Side Effects of ledipasvir and sofosbuvir: A Synthesis of Findings from 28 Studies

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Original Abstract of the Article

Main Research Findings

Ledipasvir/sofosbuvir combination therapy is a highly effective treatment for chronic hepatitis C. Many studies have shown that this combination can suppress the hepatitis C virus and achieve a sustained virological response (SVR), significantly improving outcomes for patients. Notably, 23 reported a successful case of treating donor-derived hepatitis C virus infection in transplant recipients. Additionally, 19 confirmed the effectiveness of ledipasvir/sofosbuvir combination against recurrent hepatitis C in liver transplant recipients.

Reasons for Side Effects

The side effects of ledipasvir/sofosbuvir combination therapy are believed to be linked to the drug's mechanism of action and its metabolic process within the body. For instance, 15 reported cases of severe steroid-responsive skin disorders caused by ledipasvir/sofosbuvir combination. This side effect suggests a possible immune response to the drug.

Common Side Effects

Headache

As reported in 20 , headache is a common side effect of ledipasvir/sofosbuvir combination.

Fatigue

As reported in 20 , fatigue is a common side effect of ledipasvir/sofosbuvir combination.

Skin Rash

As reported in 15 , skin rash is a side effect of ledipasvir/sofosbuvir combination, which can be severe in some cases.

Anemia

As reported in 19 , anemia may occur when ledipasvir/sofosbuvir combination is used concurrently with ribavirin.

Sexual Dysfunction

As reported in 16 , sexual dysfunction has been documented as a side effect of ledipasvir/sofosbuvir combination.

Countermeasures for Side Effects

Headache

If you experience a headache, consult your doctor. They may prescribe appropriate medication.

Fatigue

If you experience severe fatigue, consult your doctor. You may need to make lifestyle changes or be prescribed appropriate medication.

Skin Rash

Consult your doctor immediately if you develop a skin rash. You may be prescribed steroids or other medication.

Anemia

Consult your doctor if you experience symptoms of anemia. Blood tests will be conducted to determine the cause of anemia. If necessary, iron supplements or other medication will be prescribed.

Sexual Dysfunction

Consult your doctor if you experience sexual dysfunction. They will investigate whether the cause is the ledipasvir/sofosbuvir combination and consider alternative treatment options if necessary.

Comparison Between Studies

Similarities

Many studies have demonstrated that ledipasvir/sofosbuvir combination is effective in treating chronic hepatitis C. Moreover, the side effects are generally mild, and many patients can complete the course of treatment.

Differences

The age group, type of hepatitis C virus, and treatment duration of the subjects varied between studies, leading to differences in the results. For instance, 8 conducted a study with children aged 4 to 10 years, while 14 conducted a study with adolescents aged 12 to 17 years.

Important Notes for Applying Research to Real Life

While ledipasvir/sofosbuvir combination therapy holds promise as an effective treatment for chronic hepatitis C, it's essential to remember that side effects can occur. Before starting treatment, it's crucial to consult with your doctor and select the treatment most suitable for your condition.

Limitations of Current Research

Research on ledipasvir/sofosbuvir combination therapy is still ongoing and not exhaustive. Further studies are particularly needed to understand long-term side effects and the effectiveness of the combination in specific patient groups.

Future Directions for Research

Research is needed to investigate the long-term safety and efficacy of ledipasvir/sofosbuvir combination therapy. Further studies are also needed to investigate the effectiveness and side effects of this combination in specific patient groups such as the elderly, pregnant women, and children.

Conclusion

Ledipasvir/sofosbuvir combination therapy holds great potential as an effective treatment for chronic hepatitis C. However, it's important to keep in mind that side effects can occur. It's crucial to discuss treatment with your doctor and make decisions together. Future research is expected to lead to the development of even safer and more effective treatment methods.

Literature analysis of 28 papers
Positive Content
24
Neutral Content
1
Negative Content
3
Article Type
2
0
0
1
27
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.

Efficacy and safety of sofosbuvir/ ledipasvir in treatment of patients with COVID-19; A randomized clinical trial.

Author: KhaliliHossein, NourianAnahid, AhmadinejadZahra, Emadi KouchakHamid, JafariSirous, Dehghan ManshadiSayed Ali, RasolinejadMehrnaz, KebriaeezadehAbbas

Faster clinical response
Gastrointestinal events

SOF/LDP, when combined with standard care, accelerated time to clinical response in patients with mild to moderate COVID-19, but did not affect the rate of clinical response, length of hospital or ICU stay, or 14-day mortality rate. Gastrointestinal events were the most common side effect, occurring in 15.85% of patients.

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

5.

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

8.

Safety and Efficacy of 8 Weeks Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 4 in Children Aged 4-10 Years.

