Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections

Gane, Edward; Schwabe, Christian; Hyland, Robert H.; Yin, Yuehui; Svarovskaia, Evguenia S.; Stamm, Luisa M.; Brainard, Diana M.; McHutchison, John G.; Stedman, Catherine

doi:10.1053/j.gastro.2016.05.021

Cited by 62 publications

(85 citation statements)

References 20 publications

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“…The treatment paradigm for individuals with HCV infection is evolving rapidly [2][3][4]26]. High interferon-free DAA efficacy demonstrated in clinical trials appears to be translating into the "real world", even among populations considered "high risk".…”

Section: Resultsmentioning

confidence: 99%

“…Highly effective, well-tolerated interferon-free direct-acting antivirals (DAA) have revolutionised hepatitis C virus (HCV) therapeutics [1], with daily fixed-dose combination DAA regimens providing cure in greater than 95% of individuals with chronic infection [2][3][4]. The availability of DAA therapy has given rise to significant therapeutic optimism, providing an opportunity for broad treatment scale-up with the potential for HCV elimination among marginalised or "high-risk" populations, including people who inject drugs (PWID) and people with HIV/HCV coinfection [5][6][7][8].…”

Section: Introductionmentioning

confidence: 99%

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HCV Cure and Reinfection Among People With HIV/HCV Coinfection and People Who Inject Drugs

Martinello¹,

Hajarizadeh²,

Grebely³

et al. 2017

Curr HIV/AIDS Rep

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Concern that HCV reinfection may compromise HCV treatment outcomes is sometimes cited as a reason for not offering treatment to current and former PWID. However, the incidence of reinfection following interferon-based treatment for chronic HCV is low among PWID. Reinfection rates in HIV-positive men-who-have-sex-with-men (MSM) are varied, with high incidence reported in some cohorts. Mathematical modelling suggests that substantial reductions in HCV incidence and prevalence could be achieved with targeted DAA therapy among those at the highest risk of ongoing transmission. This review will summarise the recent literature on DAA efficacy in PWID and people with HIV/HCV coinfection, discuss the individual- and population-level impact of DAA treatment scale-up and reinfection, and highlight ongoing and future research questions in expanding HCV care and treatment to those populations at high risk of ongoing HCV transmission.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

HCV Cure and Reinfection Among People With HIV/HCV Coinfection and People Who Inject Drugs

Martinello¹,

Hajarizadeh²,

Grebely³

et al. 2017

Curr HIV/AIDS Rep

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show abstract

“…LEPTON was a phase 2 trial investigating the safety and efficacy of a pangenotype triple DAA therapy including SOF/VEL and GS-9857, a next generation NS3/4A protease inhibitor[81]. Three HCV-3 infected groups of patients were included: treatment naïve with compensated cirrhosis, PEG+RBV failures with cirrhosis, and DAA-failures with and without cirrhosis.…”

Section: Treatment Of Hcv Genotype 3 Infectionmentioning

confidence: 99%

Genotype 3 Infection: The Last Stand of Hepatitis C Virus

Chan

Patel

Naggie

2017

Drugs

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Hepatitis C Virus(HCV) represents a significant global disease burden with an estimated 130 – 150 million people worldwide living with chronic HCV infection. Within the 6 major clinical HCV genotypes, genotype 3 represents 22–30% of all infection, and is described as a unique entity with higher rates of steatosis, faster progression to cirrhosis, and higher rates of hepatocellular carcinoma. Hepatic steatosis in the setting of hepatitis C genotype 3 (HCV-3) is driven by viral influence on three major pathways: microsomal triglyceride transfer protein, sterol regulatory element-binding protein-1c, and peroxisome proliferator associated receptor-α. Historically with DAAs, the rates of cure for HCV-3 therapies lagged behind the other genotypes. As current therapies for HCV genotype 3 continue to close this gap, it is important to be cognizant of common drug interactions such as acid suppressing medication and amiodarone. In this review, we discuss the rates of steatosis in HCV-3, the mechanisms behind HCV-3 specific steatosis, and current and future therapies.

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“…The 8- and 12-week treatment regimens were safe and effective in treatment-naïve and pre-treated HCV patients, respectively. Of the entire study population, only two treatment-naïve and one treatment-experienced patients with cirrhosis discontinued the treatment due to AEs [28]. Table 2 summarizes the main phase II clinical trials.…”

Section: Clinical Efficacymentioning

confidence: 99%

Sofosbuvir + velpatasvir + voxilaprevir for the treatment of hepatitis C infection

Cory

Gong

Kodidela

et al. 2018

Expert Opinion on Pharmacotherapy

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Introduction Hepatitis C is a disease with a significant global impact. Over the last several years, the treatment of the disease has been revolutionized. Therapy has transformed over the last several years with the approval of second generation direct acting antivirals, and currently utilized medications for the treatment of hepatitis C are significantly more efficacious with better safety profiles than previously approved treatments. Treatment for individuals who have failed therapy on direct acting antivirals has, until recently, been complex and difficult to treat, but the approval of sofosbuvir/velpatasvir/voxilaprevir represents a new therapeutic option for these individuals. Areas covered Sofosbuvir/velpatasvir/voxilaprevir is a recently approved therapeutic combination for the treatment of hepatitis C. This article reviews the studies leading to the approval of the combination, and its efficacy and safety profile. Expert opinion Sofosbuvir/velpatasvir/voxilaprevir fills one of the previously unfilled niches for the treatment of hepatitis C, that of the treatment of individuals who have failed therapy with resistant virus. With the filling of this niche, there appears to be a general slowing of the development of new therapeutics. Although understandable, in the long term, there are considerable risks associated with the decreased development of new drugs to treat hepatitis C.

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Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections

Cited by 62 publications

References 20 publications

HCV Cure and Reinfection Among People With HIV/HCV Coinfection and People Who Inject Drugs

HCV Cure and Reinfection Among People With HIV/HCV Coinfection and People Who Inject Drugs

Genotype 3 Infection: The Last Stand of Hepatitis C Virus

Sofosbuvir + velpatasvir + voxilaprevir for the treatment of hepatitis C infection

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