Side Effects of sofosbuvir and velpatasvir: A Synthesis of Findings from 12 Studies

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Original Abstract of the Article

Main Research Findings

Sofosbuvir/velpatasvir combination is an interferon-free regimen for hepatitis C treatment with high efficacy and safety. 10 In many patients, side effects are mild, and the treatment duration is shorter. 10 However, in some patients, treatment failure may be due to the presence of resistance-associated substitutions. 10 Gastrointestinal side effects are also reported for the combination of sofosbuvir/velpatasvir. 3 The efficacy and safety of sofosbuvir/velpatasvir combination have been confirmed in patients with kidney disease and HIV infection. 9 7 Furthermore, sofosbuvir/velpatasvir combination is suggested to be effective for COVID-19 treatment. 5 However, rare cases of iatrogenic Cushing’s syndrome caused by sofosbuvir/velpatasvir combination have been reported. 2

Reasons for Side Effects

Side effects of sofosbuvir/velpatasvir combination vary depending on how the drug is metabolized in the body, and also depending on the patient’s constitution and health condition. 2 In particular, side effects are more likely to occur in patients with kidney disease and HIV infection. 9 7 Patients with resistance-associated substitutions may not experience treatment efficacy. 10

Common Side Effects

Gastrointestinal

Gastrointestinal symptoms are common side effects of sofosbuvir/velpatasvir combination. 3 Examples include nausea, vomiting, abdominal pain, and diarrhea. 3 Rarely, serious side effects such as gallbladder cancer have also been reported. 8

Others

Besides gastrointestinal side effects, headache, fatigue, and rash have also been reported. 8 Rarely, serious side effects such as Cushing’s syndrome have also been reported. 2

Countermeasures Against Side Effects

Gastrointestinal Side Effects

If you are concerned about gastrointestinal side effects, consult your doctor. 3 If necessary, your medication may be changed, or medication to reduce side effects may be prescribed. 3 Dietary therapy and lifestyle changes may also be effective. 3

Others

If you are concerned about other side effects, consult your doctor. 8 If the cause of the side effect can be identified, your medication may be changed, or medication to reduce side effects may be prescribed. 8 If you suspect a serious side effect, see your doctor immediately. 2

Comparison of Studies

Commonalities in Studies

Multiple studies have shown that sofosbuvir/velpatasvir combination is effective for hepatitis C treatment and has high safety. 10 9 8 7 5 3 4

Differences in Studies

The types and frequency of side effects differ depending on the study. 8 3 The interpretation of results needs to be cautious due to differences in the target patient population and study design. 10 9 8 7 5 3 4

Application to Real Life: Points to Note

Sofosbuvir/velpatasvir combination is an effective drug for hepatitis C treatment, but side effects are possible. 8 It is important to pay attention to gastrointestinal and endocrine side effects in particular. 3 2 It is important to consult a doctor before taking medication and choose a medication that is suitable for your constitution and health condition. 3 2

Limitations of Current Research

Research on sofosbuvir/velpatasvir combination is still insufficient. 9 8 7 2 In particular, further research is needed on long-term side effects and efficacy and safety for specific patient populations. 9 8 7 2

Future Research Directions

Further research is needed on the long-term efficacy and safety of sofosbuvir/velpatasvir combination, and efficacy and safety for specific patient populations. 9 8 7 2 Research is also needed on the interactions of sofosbuvir/velpatasvir combination with other drugs. 3 Furthermore, research is needed on whether sofosbuvir/velpatasvir combination is effective in treating diseases other than hepatitis C. 5

Conclusion

Sofosbuvir/velpatasvir combination is an effective drug for hepatitis C treatment. 8 4 However, as side effects may occur, it is important to consult a doctor before taking medication. 3 2

Literature analysis of 12 papers
Positive Content
11
Neutral Content
0
Negative Content
1
Article Type
1
0
0
0
12
1.

Absence of clinically relevant cardiovascular interaction upon add-on of mirabegron or tamsulosin to an established tamsulosin or mirabegron treatment in healthy middle-aged to elderly men.

Author: van GelderenMarcel, TretterReiner, MeijerJohn, DorrepaalCaroline, Gangaram-PandayShanti, BrooksAshley, KrauwinkelWalter, DickinsonJames

No clinically relevant changes

Co-treatment with tamsulosin and mirabegron did not result in clinically relevant changes in cardiovascular safety.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

A rare case report of iatrogenic Cushing syndrome caused by direct anti-hepatitis C virus therapy with sofosbuvir/velpatasvir.

Author: MaBo, ShangTianling, HuangJianjie, TuZhixin, WangYan, HanYujin, WangYang, WenXiaoyu, JinQinglong

hepatitis C treatment
iatrogenic Cushing syndrome

Sofosbuvir/velpatasvir (SOF/VEL) is a pan-genotypic direct-acting antiviral combination for chronic hepatitis C virus infection. While uncommon, iatrogenic Cushing syndrome (ICS) has been reported as a side effect of SOF/VEL. This case report describes a patient who developed ICS with significantly low serum adrenocorticotropic hormone and cortisol levels after receiving SOF/VEL.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

5.

