Upcoming hepatitis C clinical trial - Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

This study is not yet open for participant recruitment

A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

ClinicalTrials.gov Identifier:

NCT02966795

Drug: Glecaprevir/Pibrentasvir

Phase 3

Purpose
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (ABT-493)/pibrentasvir (ABT-530) for an 8- or 12-week treatment duration in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis, who are either HCV treatment-naïve or treatment experienced with interferon (IFN) or pegylated interferon (pegIFN) with or without ribavirin (RBV) (defined as P/R treatment-experienced) or sofosbuvir (SOF) plus RBV with or without pegIFN (defined as SOF plus RBV treatment-experienced).

Estimated Enrollment: 80
Study Start Date: December 2016

Link - https://clinicaltrials.gov/show/NCT02966795

AASLD 2016 Review - Watch Advances in Chronic Hepatitis C: Management and Treatment

After each conference this blog links to a series of education-related information on important findings related to ongoing challenges of managing and treating viral hepatitis. Listed below are three programs offering a review of key studies presented at the American Association for the Study of Liver Diseases 67th Annual Meeting 2016.

Internet symposium at ViralEd - Advances in Chronic Hepatitis C: Management and Treatment

The CME Internet Symposium: AASLD 2016 Expert Review will feature four HCV experts reviewing and discussing key presentations on chronic hepatitis C presented at AASLD 2016. The review and discussion will focus on HCV therapeutic options and developments, including: current treatment and management strategies, algorithms and recommendations; therapies in development; epidemiology; and diagnosis and clinical management of specific patient populations, including HCV/HIV co-infected and cirrhotic patients.

Click here to view program..

Clinical Care Options - Clinical Impact of New Hepatology Data From Boston 2016*

November 11-15, 2016 | Boston, Massachusetts

Examine Capsule Summaries, download slides, and review analysis by expert faculty on key studies from Boston 2016.

Begin here....

Free Registration Required, click here to register

Conference Coverage AASLD: Practice Point 5 Minute Video Clips
At Practice Point a series of 5 minute video clips highlighting hot hepatitis topics presented at the Liver Meeting 2016 is offered. 
This activity is jointly provided by the University of Nebraska Medical Center,
University of Florida College of Pharmacy
and Practice Point Communications

Click here to get started.....
Free Registration Required, click here to register

Adding Voxilaprevir to Sofosbuvir/Velpatasvir Effective for HCV Genotype 3: Presented at AASLD

Adding Voxilaprevir to Sofosbuvir/Velpatasvir Effective for HCV Genotype 3: Presented at AASLD

By Frances Morin

BOSTON -- November 17, 2016 -- Adding voxilaprevir to the combination tablet containing sofosbuvir and velpatasvir (Epclusa) for 8 weeks shows similar efficacy to sofosbuvir/velpatasvir alone for 12 weeks in the treatment of patients with hepatitis C virus (HCV) genotype 3 and cirrhosis.

“The results show that sofosbuvir/velpatasvir and voxilaprevir for 8 weeks and sofosbuvir/velpatasvir for 12 weeks each provide simple, safe, and effective treatment regimens for patients with HCV genotype 3 and cirrhosis,” said Graham R. Foster, MD, Royal London Hospital, London, United Kingdom, at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

In efforts to treat HCV with direct acting antivirals, genotype 3 infection has become notably difficult to cure, particularly in patients with cirrhosis.

For the phase 3 POLARIS-3 trial, the researchers investigated the addition of voxilaprevir 100 mg/day to sofosbuvir/velpatasvir 400 mg/100 mg/day for 8 weeks compared with sofosbuvir/velpatasvir 400 mg/100 mg/day alone for 12 weeks in 219 patients with genotype 3 HCV infection and cirrhosis.

The results showed that 96% of patients in each group achieved a sustained virologic response for at least 12 weeks after treatment (SVR12).

In the voxilaprevir group, there were 2 relapses, 1 patient withdrew consent, and there was 1 death. In the sofosbuvir/velpatasvir group, there was 1 on-treatment failure, 1 relapse, 1 discontinuation due to an adverse event (AE), and 1 lost to follow-up.

