Free medication for Hepatitis C - Icelandic state will provide medication for 1200 people

Politics and Society | Iceland Monitor

Wed 7 Oct 2015

Free medication for Hepatitis C

Over 1,000 patients suffering from Hepatitis C will be receiving free medication to treat the disease according to a new healthcare campaign announced by Minister for Health, Kristján Þór Júlíusson today.

Today, the government announced that they will be making a contract with pharmaceutical company Gilead, which will provide the Icelandic state with medication for Hepatitis C for 1200 people. Instead the Icelandic healthcare system will research the effects of the medication on patients. Also, everyone who has been diagnosed with the virus in Iceland will receive education, treatment and follow-up treatment. There are approximately 1,000 individuals in Iceland today who have Hepatitis C, which can be treated with appropriate medication. If left untreated, the disease can cause serious harm to the liver.

"This news means that everyone in Iceland diagnosed with the disease can receive treatment. Research shows that treatment with new and powerful drugs will help almost everyone to recover," said Dr. Sigurður Ólafsson at the department of liver diseases at the National University Hospital. He adds that by treating such a large number of patients they hope to prevent the disease form spreading further in Iceland.

Source

http://icelandmonitor.mbl.is/news/politics_and_society/2015/10/07/free_medication_for_hepatitis_c/

Australia could be world leader in Hepatitis C treatment: experts

Australia could be world leader in Hepatitis C treatment: experts

Listen here

Medical specialists and community groups have gathered in Sydney to discuss ways to reduce the death rates, as Penny Timms reports.

ANNIE MADDEN: We've seen an almost 150 per cent increase in the death rate from hepatitis C in the last 10 years. So that is obviously extremely concerning and something that we need to halt.

And we do have very good, very effective treatment that are available to us to address this issue. And the biggest issues are around barriers to getting access to those treatments in an affordable way, and also issues for stigma and discrimination for the groups most affected.....

Source - The World Today

Oct 7 

The World Today is a comprehensive current affairs program which backgrounds, analyses, interprets and encourages debate on events and issues of interest and importance to all Australians.

FDA approved revisions to the Olysio (simeprevir) label to include dosing recommendations for the treatment of HCV/HIV-1 coinfection and to expand the indications and usage to include genotype 4 infection.

On October 5, 2015 FDA approved revisions to the Olysio (simeprevir) label to include dosing recommendations for the treatment of HCV/HIV-1 coinfection and to expand the indications and usage to include genotype 4 infection.

The recommended dosage regimens and treatment duration for genotype 1 and HCV/HIV-1 co-infected patients was added to the following table:

Table 1: Recommended Dosage Regimens and Treatment Duration for OLYSIO, Peg IFN alfa, and RBV Combination Therapy for Treatment of CHC Infection in HCV Genotype 1 or 4 Mono infected and HCV/HIV 1  Co infected Patients
Patient Population	Treatment Regimen and Duration
Treatment naïve patients and prior relapsers*
with or without cirrhosis, who are not co infected with HIV	12 weeks of OLYSIO in combination with Peg IFN alfa and RBV followed by an additional 12 weeks of Peg IFN alfa and RBV (total treatment duration of 24 weeks)†
without cirrhosis, who are co infected with HIV
with cirrhosis, who are co infected with HIV	12 weeks of OLYSIO in combination with Peg-IFN-alfa and RBV followed by an additional 36 weeks of Peg IFN alfa and RBV (total treatment duration of 48 weeks)†
Prior non responders (including partial‡ and null responders#), with or without cirrhosis, with or without HIV co infection	12 weeks of OLYSIO in combination with Peg-IFN-alfa and RBV followed by an additional 36 weeks of Peg IFN alfa and RBV (total treatment duration of 48 weeks)†

†HIV = human immunodeficiency virus.
* Prior relapser: HCV RNA not detected at the end of prior IFN based therapy and HCV RNA detected during follow up [see Clinical Studies (14)].
‡† Recommended duration of treatment if patient does not meet stopping rules (see Table 3).
#‡ Prior partial responder: prior on-treatment ≥ 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 and HCV RNA detected at end of prior IFN based therapy [see Clinical Studies (14)].
§# Prior null responder: prior on treatment < 2 log10 reduction in HCV RNA from baseline at Week 12 during prior IFN based therapy [see Clinical Studies (14)].

