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Post Info TOPIC: Healio/HCV Updates
Tig


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HCV vaccine regimen fails to prevent chronic infections

October 5, 2019

Andrea L. Cox, MD, PhD

WASHINGTON — An investigational vaccine regimen failed to prevent chronic hepatitis C virus infection in a cohort of at-risk adults, according to results of a clinical trial presented at IDWeek.

Recently, study findings published in The Lancet suggested the WHO goal to eliminate HCV globally by 2030 will be “narrowly missed.” A vaccine, researchers said, will be crucial to elimination efforts.

Andrea L. Cox, MD, PhD, a professor of medicine at Johns Hopkins University, and colleagues conducted the first prophylactic HCV vaccine efficacy trial — a randomized, multicenter, double-blind, placebo-controlled study called Vaccine is Prevention. The vaccine regimen is based on viral vectors, consisting of a recombinant chimpanzee adenovirus 3 vector vaccine prime followed by a recombinant modified vaccinia Ankara virus boost. In the study, 455 participants aged 18 to 45 years who injected drugs received either the vaccine regimen or placebo at days 0 and 56.

The study took place at three sites in the United States — the University of California, San Francisco, Johns Hopkins and the University of New Mexico, Cox said.

According to the researchers, the overall incidence of HCV infection at 6 months was 13 infections per 100 person-years. This is substantially lower than the incidence in the background populations of the study sites, Cox said, probably because of “aggressive counseling and referral to drug treatment and needle exchange programs” during the trial.

Cox and colleagues found no difference in the development of chronic infection between the vaccine and placebo arms, with 14 cases in each. The regimen’s efficacy in preventing chronic infection was –0.53 (95% CI, –2.5 to 0.34).

However, the vaccine regimen blunted the peak HCV RNA level in recipients 1 month after vaccination compared with placebo — a statistically significant finding, Cox noted. In terms of immunogenicity, the vaccine regimen induced an immune response in 78% of recipients, which is a less robust response that what was observed in an earlier study of healthy volunteers, she said.

According to the researchers, there were no safety signals in the study, and the regimen was well-tolerated, with no serious vaccine-related adverse events.

“There remains a significant need for vaccine to interrupt transmission, and it will be critical for achieving WHO elimination goals,” Cox said. “Testing vaccines in [people who inject drugs] is possible, but additional strategies will need to be considered — ideally, with information gained from this vaccine, informing future vaccine design.” – by John Schoen

References:

Cox AL, et al. Abstract LB10. Presented at: IDWeek; Oct. 2-6, 2019; Washington.

Heffernan A, et al. Lancet 2019;doi:10.1016/S0140-6736(18)32277-3.

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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Here’s some good news!

 

 

FDA NEWS

FDA expands Mavyret approval for adults, children with any HCV genotype

 

The label expansion of Mavyret (glecaprevir/pibrentasvir, AbbVie) was based on data from the phase 3b EXPEDITION-8 study that included patients with any of the six HCV genotypes. Twelve weeks after treatment, 98% of the 343 enrolled patients achieved sustained virologic response.

“This approval provides a treatment duration of 8 weeks for both pediatric and adult patients with compensated cirrhosis regardless of HCV genotype,” Jeffrey Murray, MD, deputy director of the division of antiviral products in the FDA’s Center for Drug Evaluation and Research, said in the FDA brief. “[Glecaprevir/pibrentasvir] is a combination of direct-acting antiviral drugs that reduce the amount of HCV in the body to undetectable levels by preventing the virus from multiplying, and in most cases, curing HCV infection.”

Additional data from the EXPEDITION-8 study showed that the most common adverse events were fatigue (8%), pruritus (7%) and headache (6%).

“While over 100,000 patients have been prescribed [glecaprevir/pibrentasvir] for chronic HCV in the U.S., there are still a significant number of patients that need options,” Janet Hammond, MD, PhD, vice president of the general medicine and virology therapeutic area at AbbVie, said in a press release. “This approval provides more HCV patients an option to treat their disease in as little as 8 weeks.”

Reference: www.fda.gov; www.abbvie.com



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Resistance (RAV/RAS) and retreatment success.

 

 

Resistance-guided HCV retreatment achieves nearly 90% SVR

 

In their study, Ana Belén Pérez, from the University Hospital Reina Sofía in Córdoba, Spain, and colleagues provided indications on how to use resistance information in settings where Vosevi (sofosbuvir/velpatasvir/voxilaprevir, Gilead Sciences) may not be available.

“We believe that our data may be of special relevance for those countries where new drug combinations are still not available, and may allow treating patients at a lower cost, avoiding drug-drug interaction and preserving the three-drug combination regimen,” they wrote. “We hypothesize that SVR rates may even be improved if resistance data are discussed between experienced virologists and treating clinicians.”

The study comprised 185 patients who did not respond to Harvoni (sofosbuvir/ledipasvir, Gilead Sciences), 79 who did not respond to combination Sovaldi (sofosbuvir, Gilead Sciences) and Daklinza (daclatasvir, Bristol-Myers Squibb), and 68 who did not respond to Viekira Pak (paritaprevir/ritonavir/ombitasvir/dasabuvir), all of whom also received ribavirin.

All patients received retreatment with sofosbuvir with an NS5A inhibitor and ribavirin for 12 or 24 weeks.

“When available, velpatasvir should be the NS5A component of the new retreatment regimen; if not available, the previously used NS5A inhibitor may be recycled adding ribavirin and extending the duration for 24 weeks,” the researchers wrote.”

Results from modified intention-to-treat analysis — excluding all patients unavailable for follow-up at 12 weeks — the SVR rates were 88.1% for those previously treated with sofosbuvir/ledispasvir, 83.3% for those treated with sofosbuvir and daclatasvir and 93.7% for those treated with ombitasvir-containing regimens.

“When possible, simeprevir-based regimens should be avoided, especially for patients with cirrhosis,” Pérez and colleagues explained. They continued to explain that most of the patients infected with genotype 3 were retreated and cured with a combination of sofosbuvir, an NS5A inhibitor and ribavirin after 24 weeks or a regimen of sofosbuvir with an additional two or three drugs and ribavirin, especially if Y93H is present. – by Talitha Bennett

Disclosures: Pérez reports that the study was supported in part by grants from Fondo de Investigación Sanitaria, Plan Nacional de I+D+I and Fondo Europeo de Desarrollo Regional-FEDER, Fundación Progreso y Salud, Junta de Andalucia, and GEHEP-SEIMC.



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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The benefits of treatment and SVR continue to soar!

 

Patient-reported outcomes greatly altered by HCV treatment results

 
Zobair M. Younossi

In a follow-up analysis of participants in clinical trials, researchers found that patient-reported outcome scores increased in patients who achieved sustained virologic response after treatment for hepatitis C, whereas scores decreased in those who did not.

“Although historical treatment regimens with interferon were plagued by low efficacy and significant side effects impairing patients’ well-being and, thus, PROs, the trajectory of HCV treatment changed about 5 years ago with the development of direct-acting antiviral (DAA) agents,” Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Hospital in Virginia, and colleagues wrote. “The PRO evidence generated by these two prospective registry studies support the unquestionable benefit of SVR for patients’ experience as opposed to the clear deleterious impact of HCV viremia.”