In looking at patients according to prior treatment, 96% of treatment-naïve patients in the voxilaprevir group (72/75) achieved SVR12 compared with 99% of the sofosbuvir/velpatasvir group (76/77). Among those who received prior treatment, 97% and 91% achieved SVR 12, respectively.

The most common AEs (>10% of patients) were fatigue and headache. Rates of nausea and diarrhoea were higher in the voxilaprevir group (21% and 15%, respectively), compared with the sofosbuvir/velpatasvir group (9% and 5%).

According to the researchers, baseline NS5A resistance-associated substitutions, including Y93H, did not impact treatment outcomes for either group.

Funding for this study was provided by Gilead Sciences.

[Presentation title: A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/ Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients With Genotype 3 HCV Infection and Cirrhosis: The POLARIS-3 Study]

To read more Conference Dispatch articles, click here.

Source - https://www.firstwordpharma.com/node/1434143?tsid=28&region_id=4

Hepatitis C virus tricks liver cells to sabotage immune defenses

Hepatitis C virus tricks liver cells to sabotage immune defenses 

November 17,2016

Virus induces liver cells to make molecules that inhibit production of a key immune signaling receptor

University of Washington Health Sciences/UW Medicine

The virus that causes hepatitis C protects itself by blocking signals that call up immune defenses in liver cells, according to University of Washington researchers and colleagues reporting Nov. 14 in Nature Medicine.

"The finding helps explain why many patients fail certain drug treatments, and should help develop more effective alternate treatment protocols," said Ram Savan, the study's corresponding author and an assistant professor of immunology in the UW School of Medicine.

Hepatitis C virus is the most common cause of chronic hepatitis and the leading cause of liver cancer in the United States. It is primarily spread through contact with infected blood. Each year, more than 30,000 Americans become infected. As many as 85 percent develop life-long chronic infections. Of these patients, about one in 10 will eventually develop cirrhosis and liver cancer.

In the latest study, lead author Abigail Jarret, now a graduate student at Yale University, and her group showed that hepatitis C virus sabotages the antiviral defenses of liver cells by blunting the effect of key immune proteins called interferons.

When cells become infected, they release interferons. These in turn spur hundreds of genes that generate virus-fighting proteins within the cell. Interferons can even provoke cells to self-destruct to prevent the virus from propagating.

One of these interferons, called interferon-alpha, has been used for many years to treat chronic hepatitis C virus infections, either alone or in concert with an antiviral called ribavirin. These treatments helped many patients get rid of the virus, but the treatment fails to cure more than 60 percent of patients.

Newer, more effective drugs with fewer side effects have now largely replaced interferon-based therapies. However, it was not clear why interferon treatment failed so often. From this study, researchers hypothesized that the virus' ability to evade interferons was related to the cells themselves.

In a previous study, Savan's research team discovered that when hepatitis C virus invades a liver cell, the virus induces the cell to activate two genes -- MYH7 and MYH7B. These genes are usually active only in smooth skeletal muscle and heart cells. Once activated, these genes produce two microRNAs, molecules that can interfere with the production of other proteins.

Savan and his fellow researchers showed that these microRNAs interfered with the cell's production of two interferons. By activating the MYH7 and MYH7B genes, the invading hepatitis C viruses limit liver cells' ability to generate these interferons. The cells are then less able to resist and remove the virus.

The investigators also showed that these virally-induced microRNAs inhibit production of a receptor crucial to the cell's interferon-driven antiviral response.

Thus, these hepatitis C virus-induced microRNAs can blunt liver cell interferon-driven antiviral defenses in two ways, Jarret explained.

First, the virus inhibits the cell's ability to produce its own type III interferons.

Second, it prevents the cells from making the receptors needed in order for type I interferons to be effective.

"This may in part explain why interferon treatments, which harness a type I interferon, fail in so many patients," Jarret said.

This project was funded partly by the National Institutes of Health.

The Nature Medicine article is "Hepatitis-C-virus-induced microRNAs dampen interferon-mediated antiviral signalling."