Section 6 Adverse Reactions was updated with the following information.

OLYSIO in combination with Peg IFN alfa and RBV was studied in 106 subjects with HCV genotype 1/HIV 1 co infection. The safety profile in HCV/HIV co-infected subjects was generally comparable to HCV mono infected subjects.

OLYSIO in combination with Peg IFN alfa and RBV was studied in 107 subjects with HCV genotype 4 infection. The safety profile of OLYSIO in subjects with HCV genotype 4 infection was comparable to subjects with HCV genotype 1 infection.

Azithromycin, bedaquiline and dolutegravir were added to the list of drugs without clinically significant interactions with OLYSIO (see section 7.4 of the label).

Section 12.3 Pharmacokinetics was updated to include the following statements.

Patients co infected with HIV 1

Simeprevir exposures were slightly lower in subjects with HCV genotype 1 infection with HIV 1 co infection compared to subjects with HCV genotype 1 mono infection. This difference is not considered to be clinically meaningful.

Section 12.4 Microbiology was updated to include data on genotype 4 as follows:

Chimeric replicons carrying NS3 sequences derived from HCV protease inhibitor treatment naïve genotype 4a-, 4d-, or 4r infected patients displayed median FC in EC50 values of 0.5 (IQR: 0.4 to 0.6; N=38), 0.4 (IQR: 0.2 to 0.5; N=24), and 1.6 (IQR: 0.7 to 4.5; N=8), compared to reference genotype 1b replicon, respectively. A pooled analysis of chimeric replicons carrying the NS3 sequences from HCV protease inhibitor naïve patients infected with other HCV genotype 4 subtypes, including 4c (N=1), 4e (N=2), 4f (N=3), 4h (N=3), 4k (N=1), 4o (N=2), 4q (N=2), or unidentified subtype (N=7) displayed a median FC in EC50 value of 0.7 (IQR: 0.5 to 1.1; N=21) compared to reference genotype 1b replicon.

In the RESTORE trial in genotype 4 infected subjects, 30 out of 34 (88%) subjects who did not achieve SVR had emerging amino acid substitutions at NS3 positions Q80, T122, R155, A156 and/or D168 (mainly substitutions at position D168; 26 out of 34 [76%] subjects), similar to the emerging amino acid substitutions observed in genotype 1 infected subjects.

Table 11: SVR12 Rates by IL28B rs12979860 Genotype in Adult Patients Receiving OLYSIO 150 mg Once Daily in Combination with Peg IFN alfa and RBV (Trials C212 and RESTORE)
Trial (Population)	IL28B  rs12979860  Genotype	Treatment- Naïve  Subjects % (n/N)	Prior  Relapsers % (n/N)	Prior Partial Responders % (n/N)	Prior Null Responders % (n/N)
C212 (HIV 1 co infection)	C/C	100 (15/15)	100 (7/7)	100 (1/1)	80 (4/5)
	C/T	70 (19/27)	100 (6/6)	71 (5/7)	53 (10/19)
	T/T	80 (8/10)	0 (0/2)	50 (1/2)	50 (2/4)
RESTORE (HCV genotype 4)	C/C	100 (7/7)	100 (1/1)	-	-
	C/T	82 (14/17)	82 (14/17)	60 (3/5)	41 (9/22)
	T/T	0 (8/10)	00 (4/4)	60 (3/5)	39 (77/18)

SVR12: sustained virologic response 12 weeks after planned EOT.

Section 14 Clinical Studies was updated to include the trial results from the HCV/HIV- coinfected trial and the genotype 4 trial.

Subjects with HCV/HIV 1 Co Infection
C212 was an open label, single arm Phase 3 trial in HIV 1 subjects co infected with HCV genotype 1 who were treatment naïve or failed prior HCV therapy with Peg IFN alfa and RBV (including prior relapsers, partial responders or null responders). Non cirrhotic treatment naïve subjects or prior relapsers received 12 weeks of once daily treatment with 150 mg OLYSIO plus Peg IFN alfa 2a and RBV, followed by 12 or 36 weeks of therapy with Peg IFN alfa 2a and RBV in accordance with the protocol defined RGT criteria. Prior non responder subjects (partial and null response) and all cirrhotic subjects (METAVIR fibrosis score F4) received 36 weeks of Peg IFN alfa 2a and RBV after the initial 12 weeks of OLYSIO in combination with Peg IFN alfa 2a and RBV.

