Long-term follow-up of patients receiving boceprevir for treatment of chronic hepatitis C

Howe, Anita Y.M.; Long, Jianmin; Nickle, David C.; Barnard, Richard; Thompson, Seth; Howe, John A.; Alves, Katia

doi:10.1016/j.antiviral.2014.10.010

Cited by 25 publications

(23 citation statements)

References 19 publications

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“…Most were responders (n = 1329), 99% of whom maintained SVR until their latest follow‐up visit, confirming the long‐term durability of SVR achieved with DCV‐based regimens. This is consistent with limited follow‐up data available for pegIFNα/RBV with or without DAAs . Only 3 responders treated with DAA‐only (n = 1) or IFN‐containing regimens (n = 2) relapsed post‐parent study completion; 9, treated with DAA‐only (n = 2) or IFN‐containing (n = 7) regimens, relapsed by parent study follow‐up Week 24.…”

Section: Discussionsupporting

confidence: 81%

Long‐term follow‐up of clinical trial patients treated for chronic HCV infection with daclatasvir‐based regimens

Reddy

Pol

Thuluvath

et al. 2017

Liver International

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Background & AimsDaclatasvir has achieved high sustained virologic response (SVR) rates in diverse hepatitis C virus (HCV) populations. This study evaluated the long‐term efficacy and safety of daclatasvir‐based regimens administered during clinical studies.MethodsPatients enrolled within 6 months of parent study completion or protocol availability at the study sites. The primary objective was durability of SVR at follow‐up Week 12 (SVR12). Secondary objectives included analysing HCV sequences in non‐responders or responders who relapsed, and characterization of liver disease progression.ResultsBetween 24 February 2012 and 17 July 2015, this study enrolled and began following 1503 recipients of daclatasvir‐based regimens (follow‐up cut‐off, 13 October 2015); 60% were male, 18% aged ≥65 years, 87% had genotype‐1a (42%) or ‐1b (45%) infection, and 18% had cirrhosis. Median follow‐up from parent study follow‐up Week 12 was 111 (range, 11‐246) weeks. 1329/1489 evaluable patients were SVR12 responders; 1316/1329 maintained SVR until their latest visit. Twelve responders relapsed by (n = 9) or after (n = 3) parent study follow‐up Week 24; one was reinfected. Relapse occurred in 3/842 (0.4%) and 9/487 (2%) responders treated with interferon‐free or interferon‐containing regimens, respectively. Hepatic disease progression and new hepatocellular carcinoma were diagnosed in 15 and 23 patients, respectively. Among non‐responders, emergent non‐structural protein‐5A (NS5A) and ‐3 (NS3) substitutions were replaced by wild‐type sequences in 27/157 (17%) and 35/47 (74%) patients, respectively.ConclusionsSVR12 was durable in 99% of recipients of daclatasvir‐based regimens. Hepatic disease progression and new hepatocellular carcinoma were infrequent. Emergent NS5A substitutions persisted longer than NS3 substitutions among non‐responders.

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Section: Discussionsupporting

confidence: 81%

Long‐term follow‐up of clinical trial patients treated for chronic HCV infection with daclatasvir‐based regimens

Reddy

Pol

Thuluvath

et al. 2017

Liver International

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“…Similar rates were noticed in several smaller, one-centre studies following treatment with Peg-IFN+RBV 21,22. Addition of DAA to interferonbased therapy did not exclude the risk of relapse, as it was shown in patients after triple therapy containing either boceprevir or daclatasvir 23. 24 However according to the most recent study by Zoulim et al 25 all 200 patients who achieved SVR after interferon containing triple therapy with simeprevir maintained SVR until the last available visit with median follow-up time of 35.8 months.…”

supporting

confidence: 62%

Durability of virologic response, risk of de novo hepatocellular carcinoma, liver function and stiffness 2 years after treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in the AMBER, real‐world experience study

Flisiak

Janczewska

Łucejko

et al. 2018

Journal of Viral Hepatitis

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We followed for 2 years patients treated with direct-acting agents (DAA) to assess long-term durability of virologic response, improvement of liver function, reduction in liver stiffness (LS) and risk of hepatocellular carcinoma (HCC). The study included patients from 16 hepatologic centres involved in the AMBER, investigator-initiated study on treatment of chronic hepatitis C patients within a programme preceding EU registration of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin. A total of 204 patients among 209 from the primary study were enrolled, 200 with available testing at 2-year follow-up (2yFU) with undetectable HCV RNA (198 responders and 2 nonresponders retreated). During 2yFU, 4 patients died, 17 had hepatic decompensation and 3 needed liver transplantation. De novo hepatocellular carcinoma was diagnosed in 4 and its recurrence in 3 patients. Significant decreases in bilirubin, MELD, Child-Pugh scores and liver stiffness, and increases in albumin level were observed during 2yFU. Strengths of the study were a fixed period of post-treatment follow-up, prospective character of the study and high proportion of available patients from the primary study. The major weaknesses were lack of a comparative arm and relatively insufficient number of patients for subsets analysis. In conclusion, 2-year follow-up confirmed durability of virologic response after treatment of HCV infection with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin. It was accompanied by significant improvement of major measures of hepatic function and reduction of hepatic stiffness. Successful therapy did not prevent hepatic decompensation, HCC or death in cirrhotics that support the need for longer than 2-year monitoring for possible disease progression.

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“…Given the known fitness cost of most RAVs, it is not surprising that some RAVs decline to below the detectability of population sequencing following cessation of therapy, but in some cases specific RAVs appear to be maintained [22][23][24]. It is possible that the dominance of specific RAVs after treatment cessation is due to their inherent fitness.…”

Section: Original Articlementioning

confidence: 99%

Primer ID ultra-deep sequencing reveals dynamics of drug resistance-associated variants in breakthrough hepatitis C viruses: relevance to treatment outcome and resistance screening

et al. 2016

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Long-term follow-up of patients receiving boceprevir for treatment of chronic hepatitis C

Cited by 25 publications

References 19 publications

Long‐term follow‐up of clinical trial patients treated for chronic HCV infection with daclatasvir‐based regimens

Long‐term follow‐up of clinical trial patients treated for chronic HCV infection with daclatasvir‐based regimens

Durability of virologic response, risk of de novo hepatocellular carcinoma, liver function and stiffness 2 years after treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in the AMBER, real‐world experience study

Primer ID ultra-deep sequencing reveals dynamics of drug resistance-associated variants in breakthrough hepatitis C viruses: relevance to treatment outcome and resistance screening

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