Younossi and colleagues assessed the health-related quality of life of 4,234 patients who achieved SVR and 242 patients who did not using the SF-36 instrument. Before treatment, PRO scores of both groups were similar to or higher than the general U.S. population and similar to each other.

At baseline for this study, patients who achieved SVR experienced improvements in all eight domains of the SF-36 (range increase, 3.6-8.1; < .0001), while the scores of those without SVR remained the same with the exception of the General Health domain, which decreased by 2.8 points (P = .008).

Patients without SVR experienced further PRO decrements at 12-week follow-up: up to –7 points from before treatment in the Role Physical, General Health, Social Functioning and Role Emotional domains and both summary scores; up to –9.2 points in all PRO domains at week 24; up to –8.3 points in five domains at week 48; and up to –9 points in four domains at week 96 (< .05).

In contrast, patients with SVR experienced sustained improvement of PRO scores with up to 7 points at week 24, up to 6.9 points at week 48, and up to 6.1 points at week 96 (P < .001). Multivariate analysis confirmed that SVR correlated independently with superior scores in all PRO domains with an increased range of 4.8 points to 15.9 points (< .01).

“In order to fully understand the comprehensive benefit of HCV cure, these PRO gains should always accompany the clinical consequences of SVR, such as lower rates of cirrhosis and hepatocellular carcinoma,” Younossi and colleagues concluded. “These data must be considered by providers, payers, and policy makers to fully appreciate the comprehensive benefit of HCV cure and to assure that all HCV patients are identified and treated with the most effective antiviral regimens.” – by Talitha Bennett

Disclosures: Younossi reports that the study was partially supported by Gilead Sciences and that he has received research funds or served as consultant to AbbVie, Bristol-Myers Squibb, Gilead Sciences, Intercept, Novo Nordisk, Terns and Viking. Please see the full study for all other authors’ relevant financial disclosures.



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Some recent updates regarding initial testing recommendations. No longer are Boomers the only age group being targeted for testing. With the illegal opioid problem, the exposure from IVDU and other forms of blood exposure, we are seeing a resurgence in HCV diagnosis.

Article Link

 

PERSPECTIVE

USPSTF recommends screening all adults for HCV

 

The task force also suggests that physicians consider screening patients for HCV who are aged younger than 18 years and older than 79 years if they are at high risk for infection.

The USPSTF reported that in 2016, there were an estimated 41,200 new HCV infections in the United States and that the number of cases of acute HCV infection have increased approximately 3.5-fold over the last 10 years. The increase is largely attributable to young, white people who inject drugs, particularly those who live in rural areas, and a hike in number of women aged 15 to 44 years infected with HCV, according to the task force. obe

 

“Today, more people are infected with hepatitis C than there were a decade ago, but there are now better treatments available. The evidence now shows more people can benefit from screening,” Douglas K. Owens, MD, MS, task force chair and general internist at the Veterans Affairs Palo Alto Health Care System, said in a press release. 

The USPSTF’s draft statement and evidence review has been posted for public comment on the USPSTF website: www.uspreventiveservicestaskforce.org. Input will be accepted through Sept. 23, 2019, at www.uspreventiveservicestaskforce.org/tfcomment.htm

The new “B” recommendation replaces the USPSTF’s 2013 recommendation that clinicians screen patients at high risk for HCV and offer one-time testing to adults born between 1945 and 1965. The CDC currently recommends HCV testing for baby boomers, injection drug users, and recipients of organ transplants or blood transfusions prior to July 1992. – by Janel Miller

Disclosures : Owens reports no relevant financial disclosures. Please see the USPSTF website for all other task force members’ relevant financial disclosures.

 
 



 



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Really good news.  We're definitely closing in on this virus.

Having been cured with Sovaldi and Ribavirin, I have to be thankful for it, but it was not pretty.  I wonder if there is a reason to use this combo specifically when more recent treatments have become so much kinder?



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GT2a, VL 681,500, Less than F1, Treatment Naive

12 wks Sovaldi/Ribavirin, SOT 2/25/16, EOT 5/17/16

UND at 2,4,8 and 12 wks during treatment but ribavirin crazy.

ALT/AST normal EOT

SVR12 8/13/2016!!!!!!!!!  I WON!!

EOT 6 Months 11/12/2016  CURED

 

Tig


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We have discussed this previously, but I want to add the latest confirmation of Vosevi’s success in retreatment. It’s good stuff!

 

Vosevi safely treats HCV in patients with prior treatment failure

 

“The aim of this study was to evaluate in the real-world setting the efficacy and safety of the fixed-dose combination of sofosbuvir, velpatasvir and voxilaprevir for 12 weeks in patients with chronic hepatitis C of any genotype and with different degrees of liver fibrosis who had previously failed oral DAA therapy,” Jordi Llaneras, MD, of Hospital Universitari Vall d'Hebron, and colleagues wrote.

Researchers conducted the study across 28 hospitals in Spain. The study comprised 137 patients (75% men; median age, 56 years), with 34% having compensated liver cirrhosis and 4% with HIV coinfection. Each patient received a fixed-dose oral tablet containing 400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir (Vosevi or SOF/VEL/VOX, Gilead Sciences) without ribavirin once daily over the course of 12 weeks. 

The data revealed that 95% of patients reached SVR12. However, SVR was lower in patients with cirrhosis (89%; P = .05) and those with genotype 3 infection (80%; P < .001). The most common adverse events included headaches (36%), followed by asthenia (32%), diarrhea (12%) and nausea (12%). 

“The real-world data obtained here support the notion that SOF/VEL/VOX for 12 weeks is a safe, effective regimen for retreatment of HCV patients previously failing DAA therapy,” Llaneras and colleagues wrote. “However, lower SVR12 rates were documented in the subgroup of patients with HCV genotype 3 and liver cirrhosis who had been previously treated with sofosbuvir plus daclatasvir.”– by Alexandria Brooks

Disclosures: Llaneras reports no relevant financial disclosures. Please see the full study for all the other authors’ relevant financial disclosures.



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Helio - HCV Next 

IN THE JOURNALS

Mavyret cures 100% of adolescents with HCV in first of two-part pediatric study

 


__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

Tig


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I can’t imagine giving Sovaldi and Ribavirin to a child, but when it could prevent many of the problems associated with chronic, long term infection, it would certainly be warranted. The RIBA would be so hard on those little bodies. ¯\_(ツ)_/¯ 

Sovaldi with ribavirin safe, effective for children aged 3 years to 12 years

 

Previously, the only approved HCV treatment for patients aged younger than 12 years was pegylated interferon with ribavirin, which is “undesirable due to safety concerns, poor tolerability, and its parenteral route of administration,” according to Philip Rosenthal, MD, from the university of California San Diego, and colleagues. “Concern for the effects of pegylated interferon and ribavirin on growth and development in this age group also limits their use.”

To evaluate the safety and efficacy of Sovaldi (sofosbuvir, Gilead Sciences), the researchers enrolled 54 patients aged between 3 years and less than 12 years from 28 international sites.

All 41 patients aged 6 years to less than 12 years achieved sustained virologic response. Twelve of the 13 patients aged 3 years to less than 6 years also achieved SVR. One of the thirteen younger patients was a 4-year-old who discontinued treatment due to an adverse event of “abnormal drug taste.”

Of the 40 patients assessed for swallowability, 34 were able to swallow the 100 mg pill while the rest of the patients received sofosbuvir as granules. The researchers noted that the patient who discontinued was administered granules with applesauce and yogurt, “both of which are acidic and may have broken down the taste-mask coating of the granules,” the wrote.

