Ledipasvir plus sofosbuvir fixed-dose combination for 6 weeks in patients with acute hepatitis C virus genotype 1 monoinfection (HepNet Acute HCV IV): an open-label, single-arm, phase 2 study

Deterding, Katja; Spinner, Christoph D.; Schott, Eckart; Welzel, Tania M.; Gerken, Guido; Klinker, Hartwig; Spengler, Ulrich; Wiegand, Johannes; Wiesch, Julian Schulze zur; Pathil, Anita; Cornberg, Markus; Umgelter, Andreas; Zöllner, Caroline; Zeuzem, Stefan; Papkalla, Armin; Weber, Kristina; Hardtke, Svenja; Leyen, Heiko von der; Koch, Armin; Witzendorff, Dorothee von; Manns, Michael P.; Wedemeyer, Heiner

doi:10.1016/s1473-3099(16)30408-x

Cited by 115 publications

(84 citation statements)

References 24 publications

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“…Data are emerging regarding treatment of acute HCV infection with abbreviated courses of DAA regimens in both HCV monoinfection and HIV/HCV coinfection . There are presently insufficient data, however, to recommend abbreviated courses of any approved DAA regimens.…”

Section: Acute Hcv Infectionmentioning

confidence: 99%

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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Section: Acute Hcv Infectionmentioning

confidence: 99%

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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“…As with the excellent results observed in this study, pilot studies of shortened duration dual‐ and triple‐class DAA regimens for four, six and 8 weeks have demonstrated promising results in acute and recent HCV infection. In cohorts of acute HCV genotype 1 mono‐infection, high SVR was demonstrated with four (n = 14, SVR12 ITT 100%) and six weeks (n = 20, SVR12 ITT 100%) of sofosbuvir/ledipasvir and 8 weeks of sofosbuvir plus simeprevir (n = 15, SVR12 ITT 87%; PP 100%). Among HIV‐positive GBM with acute HCV genotypes 1a and 4, lower SVR (n = 26, SVR12 ITT 77%; PP 87%) was demonstrated with 6 weeks of sofosbuvir/ledipasvir; the three cases of relapse occurred in participants with high baseline HCV RNA (>6.9 log 10 IU/mL).…”

Section: Discussionmentioning

confidence: 99%

“…The paradigm of enhanced efficacy with shortened duration interferon‐based therapy in recent, as compared with chronic HCV infection, underpins current research questions . Clinical trials evaluating shortened duration DAA regimens in acute and recent HCV infection are underway, with early data providing encouraging results . Screening strategies in at‐risk populations recommend at least annual HCV testing .…”

Section: Introductionmentioning

confidence: 99%

Shortened therapy of eight weeks with paritaprevir/ritonavir/ombitasvir and dasabuvir is highly effective in people with recent HCV genotype 1 infection

Martinello

Bhagani

Gane

et al. 2018

Journal of Viral Hepatitis

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Paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 12 weeks are approved for treatment of chronic HCV genotype 1 infection. This study assessed the efficacy of shortened duration paritaprevir/ritonavir/ombitasvir and dasabuvir with or without ribavirin for 8 weeks among people with recent HCV infection. In this open-label single-arm trial conducted in Australia, England and New Zealand, adults with recent HCV (duration of infection <12 months) received paritaprevir/ritonavir/ombitasvir and dasabuvir (with weight-based ribavirin for genotypes 1a and 1, no subtype) for 8 weeks. The primary endpoint was sustained virological response at 12 weeks post-treatment (SVR12) in the intention-to-treat (ITT) population. Thirty people (median age 38 years, male 93%) commenced treatment (with ribavirin, 97%), of whom 77% (n = 23) were HIV-positive, 93% (n = 28) had genotype 1a infection and 53% (n = 16) had ever injected drugs. Median maximum ALT in the preceding 12 months was 433 IU/L (IQR 321, 1012). Acute clinical hepatitis with ALT > 10 x ULN was documented in 83% (n = 25); one participant (3%) had jaundice. At baseline, median estimated duration of infection was 30 weeks (range 11, 51), and median HCV RNA was 5.7 log IU/mL (range 2.7, 7.3). SVR12 was achieved in 97% (29/30; early discontinuation at week 2, n = 1; per protocol 100%, 29/29). No relapse or reinfection was observed. In conclusion, paritaprevir/ritonavir/ombitasvir and dasabuvir (with ribavirin) for eight weeks were highly effective among HIV-positive and HIV-negative individuals with recent HCV infection. These data support the use of this shortened duration direct-acting antiviral regimen in this population.

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“…The question remains, however, if even shorter courses could be effective. A 2016 study investigated a 6-week time course with ledipasvir/SOF for genotype 1 infection, showing a high SVR [35]. This contrasts to other previous trials with DAAs showing low efficacy with 6 weeks of therapy.…”

Section: Expert Opinionmentioning

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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Ledipasvir plus sofosbuvir fixed-dose combination for 6 weeks in patients with acute hepatitis C virus genotype 1 monoinfection (HepNet Acute HCV IV): an open-label, single-arm, phase 2 study

Cited by 115 publications

References 24 publications

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

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

Shortened therapy of eight weeks with paritaprevir/ritonavir/ombitasvir and dasabuvir is highly effective in people with recent HCV genotype 1 infection

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

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