Author: BehairyBehairy E, El-ArabyHanaa A, El-GuindiMohamed A, BasiounyHosam-Eldin M, FouadOla A, AyoubBassam A, MareiAyman M, SiraMostafa M

Effective HCV treatment
Safe HCV treatment
Fatigue
Headache

A shortened 8-week regimen of ledipasvir/sofosbuvir (LED/SOF) is safe and effective with 100% SVR12 in treatment-naïve children with cirrhosis aged 4-10 years with chronic HCV infection genotype 4.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Generic sofosbuvir/ledipasvir for the treatment of genotype 4 chronic hepatitis C in Egyptian children (9-12 years) and adolescents.

Author: El-ArabyHanaa A, BehairyBehairy E, El-GuindiMohamed A, AdawyNermin M, AllamAlif A, SiraAhmad M, KhedrMohamed A, ElhenawyIbrahim A, SobhyGihan A, BasiounyHosam El Din M, SalemMenan E, Abdel-AzizSamira A, FouadOla A, AyoubBassam A

HCV treatment

This study assessed the safety and efficacy of a generic sofosbuvir/ledipasvir fixed-dose combination for treating chronic hepatitis C in adolescents and children (9-12 years old).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

11.

Sustained Viral Response in Genotype 4 Chronic Hepatitis C Virus-infected Children and Adolescents Treated With Sofosbuvir/Ledipasvir.

Author: El-KaraksyHanaa, MogahedEngy Adel, AbdullatifHala, GhobrialCarolyne, El-RazikyMona S, El-KoofyNehal, El-ShabrawiMortada, GhitaHaytham, BaroudySherif, OkashaSawsan

Treats hepatitis C

This study assessed the safety and efficacy of sofosbuvir (SOF) combined with ledipasvir (LED) in genotype 4 hepatitis C virus (HCV)-infected Egyptian children and adolescents.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

12.

A pilot single arm observational study of sofosbuvir/ledipasvir (200 + 45 mg) in 6- to 12- year old children.

Author: El-ShabrawiM H F, KamalN M, El-KhayatH R, KamalE M, AbdElgawadM M A H, YakootM

Effective treatment
Safe treatment

Sofosbuvir/ledipasvir combination therapy is a safe and effective treatment for chronic hepatitis C genotype 4 infection in children aged 6 to 12 years old. The combination was well tolerated and no side effects or fatalities were reported.

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

13.

The safety and efficacy of ledipasvir/sofosbuvir with or without ribavirin in the treatment of orthotopic liver transplant recipients with recurrent hepatitis C: real-world data.

Author: PyrsopoulosNikolaos, TrilianosPanagiotis, LingiahVivek A, FungPhoenix, PunnooseMerlin

Safe treatment
Virological response
Gastrointestinal upset
Malaise

Ledipasvir/sofosbuvir with or without ribavirin was highly effective and safe in treating recurrent hepatitis C in orthotopic liver transplant recipients. The regimen resulted in near-universal sustained virological response, with few adverse effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

14.

The effectiveness and safety of ledipasvir plus sofosbuvir in adolescents with chronic hepatitis C virus genotype 4 infection: a real-world experience.

Author: El-KhayatH R, KamalE M, El-SayedM H, El-ShabrawiM, AyoubH, RizKA, MaherM, El SheemyR Y, FouadY M, AttiaD

HCV treatment
Diarrhea
Headache
Pruritus
Skin rash

The ledipasvir plus sofosbuvir regimen was well tolerated and effective in treating adolescent patients with chronic hepatitis C genotype 4.

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

15.

Severe Steroid-responsive Skin Disorders Related to Ledipasvir and Sofosbuvir for HCV.

Author: TadokoroTomoko, MorishitaAsahiro, FujitaKoji, OuraKyoko, SakamotoTeppei, NomuraTakako, TaniJoji, YoneyamaHirohito, MasakiTsutomu

Hepatitis C treatment
skin disorders

Ledipasvir and sofosbuvir (LDV/SOF) are direct-acting antiviral agents highly effective against hepatitis C virus genotype 1 infection. This case report describes a patient who developed a rash after starting LDV/SOF treatment. The rash resolved after interrupting LDV/SOF and administering prednisolone. The patient then successfully completed treatment with LDV/SOF and prednisolone. This case highlights the importance of managing skin disorders that may arise during LDV/SOF treatment.

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

16.

Sexual Dysfunction in a Patient Taking Ledipasvir/Sofosbuvir for the Treatment of Hepatitis C: A Case Report.

Author: LenzDestin U, CrutcherEffie L, GreeneElisa M

Sexual dysfunction

Sexual dysfunction, although not previously reported with ledipasvir/sofosbuvir, is a possible side effect of this hepatitis C treatment. This case report highlights a 42-year-old man who experienced sudden onset of sexual dysfunction after starting ledipasvir/sofosbuvir. His symptoms resolved upon discontinuation of the medication.

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

18.

Randomised clinical trial: sofosbuvir and ledipasvir in patients with transfusion-dependent thalassaemia and HCV genotype 1 or 4 infection.