All treatment-related adverse events were mild to moderate. For the older age group, the most common events were vomiting and headache, while the younger group most often experienced vomiting and diarrhea. All events of diarrhea lasted 5 days or fewer and resolved during treatment except for one case that lasted 2 months and resolved posttreatment. Cases of vomiting lasted for 1 or 2 days.

Study treatment did not affect pubertal development through 12 weeks of posttreatment follow-up.

“The availability of an all-oral, interferon-free, direct-acting antiviral regimen for younger children remains an unmet medical need,” Rosenthal and colleagues wrote. “The safety and efficacy of treatment with sofosbuvir plus ribavirin observed in this study supports its use in children. Treating HCV infection in pediatric patients could limit both horizontal and perinatal transmission of the virus, which could be important in reaching the World Health Organization’s goal of eliminating chronic HCV infection as a major public health threat by 2030.” – by Talitha Bennett

Disclosures: Rosenthal reports research support from AbbVie, Albireo, Bristol-Myers Squibb, Gilead, Merck, Retrophin and Roche; and consults for AbbVie, Albireo, Alexion, Audentes, Dicerna, Gilead, Intercept, Mirum, Retrophin and Roche. Please see the full study for all other authors’ relevant financial disclosures.


 



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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HCV treatment with Epclusa safe in patients undergoing dialysis for ESRD

 

“Chronic HCV infection has a significant negative impact on morbidity and mortality in patients undergoing dialysis,” Sergio M. Borgia, MD, FRCPC, from Brampton Civic Hospital in Ontario, Canada, and colleagues wrote. “HCV-infected patients with [chronic kidney disease (CKD)] have an accelerated rate of loss of kidney function, risk of progression to end-stage renal disease (ESRD), and increased risk of all-cause mortality when undergoing dialysis.”

Borgia and colleagues enrolled 59 patients with HCV and ESRD to undergo 12 weeks of treatment with Epclusa (sofosbuvir/velpatasvir, Gilead Sciences). Most were treatment-naive (78%), 92% were undergoing hemodialysis for a mean duration of 7 years (range, 0-40 years), and 8% were undergoing peritoneal dialysis.

Fifty-six patients achieved SVR (95% CI, 86-99), of whom 53 had study drug adherence rates of 90% or higher. Two patients experienced virologic relapse posttreatment and one patient was discontinued from the study after 11 weeks due to nonadherence.

Most patients experienced a mild to moderate adverse event (80%) such as fatigue, headache, nausea, vomiting and insomnia. The researchers noted no adverse events associated with renal dysfunction among the patients and that the incidence of grade 3 and grade 4 laboratory abnormalities was consistent with patients undergoing dialysis for ESRD.

“Over the last few years, several HCV treatments have been approved for use in patients with HCV infection and CKD, and each regimen has limitations,” the researchers wrote. “The data collected in this study provide information to support the use of sofosbuvir/velpatasvir in HCV-infected patients with ESRD.” – by Talitha Bennett

Disclosure: Borgia and his institution have received honoraria from AbbVie, Gilead Sciences and Merck. Please see the full study for all other authors’ relevant financial disclosures.



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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This IS an interesting update. Maybe why us 3's were seen to be harder to treat. Good reading here and i had also stuffed it over here ... ( GT3's - (and more so, maybe "certain" GT3 sub-types) - perhaps why we have most often been considered "hard to treat"  ) - where the other post (another study/some similarities) also presented some differing resistance info and additionally why us 3's could have been harder to treat. Thank goodness for the things we learn.  : ) 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

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Common polymorphism responsible for HCV genotype 3 resistance to Sovaldi

 

“Studies on [Sovaldi] ‘resistance’ have been hampered by the extraordinary efficacy of the drug, which has led to very few treatment failures,” Peter A.C. Wing, PhD, from the Queen Mary University of London in the United Kingdom, and colleagues wrote. “Our analysis shows that reduced response to [Sovaldi] may occur if multiple viral polymorphisms are combined.”

 
 

To evaluate resistance to Sovaldi (sofosbuvir, Gilead Sciences) as well as ribavirin, Wing and colleagues used capture-fusion assays to assess 14 samples of HCV genotype 3. Ten of the samples were from treatment-naive patients with advanced liver disease, while the other four were from patients who had shown response in early access programs or in vitro testing.

They found that alanine at position 150 was particularly common (40.55%) along with the valine variant (36.66%). At position 206, lysine demonstrated a frequency of 76.31% and glutamic acid presented at a frequency of 12.74%. However, an analysis of the combination of polymorphisms (A150V and K206E) showed both were present in less than 4% of the population.

Using transient replicon assay, the researchers found that each common polymorphism correlated with an eightfold reduction in sensitivity to sofosbuvir and the combination correlated with a reduced sensitivity of more than 35-fold.

The effect of these polymorphisms on ribavirin sensitivity ranged from 10-fold for K206E to more than 40-fold for A150V, but in combination, the effect was enhanced to approximately 70-fold.

“For treatment naive patients, responses to [sofosbuvir] based treatments are so effective that any impact of these viral variants is likely to be minimal and we would not recommend that such patients undergo pre-treatment ‘resistance’ testing,” Wing and colleagues concluded. “For patients who have been exposed to multiple drug regimens (including interferon and NS5a inhibitors that can lead to resistance associated polymorphisms) we speculate that the polymorphisms identified here might be of significance and we suggest that pre-treatment viral sequencing may be useful in selecting the optimal regimen for such patients.” – by Talitha Bennett

Disclosure: Wing reports no relevant financial disclosures. Please see the full study for all other author’s relevant financial disclosures.

Genotype 3 & Polymorphisms



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Wow!  Such progress!

 



__________________

GT2a, VL 681,500, Less than F1, Treatment Naive

12 wks Sovaldi/Ribavirin, SOT 2/25/16, EOT 5/17/16

UND at 2,4,8 and 12 wks during treatment but ribavirin crazy.

ALT/AST normal EOT

SVR12 8/13/2016!!!!!!!!!  I WON!!

EOT 6 Months 11/12/2016  CURED

 

Tig


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A new update on a promising HCV vaccine! Appears there is much work to be done, but they are making some advances. 

HCV Vaccine Progress



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Thankfully, my Hepatologist has been working with and training family doctors to treat HCV.  It actually is a pretty simple process for most of us.  Where I live, we also have trained teams who will come to the local hospital to get you treated.  It should be that easy everywhere.



__________________

age 65
gender F
genotype 2
fibrosis stage f0
HCV diagnosis date Oct/18
SOT May 10, 2019
HCV medication Epclusa
HCV lab results (viral load 2,950,000, AST unknown, ALT 10
No prior treatment

Tig


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Here’s a good article on the need for Generalists/GPs to get together with Specialists and bridge the gap in HCV diagnosis and treatment. There are too many people falling through that gap, for whatever reason. IMO, there’s no reason a GP couldn’t provide care. It’s not like it used to be, it’s far more effective and relatively side effect free. Well within their ability. It’s all about eradicating the virus and saving lives!

Bridge the Gap



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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I’d like to see Medicare be part of this, as well as Medicaid and the incarcerated. People on Medicare should be given the same consideration. Most aren’t rolling in the dough, either... We can do better! It’s good to see the attention being given to this. I hope to see other states get on board with more programs like this. 



