Thursday, May 25, 2017

Safe space for illegal drug consumption in Baltimore would save $6 million a year

Safe space for illegal drug consumption in Baltimore would save $6 million a year

Supervised facilities would also save lives, prevent infections and hospitalizations

Johns Hopkins University Bloomberg School of Public Health

A new cost-benefit analysis conducted by the Johns Hopkins Bloomberg School of Public Health and others suggests that $6 million in costs related to the opioid epidemic could be saved each year if a single "safe consumption" space for illicit drug users were opened in Baltimore.

It would also reduce overdose deaths, HIV and hepatitis C infections, overdose-related ambulance calls and hospitalizations - and bring scores of people into treatment, they found.

Carefully monitored "safe consumption" spaces, which are not legal in the United States but have been used in dozens of cities around the world, provide a clean indoor environment in which people can use their own drugs with medical personnel on hand to reverse overdoses should they occur. These facilities serve as access points to substance use disorder treatment and other vital social services for drug users, such as medical care and housing.

The authors of the study, published this month in the Harm Reduction Journal, say that the findings add economic evidence to the body of research that already links such spaces to a reduction in fatal drug overdoses and an increase in people seeking treatment. "Safe consumption" spaces are especially critical right now: Last year, the United States hit a record for the number of people who have died from drug overdose, and fentanyl, a more dangerous and powerful drug than heroin, is increasingly being added to heroin in places like Baltimore.

"No one has ever died from an overdose in a safe consumption space," says the study's senior author, Susan G. Sherman, PhD, MPH, a professor in the Department of Health, Behavior and Society at the Bloomberg School. "Thousands of lives have been saved. There are lots of doors people can walk through when they are addicted to drugs. We want them to walk through a door that may eventually lead to successful treatment - and keep them alive until they are ready for that."

Says Amos Irwin, MA, the study's lead author and program director at the Law Enforcement Action Partnership in Washington, D.C.: "Today, thousands of Baltimoreans are risking their lives to inject drugs instead of seeking treatment. We estimate that more than 100 new people would enter treatment every year if the city had a supervised injection facility. Bringing these people into a safe space actually helps reduce drug use, not increase it."

For their study, the researchers looked at the costs of operating a safe consumption space in Vancouver, the only one in North America. Then they estimated the impact on several health outcomes, based on Baltimore data.

They determined that running a 1,000-square-foot, 13-booth space in Baltimore for 18 hours a day would cost $1.8 million a year. Insite, the Vancouver facility, serves about 2,100 unique individuals a month, who perform roughly 180,000 injections per year in a space the same size.

Based on research done at Insite, they estimate that a Baltimore facility would generate $7.8 million in annual savings, preventing four HIV infections, 21 hepatitis C infections, 374 days in the hospital for skin and soft-tissue infections, six overdose deaths, 108 overdose-related ambulance calls, 78 emergency room visits and 27 overdose-related hospitalizations.

At the same time, an estimated 121 additional people would enter treatment.

"Six million dollars is a lot of money for one facility to save," Irwin says. "It is almost a third of Baltimore City's entire budget for HIV, sexually-transmitted infections and substance abuse treatment and prevention."

A bill allowing safe consumption spaces failed in the Maryland General Assembly this year. Last month, the Massachusetts Medical Society recommended opening safe consumption spaces in that state. These supervised injection facilities are a widely used public health intervention in 11 countries, mostly in Europe.

Sherman says many drug users in Baltimore are injecting on the streets or in abandoned houses, exposing them to possible violence, arrest and overdose death. Safe consumption spaces would provide clinical supervision and a clean environment, and they allow health professionals to connect drug users to critical health services. Such spaces maintain a strict prohibition on drug sharing or selling. These programs are not condoning illicit behavior, she says. They are meeting people where they are and connecting them with lifesaving resources.

The researchers did not estimate how many safe consumption spaces would be needed to service Baltimore's drug using population.

"We know what doesn't work when it comes to the so-called 'War on Drugs' in the United States because we have an opioid epidemic that is only getting worse," Sherman says. "The stakes are even higher now with so much heroin and other drugs adulterated with fentanyl. You can keep doing what you are doing or you can try something that has been proven by evidence and is considered usual care in a dozen nations."

"Mitigating the heroin crisis in Baltimore, MD, USA: a cost-benefit analysis of a hypothetical supervised injection facility" was written by Amos Irwin, Ehsan Jozaghi, Brian W. Weir, Sean T. Allen, Andrew Lindsay and Susan G. Sherman. Other collaborating institutions include the Criminal Justice Policy Foundation and the University of British Columbia.

The research was supported by grants from the National Institutes of Health's National Institute of Allergy and Infectious Diseases (P30AI094189) and the National Institute on Drug Abuse (T32DA007292) as well as Amherst College, the Criminal Justice Policy Foundation, the Law Enforcement Action Partnership and the Canadian Institutes of Health Research Postdoctoral Fellowship.

Evidence-based recommendations on the management of extrahepatic manifestations of chronic hepatitis C virus infection

In Case You Missed It

Journal of Hepatology
June 2017
Volume 66, Issue 6, Pages 1282–1299

Evidence-based recommendations on the management of extrahepatic manifestations of chronic hepatitis C virus infection
Manuel Ramos-Casals, Anna Linda Zignego, Clodoveo Ferri, Pilar Brito-Zerón, Soledad Retamozo, Milvia Casato, Peter Lamprecht, Alessandra Mangia, David Saadoun, Athanasios G. Tzioufas, Zobair M. Younossi, Patrice Cacoub on behalf of the International Study Group of Extrahepatic


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Introduction
The hepatitis C virus (HCV), a linear, single-stranded RNA virus identified in 1989, is a hepatotropic virus that causes liver cirrhosis and hepatocellular cancer and is a global health problem. It is recognized as one of the hepatic viruses most often associated with the development of extrahepatic manifestations (EHMs), which can be classified according to the principal underlying etiopathogenic process (autoimmune, inflammatory, metabolic or neoplastic) [1]. HCV infected patients with extrahepatic involvement require a multidisciplinary approach and a complex therapeutic management.

In the 1990s, various authors described the association between HCV infection with organ damage beyond the liver and a heterogeneous group of extrahepatic conditions including pulmonary fibrosis, cutaneous vasculitis, glomerulonephritis, Mooren ulcer, porphyria cutanea tarda and lichen planus, among others [[2], [3], [4]]. However, it is currently accepted that there is a weak association with some of these features [[1], [5]], and that cryoglobulinemic vasculitis (CV) is the key extrahepatic disease related to chronic HCV infection. There is growing interest in the association with both systemic and organ-specific autoimmune diseases and with the development of neoplastic haematologic processes due to the specific lymphotropism of HCV [[1], [6], [7]].

