Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIAID SYNERGY Phase 2 Treatment Naïve (unfavorable baseline.

Slides:

Advertisements

Similar presentations

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir Retreatment with HCV Genotype 1 NIAID Retreatment Phase 2a Treatment Experienced Osinusi.

Advertisements

Hepatitis web study Hepatitis web study Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option) POSITRON Phase 3 *Note: Published in tandem with FUSION Trial.

Hepatitis web study Hepatitis web study Sofosbuvir + Peginterferon + Ribavirin in Genotype 2 or 3 LONESTAR-2 Phase 2 Treatment Experienced Lawitz E, et.

Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin + Peginterferon in Genotypes 1-3 PROTON Phase 2 Treatment Naïve Lawitz E, et al. Lancet.

Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in Liver Transplant.

Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in GT1 SAPPHIRE-II.

Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV-HIV Coinfection: HCV GT 1,2,3,4 PHOTON-2 Trial Phase 3 Molina JM, et al. IAC. 2014;

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-1 Phase 3 Treatment Naïve Source: Afdhal N, et al. N.

Hepatitis web study Hepatitis web study Sofosbuvir, Ribavirin, GS-0938 in GT 1-4 QUANTUM Phase 2b Treatment Naïve Lalezari JP, et al. EASL. 2013; Abstract.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir + RBV in HCV GT 1,4 and Advanced Liver Disease SOLAR-1 (Cohorts A and B) Phase 2 Treatment.

Hepatitis web study Hepatitis web study Ledipasvir + Sofosbuvir +/- Ribavirin in GT 1-3 ELECTRON 2 Phase 2 Treatment Naïve and Treatment Experienced Source:

Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in GT1 SAPPHIRE-I.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2 Phase 3 Treatment Experienced Source: Afdhal N, et.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir for 8 or 12 weeks in HCV GT1 ION-3 Phase 3 Treatment Naïve Kowdley K, et al. N Engl J Med.

Hepatitis web study Hepatitis web study Sofosbuvir in Genotypes 2 or 3 VALENCE Trial Phase 3 Treatment Naïve and Treatment Experienced Zeuzem S, et al.

Hepatitis web study Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial Phase 2a, Treatment Naïve and Treatment Experienced.

Hepatitis web study Hepatitis web study Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6 ATOMIC Phase 2 Treatment Naïve Kowdley K, et al. Lancet.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in GT-1 and HIV Coinfection NIAID ERADICATE Trial Phase 2a Treatment Naïve and Treatment.

Hepatitis web study Hepatitis web study Peginterferon alfa-2a versus Interferon alfa-2a Phase 3 Treatment Naïve, Chronic HCV Zeuzem S, et al. N Engl J.

Hepatitis web study Hepatitis web study Hepatitis web study Hepatitis web study 3D (Ombitasvir-Paritaprevir-Ritonavir + Dasabuvir) + RBV in GT1 TURQUOISE-I.

Hepatitis web study Hepatitis web study Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in GT1 and Renal Disease RUBY-I Phase 3b Treatment-Naive Pockros.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in GT1 or GT4 and HIV Coinfection ION-4 Phase 3 Treatment Naïve and Treatment Experienced.

Hepatitis web study Hepatitis web study Sofosbuvir-Ledipasvir +/- Ribavirin in GT-1 LONESTAR Trial Phase 2a Treatment Naïve and Treatment Experienced Source:

Hepatitis web study Hepatitis web study Sofosbuvir in HCV-HIV Coinfection & HCV GT 1,2,3 PHOTON-1 Trial Phase 3 Sulkowski MS, et al. JAMA. 2014;312:

Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Phase 2 Curry MP, et al. Gastroenterology. 2015;148:100-7.

Hepatitis web study Hepatitis web study Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4 PEARL-I Phase 2b Treatment Naïve and Treatment Experienced.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in Treatment-Experienced GT1 with Cirrhosis SIRIUS Phase 2 Treatment Experienced Bourliere.

Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV Recurrence Following Liver Transplantation Phase 2 Charlton M, et al. Gastroenterology.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir + RBV in Sofosbuvir-Experienced HCV GT1 Retreatment of Sofosbuvir Failures Phase 2 Treatment.

Hepatitis web study Hepatitis web study 3D + RBV in Liver Transplant Recipients with Recurrent HCV GT1 CORAL-I Phase 2 Treatment Naïve and Treatment Experienced.

Hepatitis web study Hepatitis web study 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + RBV in GT1 SAPPHIRE-II Phase 3 Treatment Experienced Zeuzem.

Hepatitis web study Hepatitis web study 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + RBV in GT1 SAPPHIRE-I Phase 3 Treatment Naïve Feld JJ, et.

Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV GT 4 Egyptian Ancestry Trial Phase 2 Ruane PJ, et al. J Hepatol. 2015;62:

Hepatitis web study Hepatitis web study Simeprevir + Sofosbuvir +/- Ribavirin in Genotype 1 COSMOS Trial Phase 2a, Treatment Naïve and Treatment Experienced.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in GT1 or GT4 and HIV Coinfection ION-4 Phase 3 Treatment Naïve and Treatment Experienced.

Hepatitis web study Hepatitis web study Sofosbuvir ELECTRON (Overview): 6 parts, 22 arms Phase 2 Treatment Naïve and Treatment Experienced Source: Gilead.

Hepatitis web study Hepatitis web study Daclatasvir + Sofosbuvir in Genotype 3 ALLY-3 Study Phase 3 Treatment-Naïve and Treatment-Experienced Nelson DR,

Hepatitis web study Hepatitis web study Peginterferon alfa-2b + Ribavirin in Blacks & Non-Hispanic Whites Phase 3 Treatment Naïve, Chronic HCV Muir AJ,

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir + RBV in HCV GT 1,4 and Advanced Liver Disease SOLAR-1 (Cohorts A and B) Phase 2 Treatment.

Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin in HCV Genotype 1 NIAID/NIH Trial Phase 2, Treatment Naïve Treatment Naïve (unfavorable.

Hepatitis web study Hepatitis web study Sofosbuvir + Peginterferon + Ribavirin in Genotype 2 or 3 LONESTAR-2 Phase 2 Treatment Experienced Lawitz E, et.

Hepatitis web study Hepatitis web study Simeprevir + Sofosbuvir in GT1 with Cirrhosis OPTIMIST-2 Trial Phase 3 Treatment Naïve and Treatment Experienced.

Hepatitis web study Hepatitis web study Sofosbuvir + Ribavirin to Prevent Post-Transplant HCV Recurrence Phase 2 Curry MP, et al. Gastroenterology. 2014;September.

Daclatasvir + Asunaprevir in Genotype 1b HALLMARK-DUAL Study

Hepatitis web study Hepatitis web study Daclatasvir + Asunaprevir + Peg/RBV in Genotype 1 and 4 HALLMARK-QUAD Study Phase 3 Treatment-Experienced Jensen.

Hepatitis web study Hepatitis web study Simeprevir versus Telaprevir with PR in GT1 ATTAIN Trial Phase 3 Treatment Experienced Reddy KR, et al. Lancet.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir in HCV Genotype 4 NIAID SYNERGY (Genotype 4) Phase 2 Treatment Naïve and Treatment Experienced.

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIH SYNERGY Phase 2 Treatment Naïve (unfavorable baseline.

Daclatasvir + Sofosbuvir +/- Ribavirin in Genotype 1-3 Trial

Daclatasvir + Sofosbuvir in Genotype 3 ALLY-3 Study

Phase 3 Treatment-Naïve and Treatment-Experienced

Phase 3 Treatment-Naïve and Treatment-Experienced

Phase 3b Treatment-Naive

Phase 3 Treatment-Naïve and Treatment-Experienced

Phase 2b Treatment-Naïve

Phase 2 Treatment Naïve (unfavorable baseline treatment characteristics) Ledipasvir-Sofosbuvir +/- 3rd DAA in HCV Genotype 1 NIAID SYNERGY: Genotype.

