Hepatitis C treatment with all-oral direct-acting antivirals: Effectiveness and tolerance in a multicenter, prospective, observational study from French general hospitals (APROVVIE, ANGH)

Pariente, Alexandre; Arpurt, Jean‐Pierre; Remy, André‐Jean; Rosa-Hézode, I.; Causse, Xavier; Héluwaert, Frédéric; Macaigne, Gilles; Henrion, Jean; Renou, Christophe; Schnee, Matthieu; Salloum, Hatem; Hommel, Séverine; Pilette, Christophe; Arotçarena, Ramuntxo; Barjonet, Georges; Lison, Hortensia; Bourhis, F.; Jouannaud, Vincent; Pauwels, Arnaud; eaBricquir, Yann Le; Geagea, E; Condat, Bertrand; Ripault, Marie–Pierre; Zanditenas, David; Montigny-Lenhardt, S. de; Labadie, H; Tissot, Bertrand; Maringe, E.; Cadranel, Jean–François; Hagège, Hervé; Lesgourgues, Bruno

doi:10.1016/j.lpm.2018.06.019

Cited by 8 publications

(3 citation statements)

References 16 publications

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“…This improvement could be an attempt of the body to restore the disturbed physiological processes via developing an acquired tolerance to sofosbuvir. This fact copes with recent clinical studies in which the selfassessed overall tolerance to sofosbuvir was excellent so that patient's fatigue lessened during and also after the end of the treatment [58] . Yet, we could recommend that the ultimate goal is to provide effective anti-oxidants as an adjuvant therapy for HCV to target the COX-2 signaling pathway beside the viral genome.…”

Section: Discussionsupporting

confidence: 73%

Extra Hepatic Effects of Sofosbuvir on a Serous Model of Major and Minor Salivary Glands in Albino Rats

Saad

Aboushady

Mehanni

2019

Egyptian Journal of Histology

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Background: Extra hepatic adverse effects associated with the therapy of chronic HCV infection with sofosbuvir treatment regimens have recently arisen. Objective: This study aimed to assess the inflammatory effect of sofosbuvir and its influence on cellular proliferation, functionality and differentiation of both submandibular (SMGs) and Von Ebner's salivary glands (EGs). Methodology: 21 adult male albino rats were divided into three equal groups: GroupI (control) received orally distilled water; GroupII received orally sofosbuvir (40 mg/kg/day) dissolved in distilled water for one month and GroupIII received sofosbuvir for 2 months. SMGs and EGs sections were processed for H&E, immunohistochemical (using anti-COX-2 and anti-PCNA antibodies) and immunofluorescence (using anti α-amylase antibody) examination. Results: Compared to control group, groupII displayed atrophic changes in SMGs and EGs which were accentuated in groupIII; shrunken acini, glandular cell vacuolization, nuclear degenerative signs, wide degenerative stromal areas and flattening of excretory ductal lining with stagnant secretion as well as the transformation of few serous glandular cells into mucous-like cells particularly in SMGs of groupIII. Likewise, both glands of groupIІ showed significantly increased immunoreactivity to COX-2 in acini and some ductal cells but with a significant decrease in those of groupIII. Regarding PCNA immunoreactivity and α-amylase immunofluorescence, significantly diminished positivity in the glandular cells of both glands in groupII was detected compared to control group whilst insignificant improvement was elucidated in those of groupIII comparing to groupII except for the significant reactivity to α-amylase in EGs of groupIII. Conclusions: It was concluded that the oxidative stress associated degenerative changes caused by sofosbuvir in salivary glands after one month of administration seemed to be diminished after two months of administration due to the body acquired drug tolerance to restore the disturbed physiological processes. Hence, the use of anti-oxidants as an adjuvant treatment could be beneficial.

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Section: Discussionsupporting

confidence: 73%

Extra Hepatic Effects of Sofosbuvir on a Serous Model of Major and Minor Salivary Glands in Albino Rats

Saad

Aboushady

Mehanni

2019

Egyptian Journal of Histology

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“…It is noteworthy that some of these studies generated their findings from either a clinical trial or a structured treatment accessibility program (12)(13)(14)(15). A few of them were undertaken in settings in which the sofosbuvir-daclatasvir combination only served as an option among many others (16)(17)(18)(19)(20)(21)(22)(23), while the rest presented the data limited to specific populations, HCV genotypes and liver cirrhotic status (24)(25)(26)(27)(28)(29)(30)(31)(32).…”

