirrhosis—the symptoms become more pronounced and can become life-threatening.  In addition to the symptoms described above I have listed some of the more common serious conditions below:

• Portal Hypertension: blood cannot flow through the liver because of the extensive scarring. 
• Encephalopathy: the liver is not able to remove toxins such as ammonia, and the result is that these toxins invade the brain.  Symptoms include personality changes, and changes in sleep patterns (sleep reversal—awake all night, sleep all day).
• Ascites:  accumulation of fluids in the abdominal cavity.  
• Edema: accumulation of fluid in the extremities—usually in the feet and legs.  
• Coagulopathy: the liver is not able to produce clotting factors that stop the blood from bleeding.
• Male and Female Hormone Regulation:  the liver may not be able to regulate female and male hormones.
• Severe Itching: the impairment of bile flow that can cause severe and at times debilitating itching.
• Wasting Syndrome: the liver is not able to process nutrients so people can have severe muscle wasting and weight loss.  

Most of these conditions can be managed effectively with lifestyle changes, medications and medical procedures—at least in the short term. The most important step is to be medically monitored and managed on a regular basis.  At this point, a person should be evaluated for a liver transplant.  The problem is that there are only an estimated 6,000 available livers for the estimated 15,000 livers needed every year for transplantation in the U.S.

5.  HCV Treatment  

Hepatitis C treatment can now cure most people, the treatment duration is shorter, and treatment side effects are lower than ever.  However, once people develop cirrhosis, it becomes more difficult especially for those who are infected with genotype 3 and who have cirrhosis—the second most prevalent genotype in the United States.  Unfortunately, we also know that many insurance companies are denying coverage of hepatitis C medications to only those who are in the early stages of HCV infections (F0, F1, F2).  Many insurance companies are only covering F3 and F4 unless there are other severe complications.  Here’s the problem—if you wait until stage F3 or F4 and are cured you will have to be medically followed for the rest of your life since there is a possibility that you could still have liver disease progression. However, if you are treated early (F0, F1, F2), and cured you are free of future complications.  Does this scenario make any sense to you?  It does not make any sense to me either!

EASL 2015: ALLY-1 Trial Results Show Investigational Daclatasvir-Based Regimen Cures 94% of Post-Liver Transplant Patients with Hepatitis C and Up to 94% of Hepatitis C Patients with Cirrhosis (Child-Pugh Class A or B)

• 97% of post-transplant patients with HCV genotype 1a achieved cure
• 91% of post-transplant patients with HCV genotype 3 achieved cure  
• No need seen to alter existing transplantation medication regimens

Saturday, April 25, 2015 10:00 am EDT

(PRINCETON, N.J., APRIL 25, 2015) – Bristol-Myers Squibb Company (NYSE:BMY) today announced that primary endpoints were successfully met in ALLY-1, a Phase III clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) with either advanced cirrhosis or post-liver transplant recurrence of HCV. The data was presented as a late-breaker at The International Liver Congress™ 2015, the 50^th annual meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria from April 22-26.

“The results of the ALLY-1 trial point to the potential of this investigational daclatasvir-based regimen in a patient population with high unmet needs despite recent advances in hepatitis C treatment,” said Fred Poordad, M.D., ALLY-1 Lead Investigator and Clinical Professor of Medicine, Chief, Hepatology, University of Texas Health Science Center and VP, Academic and Clinical Affairs Texas Liver Institute. “Transplant patients take a variety of immunosuppressive medications to prevent organ rejection; that complicates the treatment of hepatitis C. In ALLY-1, we saw no drug-drug interactions between transplant and hepatitis C therapies and no need to make dose adjustments to patients’ transplant-related drugs while they received the daclatasvir-based regimen that resulted in high SVR12 rates.”

The study’s primary endpoints were reached, with 95% of post-transplant genotype 1 patients and 82% of genotype 1 patients with advanced cirrhosis achieving SVR12. Among all ALLY-1 patients, 94% of those with post-transplant HCV recurrence and 83% of all participants with advanced cirrhosis achieved cure (sustained virologic response 12 weeks after treatment; SVR12).

The Child-Pugh scoring system is commonly used to assess the severity and prognosis of chronic liver disease and cirrhosis, and uses an A through C classification (C being the most advanced) to categorize disease progression. Patients with class C cirrhosis are decompensated, often with later-stage conditions such as ascites (the build-up of fluid in the abdomen), hepatic encephalopathy (confusion or altered level of consciousness due to the liver’s inability to remove toxins from the blood), and abnormal liver function, which can complicate treatment. The ALLY-1 trial included 16 patients with decompensated cirrhosis Child-Pugh class C; nine (56%) achieved SVR12.

Over the course of the study, four advanced cirrhotic patients received a liver transplant during treatment; 3 of 4 extended treatment post-transplant (see study design below), and all 4 achieved SVR12.