Efficacy and safety of the sofosbuvir/velpatasvir combination for the treatment of patients with early mild to moderate COVID-19.

Author: MessinaVincenzo, NevolaRiccardo, IzziAntonio, De Lucia SpositoPellegrino, MarroneAldo, RegaRoberto, FuscoRaffaele, LuminoPaolina, RinaldiLuca, GaglionePasqualina, SimeoneFilomena, SassoFerdinando Carlo, MaggiPaolo, AdinolfiLuigi Elio

Disease progression prevention
Viral clearance

A multicenter case-control study evaluated the effect of sofosbuvir/velpatasvir (SOF/VEL) in patients with mild or moderate COVID-19. Patients who received SOF/VEL showed a significantly faster viral clearance compared to the control group (83% vs 13%). Early SOF/VEL treatment also appeared to prevent disease progression and had no significant side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

6.

Successful use of generic direct acting antiviral medications to treat hepatitis C-a New Zealand-wide study.

Author: AluzaiteKristina, FraserMargaret, JohnsonSteve, GilesHannah, SchultzMichael

Hepatitis C treatment

This study reviews the use of generic HCV DAA medications imported through Tasmanian FixHepC Buyer's Club in New Zealand and examines the associated side effect profiles.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

7.

Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end-stage renal disease on maintenance haemodialysis.

Author: TanejaSunil, DusejaAjay, MehtaManu, DeArka, VermaNipun, PremkumarMadhumita, DhimanRadha K, SinghVirendra, SinghMini P, RathoRadha K, RamachandranRaja, KumarVivek, KohliHarbir S

Hepatitis C treatment

This study evaluated the safety and efficacy of Sofosbuvir plus Velpatasvir fixed-dose combination in chronic hepatitis C (CHC) patients with end-stage renal disease (ESRD) on maintenance hemodialysis (MHD).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection.

Author: AsselahTarik, ShafranStephen D, BourgeoisStefan, LaiChing-Lung, MathurinPhilippe, WillemsBernard, NguyenMindie H, DavisMitchell N, HuangK C, SvarovskaiaEvguenia, OsinusiAnu, McNallyJohn, BrainardDiana M, ShaikhObaid S, TranTram T

Effective HCV treatment
Sustained virologic response
Well tolerated
Gallbladder carcinoma

Sofosbuvir-velpatasvir is a medication for chronic hepatitis C that cleared the virus in 97% of patients within 12 weeks. Most patients tolerated the drug well.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Successful treatment of genotype 3 hepatitis C infection in a noncirrhotic HIV infected patient on chronic dialysis with the combination of sofosbuvir and velpatasvir: A case report.

Author: BegovacJosip, KrznarićJuraj, BogdanićNikolina, MočibobLoris, ZekanŠime

HCV treatment success
Sustained virologic response

This case report describes a patient with HCV genotype 3 and human immunodeficiency type 1 (HIV) infection on chronic dialysis who achieved a sustained virologic response after treatment with sofosbuvir/velpatasvir. The study suggests that sofosbuvir/velpatasvir may be an option for HCV genotype 3 infection in patients coinfected with HIV on long-term dialysis.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

10.

Retreatment with sofosbuvir/velpatasvir in cirrhotic patients with genotype-4 who failed a previous interferon-free regimen: a case series.

Author: BoglioneLucio, PinnaSimone Mornese, LupiaTommaso, CaritiGiuseppe, Di PerriGiovanni

Improved SVR
Relapse
Virological breakthrough

Novel interferon-free regimens have significantly improved sustained virological response in chronic hepatitis C patients, without major side effects and with shorter treatment durations. However, treatment failure in a subset of patients was linked to resistance-associated substitutions, highlighting the need for further research on these mutations.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment.

Author: EvonDonna M, GolinCarol E, StewartPaul, FriedMichael W, AlstonShani, ReeveBryce, LokAnna S, SterlingRichard K, LimJoseph K, ReauNancy, SarkarSouvik, NelsonDavid R, ReddyK R, Di BisceglieAdrian M

Effective treatment for HCV

This study is an observational study that will enroll 1600 patients starting treatment with recently-approved direct-acting antiviral (DAA) therapies for hepatitis C. The study will focus on patient-reported outcomes, including side effects, medication adherence, and long-term impacts of treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

12.

Sofosbuvir/velpatasvir improves patient-reported outcomes in HCV patients: Results from ASTRAL-1 placebo-controlled trial.

Author: YounossiZobair M, StepanovaMaria, FeldJordan, ZeuzemStefan, JacobsonIra, AgarwalKosh, HezodeChristophe, NaderFatema, HenryLinda, HuntSharon

Improved PROs
SVR achievement

Treatment with sofosbuvir and velpatasvir for hepatitis C virus infection significantly improves patient-reported outcomes, such as general health, emotional well-being, and quality of life. These improvements are seen during treatment and after achieving sustained virologic response.

Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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