Currently, there are no international recommendations on the therapeutic management of HCV infected patients with EHMs. The first therapeutic approaches were based on immunosuppressive therapies mirroring the regimens used in non-HCV vasculitides [8]. The introduction of the first antiviral therapies combination (interferon [IFN] alpha and ribavirin [RBV]) clearly improved survival rates[9]. However, this therapeutic approach had limited virological efficacy (eradication <50% for HCV genotype 1), often required several months of therapy and had high rates of intolerance [10]. Direct-acting antiviral (DAA) therapies have recently emerged as a striking therapeutic approach for HCV infection, with a short treatment duration, minimal side effects and efficacy approaching 100% [[11], [12], [13], [14]]. These new drugs are providing the opportunity to effectively cure chronic HCV infection and reduce the burden caused by both the hepatic and extrahepatic complications of HCV, thereby offering hope for a dramatic change in patient outcomes. The objective of this international multidisciplinary consensus is to provide the first set of recommendations on a homogeneous therapeutic approach to HCV infected patients with extrahepatic involvement in the new DAA era.

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Wednesday, May 24, 2017

Indonesian buyers club helps people obtain generic hepatitis C treatment

Indonesian buyers club helps people obtain generic hepatitis C treatment

Liz Highleyman
Published: 24 May 2017
A community-led buyers club in Indonesia has helped more than 100 people get generic direct-acting antiviral (DAA) drugs to treat hepatitis C and is seeing a high cure rate, according to a presentation at the 25th International Harm Reduction Conference (HR17) last week in Montréal.

An estimated 3 million people in Indonesia are living with hepatitis C virus (HCV), according to Sindi Putri of the Indonesia AIDS Coalition (IAC). The number of people who inject drugs is estimated at nearly 106,000, of whom 77% are thought to have hepatitis C. Co-infection with HIV and HCV is common in this population.
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NAM aidsmap
Conference news: HR17
The 25th International Harm Reduction Conference (HR17) was held in Montréal, Canada from 14-17 May.

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HCV generics

Prevalence and economic burden of extrahepatic manifestations of hepatitis C virus are underestimated but can be improved with therapy

Version of Record online: 23 MAY 2017
DOI: 10.1002/hep4.1049

Prevalence and economic burden of extrahepatic manifestations of hepatitis C virus are underestimated but can be improved with therapy
Nancy Reau1,*, Francis Vekeman2, Eric Wu2, Yanjun Bao3 andYuri Sanchez Gonzalez

Links

Abstract
Despite guideline recommendations, access to hepatitis C virus (HCV) treatment is frequently restricted, with some payers approving therapy for only those with advanced disease or cirrhosis. However, delaying potentially curative treatment until the development of advanced liver disease may have costly consequences in terms of both hepatic complications and extrahepatic manifestations (EHMs) of HCV. Using a large claims database from the United States, we measured the risks and medical costs of 20 EHMs and investigated the role of treatment in different stages of liver fibrosis for mitigating the clinical and economic burden of these EHMs. After adjusting for potential confounders, including comorbid liver disease, patients with HCV had a significantly higher risk for any EHM (adjusted odds ratio, 2.23; P < 0.05) and higher EHM-related annual medical costs (adjusted medical cost difference, $6,458; P < 0.05) compared to matched patients without HCV. HCV treatment can offset the higher medical costs in patients with HCV by saving ∼$25,000 in all-cause medical costs per patient per year, with a large proportion attributable to savings in EHM-related medical costs (adjusted cost difference $12,773, P < 0.05). Finally, additional EHM-related medical costs could be saved by initiating HCV therapy in early stage fibrosis as opposed to late-stage fibrosis (adjusted medical cost difference, $10,409; P < 0.05). Conclusion: The clinical and economic burden of EHMs is substantial and can be reduced through viral eradication, especially if treatment is initiated early and not delayed until fibrosis advances. Considering that the wholesale acquisition cost of a 12-week course of therapy ranges from $55,000 to $147,000, the results of the current study suggest the cost of these treatments could be offset within 3 to 6 years by savings in all-cause medical costs. (Hepatology Communications 2017)
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Recommended Reading
A nice collection of review articles on the extrahepatic manifestations of HCV
Published in the March 2017 issue of Journal of Advanced Research

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Article link provided by Henry E. Chang.
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I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C.

U.S. FDA Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated Hepatocellular Carcinoma

U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated Hepatocellular Carcinoma

May 24, 2017 11:15 AM Eastern Daylight Time
PRINCETON, N.J.--()--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy. The FDA granted the application priority review and previously granted Opdivo orphan-drug designation for the treatment of HCC. The FDA action date is September 24, 2017.

“We believe the FDA acceptance of our application for Opdivo with priority review status is an important recognition of the significant unmet need for patients with HCC, which is often diagnosed in the advanced stage when treatment options are limited,” said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb. “We are committed to exploring new treatment options for these patients and look forward to working with the FDA to potentially extend the use of Opdivo as a treatment option in this setting.
  
The submission was based on data from the Phase 1/2 CheckMate -040 study investigating Opdivo in advanced HCC patients with and without hepatitis B virus or hepatitis C virus infections. Data from this study were recently published in The Lancet and will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 during a poster discussion session on June 3, 2017 from 4:45–6:00 PM CDT in Hall D2.

Source - http://www.businesswire.com/news/home/20170524005865/en/U.S.-Food-Drug-Administration-Accepts-Priority-Review

Indian generic version of Sofosbuvir - China captures 12 smugglers

China captures 12 smugglers of Indian pharmaceuticals
Source: Xinhua| 2017-05-24 18:48:38|Editor: ying
CHANGCHUN, May 24 (Xinhua) -- Chinese police have detained 12 people for smuggling and selling Indian-made treatments for hepatitis C and cancer, authorities said Wednesday.

Customs in Changchun, the capital city of China's Jilin Province, obtained information in November 2016 that five online stores may have smuggled Indian-made medications and sold them in China at a high price, according to Xu Zhaosha of Changchun customs
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Of Interest
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

. 2017 May 6; 8(2): 137–146.
Published online 2017 May 6. doi:  10.4292/wjgpt.v8.i2.137

Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting
Huascar Ramos, Pedro Linares, Ester Badia, Isabel Martín, Judith Gómez, Carolina Almohalla, Francisco Jorquera, Sara Calvo, Isidro García, Pilar Conde, Begoña Álvarez, Guillermo Karpman, Sara Lorenzo, Visitación Gozalo, Mónica Vásquez, Diana Joao, Marina de Benito, Lourdes Ruiz, Felipe Jiménez, Federico Sáez-Royuela, and Asociación Castellano y Leonesa de Hepatología (ACyLHE)

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Abstract
AIM
To investigated the real-world effectiveness and safety of various regimens of interferon-free treatments in patients infected with hepatitis C virus (HCV).

