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Thursday, 04/09/2015 9:37:06 PM

Thursday, April 09, 2015 9:37:06 PM

Post# of 250859
EASL HCV abstracts of interest (by no means exhaustive):

C-SALVAGE: GRAZOPREVIR (GZR; MK-5172), ELBASVIR (EBR; MK-8742) AND RIBAVIRIN (RBV) FOR CHRONIC HCV-GENOTYPE 1 (GT1) INFECTION AFTER FAILURE OF DIRECT-ACTING ANTIVIRAL (DAA) THERAPY
Conclusions: In the ongoing C-SALVAGE trial, 79 HCV GT1-infected patients who had failed PI-based regimens were treated with GZR/EBR/RBV, including 43% with cirrhosis and 84% with prior virologic failure. HCV RNA levels <15 IU/mL were achieved in all patients at the end of treatment despite a high prevalence of NS3 RAVs at baseline. Study medications were well tolerated in this population. SVR12rates, full safety data, and expanded resistance results will be presented.

RETREATMENT OF PATIENTS WHO FAILED 8 OR 12 WEEKS OF LEDIPASVIR/SOFOSBUVIR-BASED REGIMENS WITH LEDIPASVIR/SOFOSBUVIR FOR 24 WEEKS
The overall SVR4 rate was 73% (30/41): 1 breakthrough, 9 relapse, and 1 visit pending. Table 1 presents the SVR4 rates by prior treatment. Headache was the only AE reported in =10% of patients. Two patients (5%) had treatment-emergent SAEs. Complete SVR12 rates and viral sequencing results will be presented.


THE PHASE 3 C-EDGE TREATMENT-NAÏVE (TN) STUDY OF A 12-WEEK ORAL REGIMEN OF GRAZOPREVIR (GZR, MK-5172)/ELBASVIR (EBR, MK-8742) IN PATIENTS WITH CHRONIC HCV GENOTYPE (GT) 1, 4, OR 6 INFECTION (this is the biggie)


SAFETY OF OMBITASVIR/PARITAPREVIR/RITONAVIR PLUS DASABUVIR FOR TREATING HCV GT1 INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT OR END-STAGE RENAL DISEASE: THE RUBY-I STUDY (i listed this bc this is the subgroup that MRK used to get BTD status)

A PHASE 3, RANDOMISED, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 8 AND 12 WEEKS OF SIMEPREVIR (SMV) PLUS SOFOSBUVIR (SOF) IN TREATMENT-NAÏVE AND -EXPERIENCED PATIENTS WITH CHRONIC HCV GENOTYPE 1 INFECTION WITHOUT CIRRHOSIS: OPTIMIST-1 (even 8 weeks of olysio and sofo is cost prohibitive but it will be interesting to see data from teh 8 week combo. it could have implications for JNJ combo with allios acquired nuke)

C-SURFER: GRAZOPREVIR PLUS ELBASVIR IN TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS WITH HEPATITIS C VIRUS GENOTYPE 1 INFECTION AND CHRONIC KIDNEY DISEASE (BTD granted based on this data)

REAL-WORLD EFFECTIVENESS OF LEDIPASVIR/SOFOSBUVIR 8 WEEKS CHRONIC HEPATITIS C TREATMENT (GILD probably used the 8 week in negotiations with payors, but what if there is a small but meaningful difference in efficacy?)

RESPONSE GUIDED THERAPY IS NOT DEAD: LOW SUSTAINED VIROLOGIC RESPONSE (SVR) RATES IN PATIENTS WHO HAVE DETECTABLE HEPATITIS C VIRUS (HCV) AT WEEK 4 OF TREATMENT WITH SOFOSBUVIR (SOF) CONTAINING REGIMENS (will 8 week regimens get converted to 12 weeks? will insurance companies allow this?)

SAFETY AND EFFICACY OF SHORT-DURATION TREATMENT WITH GS-9857 COMBINED WITH SOFOSBUVIR/GS-5816 IN TREATMENT-NAÏVE AND DAA-EXPERIENCED GENOTYPE 1 PATIENTS WITH AND WITHOUT CIRRHOSIS (another biggie - how short can you go for naives and cirrhotics, 6 and 8 weeks respectively?)