The 106 enrolled subjects in the C212 trial had a median age of 48 years (range: 27 to 67 years; with 2% above 65 years); 85% were male; 82% were White, 14% Black or African American, 1% Asian, and 6% Hispanic; 12% had a BMI greater than or equal to 30 kg/m2; 86% had HCV RNA levels greater than 800,000 IU/mL; 68% had METAVIR fibrosis score F0, F1 or F2, 19% METAVIR fibrosis score F3, and 13% METAVIR fibrosis score F4; 82% had HCV genotype 1a, and 17% HCV genotype 1b; 28% of the overall population and 34% of the subjects with genotype 1a had Q80K polymorphism at baseline; 27% had IL28B CC genotype, 56% IL28B CT genotype, and 17% IL28B TT genotype; 50% (n=53) were HCV treatment naïve subjects, 14% (n=15) prior relapsers, 9% (n=10) prior partial responders, and 26% (n=28) prior null responders. Eighty eight percent (n=93) of the subjects were on highly active antiretroviral therapy (HAART), with nucleoside reverse transcriptase inhibitors and the integrase inhibitor raltegravir being the most commonly used HIV antiretroviral. HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors (except rilpivirine) were prohibited from use in this study.

The median baseline HIV 1 RNA levels and CD4+ cell count in subjects not on HAART were 4.18 log10 copies/mL (range: 1.3 4.9 log10 copies/mL) and 677 × 106 cells/L (range: 489 1076 × 106 cells/L), respectively. The median baseline CD4+ cell count in subjects on HAART was 561 × 106 cells/mL (range: 275 1407 × 106 cells/mL).

Table 17 shows the response rates in treatment naïve, prior relapsers, prior partial responders and null responders.

Table 17: Response Rates in Adult Subjects with HCV Genotype 1 Infection and HIV 1 Co Infection (C212 Trial)
Response Rates	Treatment Naïve Subjects N=53 % (n/N)	Prior Relapsers N=15 % (n/N)	Prior Partial Responders N=10 % (n/N)	Prior Null Responders N=28 % (n/N)
Overall SVR12 (genotype 1a and 1b) Genotype 1a Genotype 1b	79 (42/53) 77 (33/43) 90 (9/10)	87 (13/15) 83 (10/12) 100 (3/3)	70 (7/10) 67 (6/9) 100 (1/1)	57 (16/28) 54 (13/24) 75 (3/4)
Outcome for all subjects without SVR12
On treatment failure*	9 (5/53)	0 (0/15)	20 (2/10)	39 (11/28)
Viral relapse†	10 (5/48)	13 (2/15)	0 (0/7)	12 (2/17)

150 mg OLYSIO for 12 weeks with Peg IFN alfa 2a and RBV for 24 or 48 weeks.
* On treatment failure was defined as the proportion of subjects with confirmed detectable HCV RNA at EOT (including but not limited to subjects who met the protocol specified treatment stopping rules and/or experienced viral breakthrough).
† Viral relapse rates are calculated with a denominator of subjects with undetectable HCV RNA at actual EOT and with at least one follow up HCV RNA assessment. Includes one prior null responder who experienced relapse after SVR12.

Eighty nine percent (n=54/61) of the OLYSIO treated treatment naïve subjects and prior relapsers without cirrhosis were eligible for a total treatment duration of 24 weeks. In these subjects, the SVR12 rate was 87%.

Seventy-one percent (n=37/52), 93% (n=14/15), 80% (n=8/10) and 36% (n=10/28) of OLYSIO treated treatment naïve subjects, prior relapsers, prior partial responders and prior null responders had undetectable HCV RNA at week 4 (RVR). In these subjects the SVR12 rates were 89%, 93%, 75% and 90%, respectively.

Table 18 shows the SVR rates by METAVIR fibrosis scores.