METHODS
We performed an observational study to analyze different antiviral treatments administered to 462 HCV-infected patients, of which 56.7% had liver cirrhosis. HCV RNA after 4 wk of treatment and at 12 wk after treatment sustained virologic response (SVR) as well as serious adverse events (SAEs) was analyzed first for the whole cohort and then separately in patients who met or did not meet the inclusion criteria of a clinical trial (CT-met and CT-unmet, respectively).

RESULTS
The most frequently prescribed treatment was simeprevir/sofosbuvir (36.4%), followed by sofosbuvir/ledipasvir (24.9%) and ombitasvir/paritaprevir/ritonavir (r)/dasabuvir (19.9%). Ribavirin (RBV) was administered in 198 patients (42.9%). SVRs occurred in 437/462 patients (94.6%). The SVRs ranged between 93.3% and 100% for genotypes 1-4. SVRs were achieved in 96.2% patients in the CT-met group vs 91.9% patients in the CT-unmet group (P = 0.049). Undetectable HCV RNA at week 4 occurred in 72.9% of the patients. In the univariate analysis, the factors associated with SVRs were lower liver stiffness, absence of cirrhosis, higher platelet count, higher albumin levels, no RBV dose reduction, undetectable HCV RNA at week 4 and CT-met group. In the multivariate analysis, only albumin was an independent predictor of treatment failure (P = 0.04). Eleven patients (2.4%) developed SAEs; 5.2% and 0.7% of the patients in the CT-unmet and CT-met groups, respectively (P = 0.003).

CONCLUSION
A high proportion of patients with HCV infection achieved SVRs. For patients who did not meet the CT criteria, treatment regimens must be optimized.

Keywords: Hepatitis C virus infection, Genotype 1-4, Real world treatment, Direct-acting antiviral agents

Core tip: Our study analyzes the hepatitis C virus (HCV) most common genotypes treatment and all the possible combinations with direct-acting antiviral agents which are nowadays available in our country. We have found sustained virological response rates up to 90%, even in genotypes 1 and 3. The current study analyzes HCV RNA after 4 wk of treatment and 12 and 24 wk after the end of the treatment, as well as the adverse events. We analyze, separately, the patients who meet or do not meet the inclusion criteria of a clinical trial, finding that in this last group the response is lower.


DISCUSSION ONLY
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Our real-world study is representative of monoinfected, non-transplanted patients and the treatment regimens available in Spain in 2015. Because the decision to treat and the choice of treatment were entirely at the discretion of the treating physician and randomization was not possible, this study could not directly compare the effectiveness and safety of the treatment regimens.

In the general cohort, the global efficacy was high (94.6% SVR) and the results were similar to those achieved in the CTs, although almost 60% of the patients had received previous HCV antiviral treatment and more than half had liver cirrhosis.

We found that 0.4% of the subjects who achieved a SVR at week 12 subsequently relapsed at week 24 (did not achieve SVR24), and this percentage was a similar to or even lower than those found in other studies[16,17]. Therefore, this finding confirmed previous results in a real-world setting and showed good concordance between SVRs at week 12 and week 24 based on different new AAD-based regimens, including those with shorter durations and/or with drugs with lower barriers to resistance. However, in our opinion, to definitively determine a “cure” in every patient in clinical practice, a SVR must be confirmed at week 24.

Until now, few real-world setting studies have included results that consider the most frequent genotypes (1 to 4). The most significant study is the US retrospective analysis of data from 17487 patients with genotypes 1 to 4 from the Veterans Affairs (VA) National Healthcare System[18], in which a global SVR of 90.7% was found, which was lower than that in our study. This difference may be linked to early discontinuation of treatment in 4.4% of patients with available SVR data[18].

In our study, albumin was the only independent predictor of a SVR. Other studies[14,18] have also shown that albumin and other variables associated with cirrhosis or worse liver function were related to a lower SVR, thus confirming these findings in a real-world setting and with a wide number of patients and supporting the results of CTs in which patients with a more advanced liver disease have a worse response to treatment.

Most real-world studies reported results in genotype 1 HCV patients[14,19,20]. The SVR rate in our study, which included 362 genotype 1 patients, was 94.5% of the overall genotype 1 patients, which was somewhat higher than previously reported rates (SVRs over 91%), although limited differences were observed among the different DAA combinations, treatment durations and use of RBV. SMV and SOF with or without RBV was the most used treatment in our genotype 1 patients, which was likely because it was the best combination available at the beginning of the study. This treatment was used in 149 of the total genotype 1 patients. Most of these patients had liver cirrhosis and were included in the CT-unmet group because the most severe patients were prioritized. However, these patients achieved a SVR of 93.3%. In other studies with thousands of patients with genotype 1 HCV treated with this regimen, the SVR rates were lower at between 75% and 84%[14,15,21]. The main cause of the differences between our cohort and the others was likely the lower rate of subtype 1a (31.2%) and Q80K variants in our genotype 1 patients. Although these variants were not analyzed in the current study, they appeared in only 2.7% of Spanish genotype 1 patients[22].

Other treatment combinations also showed high rates of SVR in our study; i.e., 95.0% with SOF/LDV and 94.5% with OBV/PTV/r/DSV. These rates were similar to the 92.9% or 92% SVR rates derived from the first regimen presented in two US VA National Healthcare System studies[18,19] and the 94.9% or 95.1% SVR rates achieved with the second regimen in other studies in clinical practice[18,20].

In our cohort, only eleven genotype 2 patients were treated, and all of them achieved a SVR regardless of the treatment regimen used. High rates of SVR with the combination SOF + RBV were more similar to those described in Asian CTs[23] than the SVR of 79.0% or 86.2% achieved in clinical practice in the two VA studies[14,18] or the SVR of 88.2% from the recent analysis of 321 genotype 2 HCV infected HCV-TARGET participants[24]. However, the low number of genotype 2 patients in our study indicate that several of the currently recommended combinations in clinical guidelines, such as SOF and DCV[25] should be favored because they presented 100% SVR rates in all patients.

Patients with HCV genotype 3 are at a higher risk of liver disease progression and hepatocellular carcinoma development[26,27]. However, compared with other HCV genotypes, DAA combinations have lower efficacy against genotype 3 in patients with liver cirrhosis in CTs.

In the current study, the global SVR in patients with genotype 3 HCV infection was 93.3%. In our cohort, 82.2% of patients with this genotype were treated with SOF and DCV, with a global SRV rate of 90.3%-91.9% in patients with liver cirrhosis and 100% without. In others studies in real-world settings, a global SVR of 60%-70% was achieved in genotype 3 infection with SOF plus RBV[18,28]. All these studies had remarkably low rates, which was likely related to the use of combinations that are currently not recommended because of their low efficacy[25].

