Genotype-specific versus pangenotypic regimens in patients infected with HCV genotype 1b in real-world settings

Pabjan, Paweł; Brzdęk, Michał; Chrapek, Magdalena; Dziedzic, Kacper; Stępień, Piotr; Paluch, Katarzyna; Garbat, Anna; Błoniarczyk, Piotr; Reczko, Katarzyna; Zarębska-Michaluk, Dorota

doi:10.20452/pamw.16094

Cited by 3 publications

(7 citation statements)

References 43 publications

(45 reference statements)

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“…Despite the disparity between the two regimens discussed above, we did not show a statistically significant difference in SVR overall between GT-specific and pangenotypic options. This finding is consistent with the results of another Polish RWE analysis evaluating GT-specific vs pangenotypic regimens in GT1b-infected patients and according to our best knowledge there are no other analyses of a comparative nature[ 18 ]. We are aware that our study does not compare the two types of regimens head-to-head, it is a retrospective analysis and the results of comparison in this area should be approached with caution.…”

Section: Discussionsupporting

confidence: 91%

“…It is difficult to directly compare our results to other studies because to the best of our knowledge, apart from one single-center study from Poland, there is no analysis evaluating different DAA therapies all together in a GT1b-infected population with identifying negative predictors of SVR[ 18 ]. Therefore, we can refer to the prognostic factors of virologic response in the GT1b-infected patients established for a specific DAA regimen, but the findings are inconsistent.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, we can refer to the prognostic factors of virologic response in the GT1b-infected patients established for a specific DAA regimen, but the findings are inconsistent. Male sex was the only negative prognostic factor for SVR in Polish patients with GT1b infection treated with different DAA options, as well as in Romanian patients receiving OBV/PTV/r + DSV ± RBV[ 17 , 18 ]. However, a study of Chinese GT1b-infected patients treated with another GT-specific regimen GZR/EBR showed that sex did not affect virological response[ 46 ].…”

Section: Discussionmentioning

confidence: 99%

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Best therapy for the easiest to treat hepatitis C virus genotype 1b-infected patients

Zarębska-Michaluk¹,

Brzdęk²,

Jaroszewicz³

et al. 2022

World J Gastroenterol

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BACKGROUND The revolution in treatment of patients with chronic hepatitis C virus (HCV) infection dates back to the introduction of direct-acting antivirals (DAAs). The increase in efficacy was most pronounced in patients infected with genotype (GT) 1b, as this was the most poorly responsive population to treatment during the interferon era. AIM To identify the most effective interferon-free therapy for GT1b-infected patients and to determine positive and negative predictors of virological response. METHODS This real-world retrospective analysis included patients chronically infected with GT1b HCV whose data were obtained from the multicenter observational EpiTer-2 database. Treatment effectiveness was evaluated for each therapeutic regimen as the percentage of sustained virological responses (SVR). Assessment of the safety was based on the evaluation of the course of therapy, the occurrence of adverse events including serious ones, deaths during treatment and in the post 12-wk follow-up period. RESULTS The studied population consisted of 11385 patients with a mean age of 53 ± 14.8 years and a female predominance (53.4%). The majority of them were treatment-naïve (74.6%) and patients with cirrhosis accounted for 24.3%. Of the DAA regimens used, 76.9% were GT-specific with ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin being the most used option (32.4%). A total of 10903 patients responded to treatment resulting in a 98.1% in the per-protocol analysis after excluding 273 patients without SVR data. The effectiveness of all regimens exceeded 90% and the highest SVR of 98.9% was achieved in patients treated with a combination of glecaprevir/pibrentasvir. Logistic regression analyses showed that the virologic response was independently associated with female sex [odds ratio (OR) = 1.67], absence of decompensated cirrhosis at baseline (OR = 2.42) and higher baseline platelets (OR = 1.004 per 1000/μL increase), while the presence of human immunodeficiency virus (HIV) coinfection significantly decreased the odds of response (OR = 0.39). About 95%-100% of patients completed therapy irrespective of the drug regimen. At least one adverse effect occurred in 10.9%-36.3% and most of them were mild. No treatment related deaths have been reported. CONCLUSION We documented very high effectiveness and a good safety profile across all DAA regimens. Positive predictors of SVR were female sex, absence of decompensated cirrhosis at baseline and higher platelet count while HIV coinfection reduced the effectiveness.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Best therapy for the easiest to treat hepatitis C virus genotype 1b-infected patients

