Risk of hepatitis B virus reactivation with direct‐acting antivirals against hepatitis C virus: A cohort study from Egypt and meta‐analysis of published data

Kassas, Mohamed El; Shimakawa, Yusuke; Ali-Eldin, Zainab A.; Funk, A.; Wifi, Mohamed Naguib; Zaky, Samy; El-Raey, Fathiya; Esmat, Gamal; Fontanet, Arnaud

doi:10.1111/liv.13874

Cited by 16 publications

(12 citation statements)

References 41 publications

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Section: Patients With Concomitant Hbv Infectionmentioning

confidence: 99%

“…Cases of HBV re-activation (detected by the evidence of quantifiable HBV-DNA levels or an increase >1 log10 IU/mL from baseline) and ALT elevations > 2 times upper normal level have been reported in up two thirds of HBsAg positive patients treated with DAA [40,42,43]. In most patients the increase of HBV DNA levels was not associated with signs or symptoms of hepatitis and ALT elevations were mostly mild [40,[43][44][45]. Still, approximately 4% of patients with HBV re-activation after DAA treatment need to start antiviral treatment [39,40] and importantly, HBV re-activation in cirrhotic patients may lead to liver failure and death despite immediate nucleoside or nucleotide analogue (NUC) therapy [46].…”

Section: Patients With Concomitant Hbv Infectionmentioning

confidence: 99%

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Management and Treatment of Hepatitis C: Are There Still Unsolved Problems and Unique Populations?

Solitano

Torres

Pugliese

et al. 2021

Viruses

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Direct-acting antivirals (DAA) have revolutionized the treatment of patients with chronic hepatitis C virus (HCV) infection, possibly leading to HCV elimination by 2030 as endorsed by the World Health Organization (WHO). However, some patients belonging to the so-called unique or special populations are referred to as difficult-to-treat due to unreached sustained virological response, potential drug side effects or interactions or co-morbidities. Several years after the DAA introduction and on the basis of excellent findings in terms of efficacy and safety, some doubts arise around the exact meaning of the special population designation and whether this group of patients actually exists. The aim of this review is to discuss and analyze current evidence on the management and treatment of the so-called “unique populations”. We placed particular emphasis on patients with decompensated cirrhosis, chronic kidney disease (CKD), coinfections, rare genotypes, and previous treatment failure, in order to provide physicians with an updated overview of the actual problems and needs in the current scenario.

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Section: Patients With Concomitant Hbv Infectionmentioning

confidence: 99%

Section: Patients With Concomitant Hbv Infectionmentioning

confidence: 99%

Management and Treatment of Hepatitis C: Are There Still Unsolved Problems and Unique Populations?

Solitano

Torres

Pugliese

et al. 2021

Viruses

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“…In a cohort study on chronic HCV patients with positive HBsAg who underwent DAAs in Egypt, the risk of reactivation in the absence of HBV treatment was 28.6% (95% CI 15.6%–46.4%) and the risk of hepatitis in the patients who experienced reactivation 10.0% (95% CI 0.9%–57.8%). Also, the pooled risk of reactivation in HBsAg-negative anti-HBc-positive patients was negligible (0.1%, 95% CI 0–0.3%), irrespective of the presence of anti-HBs 20…”

Section: Discussionmentioning

confidence: 95%

<p>Management Of Patients With Hepatitis B Virus Reactivation Post–DAA Treatment Of Chronic Hepatitis C Virus Infection In HCV–HBV Coinfected Patients With Pretreatment HBeAg Seroconversion And Early Degree Of Hepatic Fibrosis</p>