Patients with HCV genotype 4 infection are poorly represented in pivotal CTs of second-generation DAAs[25] and in most real-world studies. In the VA study, a SVR of 87.6% with SOF and LDV and 96.4% with OBV and PTV/r was achieved in patients with this genotype[18]. In the current study, 44 patients who were HCV genotype 4-infected were treated and the SVR rate was 95% (100% with SOF and LDV, 92.3% with OBV and PTV/r and 94.7% with SMV and SOF).

The week 4 response data were available for almost all patients in the current study. We found that 72.9% of patients had an undetectable HCV RNA at week 4, similar to another analysis[19,29]. In this last real-world setting study, significant SVR rate reductions of 7.1% to 10.5% according to the addition of RBV or not, respectively, were observed in patients who did not have an undetectable HCV RNA at week 4 compared with those with undetectable HCV RNA at week 4, which was similar to the 6% observed in the current study[19]. The clinical implications of this finding on treatment decisions, such as potentially adding RBV or extending the treatment duration based on 4 wk of on-treatment HCV RNA, warrants further study.

Despite the real-world nature of our cohort, which included a higher proportion of elderly patients and many patients with liver cirrhosis, the safety and tolerability of all regimens were good. Discontinuation rates were low (< 1%), which is similar to that of CTs, and there were no deaths during treatment or follow up. In Backus et al[20] higher early discontinuation rates of 5.3% to 15.2% according to the treatment combination were found. In contrast, of the 802 patients in the genotype 1 group from the HCV-TARGET cohort treated with SMV and SOF, the rate of discontinuation for adverse events was only 2%[15].

In patients from the genotype 1 and genotype 3 groups from the HCV-TARGET cohort, the most commonly reported AEs were fatigue and headache, which is consistent with the results presented here[15,28]. However, anemia associated with RBV was less frequent in our study.

Overall, the reported rates of SAEs (2.4%) were similar to those reported in the pivotal CTs and lower than the 5.3% or the 7.3% described in other studies in “real-world”[15,28]. Again, in the three studies, the most frequent SAEs were the same decompensating events. However, in the current study, only seven of 262 cirrhotic patients experienced decompensation.

Because the real-world population is heterogeneous, it is important to investigate the treatment outcomes in patients excluded from CTs. Thus, we divided patients into two groups: Patients who met the requirements to take part in a CT and patients who did not meet these requirements. We found that the CT-unmet patients had lower rates of SVR and higher rates of SAEs, liver decompensation and treatment interruptions than the CT-met patients. Thus, in this group of patients, it might be advisable to conduct a more rigorous follow-up investigation to closely monitor tolerability and optimize treatment regimens.

This study has the usual limitations related to its observational, real-world design and electronic data collection. Resistance testing was not performed; thus, we were unable to assess the impact of this factor. The lack of randomization limited the ability to directly compare treatment groups, which is further compounded by the small number of patients in certain subgroups.

In conclusion, our study confirmed the efficacy and safety data reported in CTs in a cohort of patients with genotypes 1-4 and a wide range of basal characteristics, including a high proportion of patients with advanced fibrosis and treatment experience. Our results confirmed and occasionally improved upon the efficacy and safety results reported in other recently published real-world setting studies with a large number of patients[8,19], and these results are in sharp contrast to the lower SVR rates reported in certain early real-world studies on interferon-free therapy with second generation DAAs[14,15]. Moreover, our results indicate that treatment regimens should be optimized in patients that do not fulfill classical CT inclusion criteria because of their lower rates of SVR and higher rates of SAEs.

Tuesday, May 23, 2017

Treatment challenges fuel the silent hepatitis C epidemic

The Hill
Treatment challenges fuel the silent hepatitis C epidemic
By Dr. Jay C. Butler and Dr. David L. Lakey, opinion contributors -


The United States has reached a critical point in the hepatitis C epidemic: the virus affects at least 3.5 million Americans. Chronic hepatitis C infection is now the leading cause of liver cancer and it causes more deaths than any other blood-borne infectious disease. Untreated, the virus can destroy the liver’s ability to filter blood and produce proteins that protect our bodies from infection.
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Treatment with generic ledipasvir-sofosbuvir for 8 to 12 weeks was affective in Chinese patients with HCV genotype 1b

In the Journals
Generic ledipasvir-sofosbuvir achieved SVR12 in HCV genotype 1b

May 23, 2017
Healio
Treatment with generic ledipasvir-sofosbuvir for 8 to 12 weeks was affective in Chinese patients with hepatitis C genotype 1b, according to a recently published study.

“Genotype 1 is the most common in China, as it accounts for 58.4% of all HCV-infected persons, principally genotype 1b,” the researchers wrote. “As an eliminator of HCV and a leader of direct-acting antiviral agents (DAAs), sofosbuvir has revolutionized the treatment of [chronic hepatitis C] since 2013. However, brand name DAAs are unaffordable. Fortunately, Gilead Sciences ... approved generic ledipasvir-sofosbuvir with a very low price in many neighboring countries of China, and patients can go to these countries to purchase the drug and for treatment.”
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Of Interest
The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Updated - HCV Guidance website

In Case You Missed It
Updated Thursday, April 27, 2017



Guidelines
HCV Guidelines
The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) with the International Antiviral Society developed a living document with ever evolving guidelines to treat HCV.
Homepage - HCV Guidelines

Stay current with all guideline updates, click here.

What’s New and Updates/Changes
This version of the Guidance has been updated to reflect several key developments as indicated below. Updated references have been provided throughout the Guidance.

Global Changes Occurring throughout the document:
  • RAV changed to RAS
  • Standardized renal function parameter from CrCI to eGFR
     
Initial Treatment:
Retreatment:
Decompensated:
Renal:
Upcoming Updates:
  • Guidance will be forthcoming regarding treatment of adolescents living with chronic HCV given recent FDA-approvals

Living with Hepatitis C Virus: Misinformation appears to be the underlying cause of this stigma

Canadian Journal of Gastroenterology and Hepatology
Volume 2017 (2017), Article ID 3268650
11 pageshttps://doi.org/10.1155/2017/3268650

Review Article Living with Hepatitis C Virus: A Systematic Review and Narrative Synthesis of Qualitative Literature
Laura E. Dowsett,1,2 Stephanie Coward,1,2 Diane L. Lorenzetti,1,2,3 Gail MacKean,1,2 and Fiona Clement1,2

Received 21 November 2016; Accepted 20 March 2017; Published 26 April 2017

Abstract
Background and Aims. The lived experience of HCV has not been well documented in the literature. The aim of this systematic review was to understand the experiences of living with Hepatitis C Virus (HCV). Methods. Five databases were searched from inception until January 19, 2015. Studies were included if they focused on adults diagnosed with HCV; reported experience living with HCV; and described original research. Results. 46 studies were included. Studies found that participants had reduced quality of life due to physical symptoms. Due to physical symptoms and discrimination, many participants switched to part-time work or quit their jobs. Many individuals reported negative experiences with the healthcare system; themes of feeling unsupported, not having adequate information, and not feeling involved in decisions were reported. Stigma significantly impacted those living with HCV. Conclusions. Published literature indicates that those with HCV often feel stigmatized and unsupported in their care, relationships, and work environments, while simultaneously coping with physical and psychological symptoms. This synthesis points to areas where greater education, compassion, and patient-centered healthcare could improve the experience of people living with HCV.

