Side Effects of sofosbuvir: A Synthesis of Findings from 25 Studies

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Original Abstract of the Article

Major Research Findings

Studies on the safety and efficacy of sofosbuvir have shown promising results, with high cure rates and generally good tolerability in various patient populations, including those with HIV-1 co-infection, kidney transplantation, cirrhosis, and even children. However, some studies highlight the potential for side effects, prompting further investigation.

Reasons for Side Effects

Sofosbuvir, a direct-acting antiviral, targets specific enzymes vital for the hepatitis C virus (HCV) replication process. While highly effective at stopping viral growth, there's a possibility that sofosbuvir might also affect normal cells during this process, leading to side effects.

Common Side Effects

Fatigue

Fatigue has been reported in patients who have taken sofosbuvir. 4

Loss of appetite

Loss of appetite has been reported in patients who have taken sofosbuvir. 4

Anemia

Ribavirin, often used in combination therapy with sofosbuvir, can cause hemolytic anemia. 5

Visual disturbances

Visual disturbances have been reported in patients who have taken sofosbuvir. 25

Liver dysfunction

Liver dysfunction has been reported in patients who have taken sofosbuvir. 11

Cardiotoxicity

Sofosbuvir has been associated with potential cardiotoxicity. 7

Skin side effects

Skin side effects have been reported in patients who have taken sofosbuvir. 1

Kidney dysfunction

As sofosbuvir is primarily eliminated through the kidneys, patients with existing kidney problems might experience a higher risk of side effects. 21

Countermeasures against Side Effects

Countermeasures against Fatigue

If you experience fatigue, consult your doctor and manage your condition, including rest as needed.

Countermeasures against Loss of Appetite

If loss of appetite occurs, consult your doctor and ensure proper nutritional management, possibly including dietary therapy.

Countermeasures against Anemia

If anemia develops, consult your doctor for possible iron supplements or other treatments.

Countermeasures against Visual Disturbances

If you experience visual disturbances, consult your doctor and seek an ophthalmologist's evaluation.

Countermeasures against Liver Dysfunction

If liver dysfunction occurs, consult your doctor for necessary liver function tests and ongoing monitoring.

Countermeasures against Cardiotoxicity

If cardiotoxicity is suspected, consult your doctor immediately for appropriate treatment.

Countermeasures against Skin Side Effects

If skin side effects occur, consult your doctor for necessary treatment and management.

Countermeasures against Kidney Dysfunction

Individuals with kidney dysfunction should consult their doctor for dosage adjustments or specific considerations.

Comparison between Studies

Common points of the studies

Multiple studies have demonstrated the effectiveness of sofosbuvir in treating hepatitis C virus infection. It is generally considered a safe medication.

Differences in the studies

Some variations exist in research findings regarding the side effects of sofosbuvir. This likely stems from differences in the patient populations and research methodologies employed.

Notes on Application to Real Life

Sofosbuvir is a valuable treatment option for hepatitis C virus infection. However, remember that side effects are possible, so it is essential to follow your doctor's instructions carefully. If you have concerns about side effects, discuss them with your doctor.

Limitations of Current Research

Long-term safety studies of sofosbuvir remain limited. It is also important to recognize that sofosbuvir might not be effective for every patient.

Future Research Directions

Further research is needed to comprehensively evaluate the long-term safety of sofosbuvir. Development of alternative therapies for patients who don't respond well to sofosbuvir is also crucial.

Conclusion

Sofosbuvir is a promising treatment for hepatitis C virus infection, but side effects can occur. If you have any concerns, talk to your doctor.

Literature analysis of 25 papers
Positive Content
22
Neutral Content
2
Negative Content
1
Article Type
2
0
1
1
23
3.

Global adverse events reported for direct-acting antiviral therapies for the treatment of hepatitis C: an analysis of the World Health Organization VigiBase.

Author: HayesKaleen N, BurkardTheresa, WeilerStefan, TadrousMina, BurdenAndrea M

HCV treatment
Cardiac events
Pulmonary events

Pulmonary and cardiac events were identified as unexpected ADRs associated with DAAs and may be of interest for further research on DAA safety.

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

Language : English

4.

Antiviral therapy for HCV in hemophilia A patients with HIV-1 co-infection.

Author: XiaoHong, ChenJun, WangJiangrong, LiJuhua, YangFeia, LuHongzhou

HCV clearance
HIV suppression
Bleeding

Direct-acting antiviral (DAA) therapy is safe and well-tolerated in HIV/HCV co-infected patients with hemophilia A.