Zarębska-Michaluk¹,

Brzdęk²,

Jaroszewicz³

et al. 2022

World J Gastroenterol

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“…Despite the overall excellent efficacy of DAA pangenotypic options documented in clinical trials and many real-world experience (RWE) studies, including those carried out in Poland there is still a small percentage of patients who do not respond to therapy [5,6,9,10,11].…”

Section: Introductionmentioning

confidence: 99%

“…Polish studies previously published, including Pabian et al [11] did not include the extremely difficult-to-treat sub-population of patients who failed to respond to pangenotypic regimens simply because such patients appeared recently.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of pangenotypic retreatment of chronic hepatitis C after prior failure of pangenotypic therapies

Jaroszewicz¹,

Zarębska-Michaluk²,

Janocha-Litwin³

et al. 2023

Polish Archives of Internal Medicine

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The introduction of pangenotypic regimens represents a recent development in the treatment of chronic hepatitis C virus (HCV) infection. However, even with their excellent efficacy exceeding 95%, there remains a marginal group of patients who do not respond to antiviral treatment. Our analysis aimed to evaluate the effectiveness of retherapy with pangenotypic regimens in this narrow group of patients. Although the only pangenotypic regimen registered for such an indication is a triple combination of drugs with different viral enzyme targets, we demonstrated also high efficacy of options containing only two HCV replication cycle inhibitors. This is of particular importance in a situation of limited availability of a registered rescue option.

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Direct‐acting antivirals in women of reproductive age infected with hepatitis C virus

Dobrowolska,

Pawłowska,

Zarębska‐Michaluk

et al. 2024

Journal of Viral Hepatitis

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Eliminating hepatitis C virus (HCV) infection in the population of women of reproductive age is important not only for the health of women themselves but also for the health of newborns. This study aimed to evaluate the implementation of this goal by analysing the effectiveness of contemporary therapy in a large cohort from everyday clinical practice along with identifying factors reducing therapeutic success. The analysed population consisted of 7861 patients, including 3388 women aged 15–49, treated in 2015–2022 in 26 hepatology centres. Data were collected retrospectively using a nationwide EpiTer‐2 database. Females were significantly less often infected with HCV genotype 3 compared to males (11.2% vs. 15.7%) and less frequently showed comorbidities (40.5% vs. 44.2%) and comedications (37.2% vs. 45.2%). Hepatocellular carcinoma, liver transplantation, HIV and HBV coinfections were reported significantly less frequently in women. Regardless of the treatment type, females significantly more often reached sustained virologic response (98.8%) compared to males (96.8%). Regardless of gender, genotype 3 and cirrhosis were independent factors increasing the risk of treatment failure. Women more commonly reported adverse events, but death occurred significantly more frequently in men (0.3% vs. 0.1%), usually related to underlying advanced liver disease. We have demonstrated excellent effectiveness and safety profiles for treating HCV infection in women. This gives hope for the micro‐elimination of HCV infections in women, translating into a reduced risk of severe disease in both women and their children.

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Genotype-specific versus pangenotypic regimens in patients infected with HCV genotype 1b in real-world settings

Cited by 3 publications

References 43 publications

Best therapy for the easiest to treat hepatitis C virus genotype 1b-infected patients

Best therapy for the easiest to treat hepatitis C virus genotype 1b-infected patients

Effectiveness of pangenotypic retreatment of chronic hepatitis C after prior failure of pangenotypic therapies

Direct‐acting antivirals in women of reproductive age infected with hepatitis C virus

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