SAFETY AND EFFICACY OF SOFOSBUVIR-CONTAINING REGIMENS IN HEPATITIS C INFECTED PATIENTS WITH REDUCED RENAL FUNCTION: REAL-WORLD EXPERIENCE FROM HCV-TARGET

ASSESSMENT OF BASELINE VIRAL LOAD CUT-OFF FOR SHORTENED LEDIPASVIR/SOFOSBUVIR THERAPY BY WIDELY USED HCV RNA ASSAYS
Conclusions: A baseline viral load below 6 million (6.8 log) IU/ml was present in 59% of patients in the ION-3 registration trial and 40% in the present study based on HPS/CTM. However, measurements with CAP/CTM and ART, two assays widely used in the real-world setting, revealed that 86% and 90% of patients tested were, in principle, eligible to receive an 8-week treatment regimen. A substantial proportion of patients had fluctuating VL levels below and above 6 million IU/ml at different screening time points according to CAP/CTM that could potentially impact treatment decisions. (This is why i wouldn't want 8 weeks of harvoni if i were a pt)


IMPACT OF PILL COUNT ON MEDICATION ADHERENCE DURING THE FIRST 12 WEEKS OF HIV ANTIVIRAL TREATMENT: IMPLICATIONS FOR HCV TREATMENT
Timothy R. Juday* 1, Robert W. Baran1, Shivaji R. Manthena1, David R. Walker1
1Health Economics and Outcomes Research, Abbvie, North Chicago, United States
Conclusions: These findings suggest that pill count does not appear to be a factor in antiviral medication adherence over the initial 12-weeks of treatment. As more all-oral HCV treatments become available, this research should be replicated in the HCV population.

PREVALENCE OF CO-MORBIDITIES BY HEPATITIS C VIRUS STATUS IN THE U.S. POPULATION
.. Compared to those anti-HCV negative, adults with anti-HCV positive results had significantly higher prevalence of hypertension, history of heart failure, .. (i included this to piss off those who thought i made too much of the sofosbuvir amiodarone deal)

EFFICACY AND SAFETY OF GRAZOPREVIR/ELBASVIR +/- RBV FOR 12 WEEKS IN PATIENTS WITH HCV G1 OR G4 INFECTION WHO PREVIOUSLY FAILED PEGINTERFERON/RBV: C-EDGE TREATMENT-EXPERIENCED TRIAL
The table displays preliminary SVR4 results. (this is the data that got circulated on twitter and the only svr data mrk released in advance)
Preliminary results showed a 12 week regimen of GZR/EBR FDC was highly efficacious (but not home run out of the park efficacious, and might suggest some benefit in GT1As) with respect to SVR4 among these hard-to-cure patients, and had a favorable safety profile.
Figure:

PREDICTORS OF SUSTAINED VIRAL RESPONSE TO 4-6 WEEK DURATION THERAPY WITH LEDIPASVIR + SOFOSBUVIR + GS-9451 +/- GS-9669 IN EARLY AND ADVANCED FIBROSIS (NIH/UMD SYNERGY TRIAL)
Results: In the early fibrosis cohort, 9/25 (36%) patients receiving LDV/SOF+GS-9451 achieved SVR12, and 5/25 (20%) receiving LDV/SOF+GS-9451+GS-9669 achieved SVR12. One patient in each group was lost to follow up. Male gender (p=0.03) and baseline HCV VL (p<0.0001) were risk factors for viral relapse in univariate analysis. No patient with a pre-treatment HCV viral mutant conferring >5 fold resistance achieved SVR. In the advanced fibrosis cohort, 22/22 (100%) achieved EOT viral suppression. 6/11 (54.5%) treatment naïve and 5/9 (55.6%) treatment experienced patients achieved SVR12. (piling on multiple DAAs has it's limitations)

PROGRESSION TO ADVANCED LIVER FIBROSIS IN HIV/HCV-COINFECTED PATIENTS AND PRIORITIZATION OF NEW HEPATITIS C THERAPIES
Conclusions: In the absence of successful treatment, more than 20% of HIV/HCV-coinfected patients with null-mild liver fibrosis progress to advanced fibrosis within 5 years. Patients with >7.1 KPa (Metavir F2) display the highest risk. Therefore, all coinfected patients with any significant liver fibrosis should be considered as candidates for new DAA-based therapies. (i.e. restricting treatment in coinfected pts to only those with advanced fibrosis is particularly bad. abbv/enta are likely to get a larger share of the coinfected pts compared to monoinfected as a whole based on their collaboration w ryan white program and overall labeling)

NOVEL CYCLOPHILIN INHIBITOR CPI-431-32 SHOWS BROAD SPECTRUM ANTIVIRAL ACTIVITY BY BLOCKING REPLICATION OF HCV, HBV AND HIV-1 VIRUSES
(efficacy in non-viral liver disease has also been reported which to me is more interesting than HCV. maybe enta can finally bring a candidate to the clinic)

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