Efficacy and safety of sofosbuvir-based regimens in chronic hepatitis C patients on dialysis

Choudhary, Narendra S.; Kumar, Amit; Bodh, Vijay; Bansal, Shyam Bihari; Sharma, Reetesh; Jain, Manish; Saigal, Sanjiv; Saraf, Neeraj

doi:10.1007/s12664-017-0735-7

Cited by 23 publications

(33 citation statements)

References 10 publications

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“…In the former study 66% of patients received daily RBV and 27% received daily SOF dose, whereas our haemodialysis patients received their treatment every other day prior to haemodialysis sessions. As mentioned before many recent studies showed that lower dose of SOF is associated with lower efficacy [15][16][17][18][19][20][21] Our study has unique strengths compared to previous studies.…”

Section: Discussionmentioning

confidence: 84%

“…[13][14][15][16] Though smaller doses of the drug (200 mg/d or 400 mg on alternate day) were used by some investigators, several authors showed lower SVR rates with such doses. [15][16][17][18][19][20][21] On the other hand, high efficacy and safety of full dose SOF-containing regimens in patients with severe renal impairment were also demonstrated by many investigators. 13,17,18,[22][23][24][25][26] The purpose of this study was to report the experience of using SOF-based therapy to treat a large number of HCV patients by the health authorities in Egypt, with a significant number of them having CKD.…”

Section: Introductionmentioning

confidence: 98%

“…Though smaller doses of the drug (200 mg/d or 400 mg on alternate day) were used by some investigators, several authors showed lower SVR rates with such doses . On the other hand, high efficacy and safety of full dose SOF‐containing regimens in patients with severe renal impairment were also demonstrated by many investigators …”

Section: Introductionmentioning

confidence: 99%

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Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

Eletreby

El‐Serafy

Anees

et al. 2019

Liver International

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Background and Aims This study aimed to assess the safety and efficacy of sofosbuvir (SOF)‐based regimens in patients with moderate to severe renal impairment; a subject which has been questioned by many investigators with conflicting results. Methods This is a real‐life multicentre retrospective cohort study on 4944 chronic Hepatitis C virus (HCV) patients with chronic kidney disease (CKD) (eGFR <60 mL/min/1.73 m2) who received SOF‐based therapy in specialized treatment centres affiliated to the National Committee for the Control of Viral Hepatitis in Egypt. The efficacy and safety of SOF‐based regimens was assessed. Results Week 12 virological response rates were 97.5%, 96.7%, 85.7% and 80% in the total cohort, patients with eGFR <30 mL/min/1.73 m2, patients with associated hepatic decompensation and patients on dialysis respectively. Various treatment regimens did not statistically affect the response rates. Treatment experience, cirrhosis and diabetes were predictors of treatment failure on multivariate analysis. Serious adverse events occurred in 0.1% of cases. Forty patients (0.8%) discontinued treatment. Conclusion Sofosbuvir‐based regimens are effective and safe for treating patients with chronic HCV and moderate to severe CKD, and in those with associated hepatic decompensation.

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Section: Discussionmentioning

confidence: 84%

Section: Introductionmentioning

confidence: 98%

See 1 more Smart Citation

Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

Eletreby

El‐Serafy

Anees

et al. 2019

Liver International

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“…An attractive solution is to lower the dose of sofosbuvir, but this may not be desirable as sofosbuvir is a prodrug and the potentially decreased levels of the active metabolite GS461203 could result in decreased efficacy. Recent studies showed lower SVR rates with a lower dose of sofosbuvir (200 mg/d or 400 mg alternate day) suggesting lower dose may have lesser efficacy . In addition, Desnoyer et al, have demonstrated the safety, high efficacy and lack of accumulation of daily, full dose sofosbuvir regimens in HCV infected patients on HD compared to half dose.…”

Section: Introductionmentioning

confidence: 99%

Sofosbuvir with NS5A inhibitors in hepatitis C virus infection with severe renal insufficiency

Singh

Kumari

Kumar

et al. 2018

Journal of Viral Hepatitis

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Treatment of Hepatitis C virus (HCV) in patients with severe renal insufficiency is cumbersome as sofosbuvir is mainly excreted by the kidneys. There is paucity of data on the use of sofosbuvir and NS5A inhibitors in these patients. We hereby report our experience of treating chronic hepatitis C in patients with severe renal insufficiency with full dose sofosbuvir and NS5A inhibitors. Forty-seven patients with severe renal insufficiency (on dialysis n = 39, predialysis n = 8) with HCV infection were treated between December 2015-August 2017 with full dose sofosbuvir with ledipasvir or daclatasvir for 12/24 weeks depending on the genotype and the presence or absence of cirrhosis. The distribution of HCV genotype was genotype 1 in 32 (68.1%), genotype 3 in 13 (27.7%) and 4 in 2 (4.3%) patients. Among 12 (25.5%) patients with cirrhosis, 7 (14.9%) were decompensated with ascites. All patients had end of treatment response, and sustained viral response at 12 weeks was achieved in 45 (95.7%) patients. There was significant improvement in liver stiffness at 3 months after treatment (8.8 (3.8-42) to 7.1 (3.3-24.1) kPa; (P = 0.047)). There was no change in haemoglobin and eGFR with treatment in predialysis group (haemoglobin- 10.2 ± 1.5 g/dL vs 9.6 ± 1.3 g/dL, P = 0.44; eGFR- 19.8 ± 9.4 mL/min vs 17.9 ± 8.5 mL/min, P = 0.67). Therapy was very well accepted. Full dose sofosbuvir with NS5A inhibitors is a well tolerated and effective therapy for HCV infection in severe renal insufficiency.

