Sofosbuvir‐based treatment is safe and effective in Indian hepatitis C patients on maintenance haemodialysis: A retrospective study

Akhil, Mohammed Shujauddin; Kirushnan, Balaji; Martin, Melvin; Arumugam, Kulenthran; Prasad, NK Ganesh; Rajan, Rajesh

doi:10.1111/nep.13050

Cited by 17 publications

(17 citation statements)

References 18 publications

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“…In studies where both SVR4 and SVR 12 rates were reported, SVR4 rate was seldomly less than SVR12 rate. 1,6,10,12,13,18,19,28,29 The same applies to SVR24 rate, which was also lower than SVR12 rate in pooled analysis and had been reported only in five studies. 10,12,14,20,24 Besides, long-term virologic response might be affected by genotype, regimen or the interactions between these two factors.…”

Section: Discussionmentioning

confidence: 83%

Efficacy and safety of direct‐acting antiviral‐based treatment in hepatitis C virus infected patients with chronic renal function impairment: An updated systemic review and meta‐analysis

Yang

Liao

et al. 2020

Nephrology

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Objective: To further determine the efficacy and safety of direct-acting antiviral (DAA)-based treatments in hepatitis C virus (HCV) infected patients with renal function impairment. Methods: MEDLINE, EMBASE and the Cochrane Library were searched for relevant studies. All studies assessing the efficacy and safety of DAA-based treatments against HCV infection in patients with renal impairment and HCV infection were eligible for inclusion. Outcomes assessed included efficacy outcomes and safety outcomes. Summary estimates were obtained using an inverse-variance weighted random effect model and Freeman-Tukey double arcsine transformation. Results: Twenty-seven studies (n = 1048 participants) were included. The majority of included studies were of fair quality with Newcastle-Ottawa scale scores between 4 and 6. The pooled virologic response rates at the end of treatment or 4, 12, 24 weeks after treatment (ie, EOTR, SVR4, SVR12 and SVR24 rates) were 97.0% (95% confidence interval [CI], 94.0%-99.0%), 80.9% (95% CI, 49.3%-98.7%), 94.1% (95% CI, 91.6%-96.3%) and 89.6% (95% CI, 75.5%-98.1%), respectively. The pooled relapse rate was 6.4% (95% CI, 3.4%-10.4%). The pooled incidence of adverse events and severe adverse events leading to discontinuation were 47.6% (95% CI, 35.0%-60.4%) and 2.9% (95% CI, 1.4%-5.0%), respectively. High heterogeneity among studies exists for SVR4 and SVR24 rates. Formal statistical testing did not identify the presence of publication bias for all measured outcomes except the relapse rate. Conclusion: The results support the efficacy and safety of DAA-based treatments in this population. Future studies with better design, larger sample size and longer follow up will be the next step.

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Section: Discussionmentioning

confidence: 83%

Efficacy and safety of direct‐acting antiviral‐based treatment in hepatitis C virus infected patients with chronic renal function impairment: An updated systemic review and meta‐analysis

Yang

Liao

et al. 2020

Nephrology

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“…The included studies were published from 2015 to 2020 and contained extractable data on 514 patients enrolled from 2014 to 2016. Four studies were retrospective [10][11][12][13] and 16 were prospective [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] . Nine of the studies were conducted in India 10,12,14,16,18,20,22,25,29 , 2 in the USA 15,21 , 2 in Pakistan 24,28 , 2 in China 19,27 , 1 in France 17 , the Czech Republic 11 , Korea 13 , Iraq 26 , and 1 enrolled patients from multiple countries 23 .…”

Section: Resultsmentioning

confidence: 99%

“…A total of 19 studies reported extractable data on the SOF dose [10][11][12][13][14][16][17][18][19][20][21][22][23][24][25][26][27][28][29] and the other DAA included in the treatment regimen. In nine studies [10][11][12][13]16,19,[21][22][23] , the same treatment regimen was used for all study participants. Six studies partitioned the study participants into subgroups and followed a different treatment strategy for each subgroup 14,17,18,20,24,25 .…”

Section: Resultsmentioning

confidence: 99%

“…A sub-group analysis was not performed for the various other DAA used in the treatment regimens, due to the large variability of DAA used. Ribavirin was used in 6 studies 10,13,14,16,18,28 , simeprevir in 3 15,17,21 , ledipasvir in 8 17,[20][21][22][25][26][27]29 , daclatasvir in 9 10,11,14,[16][17][18][19][20][24][25][26][27][28][29] and velpatasvir in 2 studies 12,23 (Table 1).…”