Discussion Only
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A sizeable body of qualitative research was found that explored people’s experiences of living with HCV, many of which included people’s experiences with the healthcare system. Although the studies included a variety of population groups, common themes emerged which focused on the varying ways in which being diagnosed with and living with HCV affected people’s quality of life. Both living with the symptoms of HCV and being diagnosed with HCV contributed to the impact that HCV had on people’s lives.

For example, the stigma associated with being diagnosed with HCV affected people’s careers, relationships, and experiences with the healthcare system, as did the physical and mental health symptoms associated with HCV (e.g., fatigue, weakness, nausea, pain, depression, and anxiety).

Study participants also described having a reduced quality of life due to HCV symptoms, such as fatigue, pain, nausea, and psychological changes. Although often seen as an asymptomatic disease, these studies found that the symptoms of HCV result in considerable disruption to daily living. Three studies investigated the impact of HCV on one’s career and found that, due to physical symptoms and discrimination, many participants switched to part-time work, quit their jobs, or changed employment sectors. Additionally, the published literature suggests that, for some, an HCV diagnosis strengthened their personal relationships, while, for others, it weakened relationships; symptoms of HCV (whether physical or emotional) and fear of transmission were the factors most cited for contributing to deteriorating relationships. These findings are important as they underscore that while no clinically relevant symptoms may be present, HCV can still substantially impact a patient’s life.

Very few of these study participants with HCV reported positive experiences with the healthcare system. Themes of not feeling supported, stigma, not being given adequate information, and not feeling involved in decision-making were frequent in the literature. Although these represent only a small sample of individuals with HCV who interact with healthcare, these finding were generally consistent across studies, and may help practitioners better recognize the specific needs of patients with HCV. Poor experiences with diagnosis and treatment highlight the need for patient-centered care, with a focus on supporting and educating patients with HCV. For example, offering HCV education sessions to newly diagnosed patients may help patients feel more supported within the healthcare system.

Stigma significantly impacted those with HCV.
Two contributing factors to HCV related stigma were consistently identified: fear of transmission and association with injection drug use or risky behaviour.

Misinformation appears to be the underlying cause of this stigma.
It is likely that education, within the healthcare system, for family and friends of individuals diagnosed with HCV, and public education may reduce the stigma associated with HCV. Knowledge about the causes of HCV, as well as transmission mechanisms and transmission patterns, may reduce the feelings of stigmatization felt by those diagnosed and, in turn, may have positive implications such as more interest in being tested for HCV, increased disclosure, and improved quality of life.

At the time of diagnosis, individuals can experience feelings of distress, shame, unconcern, and relief. While most experience a feeling of shock, those who are current drug users are often not surprised and see diagnosis as inevitable. Awareness of these poor experiences with diagnosis may help illuminate areas where diagnosis communication can be improved; confusion, inadequate information, diagnosis over a phone, and diagnosis in an institutional setting all lead to feelings of dissatisfaction among those with HCV. These findings should be taken into account when considering how, where, and by whom HCV screening should be done.

Two limitations of this synthesis are as follows: non-English language studies were excluded and nearly all of the included studies were conducted in English speaking countries, with a large number being completed in Australia and the UK. Two strengths are as follows: a range of countries and a variety of populations were represented in this synthesis, and there was a lot of consistency across the studies. This means that the themes identified here are likely to be transferable to similar contexts.

Additionally, by its nature, this body of literature is difficult to synthesize; there is significant heterogeneity within the studies that have been included due to the variety of at-risk population categories, the diversity of topics explored in each paper, and the vast number of experiences captured by the included papers. Although organized by theme, this systematic review does not intend to suggest that the experiences across all populations (e.g., injection drug users and general population) are the same. However, remarkable consistency of themes across all studies does suggest that different populations may have similar experiences with HCV.

Continue reading.....

Monday, May 22, 2017

Hepatologist who prescribed $22 million worth of hepatitis C treatments said, “I think about taking care of the patients. Should I not take care of the patients because the cost is expensive?”

Clinical Gastroenterology and Hepatology
June 2017 Volume 15, Issue 6, Pages 838–840
DOI: http://dx.doi.org/10.1016/j.cgh.2017.02.026

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Cost-Effective but Bad for Health? Hepatitis C Treatment Moral Hazard, and Opportunity Cost
John B. Wong, MD , Joshua T. Cohen, PhD Division of Clinical Decision Making, Department of Medicine, Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies and Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts

Since the Food and Drug Administration approval of sofosbuvir in 2013, the initial hue and cry over the $1000 pill, once deafening with congressional hearings, insurance restrictions, and patient advocacy, now has diminished through negotiated confidential discounts and with the approval of additional direct-acting antivirals (DAAs). In this issue of Clinical Gastroenterology and Hepatology, a study by Chhatwal et al1 showed how these discounts would affect published cost-effectiveness analyses for treating hepatitis C patients infected with genotype 1.

Health economists have long promoted the idea that using cost effectiveness to guide health care spending would maximize population health. The idea is straightforward. Cost effectiveness quantifies a new therapy’s value compared with current standard care as the ratio of the new therapy’s incremental or additional cost to its incremental health benefits (measured in terms of life-years or quality-adjusted life-years [QALYs]). By standardizing the effectiveness outcome measure as QALYs, cost-effectiveness analysis uses a common metric to help stakeholders assess whether an intervention confers sufficient benefit (improved survival and quality of life) to justify its cost. The incremental cost-effectiveness ratio (ICER) is essentially the price paid for health gains. A low ratio is favorable because it means that the new intervention incurs only a small cost for each life-year or QALY added.

The idea behind cost effectiveness is that we should implement the most favorable cost-effective interventions first, followed by the somewhat less favorable cost-effective interventions, and so on, until we run out of health care resources. Mathematicians have shown (and intuition suggests) that this approach maximizes health gains achievable with a constrained fixed budget. As a short cut, we can choose a cost-effectiveness threshold (eg, a maximum price of $100,000 per QALY gained) and implement only those interventions with cost-effectiveness ratios that are less than the threshold of societal willingness to pay for health gains.

The Chhatwal et al1 systematic review identified 24 studies from 11 countries involving combinations of 11 drugs. Appendix Table 2 in Chhatwal et al1 lists all 170 ICERs for the primary intervention vs the comparator using the DAA cost as published. When examining just the 89 ICERs for second-generation DAAs, 63% had published ICERs that were less than $100,000 per QALY gained,2 making them favorably cost effective at this threshold, and 35% reported ICERS that were cost-saving, which is even better than cost effective because the second-generation DAAs improved health (added QALYs) and reduced the overall lifetime cost of treatment and disease. When assuming a DAA cost of $60,000, the proportion of cost-saving ICERs increased to 71%. Of course, applying a realistic price places the analysis at odds with the methodologic reference case recommendations of the Panel on Cost-Effectiveness in Health and Medicine,3 which advised using average wholesale prices (eg, $94,500 for sofosbuvir and ledipisvir) to encourage comparability across economic analyses.

Paradoxically, despite favorability, spending money on these medications, even with the specified price limits, could make population health worse. How can that be? To understand the impact of channeling resources to new hepatitis C antivirals, we need to examine where those resources come from and hence what benefits are being displaced—that is, what economists call the opportunity cost.4 At the extreme, treating 2 to 3 million US hepatitis C patients with sofosbuvir would incur costs approximating annual US expenditures on all drugs,5, 6 so, hypothetically, assuming a fixed drug budget, the benefit of treating all hepatitis C patients would displace the benefits of all other drugs. This trade-off holds even if antivirals are cost-saving because the health care system incurs DAA costs now and accrues savings associated with reduced expensive and life-shortening complications only in the future.

What about other solutions such as treating the neediest patients? The problem is that even just treating the 50% of patients with hepatitis C who have been identified7 would increase total drug expenditures by half. Moreover, implementing targeted treatment is challenging.8 Because payers reimburse treatment for most patients even if only a subset substantially benefits, the therapy’s true price is invisible to most patients. Moreover, clinicians typically focus on maximizing clinical benefits for their patients without regard to cost.9, 10

As one hepatologist who prescribed $22 million worth of hepatitis C treatments said, “I think about taking care of the patients. Should I not take care of the patients because the cost is expensive?”

Thus, not surprisingly, many providers react with hostility when presented with cost-effectiveness analyses.9 Economists refer to the resulting situation as the moral hazard problem: the clinician does not bear the cost of its provision; indeed, they may profit from it. Insurance increases the patient demand for health care (and hence health care expenditures) regardless of health status and possibly reduces patient incentives to follow behaviors that preserve health.4 This does not leave anyone interested in carefully weighing therapeutic costs and benefits, a situation that makes optimal allocation less likely.

To address the resulting budget impact, perhaps health policymakers should cap drug prices. Arguably, the government-maintained monopoly pricing that drug manufacturers enjoy produce profits that are too large. All economists would view selling a product for a price far greater than manufacturing costs as inefficient, or what Joseph Newhouse terms “static inefficiency.”12 Society, however, protects patents to foster research and development that improve health as a societal good. The societal challenge then is to create a system that optimizes “dynamic efficiency,”12 that is, provides enough incentives for research and development, but does not inflate profits inefficiently. Whether current laws achieve a proper balance is hotly debated.

What is clear, however, is that even if drug prices were reduced, challenges would remain. Will we ask clinicians to think not only about maximizing benefit for each of their patients, but also about the balance between cost and benefit? That type of personalized medicine would help society pay for new, innovative treatments and mitigate the budget cuts that hurt others. The Physician Charter on Professionalism promotes “a just distribution of finite resources” so that, “While meeting the needs of individual patients, physicians are required to provide health care that is based on the wise and cost-effective management of limited clinical resources.”13 DeCamp and Riggs14 highlight the tension between obligations to patients and to judicious use of societal resources. They state that trainees should focus on patient welfare as their professional identity, and that they should receive only careful, limited education about “cost-quality trade-offs.”14 Detsky and Naglie9 state that it is probably inappropriate for clinicians to consider cost effectiveness in individual patient care.

Ultimately, we cannot avoid grappling with opportunity costs and moral hazard. Because preserving drug innovation is costly, finding a way to pay those costs must be part of the solution. Even with drug price limits, we still would have to think about how we pay for new therapies and whether the opportunity cost resulting from the displacement of other medical care would be worthwhile. Optimally, we would fund new and improved therapies by defunding those therapies that deliver the least clinical value relative to their cost. Stopping even inefficient or ineffective therapy, however, is politically and clinically difficult,15 so the prospects here are limited.

Clinical practice guidelines seek to optimize patient care, including treatment decisions. The widely adopted method for developing clinical guidelines, called the Grading of Recommendations Assessment, Development, and Evaluation approach, explicitly incorporates resource utilization for alternative treatments in the evidence base for rating the quality of the evidence and the strength of recommendations.16 Unfortunately, this guidance has been implemented inconsistently and to varying extents. Even if evidence-based guideline recommendations were incorporated into routine practice, all guidelines acknowledge the role of clinical judgment when providers apply recommendations to individual patients. Despite a new emphasis on population health and initiatives such as Choosing Wisely, their impact on utilization by providers has been marginal.17, 18

Thus, both policy and provider interventions face challenges. Policy makers should identify and cut low-value health care programs; providers should distinguish patients who should not receive treatment from those who should or could wait. In the quality-improvement literature, an oft-cited quote with unclear attribution is that “Every system is perfectly designed to get the results that it gets.” Plsek19 describes health care as a complex adaptive system that will adjust itself in the presence of appropriate incentives. Epstein et al20 define patient-centered care as the quality of interaction between providers and patients, and they propose it as one such initiative with evidence supporting higher patient satisfaction, quality of care, and health outcomes, and lower health care costs. They advocate for policies that promote engaged and informed patients, receptive and responsive health professionals, and a health care environment supportive of these efforts. With health care expenditures now more than one-sixth of the US economy, the question is not just whether cost-effectiveness analysis finally will be used to inform health policy,21, 22 but also whether decision makers and clinicians will make the hard choices needed to best promote population health.