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“…Среди побочных эффектов чаще регистрирова-лись анемия (32%), инфекции (26%), нейтропения (23%), тромбоцитопения (21%), почечная недостаточ-ность (8%) [23]. Есть опыт успешного применения схемы «софосбу-вир/даклатасвир» у пациентов с терминальной почеч-ной недостаточностью, находящихся на гемодиализе [24].…”

Section: (табл 2)unclassified

Treatment of HCV Infection by a Combination of Sofosbuvir and Daclatasvir

Шульпекова

Семенистая

et al. 2017

Medicinskij sovet

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Cтандартом терапии хронической HCV-инфекции в последние годы стали препараты прямого противо-вирусного действия (ППД). Первыми предста-вителями этого класса стали ингибиторы вирусных про-теаз NS3-4 телапревир и боцепревир. На протяжении нескольких лет эти препараты применялись при инфек-ции 1-м генотипом вируса в комбинации с пегилирован-ным интерфероном (ПЭГ-ИФН) и рибавирином (РИБ) («тройная терапия»). Помимо недостаточной эффектив-ности и значительной частоты нежелательных явлений на фоне такого лечения, существенным недостатком бы-ло наличие противопоказаний к применению на стадии цирроза. Телапревир и боцепревир влияют на актив-ность CYP3A4 и кинетику других лекарств, в частности, ГЕПАТИТЫ КОМБИНАЦИЕЙ СОФОСБУВИРА И ДАКЛАТАСВИРАЦель обзора: оценить эффективность и безопасность применения пангенотипической комбинации «софосбу-вир/даклатасвир» -препаратов прямого противовирусного действия в терапии хронической HCV-инфекции на различных стадиях поражения печени. Основные положения: софосбувир -антисмысловой нуклеотид, угне-тающий РНК-зависимую РНК-полимеразу NS5B, этот препарат заслужил репутацию одного из сильнейших ан-тирепликативных средств, в том числе при резистентности к интерферону. Даклатасвир -мощный ненуклео-тидный ингибитор NS5А-белка, катализирующего образование репликативных комплексов. Оба компонента обладают доказанным эффектом в отношении 1-6 генотипов HCV. Их сочетание обеспечивает пангенотипичес-кую активность, а взаимное усиление эффекта уменьшает риск развития лекарственной устойчивости. Показа-ниями к назначению комбинации «софосбувир/даклатасвир» являются: лечение HCV-инфекции на стадии ост-рого гепатита (при 1-6 генотипах вируса), лечение HCV-инфекции на стадии хронического гепатита (при 1-6 генотипах вируса), лечение HCV-инфекции при ко-инфекции ВИЧ, лечение HCV-инфекции на стадии цирроза печени, лечение рецидива HCV-инфекции после трансплантации печени, лечение HCV-инфекции с иммуно-комплексными проявлениями. Заключение: для комбинации «софосбувир/даклатасвир» показана высокая эф-фективность в лечении HCV-инфекции 1-6 генотипов с частотой достижения УВО 93-97% на стадии гепатита и 88-95% -на стадии цирроза. Хорошая переносимость и высокая эффективность обусловили активное при-менение этой комбинации на стадии цирроза печени. Данная комбинация с успехом применяется для лечения рецидива HCV-инфекции в трансплантате печени, в том числе при ко-инфекции ВИЧ. Ключевые слова: препараты прямого противовирусного действия, софосбувир/даклатасвир, гепатит, фиброз, цирроз печени, трансплантация печени, показания к лечению хронической HCV-инфекции.

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Efficacy and safety of sofosbuvir-based regimens in chronic hepatitis C patients on dialysis

Abstract: Sofosbuvir-based regimens can be used in ESRD patients on dialysis with good efficacy.

Cited by 23 publications

References 10 publications

Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

Sofosbuvir‐containing regimens are safe and effective in the treatment of HCV patients with moderate to severe renal impairment

Sofosbuvir with NS5A inhibitors in hepatitis C virus infection with severe renal insufficiency

Treatment of HCV Infection by a Combination of Sofosbuvir and Daclatasvir

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