Table 18: SVR12 Rates by METAVIR Fibrosis Score in Adult Subjects with HCV Genotype 1 Infection and HIV 1 co Infection (C212 Trial)
Subgroup	Treatment Naïve  Subjects % (n/N)	Prior  Relapsers % (n/N)	Prior Partial Responders % (n/N)	Prior Null Responders % (n/N)
F0 2	89 (24/27)	78 (7/9)	50 (1/2)	57 (4/7)
F3 4	57 (4/7)	100 (2/2)	67 (2/3)	60 (6/10)

Two subjects had HIV virologic failure defined as confirmed HIV 1 RNA ≥ 200 copies/mL after previous < 50 copies/mL; these failures occurred 36 and 48 weeks after end of OLYSIO treatment.

Adult Subjects with HCV Genotype 4 Infection
RESTORE was an open label, single arm Phase 3 trial in subjects with HCV genotype 4 infection who were treatment naïve or failed prior therapy with Peg IFN alfa and RBV (including prior relapsers, partial responders or null responders). Treatment naïve subjects or prior relapsers received once daily treatment with 150 mg OLYSIO plus Peg IFN alfa 2a and RBV for 12 weeks, followed by 12 or 36 weeks of therapy with Peg IFN alfa 2a and RBV in accordance with the protocol defined RGT criteria. Prior non responder subjects (partial and null response) received once daily treatment with 150 mg OLYSIO plus Peg IFN alfa 2a and RBV for 12 weeks, followed by 36 weeks of Peg IFN alfa 2a and RBV.

The 107 enrolled subjects in the RESTORE trial with HCV genotype 4 had a median age of 49 years (range: 27 to 69 years; with 5% above 65 years); 79% were male; 72% were White, 28% Black or African American, and 7% Hispanic; 14% had a BMI greater than or equal to 30 kg/m2; 60% had HCV RNA levels greater than 800,000 IU/mL; 57% had METAVIR fibrosis score F0, F1 or F2, 14% METAVIR fibrosis score F3, and 29% METAVIR fibrosis score F4; 42% had HCV genotype 4a, and 24% had HCV genotype 4d; 8% had IL28B CC genotype, 58% IL28B CT genotype, and 35% IL28B TT genotype; 33% (n=35) were treatment naïve HCV subjects, 21% (n=22) prior relapsers, 9% (n=10) prior partial responders, and 37% (n=40) prior null responders.

Table 19 shows the response rates in treatment naïve, prior relapsers, prior partial responders and null responders. Table 20 shows the SVR rates by METAVIR fibrosis scores.

Table 19: Response Rates in Adult Subjects with HCV Genotype 4 Infection (RESTORE Trial)
Response Rates	Treatment Naïve Subjects N=35 % (n/N)	Prior Relapsers N=22 % (n/N)	Prior Partial Responders N=10 % (n/N)	Prior Null Responders N=40 % (n/N)
Overall SVR12	83 (29/35)	86 (19/22)	60 (6/10)	40 (16/40)
Outcome for all subjects without SVR12
On treatment failure*	9 (3/35)	9 (2/22)	20 (2/10)	45 (18/40)
Viral relapse†	9 (3/35)	5 (1/22)	20 (2/10)	15 (6/40)

150 mg OLYSIO for 12 weeks with Peg IFN alfa 2a and RBV for 24 or 48 weeks.
* On treatment failure was defined as the proportion of subjects with confirmed detectable HCV RNA at EOT (including but not limited to subjects who met the protocol specified treatment stopping rules and/or experienced viral breakthrough).
† Viral relapse rates are calculated with a denominator of subjects with undetectable (or unconfirmed detectable) HCV RNA at actual EOT.

Table 20: SVR12 Rates by METAVIR Fibrosis Score in Adult Subjects with HCV Genotype 4 Infection (RESTORE Trial)
Subgroup	Treatment Naïve Subjects % (n/N)	Prior Relapsers % (n/N)	Prior Partial Responders % (n/N)	Prior Null Responders % (n/N)
F0-2	85 (22/26)	91 (10/11)	100 (5/5)	47 (8/17)
F3-4	78 (7/9)	82 (9/11)	20 (1/5)	35 (7/20)

You will be able to view the complete label at drugs@fda or dailymed.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the Hepatitis Liaison Program visit the FDA Patient Network

