Short Duration Treatment with Sofosbuvir/Velpatasvir plus GS-9857 in Treatment-Naive Genotype 1-6 HCV-Infected Patients with or without Cirrhosis

Gane, Ed; Nguyen, M.; Kwo, Paul Y.; Kowdley, Kris V.; Reau, Nancy; Jacobson, Ira M.; Curry, Michael P.; Pearlman, Brian L.; Khalid, Omer; Everson, G.; Gordon, S.; Poulos, John E.; Sheikh, Aasim; Bernstein, David; Yang, Jenny C.; Stamm, Luisa M.; An, Di; Dvory‐Sobol, Hadas; Brainard, Diana M.; McHutchison, John G.; Tong, Myron J.; Tsai, Naoky; Beavers, Kimberly L.; Rabinovitz, Mordechai; Shiffman, M.; Stedman, Catherine A.; Läwitz, E.

doi:10.1016/s0168-8278(16)01478-1

Cited by 3 publications

(6 citation statements)

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“…Small studies have evaluated adding the pangenotypic protease inhibitor GS-9857 to sofosbuvir/velpatasvir. In non-cirrhotic patients, this triple combination given for only 6 weeks led to SVR in all 21 genotype 3 treatment-naïve patients treated, and was also highly effective across all genotypes when given for 8 weeks [57]. Extending the duration to 12 weeks in treatment-experienced patients with or without cirrhosis led to SVR in 34 of 35 (97%) patients [58].…”

Section: Genotypementioning

confidence: 99%

Second generation direct-acting antivirals – Do we expect major improvements?

Feld

Foster

2016

Journal of Hepatology

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The rapid progress in the development of direct-acting antiviral agents for hepatitis C has allowed the vast majority of patients to receive all oral therapy that will eliminate their virus. The success of the new regimens has led many to question the need for further developments in this field. Major improvements in drugs for hepatitis C are unlikely but we predict incremental improvements in the next few years. We hope that the next generation of drugs will address the unresolved issues for patients with genotype 3 infection where current treatments are still not entirely satisfactory and we anticipate improvements in the management of patients with renal failure. Shorter duration treatments, perhaps with novel modes of action, may allow simplified 'one-dose' treatments that will greatly expand our ability to treat patients who have difficulty accessing current services and we anticipate that the clinical community will better define the patients with advanced disease who will benefit from therapy prior to liver transplantation.

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Section: Genotypementioning

confidence: 99%

Second generation direct-acting antivirals – Do we expect major improvements?

Feld

Foster

2016

Journal of Hepatology

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“…Limitations of this study include the low number of patients enrolled per treatment arm, particularly treatment‐experienced patients with cirrhosis. However, other pilot studies investigating short treatment durations, including those with genotype 2 infection, had similarly limited numbers of patients enrolled, and yielded comparably low SVR12 rates . Another limitation of the current study is that OBV/PTV/r + SOF was not evaluated without RBV in genotype 3‐infected patients with cirrhosis.…”

Section: Discussionmentioning

confidence: 87%

“…However, other pilot studies investigating short treatment durations, including those with genotype 2 infection, had similarly limited numbers of patients enrolled, and yielded comparably low SVR12 rates. [29][30][31][32] Another limitation of the current study is that OBV/PTV/r + SOF was not evaluated without RBV in genotype 3-infected patients with cirrhosis. The results of the C-ISLE study as well as the POLARIS-3 study 33 suggest that RBV may not be needed when a regimen comprising these three mechanisms of action is used in genotype 3-infected patients with cirrhosis.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety results of patients with HCV genotype 2 or 3 infection treated with ombitasvir/paritaprevir/ritonavir and sofosbuvir with or without ribavirin (QUARTZ II‐III)