Evaluation StudyResearch that systematically evaluates the effectiveness of a particular program or policy. It measures its outcomes and provides important information for future decision-making.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

5.

Predictive factors of anemia during sofosbuvir and ribavirin therapy for genotype 2 chronic hepatitis C patients.

Author: UrabeAyako, SakamoriRyotaro, TahataYuki, YamadaRyoko, ImaiYasuharu, HagiwaraHideki, TamuraShinji, FukuiHiroyuki, YamadaYukinori, KanekoAkira, HijiokaTaizo, KodamaTakahiro, HikitaHayato, TatsumiTomohide, TakeharaTetsuo

SVR improvement
Treatment duration reduction
Hemolytic anemia

This study investigated factors associated with ribavirin-induced hemolytic anemia in patients with chronic hepatitis C virus (HCV) genotype 2 infection treated with sofosbuvir (SOF) and ribavirin (RBV). The study aimed to identify factors that could predict which patients might develop anemia and find safer ways to complete treatment with SOF/RBV therapy.

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

Language : English

6.

Safety and efficacy of combined sofosbuvir/daclatasvir treatment of children and adolescents with chronic hepatitis C Genotype 4.

Author: Abdel GhaffarTawhida Y, El NaghiSuzan, Abdel GawadManal, HelmySarah, Abdel GhaffarAisha, YousefMedhat, MoafyMohamad

Effective
HCV treatment
Safe
Mild side effects

Combined sofosbuvir/daclatasvir therapy was found to be effective and safe in treating chronic HCV Genotype 4 infection in children aged 8 years and above. The treatment achieved a high rate of sustained virologic response (SVR) in children, including those younger than 12 years old. Side effects were mild and did not necessitate drug discontinuation.

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

8.

Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study.

Author: El-MarakbyMai G, SolaymanMohamed H, SabriNagwa A

Hepatitis C treatment
Adverse drug reactions

This study analyzed the reported adverse drug reactions (ADRs) with direct-acting antivirals (DAAs) for hepatitis C virus (HCV) using data from VigiBase.

ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
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.

Safety, efficacy and cost of two direct-acting antiviral regimens: A comparative study in chronic hepatitis C Egyptian patients.

Author: Ibrahim Mohammed EbidAbdel-Hameed, Ashraf AhmedOsama, Hassan AgwaSara, Mohamed Abdel-MotalebSara, Mohamed ElsawyAmira, HagagRadwa Samir

Cost-effective treatment

Direct-acting antivirals (DAAs) are the primary treatment for chronic hepatitis C infection. This study compared the efficacy and cost of two DAA regimens for genotype 4 (G4) hepatitis C virus infection in Egypt.

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.

Language : English

10.

Efficacy and safety of sofosbuvir and daclatasvir with or without ribavirin in elderly patients with chronic hepatitis C virus infection.

Author: ElbazTamer, AbdoMahmoud, OmarHeba, HassanEssam A, ZaghloulAmr M, Abdel-SamieeMohamed, MoustafaAhmed, QawzaeAbdallah, GamilMostafa, EsmatGamal

HCV Treatment

Sofosbuvir and daclatasvir, with or without ribavirin, are effective and safe treatments for hepatitis C virus (HCV) infection in elderly patients (over 60 years old) with a cure rate exceeding 90%.

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.

Safety and efficacy of sofosbuvir/ledipasvir and sofosbuvir/daclatasvir in the treatment of hepatitis C in patients with decompensated cirrhosis.

Author: El KassasMohamed, AbdeenNermeen, OmranDalia, AlboraieMohamed, SalaheldinMohamed, EltabbakhMohamed, FarghalyRasha, EmadeldeenMohammed, AfifyShimaa, SweedyAhmad, GhalwashAhmed, AbbassAmr, EzzatSameera, TahoonMarwa, ELshazlyHelmy M, HamdyHassan, OmarHeba

Improved SVR rates
Severe side effects

Direct-acting antivirals (DAAs) were found to be safe and effective in treating hepatitis C virus (HCV)-related decompensated cirrhosis, with a sustained virological response (SVR)12 rate of 88.06%. Younger age was associated with higher SVR12 rates.

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

Language : English

13.

The effectiveness of sofosbuvir and daclatasvir in the treatment of hepatitis C in thalassaemia major patients and their effect on haematological factors.