Osman¹,

Ghweil²,

Sabry³

et al. 2019

IDR

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Background and aimHepatitis C virus (HCV)–HBV coinfection is a significant health problem with rapid progression of liver disease without precise diagnosis and treatment. We aimed in this study to identify if there were any role of HBV antiviral therapy in patients with HBV reactivation after direct-acting antiviral therapy in HCV–HBV coinfected patients.MethodsA prospective random study was carried out on 140 patients presenting with chronic HCV and chronic HBV coinfection. All patients had pretreatment HBeAg seroconversion, HBV DNA <2,000 IU/mL, normal liver enzymes, and F0/F1 hepatic fibrosis. They treated with sofosbuvir 400 mg and daklatasvir 60 mg once daily for 3 months. All patients underwent pretreatment hepatic fibrosis assessment using Fibro Scan and laboratory investigations: platelet count, liver-function tests, quantitative HCV PCR, HBsAg, HBc IgG, HBeAg, and HBeAb. All patients were followed up at 1, 3, 6, and 12 months from the start of HCV therapy.ResultsThe study enrolled 140 HCV–HBV coinfected patients: 55% were F0 and the rest F1. All our patients had negative HCV PCR at 1 month posttreatment and had achieved sustained virologic response with negative HCV PCR 3 months after treatment end. Four patients showed HBV reactivation with raised HBV DNA PCR and liver enzymes. Their mean age was 23.7±2.7 years, and three were male. Regarding patients with HBV reactivation, at 12 months posttreatment they showed significant decreases in liver enzymes, bilirubin, and INR, with increased platelet count (P=0.001), each with undetectable HBV PCR (P=0.001).ConclusionHBV–HCV coinfected patients with no/mild hepatic fibrosis, HBeAg seroconversion, and HBV DNA <2,000 IU/mL can complete direct-acting antiviral therapy without HBV antiviral treatment with close monitoring.

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“…9 Most cases of HBV reactivation are among HBsAgpositive patients, and the risk of reactivation appears to be negligible for HBsAg-negative, anti-HBc-positive patients. 10 FDA labelling. 6 POLARIS-2 and -3 failed to show a benefit of adding voxilaprevir to the existing regimen of SOF/VEL in DAA-naïve patients.…”

Section: Hepatitis B Virus Reactivationmentioning

confidence: 99%

“…A 2017 meta‐analysis indicated HBV reactivation occurs earlier and is clinically more significant with all‐oral DAAs versus interferon‐based therapy . Most cases of HBV reactivation are among HBsAg‐positive patients, and the risk of reactivation appears to be negligible for HBsAg‐negative, anti‐HBc‐positive patients . Some cases of HBV reactivation have resulted in fulminant hepatitis, hepatic failure, and death.…”

Section: Side Effects and Drug−drug Interactionsmentioning

confidence: 99%

Review article: novel antivirals for hepatitis C—sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir

Pearlman

Hinds

2018

Aliment Pharmacol Ther

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Summary Background In 2017, the hepatitis C treatment regimens sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) and glecaprevir/pibrentasvir (G/P) received approval from the U.S. Food and Drug Administration. Although both SOF/VEL/VOX (NS5B polymerase inhibitor/NS5A inhibitor/NS3/4A protease inhibitor) and G/P (NS3/4A protease inhibitor/NS5A inhibitor) are pangenotypic regimens, they are indicated for distinct subsets of patients with hepatitis C. Aim To compare and contrast available safety and efficacy data for SOF/VEL/VOX and G/P and outline their clinical utility. Methods For each of the regimens, this review outlines the indications, safety information, and the major clinical studies in which SOF/VEL/VOX and G/P were evaluated. Results SOF/VEL/VOX is positioned as a salvage regimen for patients previously treated with NS5A inhibitors and for genotype 1a‐ and 3‐infected patients who had failed other sofosbuvir‐containing regimens. G/P is the first pangenotypic regimen with an 8‐week duration for treatment‐naïve, non‐cirrhotic patients, and it is indicated for patients with any genotype who have advanced kidney disease, including those on dialysis. Conclusion The addition of SOF/VEL/VOX and G/P to existing hepatitis C treatment options will expand the number of patients who are eligible for and responsive to treatment, thus increasing the possibility of eliminating hepatitis C as a public health issue.

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Risk of hepatitis B virus reactivation with direct‐acting antivirals against hepatitis C virus: A cohort study from Egypt and meta‐analysis of published data

Abstract: We confirmed high HBV reactivation risk in HBsAg-positive patients undergoing DAAs, with only a minority developing clinically important hepatitis. The risk is negligible for HBsAg-negative anti-HBc-positive patients.

Cited by 16 publications

References 41 publications

Management and Treatment of Hepatitis C: Are There Still Unsolved Problems and Unique Populations?

Management and Treatment of Hepatitis C: Are There Still Unsolved Problems and Unique Populations?

<p>Management Of Patients With Hepatitis B Virus Reactivation Post–DAA Treatment Of Chronic Hepatitis C Virus Infection In HCV–HBV Coinfected Patients With Pretreatment HBeAg Seroconversion And Early Degree Of Hepatic Fibrosis</p>

Review article: novel antivirals for hepatitis C—sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir

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