Real-world effectiveness of daclatasvir plus sofosbuvir and velpatasvir/sofosbuvir in hepatitis C genotype 2 and 3

Belperio, Pamela S.; Shahoumian, Troy A.; Loomis, Timothy P.; Molé, L; Backus, Lisa I.

doi:10.1016/j.jhep.2018.09.018

Cited by 81 publications

(97 citation statements)

References 16 publications

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“…First, we did not evaluate SOF in combination with velpatasvir (VEL) for HCV‐2 patients because at the time of presentation, SOF/VEL has not been approved by regulatory authorities in Taiwan. Recently, two real‐world studies evaluating the effectiveness of brand‐name or generic SOF/VEL for HCV‐2 patients, showing that the SVR 12 rates to be 94% and 98%, respectively . Furthermore, SOF/VEL did not provide a better SVR 12 rate than SOF/DCV for these patients .…”

Section: Discussionmentioning

confidence: 99%

“…Recently, two real‐world studies evaluating the effectiveness of brand‐name or generic SOF/VEL for HCV‐2 patients, showing that the SVR 12 rates to be 94% and 98%, respectively . Furthermore, SOF/VEL did not provide a better SVR 12 rate than SOF/DCV for these patients . Taken together, SOF in combination with DCV or LDV would also be appealing for DAA‐naïve HCV‐2 patients, particularly in countries where SOF/VEL has been approved for daily practice.…”

Section: Discussionmentioning

confidence: 99%

“…Following the clinical trials which demonstrated the excellent efficacy and safety profiles, the real‐world data in HCV‐2 patients receiving SOF in combination with RBV or DCV for 12–24 weeks showed that the SVR 12 rates ranges from 92% to 100% . However, the real‐world data regarding the performance of SOF in combination with LDV for HCV‐2 patients were lacking.…”

Section: Introductionmentioning

confidence: 99%

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Sofosbuvir‐based direct acting antiviral therapies for patients with hepatitis C virus genotype 2 infection

Liu

et al. 2019

J of Gastro and Hepatol

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Background and Aim Data regarding the comparative effectiveness and safety of sofosbuvir (SOF) in combination with ribavirin (RBV), daclatasvir (DCV), or ledipasvir (LDV) for hepatitis C virus genotype 2 (HCV‐2) patients were limited. We aimed to evaluate the performance of these regimens in Taiwan. Methods One hundred eighty‐seven HCV‐2 patients with compensated liver diseases receiving SOF in combination with RBV (n = 82), DCV (n = 66), or LDV (n = 39) for 12 weeks were retrospectively enrolled. The effectiveness was determined by sustained virologic response 12 weeks off therapy (SVR12). The patient characteristics potentially related to SVR12 were compared. The safety profiles and laboratory abnormalities were assessed. Results The SVR12 rates were 93.9% (95% confidence interval [CI]: 86.5–97.4%), 98.5% (95% CI: 91.9–99.7%), and 100% (95% CI: 91.0–100%) in patients receiving SOF combined with RBV, DCV, and LDV, respectively. All patients tolerated treatment well. The stratified SVR12 rates were comparable regardless of baseline characteristics or week 4 viral decline among these regimens. Six (3.2%) patients had serious adverse events which were not related to treatment. The rates of fatigue, pruritus, and anemia tended to be higher in patients receiving RBV (22.0%, 19.5%, and 8.5%) combination than those receiving DCV (10.6%, 6.1%, and 1.5%) or LDV (10.3%, 5.1%, and 0%) combination. Conclusions Sofosbuvir in combination with RBV, DCV, or LDV for 12 weeks is effective and well‐tolerated for HCV‐2 patients. Compared with DCV or LDV combination, the risks of fatigue, pruritus, and anemia are higher in patients receiving RBV combination.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Sofosbuvir‐based direct acting antiviral therapies for patients with hepatitis C virus genotype 2 infection

Liu

et al. 2019

J of Gastro and Hepatol

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“…A recently published paper on Veteran Affairs cohort of male HCV GT2 and GT3 subjects has compared SOF + DAC with SOF/VEL: rates of SVR12 are similar, even in different subgroups. In the paper by Belperio et al the rate of SVR12 is reduced in patients with a more advanced liver disease.…”

Section: Discussionmentioning

confidence: 99%

“…In the face of an abundance of literature on different single regimens to treat HCV‐GT3, direct comparisons among different regimens are limited . Treatment recommendations are based on small, non‐randomized trials or on comparisons with suboptimal and currently dismissed regimens (ie SOF + RBV, or SOF + pegylated interferon + RBV), with HIV coinfection and cirrhosis being often underrepresented.…”

Section: Introductionmentioning

confidence: 99%

Comparison of three therapeutic regimens for genotype‐3 hepatitis C virus infection in a large real‐life multicentre cohort

Soria

Fava

Bernasconi

et al. 2020

Liver International

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Background & Aims In the direct‐acting antiviral era, treatment of genotype‐3 HCV (HCV‐GT3) is still challenging. Real‐life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir (DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap. Methods Sustained virological response 12 weeks after treatment completion (SVR12) was assessed for all HCV‐GT3 patients consecutively treated within the Lombardia web‐based Navigatore HCV‐Network; differences in SVR12 across regimens were evaluated by logistic regression. Results Of the 2082 subjects with HCV‐GT3, 1544 were evaluable for comparisons between regimens: SOF + DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV‐positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV‐RNA. SVR12 was similar across groups: 94.8% in SOF + DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P = .065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P = .007) and lower median pretreatment Log10HCV‐RNA (5.87 vs 6.20, P = .001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF + DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV‐RNA were independently associated with SVR12. Conclusions In a large real‐life setting of HCV‐GT3‐infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF + DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier‐to‐treat patients allows ribavirin‐free and shorter schedules without mining SVR12 in this <> genotype.

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Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

2020

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Real-world effectiveness of daclatasvir plus sofosbuvir and velpatasvir/sofosbuvir in hepatitis C genotype 2 and 3

Cited by 81 publications

References 16 publications

Sofosbuvir‐based direct acting antiviral therapies for patients with hepatitis C virus genotype 2 infection

Sofosbuvir‐based direct acting antiviral therapies for patients with hepatitis C virus genotype 2 infection

Comparison of three therapeutic regimens for genotype‐3 hepatitis C virus infection in a large real‐life multicentre cohort

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

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