Sofosbuvir in the Treatment of Chronic Hepatitis C: New Dog, New Tricks

Abraham, George M.; Spooner, Linda M.

doi:10.1093/cid/ciu265

Cited by 16 publications

(6 citation statements)

References 37 publications

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“…With the aim of minimizing the risk of drug‐to‐drug interactions, non‐NS3/4A protease inhibitor‐containing regimens were preferentially used when possible . At the time of study design, data on the safety of SOF in patients with severe renal impairment were lacking . Therefore, in the presence of eGFR <30 ml/min, we decided to prioritize patients with advanced liver disease by offering the only SOF‐free, protease inhibitor‐based combo EMA‐approved by that time.…”

Section: Methodsmentioning

confidence: 99%

Impact of anti-HCV direct antiviral agents on graft function and immunosuppressive drug levels in kidney transplant recipients: a call to attention in the mid-term follow-up in a single-center cohort study

et al. 2018

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The medium-term impact on graft function and immunosuppressive drug pharmacokinetics of direct antiviral agents (DAAs) among hepatitis C virus (HCV)-infected kidney transplant (KT) recipients remain unclear. We compared pre- and post-treatment 12-month trajectories of estimated glomerular filtration rate (ΔeGFR) and 24-h proteinuria (Δ24-h proteinuria) in 49 recipients treated with DAAs (mostly sofosbuvir plus ledipasvir). Among evaluable patients, 66.7% and 100.0% had undetectable viral load by week 4 and end of therapy (EoT). The sustained virologic response rate at 12 weeks was 95.8%. Overall, 80.6% of patients receiving tacrolimus required dose escalation while on DAA-based therapy (median increase of 66.7%) to maintain target levels. Tacrolimus levels resulted to be higher at 12 months compared to EoT (7.8 ± 2.1 vs. 6.7 ± 2.0 ng/ml; P-value = 0.002). No changes in graft function during the course of therapy were observed. However, eGFR significantly decreased (P-value <0.001) throughout the first 12 months after EoT. Median ΔeGFR and Δ24-h over pre- and post-treatment periods were 3.9% and -6.1% (P-value = 0.002) and -5.3% and 26.2% (P-value = 0.057). Caution should be exercised when adjusting immunosuppression in HCV-infected KT recipients upon initiation of DAAs, followed by mid-term monitoring of immunosuppressive drug levels and graft function.

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Section: Methodsmentioning

confidence: 99%

Impact of anti-HCV direct antiviral agents on graft function and immunosuppressive drug levels in kidney transplant recipients: a call to attention in the mid-term follow-up in a single-center cohort study

et al. 2018

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“…However, it is not effective if taken alone and leads to drug resistance. 8 So, it is recommended to take Sofosbuvir with another directacting antiviral drug like Ribavirin.…”

Section: Introductionmentioning

confidence: 99%

Development and Characterization of a Combination Tablet Dosage Form Containing Sofosbuvir and Ribavirin Using Design of Experiments (DoE) Approach

Islam

Alam

Sikdar

et al. 2021

Dhaka Univ. J. Pharm. Sci

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Worldwide more than 180 million people get infected by chronic Hepatitis C Virus (HCV) and around 700,000 people pass away every year due to HCV related problems. Sofosbuvir and Ribavirin are prescribed as combined medication for the management of HCV infection globally. Therefore, optimization of a pharmaceutical dosage form containing Sofosbuvir and Ribavirin can open a new hope in the treatment of HCV infection. This study was conducted by using the Design of Experiments (DoE) approach. It is a systematic process aiming to determine the correlation between formulation factors affecting the approach and the output of the approach. During the development of formulations, two factors were considered, which are Croscarmellose Sodium (CCS) and Povidone K30 (PK30) at different concentrations ranging from 0.19% to 2.31% of the total tablet weight in 9 different formulations. Their effect on disintegration time (DT) was evaluated through statistical method and it was found between 3±0.003 and 6.5±0.015 minutes. The use of these two different disintegrants exhibited a significant effect on DT. The contour plot showed predicted ranges of concentrations of CCS and PK30 for desired DT. Fourier Transform Infrared Spectroscopy (FTIR) data, Thermogravimetric Analysis (TGA) and X-ray Diffractometry (XRD) spectrums confirmed that there was no interaction between Sofosbuvir and Ribavirin or with any other excipients used in this experiment. Dhaka Univ. J. Pharm. Sci. 20(1): 121-133, 2021 (June)

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“…In genotype 2, sofosbuvir and ribavirin for 12 weeks achieved an SVR of ≥90% with little effect from cirrhosis, but genotype 3 was less responsive, especially in the presence of cirrhosis . Sofosbuvir is renally eliminated and does not require adjustment (once‐daily dose of 400 mg) in mild to moderate renal insufficiency, or in any degree of hepatic impairment; it is not metabolized by cytochrome P450 isoenzymes, nor does it induce or inhibit the metabolism of agents that are substrates of these enzymes . Sofosbuvir has a high barrier to resistance; in vivo , a double mutation (L159F/L320F) may emerge that confers low‐level resistance to both mericitabine and sofosbuvir .…”

Section: Ns5b (Nucleoside‐type) Inhibitors (Table )mentioning

confidence: 99%

Development of antiviral drugs for the treatment of hepatitis C at an accelerating pace

Clercq

2015

Reviews in Medical Virology

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Anno 2015, the race for developing the ideal therapy, or what is now called "cure," for hepatitis C virus infection has continued unabatedly. The targets (NS3/4A protease, NS5A protein, and NS5B polymerase) have remained the same, and the number of compounds [direct-acting antivirals (DAAs)] interacting with these targets has continued to increase. Whereas pan-genotypic activity has remained a mandatory requirement, the problem of virus drug resistance has become less crucial. The need for combining DAAs acting at different sites has remained compelling, with the drugs used for combinations emanating from the same pharmaceutical company, that is, Gilead (sofosbuvir and ledipasvir) (Gilead Sciences, Foster City, CA, USA) (AbbVie, North Chicago, IL, USA), AbbVie (ABT/r, ombitasvir, and dasabuvir), and BMS (Bristol-Myers Squibb), (New York City, NY, USA) (asunaprevir and daclatasvir) among the leading contenders. At stake is the definitive cure of HCV infection [as reflected by a sustained viral response (SVR) after 12 weeks of treatment]. This SVR is expected to reduce cirrhosis and hepatocellular carcinoma, two complications inherently linked to HCV infection. Unlike hepatitis B virus and human immunodeficiency virus, HCV infection can be definitely and permanently cured by antiviral therapy because HCV has no long-term reservoir in the body. Peginterferon combined with ribavirin and even the first-wave protease inhibitors telaprevir and boceprevir now belong to the milestones that had an important, although historical, role in the final conquest of hepatitis C.

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Sofosbuvir in the Treatment of Chronic Hepatitis C: New Dog, New Tricks

Cited by 16 publications

References 37 publications

Impact of anti-HCV direct antiviral agents on graft function and immunosuppressive drug levels in kidney transplant recipients: a call to attention in the mid-term follow-up in a single-center cohort study

Impact of anti-HCV direct antiviral agents on graft function and immunosuppressive drug levels in kidney transplant recipients: a call to attention in the mid-term follow-up in a single-center cohort study

Development and Characterization of a Combination Tablet Dosage Form Containing Sofosbuvir and Ribavirin Using Design of Experiments (DoE) Approach

Development of antiviral drugs for the treatment of hepatitis C at an accelerating pace

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