Phase 3 Treatment-Naïve and Treatment-Experienced

Simeprevir in HIV Coinfection, GT-1 C212 Trial

Ombitasvir + Paritaprevir + Ritonavir +/- Ribavirin in HCV GT4 PEARL-I

Phase 3 Treatment-Naïve and Treatment-Experienced

Daclatasvir + Peg/RBV in Treatment-Naïve Genotype 4 COMMAND-4 Study

Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2

Phase 2 Treatment Naïve and Treatment Experienced

Ledipasvir-Sofosbuvir +/- Ribavirin for 8 or 12 weeks in HCV GT1 ION-3

Phase 3 Treatment Naïve and Treatment Experienced HIV Coinfection

Phase 3 Treatment-Naïve and Treatment-Experienced

Phase 2 Treatment Experienced (with Sofosbuvir and Ribavirin)

Phase 3 Treatment-Naïve and Treatment-Experienced

Phase 3 Treatment-Naïve and Treatment-Experienced

Glecaprevir-Pibrentasvir in Non-Cirrhotic Genotype 2 ENDURANCE-2

Presentation transcript:

Hepatitis web study Hepatitis web study Ledipasvir-Sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIAID SYNERGY Phase 2 Treatment Naïve (unfavorable baseline treatment characteristics) Kohli A, et al. Lancet. 2015:385:

Hepatitis web study Source: Kohli A, et al. Lancet. 2015:385: Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1 NIAID SYNERGY Trial: Features

Hepatitis web study Source: Kohli A, et al. Lancet. 2015:385: Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1 NIAID SYNERGY Trial: Features LDV-SOF + GS-9669 Treatment Naïve All stages fibrosis n = 20 LDV-SOF + GS-9451 n = 20 LDV-SOF Treatment Naïve Cirrhosis excluded Abbreviations: LDV-SOF= ledipasvir-sofosbuvir Drug Dosing Ledipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once daily GS-9669: 500 mg once daily GS-9451: 80 mg once daily Week SVR12

Hepatitis web study Source: Kohli A, et al. Lancet. 2015:385: Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1 NIAID SYNERGY Trial: Participants Baseline Characteristic LDV-SOF x 12 weeks (n=20) LDV-SOF + GS-9669 x 6 weeks (n=20) LDV-SOF + GS-9451 x 6 weeks (n=20) Age, mean5754 Male, % Black, % White, % HCV genotype, % 1A 1B HCV RNA >800,000 IU/ml, % IL28B CT/TT, % Advanced fibrosis, % Knodell score 3 Knodell score

Hepatitis web study Source: Kohli A, et al. Lancet. 2015:385: Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1 NIAID SYNERGY Trial: Viral Kinetics Time (days) Log 10 Median HCV RNA (IU/ml) Sofosbuvir + Ledipasvir Sofosbuvir + Ledipasvir + GS-9669 Sofosbuvir + Ledipasvir + GS-9451 *p<0.05

Hepatitis web study Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1 NIAID SYNERGY Trial: Features NIH SYNERGY: SVR 12 by Treatment Regimen Source: Kohli A, et al. Lancet. 2015:385: /2019/20*19/20^ *1 patient relapsed 2 weeks after completion of treatment ^1 patient lost to follow-up after reaching SVR at 4 weeks

Hepatitis web study Source: Kohli A, et al. Lancet. 2015:385: Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1 NIAID SYNERGY Trial: Interpretation Interpretation: “In this small proof-of-concept study, two different three- drug regimens that were given for 6 weeks resulted in high cure rates for HCV infection with excellent tolerability. Addition of a third potent direct-acting antiviral drug can reduce the duration of treatment required to achieve sustained viral response in patients with chronic HCV genotype 1 infection without cirrhosis.”

Hepatitis web study Hepatitis web study This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention.