Treatment of hepatitis C: the use of the new pangenotypic direct‐acting antivirals in “special populations”

Pol, Stanislas; Parlati, Lucia

doi:10.1111/liv.13626

Cited by 40 publications

(25 citation statements)

References 48 publications

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“…The efficacy and safety of the once-daily, RBV-free, glecaprevir/pibrentasvir regimen was evaluated in HCV-infected patients in eight global registrational phase 2 and 3 studies: SURVEYOR-1 and -2, ENDURANCE-1, -2, -3, and -4, and EXPEDITION-1 and -4 ( 20 – 28 ). Phylogenetic analysis of HCV sequences obtained from 2,173 patients in the ITT population with available baseline NS3/4A and/or NS5A sequences identified 37 subtypes.…”

Section: Discussionmentioning

confidence: 99%

“…Glecaprevir, an HCV NS3/4A protease inhibitor (identified by AbbVie and Enanta), and pibrentasvir, an NS5A inhibitor, are next-generation HCV inhibitors with in vitro antiviral activity against genotypes 1 through 6, with no or little loss of potency against common resistance-associated amino acid substitutions ( 18 , 19 ). Glecaprevir at 300 mg and pibrentasvir at 120 mg (without RBV), coformulated into a fixed-dose combination tablet taken once daily with food, were evaluated as a pan-genotypic regimen in eight phase 2 and 3 clinical studies: SURVEYOR-1 and -2, ENDURANCE-1, -2, -3, and -4, and EXPEDITION-1 and -4 ( 20 – 28 ). The trials evaluated glecaprevir/pibrentasvir for 8, 12, and 16 weeks in patients chronically infected with GT1, -2, -3, -4, -5 and -6 and compensated liver disease (with and without cirrhosis), including treatment-naive (TN) patients and treatment-experienced (TE) patients treated with pegylated IFN (peg-IFN) and RBV with or without sofosbuvir (TE-PRS), patients with HIV coinfection, and patients with advanced renal disease.…”

Section: Introductionmentioning

confidence: 99%

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Pooled Resistance Analysis in Patients with Hepatitis C Virus Genotype 1 to 6 Infection Treated with Glecaprevir-Pibrentasvir in Phase 2 and 3 Clinical Trials

Krishnan

Pilot‐Matias

Schnell

et al. 2018

Antimicrob Agents Chemother

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Over 2,200 patients infected with hepatitis C virus (HCV) genotypes (GT) 1 to 6, with or without cirrhosis, who were treatment naive or experienced to interferon, ribavirin, and/or sofosbuvir were treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks in eight registrational phase 2 and 3 clinical studies. High rates of sustained virologic response at 12 weeks postdosing (SVR12) were achieved with a <1% virologic failure (VF) rate.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Pooled Resistance Analysis in Patients with Hepatitis C Virus Genotype 1 to 6 Infection Treated with Glecaprevir-Pibrentasvir in Phase 2 and 3 Clinical Trials

Krishnan

Pilot‐Matias

Schnell

et al. 2018

Antimicrob Agents Chemother

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“…Recognized as being predominantly sexually transmitted, the spread of HCV among MSM may have been facilitated by other concurrent sexually transmitted diseases (STDs), unprotected anal sex, serosorting, chemsex, increased international travel and the dynamics of social networking resulting from advances in communication technology . However, high HCV cure rates have become achievable with direct antiviral agents (DAAs) against HCV . Unrestricted DAA availability in the Netherlands has led to a 51% decrease in acute HCV infections among HIV–positive MSM .…”

Section: Introductionmentioning

confidence: 99%

Molecular epidemiology of acute HCV infection in HIV–positive patients from Hong Kong, Taipei, Tokyo

Sun

Uemura

Wong

et al. 2019

Liver International

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Background: Acute hepatitis C virus (HCV) infections have been increasingly reported among human immunodeficiency virus (HIV)-positive men who have sex with men (MSM) in the Asia-Pacific region. It remains unknown whether international network of HCV transmission has occurred in this region. Methods: HIV-positive patients with acute HCV infection, defined as HCV seroconversion within a year or documented acute hepatitis with seroconversion, diagnosed in Hong Kong, Taipei and Tokyo during 2010-2016 were included in this molecular epidemiology study. The NS5B region of the HCV genome (365 bp) was amplified using nested polymerase chain reaction and sequenced. Results: Of 234 HIV-positive patients with acute HCV infection, all were male with 94% being MSM. At the diagnosis of acute HCV infection, 73.5% had concurrent sexually transmitted diseases and 88.0% were receiving combination antiretroviral therapy. The most prevalent HCV genotype was 3a, 2a and 1b in Hong Kong, Taipei and Tokyo respectively. Nine independent clusters belonging to five genotypes (1b, 2a, 2c, 3a and 6a) were identified, each of which occurred in one city without overlapping except for one 3a sequence from Taipei that was closely related genetically to the Hong Kong cluster. Conclusions: No international network of HCV transmission was identified among HIV-positive patients in the three Asia-Pacific cities. The transmission dynamics of