A Growing Group Of Doctors Are Big-Money Prescribers In Medicare

A Growing Group Of Doctors Are Big-Money Prescribers In Medicare

The number of doctors who each prescribe millions of dollars of medications annually in Medicare's drug program has soared, driven by expensive hepatitis C treatments and rising drug prices overall, federal data obtained by ProPublica show.

The number of providers who topped the $5 million mark for prescriptions increased more than tenfold, from 41 in 2011 to 514 in 2015. The number of prescribers — mostly physicians but also nurse practitioners — exceeding $10 million in drug costs jumped from two to 70 over the same time period, according to the data.

Most of the doctors atop the spending list prescribed Harvoni or Sovaldi, relatively new drugs that cure hepatitis C. Other providers on the list prescribed pricey drugs to treat cancer, multiple sclerosis and rheumatoid arthritis.

Continue reading.....

Coffee Consumption and Herbal Tea Tied to Lower Liver Stiffness

Herbal Tea, Coffee Consumption Tied to Lower Liver Stiffness

Tea and coffee consumption is ubiquitous around the world. Both contain polyphenols, caffeine, as well as other chemical components. Polyphenols and caffeine are suspected to improve liver health; for example, previous research has suggested that coffee might prevent liver cirrhosis. However, whether or not this is true for fibrosis in the general population is not known.

AASLD Coverage
Nov 11, 2016
Herbal Tea, Coffee Consumption Tied to Lower Liver Stiffness
Herbal tea and coffee might protect the liver among healthy adults, according to findings presented at The Liver Meeting® 2016.

“High coffee consumption appears protective of liver stiffness even in individuals with no known liver disease,” reported lead study coauthor Louise J. Alferink, of the Gastroenterology and Hepatology of the Erasmus Medical Center, Rotterdam, Netherlands. 

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Additional updates @ MPR

People who drink coffee are less likely to develop nonalcoholic fatty liver disease (NAFLD), a new literature review suggests. And people with NAFLD who drink coffee regularly are less likely to develop liver fibrosis.

AASLD Coverage
Nov 12,2016

Drinking Coffee Found to Significantly Decrease NAFLD Risk
Coffee drinkers significantly decrease their risk of nonalcoholic fatty liver disease (NAFLD), and regular drinking also decreases risk of liver fibrosis, according to results of a systematic review and meta-analysis presented at The Liver Meeting® 2016.

“Whether consumption of coffee could be considered as a preventative measure against NAFLD needs further investigations,” reported Karn Wijarnpreecha, MD, of the department of internal medicine at Bassett Medical Center and Columbia University College of Physicians and Surgeons, Cooperstown, NY, and colleagues.
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Additional updates @ MPR

Hepatitis C Treatment Uptake among Patients Who Have Received Opioid Substitution Treatment: A Population-Based Study

Hepatitis C Treatment Uptake among Patients Who Have Received Opioid Substitution Treatment: A Population-Based Study
Håvard Midgard , Jørgen G. Bramness, Svetlana Skurtveit, John W. Haukeland, Olav Dalgard Published: November 15, 2016 http://dx.doi.org/10.1371/journal.pone.0166451

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Abstract
Background and Aims
There is limited data on hepatitis C (HCV) treatment uptake among people who inject drugs including individuals receiving opioid substitution treatment (OST). We aimed to calculate cumulative HCV treatment uptake, estimate annual treatment rates, and identify factors associated with HCV treatment among individuals who have received OST in Norway.

Methods
This observational study was based on linked data from The Norwegian Prescription Database and The Norwegian Surveillance System for Communicable Diseases between 2004 and 2013. Both registries have national coverage. From a total of 9919 individuals who had been dispensed OST (methadone, buprenorphine or buprenorphine-naloxone), we included 3755 individuals who had been notified with HCV infection. In this population, dispensions of HCV treatment (pegylated interferon and ribavirin), benzodiazepines, selective serotonin reuptake inhibitors and antipsychotics were studied.