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Tig

63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Lucky the 10,000 people in Louisiana (patients who are on medicare or are incarcerated), they will be the recipients (over the next 1 1/2 years) to get treated with Epclusa. 

 

Helio - HCV Next

Louisiana picks Gilead subsidiary for Netflix style HCV subscription plan

 


__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

Tig


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This is great news and a very positive step toward eradicating this disease in our Veterans!

The US Veterans Administration is on course to eliminate HCV in Veterans in the next 2 months! That’s a great (lofty) goal and I hope they’re successful! They have some work to do. Best of luck to all!

Veterans Hope



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63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Lots of positive articles and news in these updates.  Wow.



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12 wks Sovaldi/Ribavirin, SOT 2/25/16, EOT 5/17/16

UND at 2,4,8 and 12 wks during treatment but ribavirin crazy.

ALT/AST normal EOT

SVR12 8/13/2016!!!!!!!!!  I WON!!

EOT 6 Months 11/12/2016  CURED

 



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There's an article around here (somewhere) about how we are doing in the likelihood of eradicating HCV ... and this link (a trial) has to do with that. This trial experiment ( https://clinicaltrials.gov/ct2/show/NCT01436357 ) was mentioned in the article - and scientists/infection control people are all awaiting the outcomes, to see the results, the data on this very long trial - 5 years all in all?? Wouldn't we all like to know whether these "vaccinations" will provide significant protection to high exposure risk groups to prevent them from getting chronic hep C (being that they say eradication will be difficult to achieve without vaccines). 

I wonder ... if the "actual" trial start was in 2011?, that seems SO long ago, and if that means the trial data is now being finalized for publication soon?? With only 500-600 participants recruited in 2011?, over all these years I bet they lost more than few to dropping out of the trial for one reason or another! 

I hope they publish trial outcomes soon, and, that we get to hear about it! C.



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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HBV related HCC risks reduced by Aspirin therapy? Yep...

HBV/HCC Aspirin Therapy



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There are some informative and yes, interesting articles this month. The testosterone piece is worth a read for the men. We have had discussions on this in the past. Good to see them figure it out. It might explain the fatigue and slow metabolism... 

Healio/HCV Next Updates



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Helio - News

Dicerna completes first dosing in phase 1 trial of RNA-based HBV therapy

 


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GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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This is not a "Helio" article (it's a Medscape" one) but it does have the very same concern/topic as the prior Helio article in this thread - just thought i would drop this second similar article here so they could both be read side by side. 

Screen All New Cancer Patients for Hepatitis?

Kristin Jenkins, January 23, 2019

 

A new study has found "a large reservoir of patients with cancer and undiagnosed hepatitis virus infections" and has reignited the question of whether all newly diagnosed cancer patients should be screened for hepatitis.

The Viral Screening in Newly Diagnosed Cancer Patients (S1204) study involved 3051 patients and found that 6.5% had previously been infected with hepatitis B virus (HBV), 0.6% had chronic HBV infection, 2.4% had hepatitis C(HCV) infection, and 1.1% were infected with HIV.

The study was published online on January 17 in JAMA Oncology.

At enrollment, 87.3% of patients did not know that they had previously been infected with HBV. Similarly, 42.1% of the cases of chronic HBV infection, 31.0% of the cases of HCV infection, and 5.9% of the cases of HIV infection were undiagnosed.

 

Cancer patients with HBV or HCV infection are at risk for viral reactivation and potentially life-threatening clinical outcomes, say the authors, led by Scott D. Ramsay, MD, PhD, director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center, in Seattle, Washington.

"Many patients had no known risk factors for infection, suggesting that current risk-based models for screening may be insufficient," they add.

Universal screening for HBV and HCV prior to cancer therapy "may be warranted," they write.

The investigators conclude, however, that "[t]he low rate of undiagnosed HIV infection may not support universal screening of newly diagnosed cancer patients [for HIV]."

Screening Could Prevent Complications

Universal screening for HBV, HCV, and HIV infection is not routinely performed in patients diagnosed with cancer. What's more, the use of such screening remains controversial among oncologists, the researchers point out.

These results "provide new evidence to inform a discussion in the oncology community about whether we should require hepatitis screenings," said Ramsay in a statement.

Universal screening could prevent complications from hepatitis, such as liver failure and kidney disease, the investigators say. Immunosuppressive cancer drugs such as rituximab (Rituxan, Genentech, Biogen Idec) - used to treat CD20-positive T-cell lymphomas and leukemias - can cause some viruses to reactivate and multiply.

 

"Because the true risk of severe adverse events associated with most cancer treatments in persons with latent infections is unknown, the putative benefits of delaying or modifying cancer treatment remain speculative...," the authors say.

 

However, they add, "...the risk that these changes pose to outcomes for patients with newly diagnosed cancer are real."

Study Details

For the study, data were collected from patients enrolled at nine academic and nine community oncology centers affiliated with the SWOG (formerly the Southwest Oncology Group) Cancer Research Network, a National Cancer Institutesponsored cancer clinical trials cooperative group.

 

Data were collected between August 29, 2013, and February 15, 2017. The median age of the patients was 60.6 years, 60.4% of the patients were women, 18.1% were African Americans, and 18.3% were of Hispanic ethnicity.

 

Breast cancer was diagnosed in 34.7% of patients, blood/marrow malignancy in 12.1%, colorectal cancer in 11.9%, and lung cancer in 11.7%.

 

Of those patients who did not know that they had previously been infected with HBV, 27.4% had no known risk factors. Similarly, 21.1% of patients with chronic HBV, 32.4% of those with HCV, and 20.6% with undiagnosed HIV had no identifiable risk factors. This suggests that current risk-based models for screening may be insufficient, the researchers say.

 

Universal Screening for All New Cancer Patients

When approached for comment, Harrys A. Torres, MD, associate professor in the Department of Infectious Diseases at the MD Anderson Cancer Center, Houston, Texas, said this 18-center evaluation study was "extremely important."

Torres, who is also associate adjunct professor in the Department of Gastroenterology, Hepatology and Nutrition, is founding director of the HCV clinic - the first in the United States to manage HCV infection in all cancer patients.

 

"We agree with the authors that all cancer patients should be screened for HBV and HCV," said Torres.

All cancer patients should be screened for HBV and HCV.Dr Harrys Torres
 

"Now the push for universal screening is coming from a great many academic and community cancer centers, not just one," he told Medscape Medical News.

 

At MD Anderson, universal screening for HBV, HCV, and HIV has been standard practice in hematologic services since 2007. "This started after rituximab was found to be associated with hepatitis B reactivation," Torres said.

 

In 2016, screening for HCV infection at MD Anderson was expanded to include all patients with cancer, including those with solid tumors. The vast majority of cases are newly diagnosed, said Torres. The next step is to screen most patients for HBV and HIV as part of a stepwise plan.

 

Torres partially agreed with the study authors on the matter of universal HIV screening. However, he emphasized that more data are needed before it can be said that universal HIV screening is not warranted, particularly if screening is recommended for HBV and HCV.

 

Results from a 2014 MD Anderson study supported HIV testing in cancer patients before they started cancer therapy, he noted.