In the study, there were no serious adverse events related to study medications throughout the treatment phase. The most common adverse events (≥10%) were headache (15%, 36%), fatigue (18%, 28%), anemia (20%, 19%), diarrhea (8%, 19%), nausea (17%, 6%), and arthralgia (2%, 13%) in the advanced cirrhotic and post-transplant cohorts, respectively. One patient discontinued therapy after 31 days due to headache, but still achieved SVR12. Nine patients in the cirrhosis cohort relapsed post-treatment, and one had detectable HCV RNA at the end of treatment; there were no on-treatment virologic breakthroughs. Three patients (genotypes 1a, 1b, 3) in the post-transplantation cohort relapsed. All 12 patients with relapse are being retreated with daclatasvir and sofosbuvir with ribavirin for 24 weeks.

 HCV is the leading indication for liver transplantation worldwide. Without treatment, HCV infection of the new liver after transplant is inevitable, and is associated with rapid progression to cirrhosis and death in up to 30% of patients within 5 years. The ALLY-1 study is the third study to report out of the Phase III ALLY program, which evaluates daclatasvir in combination with sofosbuvir in multiple high-unmet need patient populations and is at the center of Bristol-Myers Squibb’s HCV research focus. The ALLY-2 and ALLY-3 studies have previously been presented at the 2015 Conference for Retroviral and Opportunistic Infections and the 2014 American Association for the Study of the Liver’s The Liver Meeting, respectively, and subanalyses from each study with the ribavirin-free regimen of daclatasvir and sofosbuvir were presented as posters during EASL 2015.

Additionally, EASL issued 2015 Hepatitis C treatment guidelines that include a regimen of daclatasvir+sofosbuvir as the first 12-week treatment for patients with genotype-3 virus. The EASL guidelines now list daclatasvir+sofosbuvir regimens as options for treating all HCV genotypes and for use with patients coinfected with HCV/HIV. (Guidelines available here.)

Other Bristol-Myers Squibb presentations at The International Liver Congress included data from compassionate use programs in the EU that add to the real-world clinical evidence informing the use of daclatasvir-based regimens to treat patients with HCV conditions posing high unmet medical needs.

“The ALLY-1 trial results build off the ALLY-2 and ALLY-3 studies by demonstrating the versatility of the daclatasvir-based regimen to provide HCV cure in multiple patient populations that have been historically hard to manage, such as HCV genotype 3 patients, HIV/HCV coinfected patients, and patients with decompensated cirrhosis,” said Douglas Manion, M.D., Head of Specialty Development, Bristol-Myers Squibb. “Post-liver transplant and cirrhotic patients represent a still-unmet need and continue to present challenges to currently available regimens.”

About ALLY-1: Study Design
This Phase III open-label clinical trial enrolled treatment-naïve and treatment-experienced patients with HCV infection of any genotype in 2 cohorts: advanced cirrhosis (n=60) and post-liver transplant with HCV recurrence (n=53). All patients received daclatasvir 60 mg plus sofosbuvir 400 mg once-daily with ribavirin initially dosed at 600 mg/d (with potential for adjustment based on hemoglobin levels and creatinine clearance) for 12 weeks. Patients receiving a variety of immunosuppressive agents were permitted. In the cirrhosis cohort, patients transplanted during treatment could receive 12 weeks of extended treatment immediately post-transplant, regardless of treatment duration before transplant. The primary endpoint was the SVR12 rate (defined as HCV RNA <LLOQ (25 IU/mL) at post-treatment week 12) among genotype 1 patients in each cohort.

Read complete press release here....

Janssen Announces SVR12 Rates with Twelve Weeks of Treatment with All-Oral, Once-Daily Regimen of Simeprevir Plus Sofosbuvir in Genotype 1 HCV Patients With and Without Cirrhosis

– Data from OPTIMIST-1 and OPTIMIST-2 Trials Showing SVR12 Rates of 97 Percent and 84 Percent to be Presented at The International Liver Congress™ 2015 of the European Association for the Study of the Liver -

– SVR12 Rates of up to 100 Percent Achieved Among Subgroups in Both Trials –

CORK, Ireland--(BUSINESS WIRE)--Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), today announced results for its hepatitis C treatment simeprevir at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) in Vienna. Late-breaking results from the Phase 3 OPTIMIST-1 and OPTIMIST-2 trials highlight the clinical outcomes of simeprevir in an all-oral combination regimen in a wide range of patients with hepatitis C virus (HCV) infection.