Results
Among 3755 OST patients notified with HCV infection, 539 (14%) had received HCV treatment during the study period. Annual HCV treatment rates during OST ranged between 1.3% (95% confidence interval [CI] 0.7–2.2) in 2005 and 2.6% (95% CI 1.9–3.5) in 2008 with no significant changes over time. HCV treatment uptake was not associated with age or gender, but associated with duration of active OST (adjusted odds ratio [aOR] 1.11 per year; 95% CI 1.07–1.15), high (> 80%) OST continuity (aOR 1.62; 95% CI 1.17–2.25), and heavy benzodiazepine use (aOR 0.65; 95% CI 0.49–0.87).

Conclusions
Cumulative HCV treatment uptake among OST patients notified with HCV infection in Norway between 2004 and 2013 was 14%. Annual treatment rates during OST remained unchanged below 3% per year. High continuity of OST over time and absence of heavy benzodiazepine use predicted HCV treatment uptake. Increased awareness for HCV among OST patients is needed as tolerable and efficient directly acting antiviral treatment is being introduced.

Discussion Only

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This population-based observational study evaluated HCV treatment uptake in Norway between 2004 and 2013 among individuals who had received OST and were notified with HCV infection. Cumulative HCV treatment uptake was 14% and annual treatment rates during OST ranged between 1.3% and 2.6% with no significant changes over time. HCV treatment was associated with duration of active OST, high OST continuity and absence of heavy benzodiazepine use, but was not associated with age or gender. This study provides unique baseline data on HCV treatment uptake among OST patients over a ten-year period prior to the availability of DAA treatment.

The results from this study are consistent with findings from a Norwegian cohort of PWID who previously had been admitted for residential drug dependency treatment, in which 19% of individuals with chronic HCV infection had received HCV treatment during a 16 years observation period [45]. The majority of treated individuals in the present study had received HCV treatment during OST. Still, annual treatment uptake during OST was only marginally higher than treatment rates reported in community-based cohorts of PWID not engaged in OST [12–15]. Although the Norwegian OST program was expanding during the study period, this did not translate into increasing HCV treatment uptake. This could be explained by a reluctance to offer OST patients IFN-based treatment, but might also suggest a low awareness of HCV infection in OST programs in general. Prescription of OST to more vulnerable individuals during the final part of the study period could also have played a role. Stable low treatment rates in this population might therefore reflect ongoing drug use as a barrier to HCV care on both patient- and provider-levels [19]. However, there has been a trend in Norway to increasingly provide HCV treatment for active PWID [43].

Cumulative HCV treatment uptake was similar in all age groups and there was no association between age and HCV treatment. Among diseased HCV RNA positive individuals in a large Norwegian cohort of PWID, advanced liver fibrosis or cirrhosis on autopsy was seen in 35% of those who died 25 years or more after exposure to the virus [46]. In the same cohort, liver disease was the cause of death in 30% of deceased individuals above 50 years of age [4]. Given the high burden of HCV-related liver disease reported from this and other ageing cohorts of PWID with untreated HCV infection [47], it is a concern that treatment uptake was only 15% among individuals above 50 years at the end of the observation.

Certain characteristics of OST were associated with HCV treatment. The odds of receiving HCV treatment increased by 11% for every year spent in active OST. OST continuity by itself was also important; in fact, individuals in active OST more than 80% of the time had 64% increased odds of receiving HCV treatment compared to those with low OST continuity. These are novel findings that raise the hypothesis that retention in OST could promote health-seeking behaviour and facilitate HCV treatment.

This study also found associations between specific drug dispensions and HCV treatment. Heavy, but not moderate benzodiazepine use was associated with decreased odds of receiving HCV treatment, a finding that might reflect a psychosocial vulnerability that characterizes a group of OST patients. Benzodiazepine use is common among Norwegian OST patients and is shown to be associated with negative outcomes including poor social functioning and reduced retention in OST programs [48]. Psychiatric disease is a well-known barrier for IFN-based HCV treatment [18], but no association between dispensions of antipsychotics and HCV treatment was found in this study. SSRI use, however, was more common in patients treated for HCV, but this difference could be attributed to SSRI use initiated during or after HCV treatment. This finding might imply that the increased SSRI use was a consequence of psychiatric side effects of IFN-based treatment [49].