U.S. FDA Grants Priority Review For Daklinza (daclatasvir) sNDAs

U.S. FDA Grants Priority Review For Daklinza (daclatasvir) sNDAs

Three applications are under review for Daklinza in combination with sofosbuvir with or without ribavirin to treat chronic hepatitis C patients with decompensated cirrhosis, post-liver transplant recurrence of HCV, and coinfection with HIV-1

Bristol-Myers Squibb’s U.S. registration focus for Daklinza is based on addressing the treatment needs of challenging HCV patient populations

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review three supplemental New Drug Applications (sNDAs) for Daklinza(daclatasvir), an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin. The applications are for the treatment of patients with chronic hepatitis C (HCV) coinfected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.

In the U.S., the FDA grants priority review status when an investigational medicine, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. The FDA will review the three Daklinza sNDAs within a six-month timeframe.

“Hepatitis C is not a one-size-fits-all, monolithic disease. Our focus for the Daklinza-sofosbuvir regimen centers on addressing the needs of HCV patient subpopulations who need new options even in light of the extraordinary advances that have occurred in HCV treatment,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “We look forward to working with the FDA toward the goal of eventually helping many difficult-to-treat HCV patients.”

Daklinza was initially approved in the U.S. in July 2015 and is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. The new sNDAs accepted by the FDA for review include data from the ALLY-1 and ALLY-2 clinical trials. ALLY-2 evaluated the once-daily 12-week combination of Daklinza and sofosbuvir for the treatment of patients with HCV coinfected with HIV-1, a patient population that historically has been challenging to treat, in large part due to the complexities of the overlapping therapeutic regimens used to treat each infection. ALLY-1 evaluated a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with HCV with either advanced cirrhosis or post-liver transplant recurrence of HCV.

In May 2015, Daklinza with sofosbuvir received FDA Breakthrough Therapy Designation for HCV genotype 1 patients with advanced cirrhosis (Child-Pugh Class B or C) and those who develop genotype 1 HCV recurrence post-liver transplant. Breakthrough Therapy Designation, according to the FDA, is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for this designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

About Bristol-Myers Squibb in HCV

Bristol-Myers Squibb’s research efforts are focused on advancing compounds to deliver the most value to HCV patients with high unmet needs. At the core of our portfolio isDaklinza, a NS5A complex inhibitor which continues to be investigated in multiple treatment regimens and in patients with high disease burden.

In July 2014, Japan became the first country in the world to approve the use of a daclatasvir-based regimen for the treatment of chronic HCV. Since then, daclatasvir-based regimens have been approved in more than 50 countries, including the United States, across Europe, and in numerous other countries in Central and South America, the Middle East and the Asia-Pacific region.

Indication and Important Safety Information - Daklinza™ (daclatasvir)

INDICATION

Daklinza™ (daclatasvir) is indicated for use with sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection.

Limitations of Use:
Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving Daklinza in combination with sofosbuvir for 12 weeks.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Drugs Contraindicated with Daklinza: strong inducers of CYP3A that may lead to loss of efficacy of Daklinza include, but are not limited to:
Phenytoin, carbamazepine, rifampin, St. John’s wort (Hypericum perforatum).

WARNINGS and PRECAUTIONS

-- Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Coadministration of Daklinza and other drugs may result in known or potentially significant drug interactions. Interactions may include the loss of therapeutic effect of Daklinza and possible development of resistance, dosage adjustments for other agents or Daklinza, possible clinically significant adverse events from greater exposure for the other agents or Daklinza.
Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone: Post-marketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with sofosbuvir in combination with another direct-acting antiviral, including Daklinza. A fatal cardiac arrest was reported with ledipasvir/sofosbuvir.
Coadministration of amiodarone with Daklinza in combination with sofosbuvir is not recommended. For patients taking amiodarone who have no alternative treatment options, patients should undergo cardiac monitoring, as outlined in Section 5.2 of the prescribing information.
Bradycardia generally resolved after discontinuation of HCV treatment.
Patients also taking beta blockers or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone.

ADVERSE REACTIONS
The most common adverse reactions were (≥ 5%): headache (14%), fatigue (14%), nausea (8%), and diarrhea (5%).