“Chronic HCV infection is a leading cause of cirrhosis, and once it is developed, these patients can be very difficult to cure. The results of the OPTIMIST-2 study demonstrate the safety and efficacy of the all-oral regimen of simeprevir and sofosbuvir for genotype 1 chronic HCV patients with cirrhosis”

“The new data for simeprevir presented at The International Liver Congress™ confirms its efficacy when combined with sofosbuvir in an all-oral, ribavirin-free regimen for HCV patients, including those who are treatment-naïve and treatment-experienced, both with and without cirrhosis,” said Gaston Picchio, hepatitis disease area leader, Janssen. “These data further demonstrate the role of simeprevir within the HCV treatment landscape, as it provides patients with an important therapeutic option.”

The results from the OPTIMIST-1 and OPTIMIST-2 trials are the first Phase 3 data to be presented on simeprevir in combination with sofosbuvir (SMV/SOF) in patients with genotype 1 chronic HCV infection, both with and without cirrhosis. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

OPTIMIST-1¹

• OPTIMIST-1 is a Phase 3, randomised, open-label trial to investigate the efficacy and safety of the all-oral regimen of SMV/SOF among treatment-naïve and treatment-experienced genotype 1 chronic HCV-infected patients without cirrhosis. The primary objective was to show superior sustained virologic response (SVR) at 12 weeks after treatment (SVR12) with 12 and eight weeks of treatment with SMV/SOF versus a historical control (patients previously treated with approved regimens containing a direct-acting antiviral, pegylated interferon and ribavirin).
• Ninety-seven (97) percent of patients treated with SMV/SOF for 12 weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate of 87 percent among the historical control.
  • SVR12 rates of 100 percent were seen among patients with IL28B CC genotype (n=43/43) and those with baseline NS5A and NS3 Q80K polymorphisms (n=9/9).
• Patients treated with eight weeks of SMV/SOF achieved an SVR12 rate of 83 percent (n=128/155), which was not superior to the SVR12 rate of 83 percent in the historical control.
  • High SVR12 rates were seen among patients with baseline HCV RNA <4 million IU/mL (96 percent; n=46/48), IL28B CC genotype (93 percent; n=38/41), patients with genotype 1b HCV infection (92 percent; n=36/39) and patients without baseline NS5A and Q80K polymorphisms (89 percent; n=78/88).
• The most frequently reported adverse events in the 12-week and eight-week treatment arms were headache (14 and 17 percent, respectively), fatigue (12 and 15 percent, respectively) and nausea (15 and 9 percent, respectively).

OPTIMIST-2²

• OPTIMIST-2 is a Phase 3, open-label, single-arm trial to investigate the efficacy and safety of SMV/SOF in treatment-naïve and treatment-experienced genotype 1 chronic HCV-infected patients with cirrhosis. The primary objective was to show superior SVR12 with 12 weeks of treatment with SMV/SOF versus a historical control.
• Twelve (12) weeks of treatment with SMV/SOF resulted in SVR12 rates of 84 percent (n=86/103), which was superior to the SVR12 rate of 70 percent in the historical control.
• Higher SVR12 rates were seen in patients with baseline NS5A polymorphisms with or without NS3 Q80K polymorphisms (100 percent; n=13/13), patients with albumin ≥4 g/dL (94 percent; n=47/50) and treatment-naïve patients (88 percent; n=44/50).
• The most common adverse events were fatigue (20 percent), headache (20 percent) and nausea (11 percent).

“Chronic HCV infection is a leading cause of cirrhosis, and once it is developed, these patients can be very difficult to cure. The results of the OPTIMIST-2 study demonstrate the safety and efficacy of the all-oral regimen of simeprevir and sofosbuvir for genotype 1 chronic HCV patients with cirrhosis,” said Eric Lawitz, M.D., Texas Liver Institute, principal investigator of the OPTIMIST-2 study.

About Janssen’s HCV Development Programme
The goal of the Janssen hepatitis C virus (HCV) clinical development programme is to provide physicians with multiple treatment options in order to offer patients the best possible chance at successful therapy.

Ongoing studies focus on the investigation of the NS3/4A protease inhibitor simeprevir in a number of different treatment combinations and HCV patient populations, including those who are difficult to cure.

Janssen’s HCV pipeline also includes JNJ-56914845, an investigational NS5A replication complex inhibitor currently in Phase 2 studies, and following the acquisition of Alios BioPharma by Johnson & Johnson in November 2014, AL-335, a uridine-based nucleotide analog in Phase 1 development, and AL-516, a guanosine-based nucleotide analog NS5B polymerase inhibitor in pre-clinical development.

These compounds are being developed with the intent of targeting critical steps of the HCV replication cycle.

About Simeprevir (OLYSIO^®)
Simeprevir is an NS3/4A protease inhibitor which has been developed by Janssen Sciences Ireland UC in collaboration with Medivir AB.

In November 2013, simeprevir was initially approved by the U.S. Food and Drug Administration, and in May 2014, it was granted marketing authorisation by the European Commission. Subsequent marketing authorisations have followed in several other countries around the world. Indications vary by market.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorisation held by Janssen-Cilag International NV.

Read complete press release here...