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confidence: 99%

A Two-Year Outcome Evaluation of Government-Led Initiative to Upscale Hospital-based Hepatitis C Treatment Using a Standard Two-Drug Regimen in Malaysia

et al. 2021

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Background: Malaysia has been fully committed to the global endeavor to eliminate hepatitis C virus (HCV) infection by 2030. In early 2018, the Ministry of Health (MOH) embarked on a “one-size-fits-all strategy” by introducing generic versions of sofosbuvir and daclatasvir as the standard treatment for HCV infection in public hospitals nationwide. Objectives: To evaluate the outcomes of such an initiative in multiple aspects, including the number and characteristics of patients treated, the extent of evidence-based drug use, the treatment completion status, individual responses to treatment, common side effects of treatment, and its economic implications. Methods: The findings were generated from the data compiled by the MOH, capturing the information regarding the treatment provided to adult HCV-infected patients in 16 selected hospitals between April 2018 and March 2020, along with the drug costs incurred. Results: A total of 1,797 patients were treated, nearly four times more than the patients receiving interferon-based treatment across the country in the preceding two years. Approximately one-third of them had liver cirrhosis, and the main HCV genotypes were 3 (46.9%) and 1a (20.0%). Dosing, treatment duration and the addition of ribavirin to the treatment generally agreed with the recommendations of the MOH. More than 90% of the patients completed the treatment course, and a sustained virologic response (SVR) rate of 95.4% (95% CI: 94.2, 96.7%) was recorded in those with a known treatment outcome (n = 1,163). The SVR achievement did not vary across HCV genotypes and cirrhosis status, but those ≥ 50 years of age (adjusted OR: 2.13; 95% CI: 1.16, 3.92) were more likely to fail the treatment. Side effects were rare. Anemia and fatigue caused treatment discontinuation in only 0.3% of the patients. The total drug expenditure reached US$678,258.20, and the mean cost of a 12-week treatment course of sofosbuvir and daclatasvir (US$235.16) was lower than the cost expected by the MOH (US$300). Conclusions: The findings demonstrate a high degree of real-world effectiveness, safety, and affordability of the standard treatment, suggesting that such a government-led initiative was reasonable and timely and could be extended to include more public health institutions.

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“…Upon studying the follow-up parameters of the patients who developed HCC in the current study it was found that there was an increase in Child scores, ALT, AST, bilirubin, WBCs, INR, and AFP values while there was a decrease in albumin, hemoglobin, and platelets levels, those results came in agreement with those detected by Rewisha et al 13 Concerning the virological response, patients in this study achieved 100% SVR which is greater than the percentages of both Mann et al (84.9%) and Pariente et al (91.1%); this difference in results may be attributed to the genotype difference of the patients and their response to the Sof/Dac regimen. 15,16 Concerning the biochemical parameters of the patients in the two groups, the comparison resulted in significantly lower values in SOF/DAC group than SOF/DAC/RIB group in child score, bilirubin, INR, and AFP with P values <0.05. On the contrary, the SOF/DAC/RIB group showed significantly lower values than the SOF/DAC group in albumin, WBCs, hemoglobin, platelet, and glycated hemoglobin levels with P values <0.05.…”

Section: Discussionmentioning

confidence: 99%

New incidence or recurrence hepatocellular carcinoma (HCC) in genotype 4 hepatitis C virus treated with sofosbuvir/daclatasvir with or without ribavirin

Essawy

Mehrez²,

Shaheen

et al. 2021

F1000Res

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Background: Several studies have resulted in controversial data about the recurrence or new incidence of hepatocellular carcinoma (HCC) in patients with hepatitis C who were treated with direct-acting antivirals (DAAs). Aim: This observational study aimed to assess the occurrence rate of HCC in patients who developed a sustained virological response (SVR).. METHOD: A six-month prospective study was done at the National Hepatology and Tropical Medicine Research Institute [NHTMRI] in Cairo, Egypt on 150 chronic hepatitis C (CHC) patients treated with sofosbuvir and daclatasvir with or without ribavirin. Patients were assigned into two groups according to their laboratory values to either receive sofosbuvir/daclatasvir and ribavirin (S/D/R) or receive only sofosbuvir/daclatasvir (S/D). The main outcome measure was the occurrence of HCC. Results: SVR-12 was 100%. 8.5% of patients developed HCC in the S/D/R group, while 0% in the S/D group. Conclusion: New incidence or recurrence of HCC may occur in CHC genotype 4 cirrhotic patients receiving sofosbuvir/daclatasvir and ribavirin (difficult to treat) although achieving SVR. The cause of HCC development in this study is cirrhosis, not the administered DAAs.

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Hepatitis C treatment with all-oral direct-acting antivirals: Effectiveness and tolerance in a multicenter, prospective, observational study from French general hospitals (APROVVIE, ANGH)

Cited by 8 publications

References 16 publications

Extra Hepatic Effects of Sofosbuvir on a Serous Model of Major and Minor Salivary Glands in Albino Rats

Extra Hepatic Effects of Sofosbuvir on a Serous Model of Major and Minor Salivary Glands in Albino Rats

A Two-Year Outcome Evaluation of Government-Led Initiative to Upscale Hospital-based Hepatitis C Treatment Using a Standard Two-Drug Regimen in Malaysia

New incidence or recurrence hepatocellular carcinoma (HCC) in genotype 4 hepatitis C virus treated with sofosbuvir/daclatasvir with or without ribavirin

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