DRUG INTERACTIONS
CYP3A: Daklinza is a substrate. Moderate or strong inducers may decrease plasma levels and effect of Daklinza. Strong inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) may increase plasma levels of Daklinza.
P-gp, OATP 1B1 and 1B3, and BCRP: Daklinza is an inhibitor, and may increase exposure to substrates, potentially increasing or prolonging their adverse effect.

See Section 7 of the Full Prescribing Information for additional established and other potentially significant drug interactions and related dose modification recommendations.

Daklinza in Pregnancy: No data with Daklinza in pregnant women are available to inform a drug-associated risk. Animal studies of Daklinza at exposure above the recommended human dose have shown maternal and embryofetal toxicity. Consider the benefits and risks of Daklinza when prescribing Daklinza to a pregnant woman.

Nursing Mothers: Daklinza was excreted into the milk of lactating rats; it is not known if Daklinza is excreted into human milk. Consider the benefits and risks to the mother and infant when breastfeeding.

Please click here for the Daklinza full prescribing information.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information please visit www.bms.com or follow us on Twitter attwitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Daklinza will be approved for the additional indication mentioned above. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Canadian Leaders Must Work to Eradicate HIV and Hepatitis C

Canadian Leaders Must Work to Eradicate HIV and Hepatitis C

On Oct. 19, voters will decide what kind of Canada they want to live in: one that takes the gold for protecting the health and human rights of all its people, or one that continues to be outperformed.

When it comes to the HIV and hepatitis C (HCV) response, Canada is a laggard both at home and abroad. Major developments in HIV and HCV treatment mean that the lives of thousands of Canadians could be greatly improved and even saved. But those living with HIV and HCV are not being identified or reached effectively to receive treatment, and this treatment is not always available or accessible.

Continue reading...

iPhone app provides a window into patients' real-world experiences with hepatitis C

C Tracker lets hepatitis C patients participate in outcomes research from their iPhone

Boston Children's Hospital

Posted on: 05 Oct 15
C Tracker lets hepatitis C patients participate in outcomes research from their iPhone Research Kit-based app will capture real-world daily impacts of hepatitis C to help drive improvements in treatment

C Tracker is free and available for download on the App Store.

Video



BOSTON, Oct. 5, 2015 /PRNewswire/ -- Boston Children's Hospital and Boston Children's Computational Health Informatics Program (CHIP) are pleased to announce the release of C Tracker, an iPhone app developed using ResearchKit that will let patients living with chronic hepatitis C become active participants in outcomes research, using technology they already have in their pocket.

More than three million Americans suffer from the negative effects of hepatitis C. Highly effective medications for hepatitis C have become available in recent years, but there are only limited data on how patients respond to these drugs in the real world. C Tracker offers an unprecedented opportunity to fill that gap by capturing the daily experiences of hepatitis C patients along the full spectrum of the disease—information that could collectively help drive improvements in treatment.

The app engages populations in hepatitis C studies on a national or international scale, free of the constraints of geography.

"By and large, the data we have now about hepatitis C treatments come from traditional clinical trials," explained Ken Mandl, MD, MPH, director of CHIP, and principal investigator of the C Tracker project. "With C Tracker, we can listen to the patient voice to learn how people live with hepatitis in the real world.

"C Tracker will evaluate the impact of hepatitis C on people's lives in ways we never could before," he added. "It turns research participation into a patient-driven, democratic endeavor."

Patients living with chronic hepatitis C-related liver disease can use C Tracker to track their health, medication use and quality of life over the course of months or years. C Tracker uses Apple's HealthKit to collect a patient's daily activity and other relevant health data with patient permission. The anonymized data will provide a window into patients' real-world experiences with hepatitis C.

Along with C Tracker, the CHIP team has also included a framework, called C3-PRO (Consent, Contact and Community framework for Patient Reported Outcomes) that can connect any Apple ResearchKit app to an open source data platform called i2b2. Already in use across more than a hundred academic medical centers, i2b2 lets centers analyze and share clinical data for research.

"ResearchKit makes it simple to create easy to use research apps that allow us to take research out of the clinic to where patients are," said Pascal Pfiffner, MD, PhD, a postdoctoral fellow in CHIP and lead software developer of C Tracker. "C3-PRO seamlessly integrates data collected from ResearchKit apps with data from the care delivery system."