 

"These three infections can be acquired in the same way, have common risk factors, and can induce other cancers that can present as second primary cancers in patients coming with different underlying malignancies. I see this from an infection perspective, and transmission is going to be an issue. Now that we have the data for HBV and HCV, we have to get the data for HIV."

 

Torres pointed out that in the current analysis, Ramsay and colleagues found an increased risk for liver cancer as well as cancer of the prostate, lung, and breast.

 

In a 2018 study, Torres and colleagues reported that 15% of HCV-infected patients who had different primary cancers developed HCV-associated hepatocellular carcinoma as a second primary malignancy. This is an often overlooked presentation of liver cancer, they say.

 

The current study findings validate those from a 2018 MD Anderson study led by Jessica Hwang, MD, MPH, said Torres. That study demonstrated that universal HBV testing was more efficient than risk-based screening.

The results from the current study also parallel findings from 2017 study and a 2018 study, both of which showed that selective screening practices for HCV were not optimal for identifying all infected cancer patients, he said.

 

"With the availability of nucleos(t)ide analogues to treat HBV and direct-acting antivirals to treat HCV, infected cancer patients can be treated to prevent viral reactivation, progression of liver disease, and allow access to cancer treatment, including clinical trials," said Torres.

 

As previously reported by Medscape Medical News, there is evidence of the impact of reactivation of HBV and HCV infection in patients undergoing immunosuppressive chemotherapy. In two separate studies, researchers at MD Anderson concluded that greater surveillance for HBV and safer hematologic-sparing treatments for HCV are required.

 

In 2015, the American Gastroenterological Association issued a guideline for the prevention and treatment of HBV reactivation during immunosuppressive drug therapy.

 

Subsequently, a review and meta-analysis of prophylaxis management for HBV reactivation in patients with breast cancer undergoing chemotherapy was published, as reported by Medscape Medical News.

Until more data are available, the US Centers for Disease Control and Prevention and the US Preventive Services Task Force (USPSTF) recommend that universal one-time HIV screening be conducted in patients aged 13 to 65 years and in women who are pregnant, Torres pointed out.

 

One-time screening for HCV is also recommended for individuals born between 1945 and 1965, Ramsay and colleagues note.

 

"This is particularly relevant if we want to reduce transmission to uninfected persons and reduce the risk of AIDS-related events, such as development of AIDS-defining cancers," said Torres. The USPSTF is currently reviewing its screening guidelines and is expected to issue new recommendations, he pointed out.

 

The National Comprehensive Cancer Network recommends HIV screening for persons with newly diagnosed lymphomas, the researchers say. However, the American Society of Clinical Oncology and the National Comprehensive Cancer Network do not have recommendations for universal HCV and HIV screening.

 

In their article, Ramsay and colleagues acknowledge that universal screening would increase the cost of cancer care. Ramsay is currently conducting an analysis of results from another SWOG study to determine the cost-effectiveness of universal hepatitis and HIV screening. The results are expected later this year.

 

Torres said that three recently published articles that present cost analyses in the United States and Europe show that universal HCV screening in the community is cost-effective. Similar results are expected in cancer patients, given the significant morbidity and mortality of HCV in this patient population, he added.

 

The study was funded by the National Cancer Institute of the National Institutes of Health. Ramsey has disclosed no relevant financial relationships. A number of coauthors have disclosed relationships with industry. Torres has relationships with Gilead Sciences, Inc, and Merck & Company Inc, with all funds paid to the University of Texas MD Anderson Cancer Center. He also has financial relationships with Gilead Sciences, Inc, Merck & Company Inc, and Dynavax Technologies.

 

JAMA Oncol. Published online January 17, 2019. Full text

 



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Helio - HCV Next

IN THE JOURNALS

Undiagnosed HBV, HCV, HIV prevalent in newly diagnosed cancer cases

 


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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Re: references to "Polaris 1" = Vosevi, and references to "C-Swift" = Zepatier.

BTW, Dr. Lawitz is named on C-Swift trials. 

_____________________________________________________________

Helio - HCV Next - COVER STORY

Looking Back on an Unprecedented Revolution in Medicine

 


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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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More good news on Mavyret!

Mavyret achieves 97% SVR in real-world cohort of patients with HCV

 

“In clinical trials, restricted inclusion and exclusion criteria for the targeted patients may influence outcomes,” Roberta D'Ambrosio, MD, from the University of Milan in Italy, and colleagues wrote. “We demonstrated for the first time the excellent effectiveness and safety of [Mavyret] in a large cohort of HCV patients treated in an Italian real-life setting.”

The real-world cohort comprised 723 patients with hepatitis C who underwent treatment with Mavyret (glecaprevir/pibrentasvir, AbbVie) for 8 weeks (88%), 12 weeks (11%) or 16 weeks (1%). Fifty-seven participants had compensated cirrhosis and 116 were interferon-experienced. Genotypes included 1, 2, 3 and 4.

Thirty-five patients were lost to follow-up and three patients died during the study due to reasons unrelated to treatment.

At end of treatment, 97% of patients in all treatment duration groups achieved SVR. Specifically, the rate of SVR by intention-to-treat was 94% (95% CI, 92-96) and by per-protocol analysis was 99.3% (95% CI, 98.6-99.9).

The researchers noted that therapy compliance was excellent across all centers. Of the 10 patients who were undertreated, nine achieved SVR and one was lost to follow-up.

Four patients discontinued treatment early due to adverse events. However, all four achieved SVR.

Referring to patients with genotypes 1a and 3, advanced fibrosis, high HCV RNA, and high BMI, D’Ambrosio and colleagues wrote that “even in the relatively limited subgroup of patients carrying clinical features usually associated with lower chances of achieving an SVR, [glecaprevir/pibrentasvir] treatment resulted in optimal effectiveness.” – by Talitha Bennett

Disclosure: D’Ambrosio reports financial connections with AbbVie, Gilead and Merck Sharp & Dohme. Please see the full study for the other authors’ relevant financial disclosures.



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I knew this, but this is the kind of information we need to share with those thinking they have time to wait. Never forget, the Dragon never sleeps...

DAAs reduce HCC, decompensation risk compared with no treatment

 

Haesuk Park, MD, assistant professor in the College of Pharmacy at the University of Florida, aimed to determine the impact of all-oral DAA treatment on the incidence rate of HCC and decompensated cirrhosis, along with the economic outcomes of DAA treatment. “We looked at liver-related costs, and all-cause costs,” Park said.

She noted that access to HCV therapy has been frequently restricted due to high drug costs, among other reasons, leading to treatment delays. “This delay may have costly consequences,” she said.

The cohort for clinical outcomes included 26,105 patients. Of that group, 7,928 received DAA’s and 18,177 were untreated. For the economic outcomes, there were 8,064 patients, with 4,032 patients each in the treated and untreated groups.

Treatment outcomes showed that DAA therapy yielded a significant reduction in risk for developing HCC compared with no treatment (HR = 0.28; 95% CI, 0.15-0.52) among patients with compensated cirrhosis. This trend persisted among those without cirrhosis, with DAA therapy also reducing HCC risk compared with no treatment (HR = 0.43; 95% CI, 0.26-0.71). “The crude incidence for HCC risk was four times higher in the untreated patients compared with treated patients,” Park said.

Sensitivity and subgroup analyses shows that this trend of reduced HCC risk for treatment vs. no treatment persisted, regardless of cirrhosis status, among patients with no cancer history; among those diagnosed with HCC 3 or more months after baseline; and among those who received minimum effective treatment. “The results were consistent,” Park said.