Author: ZamaniFarhad, AjdarkoshHossein, Safarnezhad-TameshkelFahimeh, AzarkeivanAzita, KeyvaniHossein, NaserifarFarshad, VafaeimaneshJamshid

Effective HCV treatment
No effect on blood transfusion needs
Reduced ferritin levels
Reduced liver enzymes
Tolerable treatment regimen

The combination of sofosbuvir and daclatasvir was an effective and tolerable treatment regimen for patients with major beta thalassemia and hepatitis C virus infection. 98.4% of patients responded to treatment and the regimen did not affect the amount of anemia or the need for blood transfusions.

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

14.

Treatment of Hepatitis C Cirrhotic Patients With Directly Acting Antivirals: A Multicenter Study.

Author: ElfertAsem Ahmed, Abd-ElsalamSherief, Abo-AliLobna, EldemerdashTaher, Abou-SaifSabry, ElsabaghHala Mostafa, EbeidAbla, BadawiRehab

High cure rates for HCV
Reduced treatment duration

Sofosbuvir-based regimens have achieved high cure rates for HCV infection. This study investigated the safety and effectiveness of sofosbuvir-based regimens in treating HCV-infected Egyptian cirrhotic patients.

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

16.

Quadruple Therapy Offers High SVR Rates in Patients with HCV Genotype 4 with Previous Treatment Failure.

Author: Abo-AmerYousry Esam-Eldin, BadawiRehab, El-AbgeegyMohamed, ElserganyHeba Fadl, MohamedAhmed Abdelhaleem, MostafaSahar Mohamed, AlegailyHatem Samir, SolimanShaimaa, ElnawasanySally, Abd-ElsalamSherief

Reduced HCV infection
Reduced disease morbidities
Treatment failure

Direct-acting antivirals (DAAs) have revolutionized hepatitis C treatment. However, some patients still experience treatment failure. This study looked at the effectiveness and safety of a quadruple regimen of DAAs (sofosbuvir, daclatasvir, simeprevir, and ribavirin) in patients who had previously been treated with DAAs.

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

Language : English

18.

Pharmacokinetic interaction between atorvastatin and fixed-dose combination of sofosbuvir/ledipasvir in healthy male Egyptian volunteers.

Author: ElmekawyH A, BelalF, AbdelazizA E, AbdelkawyK S, AliA A, ElbarbryF

This study evaluates the pharmacokinetic interaction between atorvastatin and a fixed-dose combination of sofosbuvir/ledipasvir in patients with comorbid heart and liver disorders.

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.

Language : English

20.

Efficacy and safety of sofosbuvir-based therapy in hepatitis C virus recurrence post living donor liver transplant: A real life egyptian experience.

Author: YosryAyman, Gamal EldeenHadeel, MedhatEman, MehrezMai, ZayedNaglaa, ElakelWafaa, AbdelmoniemReham, KaddahMona, AbdelazizAshraf, EsmatGamal, El-SerafyMagdy, DossWahid

HCV recurrence treatment

Sofosbuvir-based regimens are effective and safe for treating recurrent HCV post-liver transplantation.

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

Language : English

21.

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

23.

Possible acute rejection associated with the use of the new anti-hepatitis C virus medications.

Author: KarkoutKhaled A, Al SherifSaleema, HusseinQutaiba, AlbawardiAlia, BoobesYousef

Direct-acting antiviral agents
Acute rejection
Kidney transplant

This case report presents a patient who experienced a possible acute rejection of a kidney transplant after treatment with direct-acting antiviral agents for hepatitis C virus (HCV) infection. While the case is limited by the absence of donor-specific antibodies, it highlights the potential for these medications to cause adverse effects in transplant patients.

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.

Language : English

24.

Diagnostic approach to elucidate the efficacy and side effects of direct-acting antivirals in HCV infected patients.

Author: YounasSonia, MukhtarHamid, GoharUmar Farooq, AlsrhaniAbdullah, AlzahraniBadr, JunaidKashaf, QamarMuhammad Usman, EjazHasan

HCV treatment

This study aimed to monitor the effectiveness and side effects of direct-acting antivirals in the management of HCV infections.

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

Language : English

25.

Visual symptoms with Sofosbuvir in hepatitis C treatment - a case report from Pakistan.

Author: HasnainAliya, ShahSabeen, HampejskovaLindsay

Hepatitis C treatment
Visual disturbances

This case report describes visual disturbances caused by Sofosbuvir, a pan-genotypic DAA used for hepatitis C treatment. The report highlights the importance of monitoring for unanticipated side effects of this relatively new drug class.

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.

Language : English

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