"Traditional clinical trials are plagued by abysmal accrual rates, slowing progress in discovering cures," Mandl said. "We foresee a future where ResearchKit apps like C Tracker lower the barrier to participation and speed medical progress."

C Tracker is free and available for download on the App Store.

To learn more about C Tracker, visit c-tracker.org.

More: http://www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID=133315#.VhKDGflViko#ixzz3nhbe4b79

New HCV NS5A inhibitor EDP-239 looks good in early studies, more evidence supports early hepatitis C treatment

New HCV NS5A inhibitor EDP-239 looks good in early studies, more evidence supports early hepatitis C treatment

Liz Highleyman
Produced in collaboration with hivandhepatitis.com
Published: 05 October 2015

A new hepatitis C virus (HCV) NS5A inhibitor being developed by Enanta – EDP-239 – was well-tolerated and demonstrated promising antiviral activity against genotype 1 HCV in a single-dose monotherapy study presented at the 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) last week in San Diego, USA. Other researchers reported that HCV co-infection and progressive liver disease contribute to mortality among people with HIV, offering further evidence in support of prompt hepatitis C treatment.

Continue reading...

Hepatitis C Untreated- NYU Researchers Find Serious Liver Damage in Mid- to Late-Adulthood Among People Who Inject Drugs

NYU Researchers Find Development of Serious Liver Damage in Mid- to Late-Adulthood Among People Who Inject Drugs Untreated With Hepatitis C

October 5, 2015

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.

“Understanding HCV disease progression rates among people who inject drugs (PWID) is important to setting policy to expand access to detection, diagnosis and treatment, and in forecasting the burden of disease,” said Holly Hagan, PhD, the principal investigator for the HCV Synthesis Project, who also is a professor at New York University College of Nursing (NYUCN) and co-director at CDUHR. “In this study we synthesized existing data on the natural history of HCV among PWID, including fibrosis progression rates and the incidence of compensated cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma.”

Among the PWID, the mean age they acquired HCV was 21 years, and the mean duration of infection was 14 years. “Based on our analysis of fibrosis progression, PWID, on average, will have moderate liver fibrosis between 26–38 years after HCV infection and will develop cirrhosis within 34–46 years,” said Dr. Hagan. “In the course of the disease progression, cirrhosis may lead to HCC, the prognosis for which is extremely poor—the median length of survival is approximately 12–15 months. Since PWID tend to be infected at an early age, they are likely to develop HCC in mid- to late-adulthood, resulting in losses of individuals in their most productive period of life.”

Given their findings, the researchers note the health-related benefits of early engagement, especially since the new HCV treatments feature shorter drug regimens that are very likely to result in cure. However, such options are expensive and their eligibility guidelines may explicitly exclude active drug users. Furthermore, many public insurance programs in the United States, such as Medicaid, have restricted coverage of these new treatments to those in the more advanced stages of the disease.

“These limitations may delay treatment for years and, thus, will disproportionately affect PWID and other low-income patients,” said Dr. Hagan. “These restrictions also are in conflict with new HCV treatment guidelines from the American Association for the Study of Liver Disease (2015), which explicitly state that active injection drug users should be prioritized for treatment in part because of the risk of transmission to susceptible injection partners.”

Dr. Hagan and the team of NYU researchers hope that by providing a better understanding of HCV progression rates among PWID, they can help inform policy to expand access to detection, diagnosis, and treatment. However, Dr. Hagan emphasized that there is a clear need for further study into the impact of alcohol consumption and other factors on disease development in PWID, as there are few studies that consistently report this information. Dr. Hagan added: “Unfortunately, the restrictions on HCV treatment force us to identify other ways to slow disease progression.”

Researcher Affiliations: Daniel J. Smith a; Joan Combellick a; Ashly E. Jordan a,b; Holly Hagan a,b.

a. College of Nursing, New York University, NY, NY, USA

b. Center for Drug Use and HIV Research, New York University, NY, NY, USA

Acknowledgements: The authors of this study gratefully acknowledge Dr. Jason Fletcher for his statistical assistance. This study was supported by the National Institutes of Health, grant numbers 1R01DA034637 and P30DA011041.