She added that factors associated with HCC included male sex, older age, diabetes, cirrhosis, and cancer history.

Among participants with compensated cirrhosis, DAA treatment reduced decompensation risk compared with no treatment (HR = 0.38; 95% CI, 0.26-0.56). Similarly, treatment also decreased decompensation risk among those without cirrhosis (HR = 0.42; 95% CI, 0.3-0.58). “We found that DAA therapy was associated with a 62% decrease in [decompensated cirrhosis] risk in patients with compensated cirrhosis and a 58% decrease in patients without cirrhosis,” Park said.

Cost analysis findings showed that compared with no treatment, DAA treatment reduced liver-related costs among patients with compensated cirrhosis by $2,826 (P <. 001). For all-cause costs, this reduction was $13,739 (P < .001).

“In the short term, all-oral DAA treatment for HCV infection was associated with a decreased risk of developing HCC and [decompensated cirrhosis],” Park said. “DAA treatment was associated with a decline in health expenditures for both liver-related and all-cause related costs in patients with compensated cirrhosis.”

Park noted that a longitudinal study is necessary to confirm these findings. “Despite these positive findings, and the availability of these highly effective, all-oral DAA therapies, the majority of HCV patients within our study were not treated,” Park said. – by Rob Volansky

 

Reference:

Park H, et al. Abstract 146. Presented at: The Liver Meeting 2018; Nov. 9-13, 2018; San Francisco.



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Lam and Tig - I have never been one for any "budget" when it comes to MY health, and I have always defaulted to .... when in doubt, more should be better, in this article below, the part that was most appealing to me was the increased frequency of the VL and lab testing, the "concept" of "individualized" care versus cookie cutter care, I do not like to see blind molds that do not fit everyone, and the shoving of squares through round holes is not the ideal in many treatment models. I am still having trouble with VL's being taken at week 4 (on a 12 week course) and then nothing until SVR12!

I am not condoning the shortening of treatments, I am merely presenting the data that has come out, as interesting fodder to think about, here, and in the other posting I made (on the same study material).

Yes, a very small study and numbers, but still, it IS published, (and we have already seen course lengths drop,people have already been getting 8 week harvey therapy!). Shortened courses is still a hot and current topic in Mav articles too, not just the other drugs mentioned here. This small data was heaviest for VEL, ZEP, Harvey in that order and very few Mavs. Also too bad, was that even though this was a re-treatment for some, of these 19 people, Vosevi was not a drug used here.

I keep "re"-reading that skinny-looking 83%, but then I also keep RE-READing the whole of the info and paragraphs and suss the "original" number of participants - they originally started out (technically) with 22 people total, but in the end, they only used 16 people to see who was SVR12? ... out of the 16, only one person failed. What is the success rate of 15 SVR12's out of 16 people? ... that might be another way to read this data! ... 15 people with SVR12, plus one failed GT3 = 16 total, 3 further people seem to drop off their measuring at EOT and at EOT+4weeks (which would have totaled 19 people), and no mention of the last (just now missing?) 3 people (who would have been included in the original 22 people)!

Was never no good with math - you guys enlighten me please with your counting of heads? How I am "countings" heads, and interpreting their study "semantics" (endpoints), of who had what, when and how many of them did so, may be skewing how bad or good this 83% is. How do you decipher all their data to equate to 83%? - basically, I see 15 out of 16 people with SVR12 (and that works out to about 93.75%)!

Another oddity to keep in mind, as far as measuring/counting, is that there were only 11 people total (out of this so-called original 22 people) who even ended up having their course length reduced to be less than 12 weeks, the rest of the folk (who at least started treatment, if not finishing it) were determined to need the whole 12 weeks.  

I prefer big studies too, like some of Gileads. Mind you, there were not that many of us 3's in their trials, nor too many of us in their 8 week Vosevi arms.

Studies can always start off small, but may grow as they garner merit to improve on the data gathering.

I wish they HAD spoken more about the math "formula" they used ... how much of a dropped VL (or whatever) at "day 2, week 1, and perhaps even more importantly, at week 2 and week 4" was used as their ruler. THAT would have been interesting to know as well!

Lots of labs and liberal drugs I say, until I stand corrected (hm, heehee, I do stand here as a cured 3 though, and only on 8 weeks duration of Vosevi!) but, then again, ... Vosevi IS in a league all of it's own (i care to believe), I would still err on the side of overkill, over-treatment. Gilead, once they made their triplet available as a rescue treatment, has made no peep to decrease their 12 week scripts to 8 weeks. Fine by me. I am still for individualized/personalized courses of whatever in medicine (IF we want to talk about frequent following and assessments), for safe but efficient "response-guided" therapies.  C.



-- Edited by Canuck on Monday 26th of November 2018 12:06:28 AM

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GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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Agreed.... There’s too much attention being made to cost savings by shortening courses of care. If they want to actually win this battle, profits need to be secondary. If manufacturers can make sweetheart deals with other countries utilizing generic substitutes, that cost 1/10th the price, they should do it for everyone. We have to make our thoughts known and advocate for affordable access to these life saving drugs, in sufficient quantities and courses of care.

jmho...  ¯\_(ツ)_/¯ 



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Only 83% reaching SVR12 is not acceptable IMO ... but the study is too small to be statistically significant at this time. I trust the large studies like ASTRAL 1 - 3. Saving 20% is not a fair trade off if you do not reach SVR12 and then have to also pay for a course of Vosevi.



-- Edited by lamassu on Sunday 25th of November 2018 09:20:52 AM

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See also, a previous (earlier) article (posted here - Shortening HCV Treatment Courses ) -the same topic/same meeting/same info as below, but this article does contains more (further) specific info on which drugs were used though: 

 

Helio article on the Liver Meeting

Response-guided therapy may shorten HCV treatment time by 50%

 


__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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EXPEDITION-8: Mavyret nearly perfect in 8-week regimen. (Link)

 

“Excellent real-world data confirms the high SVR data,” Robert S. Brown Jr., MD, of the Center for Liver Disease and Transplantation at New York Presbyterian Hospital and Cornell Medical College Department of Medicine, said. “The idea came to us to investigate an 8-week duration in treatment-naive patients with compensated cirrhosis, so we were looking at exactly that question.”

Brown presented data for the ongoing phase 3, non-randomized, single arm, open-label, multicenter study in 280 treatment-naive patients dosed with Mavyret (glecaprevir/pibrentasvir, AbbVie). The presentation included data from patients with all HCV genotypes except genotype 3. 

The study included both per-protocol and intention-to-treat (ITT) analyses. The per-protocol analysis had a non-inferiority margin of 94% SVR, while the boundary for the ITT analysis was 99%. Virologic failures, relapses, adverse events, and resistance variants comprised secondary endpoints.

Results indicated an SVR rate of 100% in the per protocol analysis and 98% in the ITT population. “There were no virologic failures,” Brown said.

Safety data showed six serious adverse events. “None were determined to be drug-related,” Brown said. No events led to discontinuation of therapies, and no events were seen in more than 10% of the population. “This was consistent with what we’ve seen in prior [glecaprevir/pibrentasvir] trials.”

Brown added that there were no alanine aminotransferase elevations above twice or three times the upper limit of normal. “There were no liver related toxicities,” he added.