Shafran

Shaw

Charafeddine

et al. 2017

Journal of Viral Hepatitis

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The efficacy and safety of an investigational combination of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) plus sofosbuvir (SOF) ± ribavirin (RBV) in patients with HCV genotype 2 or 3 infection with or without cirrhosis was evaluated. Patients with HCV genotype 3 infection without cirrhosis were randomized to receive OBV/PTV/r + SOF ± RBV for 12 weeks; OBV/PTV/r + SOF + RBV was administered to genotype 3-infected patients with cirrhosis for 12 weeks and to genotype 2-infected patients without cirrhosis for either 6 or 8 weeks. Efficacy was assessed by sustained virologic response [HCV RNA <25 IU/mL] 12 weeks post-treatment (SVR12). Safety was assessed in all treated patients. In patients with genotype 3 infection with or without cirrhosis treated with 12 weeks of OBV/PTV/r + SOF ± RBV, the overall SVR12 rate was 98% (50/51), with no virologic failures. Patients with genotype 2 infection treated with OBV/PTV/r + SOF + RBV had SVR12 rates of 90% (9/10) and 44% (4/9) following 8- and 6-week treatment durations, respectively; failure to achieve SVR12 for these patients was due to relapse without baseline or treatment-emergent resistance-associated substitutions. Thus, the investigational combination of OBV/PTV/r with SOF ± RBV was well tolerated and achieved high SVR rates with no virologic failures in patients with genotype 3 infection. Combining direct-acting antivirals with complementary mechanisms of action and different viral targets may be an effective treatment strategy that may allow for shorter durations of therapy.

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“…In a phase 2 study, 6 weeks of sofosbuvir, velpatasvir, and GS-9857 in 21 treatment-naïve patients with cirrhosis resulted in an SVR rate of 100%. 24 In cirrhotic patients treated for eight weeks with this regimen, the SVR was 94% (17/18). 24…”

Section: Daa Therapy In Treatment-naïve Gt3 Hcv Patientsmentioning

confidence: 94%

“…In a phase 2 study, 6 weeks of sofosbuvir, velpatasvir, and GS-9857 in 21 treatmentnaïve patients with cirrhosis resulted in an SVR rate of 100%. 24 In cirrhotic patients treated for eight weeks with this regimen, the SVR was 94% (17/18). 24 Sofosbuvir in addition to ombitasvir, an NS5A inhibitor, and ritonavir-boosted paritaprevir, an NS3/4A protease inhibitor, may be yet another option for the treatment of GT3 patients.…”

Section: Daa Therapy In Treatment-naïve Gt3 Hcv Patientsmentioning

confidence: 94%

Treatment of Genotype 3 Chronic Hepatitis C Virus Infection

Sadler

Agarwal

2017

Clinical Medicine Insights: Therapeutics

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Genotype 3 (GT3) hepatitis C virus (HCV), the second most common HCV genotype worldwide, has emerged as the most difficult-to-cure genotype. Sustained virological response (SVR) rates with new direct-acting antiviral regimens for GT3 patients who are treatment-naïve and noncirrhotic are now similar to those seen in patients with non-GT3 HCV infection. However, GT3 HCV patients who are treatment-experienced or who have cirrhosis, particularly those with decompensated disease, continue to be a more challenging group to treat due to lower SVR rates. Here, we review the current evidence for the treatment of patients with GT3 HCV including current data for patients with GT3 HCV who are HIV coinfected. Future studies in GT3 HCV treatment will need to focus on direct-acting antiviral combinations that improve cure rates and potentially eliminate the need for ribavirin in GT3 patients who have advanced liver disease. The significance of HCV resistance-associated variants in GT3 HCV patients who have failed prior treatment also needs further assessment to help guide re-treatment strategies.

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Short Duration Treatment with Sofosbuvir/Velpatasvir plus GS-9857 in Treatment-Naive Genotype 1-6 HCV-Infected Patients with or without Cirrhosis

Cited by 3 publications

References 0 publications

Second generation direct-acting antivirals – Do we expect major improvements?

Second generation direct-acting antivirals – Do we expect major improvements?

Efficacy and safety results of patients with HCV genotype 2 or 3 infection treated with ombitasvir/paritaprevir/ritonavir and sofosbuvir with or without ribavirin (QUARTZ II‐III)

Treatment of Genotype 3 Chronic Hepatitis C Virus Infection

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