References
  1. 1Chhatwal, J., He, T., Hur, C. et al. Direct-acting antiviral agents for patients with hepatitis C virus genotype 1 infection are cost-saving. Clin Gastroenterol Hepatol. 2017; 15: 827–837
  2. 2Neumann, P.J., Cohen, J.T., and Weinstein, M.C. Updating cost-effectiveness–the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014; 371: 796–797
  3. 3Gold, M.R., Siegel, J.E., Russell, L.B. et al. Cost-effectiveness in health and medicine. Oxford University Press, New York; 1996
  4. 4Fuchs, V.R. Major concepts of health care economics. Ann Intern Med. 2015; 162: 380–383
  5. 5Senior, M. Sovaldi makes blockbuster history, ignites drug pricing unrest. Nat Biotechnol. 2014; 32: 501–502
  6. 6Sussman, N.L., Remien, C.H., and Kanwal, F. The end of hepatitis C. Clin Gastroenterol Hepatol. 2014; 12: 533–536
  7. 7Holmberg, S.D., Spradling, P.R., Moorman, A.C. et al. Hepatitis C in the United States. N Engl J Med. 2013; 368: 1859–1861
  8. 8Lo Re, V. 3rd, Gowda, C., Urick, P.N. et al. Disparities in absolute denial of modern hepatitis C therapy by type of insurance. Clin Gastroenterol Hepatol. 2016; 14: 1035–1043
  9. 9Detsky, A.S. and Naglie, I.G. A clinician's guide to cost-effectiveness analysis. Ann Intern Med. 1990; 113: 147–154
  10. 10Muir, A.J. and Naggie, S. Hepatitis C virus treatment: is it possible to cure all hepatitis C virus patients?. Clin Gastroenterol Hepatol. 2015; 13: 2166–2172
  11. 11Ornstein, C. The cost of a cure: Medicare spent $4.5 billion on new hepatitis C drugs last year. ProPublica, New York; 2015
  12. 12Reinhardt, U.E. The dollar value of an extra year of life. Economix. New York Times, New York; 2014
  13. 13American Board of Internal Medicine Foundation. Physician charter. ABIM Foundation, Philadelphia; 2005
  14. 14DeCamp, M. and Riggs, K.R. Navigating ethical tensions in high-value care education. JAMA. 2016; 316: 2189–2190
  15. 15Ubel, P.A. and Asch, D.A. Creating value in health by understanding and overcoming resistance to de-innovation. Health Aff (Millwood). 2015; 34: 239–244
  16. 16Brunetti, M., Shemilt, I., Pregno, S. et al. GRADE guidelines: 10. Considering resource use and rating the quality of economic evidence. J Clin Epidemiol. 2013; 66: 140–150
  17. 17Rosenberg, A., Agiro, A., Gottlieb, M. et al. Early trends among seven recommendations from the Choosing Wisely campaign. JAMA Intern Med. 2015; 175: 1913–1920
  18. 18Naik, A.D., Hinojosa-Lindsey, M., Arney, J. et al. Choosing Wisely and the perceived drivers of endoscopy use. Clin Gastroenterol Hepatol. 2013; 11: 753–755
  19. 19Plsek, P. Innovative thinking for the improvement of medical systems. Ann Intern Med. 1999; 131: 438–444
  20. 20Epstein, R.M., Fiscella, K., Lesser, C.S. et al. Why the nation needs a policy push on patient-centered health care. Health Aff (Millwood). 2010; 29: 1489–1495
  21. 21Weinstein, M.C. and Stason, W.B. Hypertension: a policy perspective. Harvard University Press, Cambridge; 1976
  22. 22Wong, J.B., Mulrow, C., and Sox, H.C. Health policy and cost-effectiveness analysis: yes we can. Yes we must. Ann Intern Med. 2009; 150: 274–275

May 2017 - Recruiting and upcoming hepatitis C clinical trials 

May 2017 - Recruiting and upcoming hepatitis C clinical trials

This is not a complete list of hepatitis C clinical trials, to find out if a study is enrolling patients in your area please click here.

The clinical trials listed on this page can be found online at ClinicalTrials.gov. A Web site maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

For viral hepatitis clinical trials listed by state visit CenterWatch.
CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties.

HCV Advocate

Clinical Trials Reference Guide
Users can search for a hepatitis C clinical trial by category (genotype), or learn how to evaluate a clinical trial and become familiar with commonly used terms. HCV Advocate offers an easy to navigate HCV Medications Blog as well, organized by HCV genotype.

Recommended Reading
Index of current articles with data about investigational regimens to treat the hepatitis C virus.
This review summarizes the clinical potential of velpatasvir-sofosbuvir, velpatasvir-voxilaprevir-sofosbuvir and glecaprevir-pibrentasvir, discussing key results and future directions.

Helpful Links
Premier Hepatitis C Websites, Blogs and Support Forums

https://clinicaltrials.gov/ct2/results?term=hepatitis+c&Search=Search
____________________________________________
This study is currently recruiting participants
United States Puerto Rico
Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
ClinicalTrials.gov Identifier:
NCT03118843
First received: April 13, 2017
Last updated: May 10, 2017
Last verified: May 2017
The primary objectives of this study are to determine the efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks as measured by the proportion of participants with sustained viral response 12 weeks after cessation of treatment (SVR12) and to evaluate the safety and tolerability of treatment with SOF/VEL/VOX FDC.
____________________________________________
This study is currently recruiting participants
United States, Maryland
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Subjects With Previous DAA Experience