Baseline data showed that patients had a mean FibroScan (Echosens) score of 23.7, according to Brown. “Bilirubin was normal,” he said. “About 20% had platelets under 100,000.”

“These results support an 8-week duration of [glecaprevir/pibrentasvir] for treatment-naive patients with HCV,” Brown said. “We eagerly await the genotype 3 data. This adds to our treatment regimen.” – by Rob Volansky



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Great thread Tig thanks. I spoke with my GE last week and he said he and his colleagues have been writing more scripts for Mavyret than Epclusa or Harvoni due to the cost difference. Gilead has been losing market share and had no choice but to come out with generic Epclusa and Harvoni in the US. Then the generic Epclusa or Harvoni will be less costly than Mavvret. When I was treated earlier this year Epclusa was my only choice as my Medicare advantage plan did not cover Mavyret yet. Starting in 2019 they will and also Vosevi. Competition is good for consumers. Since Vosevi is the DAA of last resort I don't expect a generic any time soon.



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Male, 66, Dx 1990, GT 2a/2c. Pre-tx VL 11,500,000, ALT 10, AST 18, F3, 12.4 kPa. Rx: 12 weeks Epclusa, SOT 3/8/18, EOT 5/30/18. Week 2 VL 50, ALT 12, AST 21. EOT + 12 weeks: VL not detected, ALT 11, AST 19. EOT + 24 weeks VL not detected, ALT 9, AST 24. 8/15/19 F2 8.8 kPa.

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Genetic study and FDA approval into the use of 23 and Me to determine advances in medication metabolism. This used to be helpful in determining RAS impact on rates of success and treatment length. Nice to see it is expanding.

Medication Metabolism



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63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Here’s some information on HCV vaccine research.

 

HCV vaccine critical for global virus control 

 

However, there are several barriers to HCV vaccine development, including virus diversity, limited models for testing vaccines, and incomplete understanding of protective immune responses.

“Although pharmaceutical companies invest in drug development, vaccine development requires investment from sources beyond government and charitable foundations,” Justin R. Bailey, MD, PhD, from the Johns Hopkins University School of Medicine in Maryland, and colleagues wrote. “A prophylactic HCV vaccine is an important part of a successful strategy for global control. Although development is not easy, the quest is a worthy challenge.”

HCV genetic diversity presents one of the principal challenges for vaccine development, considering there are seven known genotypes — and a possible eighth recently discovered — with more than 80 subtypes. Additionally, immune selection and error-prone polymerase of the virus generate “a diverse quasispecies of related but genetically distinct viral variants” in individuals, according to Bailey and colleagues.

Another barrier to HCV vaccine development is the lack of in vitro or animal models available to determine whether a vaccine induces protective immunity.

“Direct infusion of HCV-infected human plasma might be considered, but would require careful screening for other pathogens and, even with thoughtful selection of inoculum levels and HCV genotypes, might fail to completely recapitulate natural exposure,” the researchers wrote. “Although our incomplete understanding of protective immunity against HCV is a barrier to vaccine development, studies have provided substantial evidence that protective immunity does exist.”

Regarding spontaneous clearance of HCV, both chimpanzees and humans have demonstrated recurrent HCV viremia following additional HCV exposure after initial control. This, according to the researchers, shows that spontaneous clearance of primary HCV does not generate sterilizing immunity.

However, previous studies have reported clearance of multiple infections with homologous and heterologous viruses in chimpanzees and humans. Rapid and effective control of viral replication with subsequent exposures indicates that adaptive immunity is induced and protects against chronic infection.

“Additional research on effective immune control of HCV is needed to develop a vaccine, including studies of people with repeated spontaneous control of diverse HCV infections over time,” Bailey and colleagues wrote. “Vaccine strategies meant to overcome the enormous diversity of HCV must generate a broad immune response, capable of responding to abundant variations. Selecting antigens to maximize the induction of T-cell and antibody responses that elicit successful responses remains an active area of research.” – by Talitha Bennett



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63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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You beat me to this notice. My email must be slower than yours. Mine just arrived!

This is great news, but I’m thinking Gilead can beat that price by $20K, considering it’s available overseas for less than $2K. Oh well, every step forward that makes these great new treatments more available, to all that need it, the better. Hopefully we’ll see insurance carriers more willing to treat on demand, when requested by healthcare providers. Fingers crossed for that day!



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63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Interesting! A price "reduction" (sometime in 2019) for long-time existing Harvoni, and, for the relatively (comparatively) new-comer Epclusa as well! Hm - food for thought there. 

 

Helio - HCVnext

Gilead announces launch of Epclusa, Harvoni generics for HCV

 


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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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The Louisiana-access thing article is a very good one! - i used it already, over in "Access to drugs " ... as it also fits in there, along the  "access to drugs/treatment and barrier removal" theme. smile

Don't we appreciate these good topics! Oh we live in curious times. wink C.



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

Tig


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Hmmm...  Does this mean we have to tune in for further developments? wink

 

FEATURE

Louisiana developing ‘Netflix’ style subscription plan for HCV treatment

 
Pete Croughan, MD
Pete Croughan

HCV Next spoke with the department’s chief of staff, Pete Croughan, MD, about the landscape of HCV in the state and the novel payment model designed to expand treatment despite the expensive cost of direct-acting antivirals.

“Hepatitis C is definitely an epidemic here, like it is in many places, and equally tied to the opioid epidemic due primarily to transmission through reuse of needles,” Croughan told HCV Next. “National data has shown that rates of acute infections tripled in the last 5 years. This corresponds with our own internal data on increased rates of infection.”

While the state has adequate data on the number of individuals infected with HCV through Medicaid, Croughan explained that the health department is focused on improving surveillance in correctional facilities, which is significantly lacking. National data, he said, place HCV prevalence in correctional facilities between 15% and 40%. Until screening is expanded in Louisiana, “we’re not going to know how many people are infected with HCV in our justice system,” he said.

Prior authorization criteria had also presented a barrier to treatment for state residents. Like many states, prior authorization initially restricted treatment based on at least 1 year of sobriety, prescriber specialty and the patient’s fibrosis score. However, cost-effective data that followed the introduction of new DAAs led the health department to evaluate what criteria was the most restrictive and least evidence-based with the help of the physician community and health advocates in New Orleans.

“We wound up changing our sobriety restriction to only needing a provider access statement that the patient is able to complete treatment, we removed the provider specialty restriction, and we eliminated fibrosis scores for HCV and HIV-coinfected individuals,” Croughan said. “Our hope is to eliminate this disease — that’s been our goal from the beginning — but the challenge has been how to pay for it. We’re among the poorer states and we’re trying to find space to treat large numbers of people. That’s where we think the subscription model in a win-win-win, for patients, the state and potentially pharmaceutical partners.”

Working with Rebekeh Gee, MD, Secretary of the Louisiana Department of Health, Croughan and colleagues developed the concept of a subscription payment model that has been described by some as the “Netflix model.



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63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Seems they are developing a new test that is referred to as a “Liquid Biopsy”. Sounds very promising and combines with other fibrosis testing models, should help to identify problems well ahead of some conventional means. 

Healio Updates Credit

Liquid biopsy identifies chronic liver disease, liver cancer vs. healthy blood

 

Irun Bhan, MD, from the Massachusetts General Hospital, and colleagues stated that hepatic circulating epithelial cells (CECs) could serve as a significant biomarker in the diagnosis and monitoring of CLD and HCC.

Bhan and colleagues developed an antigen-agnostic cell sorting device — the iChip — which isolates CECs while preserving cell viability and high-quality RNA content.

To determine the iChip’s ability to detect CECs in patients without HCC and discriminate between CECs in patients with and without HCC, the researchers obtained blood samples from 10 healthy donors, 39 patients with CLD and no evidence of HCC, 54 patients with HCC, and 10 who underwent curative treatment for HCC with no evidence of disease.

The procedure including RNA sequencing and immunofluorescent quantification with a threshold of 5 cells per 10 mL of whole blood.

CECs presented in a similar proportion of patients with CLD (79%), those with HCC (81%) and those with no evidence of HCC after treatment (90%) in contrast to 5% in the healthy donors (< .01).

Among patients with CLD, those with advanced fibrosis (stage 3 or 4) had a higher concentration of CECs compared with those without advanced fibrosis (5.1 vs. 0.7 cells/mL; < .01).

In a subanalysis, the researchers found that liquid biopsy CEC detection could phenotypically differentiate underlying disease state in cases of chronic liver disease vs. HCC with a preliminary sensitivity of 85% at a specificity of 95%.

“Here we report the novel detection of cells from diseased livers circulating in the bloodstream both by immunofluorescence and [RNA-sequencing] and the potential to use these cells as biomarkers. Important applications of this liquid biopsy may include CLD etiology determination, fibrosis staging, and HCC surveillance,” Bhan and colleagues wrote. “Further study of CECs could open a new field of biomarker development leading to a spectrum of non-invasive diagnosis and monitoring techniques for patients with liver disease.” – by Talitha Bennett



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63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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Eww!

Read one on "bio-film" and what's left after hundreds of ineffectual wipes/swipes/scrubs/cleanings of high risk objects in high risk places when cleaning is not done right, places the public can end up being in - like ... in hospitals - more ew! Splashing or spraying around a potent broad spectrum solution does not necessarily make up for bad cleaning technique. Ya jes kint be too careful alright. wink C.



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

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While on treatment or not, it’s very important to protect yourself from all beasties, great and small. This article regarding airport security trays (TSA), is sure to make you sit up and take notice. Always, always, wash your hands thoroughly after handling them or any public surface. They are ALL contaminated and you never know what you are being exposed to. Consider the recent discussion we had on the possibility of exposure to Hepatitis A. This is exactly how some can be exposed to a virus, regardless of how cautious we are.

Airport Beasties



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63 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 5+ years!

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So, the Eugene Melnyk (owner of the Ottawa Senators hockey team here in Ontario, Canada) that I had mentioned in my prior post below? ... here is the link to the old, old post I first made about him and his transplant, and how since then he has been active and fundraising to improve liver transplantation conditions. It was in his first interviews that he and his docs were speaking of the want to improve the "keeping of livers" (among other things). 

Eugene Melnyk - transplant recipient

 

Here is another article regarding work at Ontario's "Toronto General Hospital" transplant facility (dated summer of 2015) - we can see they have been working on this kind of "keeping" equipment for some time now (and, all over the world as well it seems).

Device keeps donor liver healthy outside body until transplant

https://www.uhn.ca/.../device_keeps_donor_liver_healthy_outside_body_until_transpl...
 
Jul 22, 2015 - Device keeps donor liver healthy outside body until transplant ... Dr. Selzner, who is also a clinician-scientist at the Toronto General Research ... The technique of warm organ perfusion outside the body was pioneered in the ...
 

Eugene keeps having these annual fund and awareness raising campaign galas for "The Organ Project", good for him. He had "Bare Naked Ladies" there this year, and he gets very interesting and talented people there! Good people doing good things. smile 



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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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Helio - Transplants

I posted elsewhere on the site about the owner of the hockey team the "Senators?" here in Canada land - he had hisef a shocking and successful transplant, and learned a lot through the process and in short order, he did some fund raising to try to support and assist his transplant hospital docs drum up better means of dealing with the donor livers whilst they are being kept for placement. I wonder how similar (or not) the Canadian docs methods were to these US docs system?  

UT Southwestern demonstrates efficacy of portable donor liver system

 


-- Edited by Canuck on Friday 31st of August 2018 01:18:31 AM

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HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)



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Cool pic, Tig! 



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F, 51, GT3, HCV since 1989, no alcohol since 1999, Fibrosis score F0-1 (.36), VL 216,000, ALT 23, AST 26, Epclusa SOT 7/26/18 EOT 10/18/18. Thank you God. 

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The graininess keeps the facial recognition software confused... wink



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Yes, it is a beautiful thing this Vosevi! I was just about to post this very same article (that you just did), and voila, you have done the good news service, and here the article sits and shines in all it's glory! Seems people can't keep good news quiet too long! We have to thank (credit) Gilead for bringing us all these new "good news" drugs!  biggrin C.

Hey, who's that guy in your avatar, looks kinda familiar, i think? Um, kinda grainy that photo tho ain't it? Could ya meebe play with the contrast tools?



__________________

HCV/HBV 1973. HBV resolved. HCV undiagnosed to 2015. 64 y.o. F. Canada.

GT3a, Fibroscan F3/12 kPa - F4/12.6 kPa, VL log 7.01 (10,182,417), steatosis, high iron load.

SOF/VEL with/without GS-9857 trial - NCT02639338.

SOT March 10 - EOT May 5, 2016 - SOF/VEL/VOX 8 week trial.

 

(SEE UPDATES IN BIO)

Tig


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It’s simply an excellent treatment...

Resistance did not affect SVR rates in trials of Vosevi for HCV

 

“In contrast to the prior studies of regimens targeting two distinct HCV proteins, the presence of NS3, NS5A and/or NS5B NI RASs did not affect treatment outcome in DAA-experienced patients including those who were previously treated with NS5A inhibitors upon treatment with [Vosevi] for 12 weeks in phase 3 trials,” Christoph Sarrazin, MD, from the Goethe University Hospital in Frankfurt, Germany, and colleagues wrote.

Sarrazin and colleagues’ review included data from the POLARIS-1 and POLARIS-4 studies of Vosevi (sofosbuvir/velpatasvir/voxilaprevirfor, Gilead Sciences), which included patients with HCV genotype 1 through 6.

SVR rates were 96.8% or higher for patients with either or both NS3 and NS5A RASs and 97.7% or higher for patients without RASs, which was not significantly different.

In a subanalysis of patients who had experience with earlier generation pegylated interferon therapy, the researchers found SVR rates of 95.1% or higher among patients with NS3 RASs.

Additionally, despite RAS position among patients with NS5A RASs, patients achieved SVR rates of 97% or higher.

“NS5A inhibitors are a common component of DAA regimens and more recently developed agents have demonstrated pangenotypic activity,” Sarrazin and colleagues wrote. “These results show that daily treatment with the single-tablet regimen of [Vosevi] for 12 weeks is highly effective for a broad range of DAA-experienced patients infected with HCV of any genotype regardless the presence of RASs.” – by Talitha Benenett

Disclosure: Sarrazin reports he has received research or grant support from Abbott, Achillion, Astra, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Janssen, Merck Sharp & Dohme, Qiagen, Roche and Siemens. Please see the full study for the other authors’ relevant financial disclosures

 



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