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“…Hepatitis C treatment has undergone several changes in recent years, especially after the arrival of direct-acting antivirals (DAAs) (1) . Acting at different stages of viral replication, these drugs reach sustained virological response (SVR) levels higher than 90%, resulting in a curable infection not only in the general population, but also in special groups such as transplanted and dialysis patients (2,3) .…”

Section: Introductionmentioning

confidence: 99%

Hepatitis C Treatment of Renal Transplant and Chronic Kidney Disease Patients: Efficacy and Safety of Direct-Acting Antiviral Regimens Containing Sofosbuvir

Michels

Feldner

Carvalho-Filho

et al. 2020

Arq. Gastroenterol.

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BACKGROUND: Direct-acting antivirals have revolutionized hepatitis C treatment, also for patients with chronic kidney disease (CKD), but some controversy exists regarding the use of sofosbuvir (SOF) in patients with glomerular filtration rate (GFR) <30 mL/min. OBJECTIVE: To evaluate the efficacy and safety of these regimens for hepatitis C treatment of patients with CKD and after renal transplantation, as well as the impact of SOF on renal function in non-dialysis patients. METHODS: All patients with hepatitis C and CKD or renal transplant treated with direct-acting antivirals at a referral center in Brazil between January 2016 and August 2017 were included. Efficacy was evaluated based on viral load (HCV RNA) and a sustained virological response (SVR) consisting of undetectable RNA 12 and/or 24 weeks after the end of treatment (SVR12 and SVR24) was defined as cure. Safety was determined by adverse events and ribavirin, when combined, was administered in escalating doses to all patients with GFR <60 mL/min. The impact of SOF on renal function was determined by the measurement of baseline creatinine during and after the end of treatment and its increase was evaluated using the Acute Kidney Injury Network (AKIN) classification. RESULTS: A total of 241 patients (52.7% females) with a mean age of 60.72±10.47 years were included. The combination of SOF+daclatasvir was the predominant regimen in 75.6% of cases and anemia was present in 28% of patients who used ribavirin (P=0.04). The SVR12 and SVR24 rates were 99.3% and 97.1%, respectively. The treatment was well tolerated and there were no major clinically relevant adverse events, with the most prevalent being asthenia (57.7%), itching (41.1%), headache (40.7%), and irritability (40.2%). Among conservatively treated and renal transplant patients, oscillations of creatinine levels (AKIN I) were observed in 12.5% of cases during treatment and persisted in only 8.5% after the end of treatment. Of these, 2.0% had an initial GFR <30 mL/min and this percentage decreased to 1.1% after SOF use. Only 0.5% and 1.6% of the patients progressed to AKIN II and AKIN III elevation, respectively. CONCLUSION: The direct-acting antivirals were safe and efficacious in CKD patients treated with SOF-containing regimens, with the observation of high SVR rates, good tolerability and few severe adverse events. The combination with ribavirin increased the risk of anemia and the administration of escalating doses seems to be useful in patients with GFR <60 mL/min. In patients with GFR <30 mL/min, SOF had no significant renal impact, with serum creatinine returning to levels close to baseline after treatment.

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Treatment of hepatitis C: the use of the new pangenotypic direct‐acting antivirals in “special populations”

Abstract: Background & Aims: The recommended combination of pangenotypic direct-acting anti-

Cited by 40 publications

References 48 publications

Pooled Resistance Analysis in Patients with Hepatitis C Virus Genotype 1 to 6 Infection Treated with Glecaprevir-Pibrentasvir in Phase 2 and 3 Clinical Trials

Pooled Resistance Analysis in Patients with Hepatitis C Virus Genotype 1 to 6 Infection Treated with Glecaprevir-Pibrentasvir in Phase 2 and 3 Clinical Trials

Molecular epidemiology of acute HCV infection in HIV–positive patients from Hong Kong, Taipei, Tokyo

Hepatitis C Treatment of Renal Transplant and Chronic Kidney Disease Patients: Efficacy and Safety of Direct-Acting Antiviral Regimens Containing Sofosbuvir

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