The main strength of this study is its population-based approach, providing a large sample of individuals with opiate dependency who had received OST during a ten-year period. A liberal inclusion of individuals with only sporadic or short-term exposure to OST has ensured a study population more representative of Norwegian PWID. This study is the first to document HCV treatment uptake in this essential target group for HCV treatment, providing important baseline data prior to the availability of DAA treatment.

An inherent limitation of this study is the lack of clinical data available from the registries. This may have impeded detection of factors associated with HCV treatment, although novel pharmaco-epidemiological associations have been identified. Another limitation is that OST administered to institutionalized patients was not registered in NorPD prior to 2008. HCV treatment, however, has almost exclusively been initiated in the outpatient setting and has therefore been captured by the registry throughout the study period. Consequently, annual HCV treatment rates during OST may have been underestimated prior to 2008, since some individuals probably have been misclassified as being treated prior to OST. This might explain the lower trend in treatment rates observed in this period. This bias may also have undervalued OST duration and OST continuity in some individuals, but cumulative HCV treatment uptake has not been affected.

The quality of the MSIS data brings important limitations to this study. Firstly, the registry does not adequately discriminate chronic HCV infections from acute HCV infections with spontaneous clearance. Thus, by including all notified individuals regardless of the method of detection, treatment uptake may have been underestimated. Secondly, the low notification rate is a recognized problem that probably reflects vulnerable notification routines and lacking notifications of chronic infection prior to 2008, as well as low testing activity in OST programs. Also, this study may have missed some individuals notified prior to the study period. Nevertheless, this study has shown that only 38% of OST patients were notified with HCV infection and that only 57% of patients treated for HCV were notified. Although notifications rates among treated individuals improved, it is still a concern that one in four individuals treated for HCV remained un-notified towards the end of the study period.

Restricting the study population to individuals notified with HCV infection has limited the sample size and excluded more than 40% of all patients actually treated for HCV. Although most characteristics were similar between notified and un-notified individuals, un-notified patients were on average three years older than notified individuals. This suggests that the linkage to MSIS may have introduced an age-related selection bias, excluding a group of older HCV infected individuals. Treatment uptake in older age groups may therefore have been underestimated. However, this bias has probably not altered the main finding of the study. Cumulative HCV treatment uptake among all OST patients was 9.5%, and assuming 60% HCV RNA prevalence in the ageing OST population [26, 37], this finding would correspond to 16% treatment uptake among all individuals with presumed chronic HCV infection.

The current availability of tolerable, short-duration and highly efficient DAA regimens has led to significant therapeutic optimism with possibilities for broadened treatment uptake and subsequent HCV elimination among PWID [23, 50–52]. Although derived from IFN-based treatment, the findings from this study are highly relevant, providing baseline data on HCV treatment uptake prior to the introduction of DAAs. Collectively, the findings from this study underscore the need for increased awareness for HCV infection in a growing population of PWID including OST patients now being eligible for HCV treatment. The results should inform health political decisions and support improved HCV testing activity and linkage to HCV care among individuals receiving OST. Although treatment uptake is expected to increase, challenges concerning drug pricing and delivery of care will probably remain. Future studies should therefore monitor treatment rates in this population.

In conclusion, this study has shown that HCV treatment uptake among patients who have received OST in Norway was low and stable during the final ten years of the IFN-based treatment era. Although long-term stability in OST might facilitate HCV treatment, the findings from this study highlight the need for improved awareness for HCV infection in this increasingly important target group for HCV treatment.

• Abstract
• Introduction
• Materials and Methods
• Results
• Discussion
• Supporting Information
• Acknowledgments
• Author Contributions
• References

AbbVie's Glecaprevir/Pibrentasvir (G/P) Shows High SVR Rates in Chronic Hepatitis C Patients with Severe Chronic Kidney Disease

AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Shows High SVR Rates in Chronic Hepatitis C Patients with Severe Chronic Kidney Disease