Author: MangiaA, SarliR, GamberiniR, PigaA, CenderelloG, PiazzollaV, SantoroR, CarusoV, QuartaA, GangaR, CopettiM, ForniG

HCV treatment
HCC risk
Side effects

This study examines the high rate of hepatitis C virus (HCV) infection in patients with thalassemia major, which is caused by contaminated blood transfusions. Patients with HCV infection have a higher risk of developing liver cancer. The side effects of the traditional treatment with Peg-IFN and Ribavirin have limited its use.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

19.

Effectiveness of Ledipasvir/Sofosbuvir with/without Ribavarin in Liver Transplant Recipients with Hepatitis C.

Author: SaabSammy, RheemJustin, JimenezMelissa A, FongTiffany M, MaiMichelle H, KachadoorianCaterina A, EsmailzadehNegin L, BauSherona N, KangSusan, RamirezSamantha D, GrottsJonathan, ChoiGina, DurazoFrancisco A, El-KabanyMohammed M, HanSteven-Huy B, BusuttilRonald W

HCV treatment
Interferon-free
Anemia

This study examines the safety and efficacy of ledipasvir/sofosbuvir, with and without ribavirin, for the treatment of recurrent hepatitis C virus (HCV) infection in liver transplant recipients. The treatment was found to be effective and well-tolerated, with 94% of patients achieving sustained viral response. However, ribavirin was associated with anemia in some patients.

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

Language : English

20.

Effectiveness of ledipasvir/sofosbuvir in real-world patients with chronic hepatitis C: a collaborative treatment approach.

Author: JohnsonSteven W, AmmiratiShelby R, HartisCharles E, WeberStephen F, MorganMichael R, DarnellTimothy A, SilwalAdwait, SchmidlinHolly N, PriestDavid H

Treats Hepatitis C
Hepatic Decompensation

This study evaluated the effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in treating chronic hepatitis C virus (HCV) in routine clinical practice. The results show that LDV/SOF, when used as part of a standardized interprofessional treatment protocol, is associated with high sustained virological response (SVR) rates and good tolerability.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

21.

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

22.

Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection.

Author: CrespoJavier, CallejaJose Luis, FernándezInmaculada, SacristanBegoña, Ruiz-AntoránBelén, AmpueroJavier, Hernández-CondeMarta, García-SamaniegoJavier, GeaFrancisco, ButiMaria, CabezasJoaquin, LensSabela, MorillasRosa Maria, SalcinesJose Ramon, PascasioJuan Manuel, TurnesJuan, Sáez-RoyuelaFederico, ArenasJuan, RincónDiego, PrietoMartin, JorqueraFrancisco, Sanchez RuanoJuan Jose, NavascuésCarmen A, MolinaEsther, MoyaAdolfo Gallego, Moreno-PlanasJosé Maria,

HCV genotype 4 treatment
SAEs

This cohort study investigates the effectiveness and safety of direct-acting antiviral agents (DAAs) for treating hepatitis C virus (HCV) genotype 4 infection in routine practice, highlighting the need for more data to guide treatment decisions for this underrepresented population.

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

Language : English

23.

Miliary tuberculosis infection during hepatitis C treatment with sofosbuvir and ledipasvir plus ribavirin.

Author: Ballester-FerréMaria Pilar, MartínezFernando, Garcia-GimenoNatalia, MoraFrancisco, SerraMiguel A

HCV treatment
Miliary tuberculosis

This case report describes an HCV-infected patient who developed miliary tuberculosis after completing treatment with sofosbuvir/ledipasvir plus ribavirin. This highlights the importance of considering opportunistic infections, particularly TB, in patients undergoing HCV therapy.

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.

Successful treatment of donor-derived hepatitis C viral infection in three transplant recipients from a donor at increased risk for bloodborne pathogens.

Author: ShahAshesh P, CameronAndrew, SinghPooja, FrankAdam M, FenkelJonathan M

HCV treatment
Transplant rejection

This case report describes the successful treatment of hepatitis C virus (HCV) transmitted from a NAT-negative donor to three HCV-negative recipients. All recipients received ledipasvir/sofosbuvir therapy and achieved a sustained viral response.

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

25.

High rates of hepatitis C virus (HCV) cure using direct-acting antivirals in HIV/HCV-coinfected patients: a real-world perspective.

Author: HawkinsClaudia, GrantJennifer, AmmermanLauren Rose, PalellaFrank, MclaughlinMilena, GreenRichard, McgregorDonna, StosorValentina

Effective HCV treatment
Well-tolerated

Direct-acting antiviral (DAA) drug combinations were highly effective and well tolerated in HIV/HCV-coinfected patients. The SVR12 rate was 92% in patients who completed therapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

28.

Emerging options for treating hepatitis C infection.

Author: FantasiaHeidi Collins

HCV treatment
side effects

This review discussed the treatment of hepatitis C infection.

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

Language : English

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