Section: Resultsmentioning

confidence: 99%

“…A total of 16 studies reported extractable data on adverse events [10][11][12][13][14][16][17][18][19][21][22][23]25,[27][28][29] ( Table 2). The most commonly reported adverse events were anemia (10 studies) 10,[12][13][14][16][17][18]21,23,28 , headache (8 studies) 12,17,[21][22][23]25,27,29 , fatigue (6 studies) 13,16,17,19,23,25 , nausea or vomiting (5 studies) 19,21,23,25,29 , insomnia (5 studies) 13,19,21,23,29…”

Section: Resultsmentioning

confidence: 99%

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Efficacy and safety of sofosbuvir in the treatment of hep C among patients on hemodialysis: a systematic review and meta-analysis

Shehadeh

Kalligeros

Byrd

et al. 2020

Sci Rep

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Hepatitis C virus (HCV) infection among maintenance hemodialysis patients is implicated in increased morbidity and mortality compared to uninfected patients. Sofosbuvir (SOF)-based regimens may not be optimal among patients requiring hemodialysis. Several studies, however, provide evidence that use of SOF among HCV-positive patients with renal impairment, is effective and safe. We searched Pubmed and Embase to identify studies reporting the efficacy and safety of SOF-based regimens for the treatment of HCV-positive patients on maintenance hemodialysis and performed a random effects meta-analysis. The overall pooled estimate of the efficacy of SOF-based therapy was 95% (95% CI 91-98%). The efficacy of the SOF-based regimen was 92% (95% CI 80-99%), 98% (95% CI 96-100%), and 100% (95% CI 95-100%) for the following doses: 400 mg on alternate days, 400 mg daily, and 200 mg daily, respectively. The most frequent adverse event was fatigue with a pooled prevalence of 16% (95% CI 5-29%), followed by anemia 15% (95% CI 3-31%), and nausea or vomiting 14% (95% CI 4-27%). Anemia was more prevalent in treatment regimens containing ribavirin (46%, 95% CI 33-59%) compared to ribavirin-free regimens (3%, 95% CI 0-9%). This study suggests that SOF-based regimens in the treatment of HCV infection among hemodialysis patients are both effective and safe. Patients requiring hemodialysis are at an increased risk of acquiring hepatitis C virus (HCV) 1. Approximately 5% of patients on hemodialysis are diagnosed with HCV, compared to 1% in the United States population 2,3 and, among hemodialysis patients, HCV infection is associated with poor outcomes with substantially higher rates of hepatic-related mortality and hospitalizations, and lower health-related quality of life scores, compared to HCV negative hemodialysis patients 4. National guidelines for the treatment of HCV infection among hemodialysis patients recommend several direct-acting antivirals (DAA) 5,6. Sofosbuvir (SOF)-based regimens are not recommended for patients requiring hemodialysis since renal clearance of SOF is the major elimination pathway, although since the recent U.S. Federal Drug Administration change in label, removing restrictions on its use in renal impairment, this will undoubtedly change 7. Nevertheless, clinical studies provide evidence that use of SOF, among HCV positive patients with renal impairment, is effective and safe 8,9. Data focusing only on patients requiring maintenance hemodialysis are limited. Thus, we performed a systematic review and meta-analysis to quantify the efficacy and safety of SOF-based regimens among the subset of patients with severe renal impairment that required maintenance hemodialysis.

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Treatment of hepatitis C infection among Egyptian hemodialysis patients: the dream becomes a reality

et al. 2019

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Sofosbuvir‐based treatment is safe and effective in Indian hepatitis C patients on maintenance haemodialysis: A retrospective study

Cited by 17 publications

References 18 publications

Efficacy and safety of direct‐acting antiviral‐based treatment in hepatitis C virus infected patients with chronic renal function impairment: An updated systemic review and meta‐analysis

Efficacy and safety of direct‐acting antiviral‐based treatment in hepatitis C virus infected patients with chronic renal function impairment: An updated systemic review and meta‐analysis

Efficacy and safety of sofosbuvir in the treatment of hep C among patients on hemodialysis: a systematic review and meta-analysis

Treatment of hepatitis C infection among Egyptian hemodialysis patients: the dream becomes a reality

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