ClinicalTrials.gov Identifier:
NCT02745535
First received: April 11, 2016
Last updated: March 21, 2017
Last verified: March 2017
This study will evaluate the safety, tolerability, and efficacy of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C infection who have failed to eradicate hepatitis C despite previous combination directly acting antiviral therapy.
____________________________________________
This study is currently recruiting participants
United States
ClinicalTrials.gov Identifier:
NCT02994056
First received: December 13, 2016
Last updated: April 17, 2017
Last verified: April 2017
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class C cirrhosis.
____________________________________________
This study is currently recruiting participants
United States Belgium Italy United Kingdom
ClinicalTrials.gov Identifier:
NCT03022981
First received: January 13, 2017
Last updated: May 17, 2017
Last verified: May 2017
This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase.
The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.
The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
____________________________________________
This study is currently recruiting participants
51 Study Locations United States, Australia, Belgium, India, Italy, New Zealand, United Kingdom
Sponsor: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02175758
Purpose
This study will have two parts as follows:
The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively. 
____________________________________________
Recruiting
34 Study Locations United States United Kingdom New Zealand Australia United Kingdom
Sponsor: Gilead Sciences
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/-Ribavirin in Adolescents and Children With Chronic HCV-Infection
ClinicalTrials.gov Identifier: NCT02249182
Purpose
This study will have two parts as follows:
The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofobuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/- Ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV.
____________________________________________
This study is currently recruiting participants
Australia
A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use
ClinicalTrials.gov Identifier:
NCT02336139
First received: January 4, 2015
Last updated: May 15, 2016
Last verified: May 2016
To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.
____________________________________________
This study is currently recruiting participants
Japan
ClinicalTrials.gov Identifier:
NCT02996682
First received: December 15, 2016
Last updated: May 3, 2017
Last verified: May 2017
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic HCV infection and decompensated cirrhosis.
____________________________________________
This study is currently recruiting participants
China Vietnam Thailand Singapore Malaysia
ClinicalTrials.gov Identifier:
NCT02671500
First received: January 29, 2016
Last updated: May 3, 2017
Last verified: May 2017
This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in treatment-naive and treatment-experienced participants with chronic hepatitis C virus (HCV) infection.
____________________________________________
This study is currently recruiting participants
New Zealand
NCT02728206
First received: March 31, 2016
Last updated: March 29, 2017
Last verified: March 2017
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.
____________________________________________
This study is currently recruiting participants
India
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
ClinicalTrials.gov Identifier:
NCT03074331
First received: February 24, 2017
Last updated: May 18, 2017
Last verified: May 2017
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection.
____________________________________________
This study is currently recruiting participants
United States, Nebraska
Sponsor: University of Nebraska
Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics
ClinicalTrials.gov Identifier: NCT02759861
Purpose
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection
____________________________________________
This study is currently recruiting participants
Sponsor: University of Florida
45 study locations in the United States
Sponsor: University of Florida
ClinicalTrials.gov Identifier: NCT02786537
Purpose
Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to learn whether they work equally well under real-world conditions. Phase 2 of this study will begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments. Patients receiving HCV therapy in community and academic clinics will be offered the opportunity to consent to be randomly assigned to one of three regimens and then observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management will be assumed by usual care conditions, and patient-reported outcomes will be collected outside clinic in keeping with pragmatic design principles.
Drug: sofosbuvir/ledipasvir
Drug: ombitasvir/paritaprevir/ritonavir (Phase 1 only)
Drug: elbasvir/grazoprevir
Drug: Dasabuvir
____________________________________________
This study is currently recruiting participants
United States
ClinicalTrials.gov Identifier:
NCT03092375
First received: March 21, 2017
Last updated: May 19, 2017
Last verified: May 2017
The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.
____________________________________________
This study is currently recruiting participants
United States Australia Belgium Canada France  New Zealand Singapore South Africa
ClinicalTrials.gov Identifier:
NCT02966795
First received: November 15, 2016
Last updated: April 14, 2017
Last verified: April 2017
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).
____________________________________________
This study is currently recruiting participants
United States Puerto Rico
ClinicalTrials.gov Identifier:
NCT03067129
First received: February 24, 2017
Last updated: April 28, 2017
Last verified: April 2017
An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir (GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age group and the remainder of participants will be enrolled for the evaluation of safety and efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment, based on available PK and clinical data to achieve therapeutic exposures that have been safe and efficacious in adults.
Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include participants who are in 12 to < 18 years of age who can swallow the adult formulation of GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.
____________________________________________
Expanded access is currently available for this treatment.
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com
Expanded Access to Glecaprevir/ Pibrentasvir
NCT03123965
First received: April 18, 2017
Last updated: NA
Last verified: April 2017
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to glecaprevir/ pibrentasvir prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.
____________________________________________
This study is currently recruiting participants
United States Italy Puerto Rico
ClinicalTrials.gov Identifier:
NCT03089944
First received: March 22, 2017
Last updated: April 28, 2017
____________________________________________
This study is currently recruiting participants
United States Canada Italy Puerto Rico
ClinicalTrials.gov Identifier:
NCT03069365
First received: February 28, 2017
Last updated: April 28, 2017
Last verified: April 2017
This Phase 3b, open-label, non-randomized study will evaluate the efficacy and safety of Glecaprevir/Pibrentasvir (GLE/PIB) for 8, 12, or 16 weeks in in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection with or without compensated liver cirrhosis and with chronic renal impairment in both HCV treatment-naïve and prior treatment-experienced participants.
____________________________________________
This study is not yet open for participant recruitment
France
ClinicalTrials.gov Identifier:
NCT02973503
First received: October 14, 2016
Last updated: November 22, 2016
Last verified: November 2016
A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis
____________________________________________
This study is not yet open for participant recruitment
ClinicalTrials.gov Identifier:
NCT02940691
First received: October 19, 2016
Last updated: October 20, 2016
Last verified: October 2016
This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who inject drugs (PWID) with recent injecting drug use and chronic HCV genotype 1 or 4 infection.
____________________________________________
This study is not yet open for participant recruitment
Sponsor: Fundacion SEIMC-GESIDA
Spain
ClinicalTrials.gov Identifier:
NCT03105349
First received: March 16, 2017
Last updated: April 6, 2017
Last verified: March 2017
This is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the NS5A
____________________________________________
This study is not yet open for participant recruitment
Sponsor: Kirby Institute
Australia Canada New Zealand
NCT03117569
First received: April 7, 2017
Last updated: April 12, 2017
Last verified: April 2017
The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified.
Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification.
Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks.
One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).
____________________________________________
This study is not yet open for participant recruitment
France
ClinicalTrials.gov Identifier:
NCT03111108
First received: April 6, 2017
Last updated: NA
Last verified: March 2017
The purpose of this study was to evaluate the efficacy of each treatment arm using a fixed dose combination (FDC) of EBR/GZR as assessed by the percentage of participants achieving sustained virologic response, defined as HCV ribonucleic acid (RNA) <Lower Limit of Quantitation (LLOQ) 12 weeks after the end of all study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.
____________________________________________
This study is currently recruiting participants
Over 20 study locations in the United States, France, Germany, Spain, Sweden
Sponsor: Merck Sharp & Dohme Corp.
Efficacy and Safety of MK-3682B (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)
ClinicalTrials.gov Identifier: NCT02613403
Purpose
This is a randomized, multicenter, open-label trial of the combination regimen of MK-5172 (grazoprevir [GZR]) (100 mg), MK-3682 (450 mg) and MK-8408 (ruzasvir) (60 mg) for 16 weeks with ribavirin (RBV) or 24 weeks without RBV in cirrhotic (C) or non-cirrhotic (NC) hepatitis C virus (HCV) genotype (GT) 1 or GT3-infected participants who have previously failed a direct-acting antiviral regimen (DAA). The combination regimen will be administered as two fixed-dose combination (FDC) tablets, referred to as MK-3682B, given once-daily.
The study will evaluate the efficacy of the combination regimen of MK-5172 (GZR), MK-3682 and MK-8408 (ruzasvir) with or without ribavirin as assessed by the proportion of participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy.
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This study is currently recruiting participants
United States, Texas, New Zealand
Sponsor: Merck Sharp & Dohme Corp.
Efficacy and Safety of MK-3682 + Ruzasvir (MK-8408) in Treating Hepatitis C Virus Infection Genotypes 1-6 (MK-3682-041)
ClinicalTrials.gov Identifier: NCT02956629
Purpose
This is a nonrandomized, multi-site, open-label trial to evaluate a novel two-drug combination regimen (MK-3682 450 mg + ruzasvir [RZR; MK-8408] 180 mg once daily [q.d.] for 12 weeks) in male and female treatment-naïve (TN) or treatment-experienced (TE) participants with chronic hepatitis C virus (HCV) infection genotype (GT) GT1, GT2, GT3, GT4, GT5, or GT6 who have not previously received HCV direct-acting antiviral (DAA) therapy. Cirrhotic (C) and non-cirrhotic (NC) participants with and without human immunodeficiency virus (HIV) co-infection will be enrolled.

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