- 98 percent of patients across all major HCV genotypes (GT1-6) with severe chronic kidney disease (CKD), including patients on dialysis, achieved SVR12 with 12 weeks of G/P in the primary intent-to-treat analysis, regardless of previous treatment status or presence of compensated cirrhosis
- 100 percent of patients achieved SVR12 in a modified intent-to-treat analysis
- G/P is an investigational, pan-genotypic, once-daily, ribavirin-free, fixed-dose combination for the treatment of chronic HCV
- Development of new regimens to treat HCV patients with CKD remains a critical unmet medical need across genotypes1

NORTH CHICAGO, IL, USA I November 15, 2016 I AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR12) with its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR12 was achieved in 100 percent (n=102/102) of severe CKD patients; mITT excludes patients who did not achieve SVR for reasons other than virologic failure. These new data from the Phase 3 EXPEDITION-4 study, evaluating patients with chronic HCV infection across all major genotypes (GT1-6) and severe CKD, will be presented as a late-breaker today at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.

The EXPEDITION-4 results are the latest to be released from registrational studies in AbbVie's G/P clinical development program, designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing areas of continued unmet need.

"HCV patients with severe chronic kidney disease present a complex challenge for physicians to treat, particularly as kidney disease progresses, and if the patient has genotype 2 or 3 or has compensated cirrhosis," said Ed Gane, M.D., professor of medicine at the University of Auckland in Auckland, New Zealand. "The results seen in EXPEDITION-4 are a positive development in AbbVie's investigation of the G/P regimen for patients with chronic kidney disease, who currently have limited HCV treatment options."

HCV is common among people with severe CKD, reaching prevalence of up to 80 percent in some regions of the world.2 In the U.S., it is estimated that over 500,000 people have both chronic HCV and CKD.3 Some chronic HCV infected patients with severe CKD, particularly those with GT2 and GT3 HCV infection, currently don't have access to direct-acting antivirals (DAAs). The development of new, safe and effective regimens to treat HCV in these patients remains a critical unmet medical need.1

"With our investigational, pan-genotypic regimen, our goal is to provide a safe and effective cure to patients across genotypes, including patients with severe chronic kidney disease, regardless of previous treatment status or presence of compensated cirrhosis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Our clinical development program reflects our ongoing commitment to addressing treatment areas of continued unmet need."

The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney disease, including 85 patients (82 percent) who were receiving dialysis at enrollment and 20 patients (19 percent) who had compensated cirrhosis. The study also included those who were not cured with previous sofosbuvir (SOF) with ribavirin (RBV) or interferon (IFN) with RBV; with or without SOF (44 patients, 42 percent).

The majority of treatment related adverse events (AEs) were mild or moderate. The most commonly reported AEs included pruritus, fatigue and nausea. Of the 24 percent of patients who experienced serious AEs, none were considered related to G/P. Four AEs (4 percent) led to the discontinuation of G/P and one patient died after achieving SVR4 due to a serious AE (intracerebral hemorrhage) considered not-related to G/P.

*Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

About the EXPEDITION-4 Study

EXPEDITION-4 is a single-arm, open-label, Phase 3 study evaluating the safety and efficacy of 12 weeks of G/P in patients with GT1-6 chronic HCV infection and chronic kidney disease, including those on dialysis. The primary efficacy endpoint is SVR12.

Patients had severe or end stage kidney disease (stage 4 and 5 CKD), with an eGFR < 30 mL/min/1.73 m2 required at screening. Prior treatment in the study is defined as treatment with IFN/pegIFN ± RBV, or SOF + RBV ± pegIFN therapy.

Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov/.

About AbbVie's HCV Clinical Development Program

AbbVie's glecaprevir/pibrentasvir (G/P) clinical development program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing treatment areas of continued unmet need.

G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis.

G/P is an investigational, once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral tablets.

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 American Association for the Study of Liver Diseases. Recommendations for Testing, Managing, and Treating Hepatitis C, February 24, 2016, http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have. Accessed March 15, 2016.
2 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
3 IMS Health, July 2016. Parsippany, NJ; Medivo, July 2016. New York, NY (Estimate based on IMS Health Dx Medical Claims 12/2013-4/2016; IMS Health Life Link Patient Level Data 12/2013-4/2016; Medivo Lab Data 12/2013-4/2016).