Side Effects of ombitasvir paritaprevir: A Synthesis of Findings from 22 Studies

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Original Abstract of the Article

Major findings

Ombitasvir/paritaprevir/ritonavir/dasabuvir (OBV/PTV/r/DSV) has been shown to be highly effective in treating chronic hepatitis C virus (HCV) infection, especially in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A). 14 、 18 These findings were confirmed in several real-world studies from Latin America, Romania, and Brazil, where more than 95% of patients achieved sustained virologic response at week 12 (SVR12) after treatment. 14 、 12 、 5

Reason for side effects

Side effects associated with OBV/PTV/r/DSV may be related to the mechanism of action of the drugs. OBV/PTV/r/DSV work by inhibiting enzymes involved in the replication of HCV. This inhibition could lead to adverse effects in some patients.

Common side effects

Pruritus (itching)

Pruritus has been reported as the most common side effect of OBV/PTV/r/DSV in several studies. 14 、 11 Itching is thought to be associated with increased bile acid levels caused by OBV/PTV/r/DSV. 11

Hyperbilirubinemia (increased bilirubin levels)

Hyperbilirubinemia has been reported as a side effect of OBV/PTV/r/DSV. 14 It may indicate a decline in liver function. Many of the patients who experienced hyperbilirubinemia had Child-Pugh B cirrhosis at baseline, suggesting that OBV/PTV/r/DSV may be associated with worsening of cirrhosis. 14

Asthenia (weakness)

Asthenia has been reported as a side effect of OBV/PTV/r/DSV. 14 Asthenia was not a serious side effect that required treatment discontinuation, but it could impact patients' quality of life.

Management of side effects

Pruritus (itching)

Medications like antihistamines or steroid creams can be used to relieve itching. 11

Hyperbilirubinemia (increased bilirubin levels)

Hyperbilirubinemia may suggest a decline in liver function and requires medical attention. Doctors will assess liver function and provide appropriate treatment if needed. 14

Asthenia (weakness)

Managing asthenia includes ensuring adequate rest and hydration. 14

Comparison across studies

Commonalities

Multiple studies have shown that OBV/PTV/r/DSV is effective in treating HCV infection. 14 、 18 、 11 、 12 、 5 、 15 、 16 、 1 、 20 、 6 、 22 、 9 、 21 、 7 、 8 、 17 、 3 、 4 、 10 、 2 、 13 、 19 These studies also suggest that OBV/PTV/r/DSV is generally safe.

Differences

There are variations in the characteristics of the patient populations and the incidence of side effects across studies. For example, 14 reported a higher rate of treatment discontinuation in patients with Child-Pugh B cirrhosis compared to 12 which observed a lower discontinuation rate in patients with Child-Pugh A cirrhosis.

Considerations for real-world application

OBV/PTV/r/DSV is an effective treatment for HCV infection. However, not all patients will experience side effects. Consult with your doctor if side effects occur. It's particularly important for patients with cirrhosis to consult with their doctor before starting treatment. 14 、 18 、 11 、 12 、 5 、 15 、 16 、 1 、 20 、 6 、 22 、 9 、 21 、 7 、 8 、 17 、 3 、 4 、 10 、 2 、 13 、 19

Limitations of current research

Many studies on OBV/PTV/r/DSV are relatively small and limited to specific patient populations. Additionally, these studies may not have thoroughly investigated particular side effects. Therefore, caution is needed when generalizing these findings.

Directions for future research

Larger, longer-term studies are needed to evaluate the long-term safety and efficacy of OBV/PTV/r/DSV. Studies that examine side effects in more detail are also necessary. Moreover, research comparing OBV/PTV/r/DSV to other treatment options is crucial.

Conclusion

OBV/PTV/r/DSV is an effective treatment for HCV infection. However, the possibility of side effects should be considered. Consult with your doctor before starting treatment with OBV/PTV/r/DSV and ensure you understand the risks and benefits of the medication.

Literature analysis of 22 papers
Positive Content
22
Neutral Content
0
Negative Content
0
Article Type
1
0
0
4
22
1.

Efficacy and safety of ombitasvir/paritaprevir/ritonavir-based therapy in HCV patients with chronic kidney disease.

Author: El-SayedMohammad, ElserafyMagdy, El RazikyMaissa, ElakelWafaa, SaadYasmin, FayadTarek, KoranyMohamed, MehrezMai, SalamaRabab, MahrousMaged, ZakiAyman, HassanyMohamed, AmmarIslam, ElsaeedKadry, ElshazlyYehia, DossWahid

Effective treatment
Anemia

Ombitasvir/paritaprevir/ritonavir-based therapy was highly effective in treating chronic hepatitis C virus (HCV) infection in patients with chronic kidney disease (CKD), including those on hemodialysis. The most common side effect was anemia, which was more prevalent in patients with CKD.

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

Language : English

2.

Efficacy and Safety of Ombitasvir/Paritaprevir/ Ritonavir + Dasabuvir ± Ribavirin Combinations in Patients with Genotype 1 Hepatitis C and Inherited Bleeding Disorders.

Author: SonsuzAbdullah, BozcanSelma, Hatemiİbrahim, ÖzdemirSebati, CanbakanBillur, YıldırımSüleyman, Gültürkİlkay, ArCem

Hepatitis C treatment

This study reports the efficacy and safety of ombitasvir + paritaprevir/ritonavir and dasabuvir combination in treating hepatitis C in patients with inherited bleeding disorders.

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

Language : English

3.

Ombitasvir/paritaprevir/ritonavir & dasabuvir ± ribavirin following protease inhibitors failure - a prospective multi-centre trial.

Author: DeutschLiat, HouriInbal, Ben-AriZiv, ShlomaiAmir, VeitsmanElla, Cohen-EzraOranit, IssacharAssaf, MorOrna, GozlanYael, BruckRafael, MenachemYoram, Zelber-SagiShira, KatchmanHelena, ShiboletOren

HCV treatment
Side effects

Hepatitis C virus (HCV) infection can lead to chronic liver disease and hepatocellular carcinoma. First-generation protease inhibitors (PI) + peg-interferon (pegIFN) and ribavirin (RBV) achieved SVR rates of 65-75% but had side effects. This study evaluated the safety and efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir (3D) ± RBV in HCV genotype 1 patients who failed previous treatment with first-generation PIs.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of 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.

Language : English

5.

Direct antiviral therapy for treatment of hepatitis C: A real-world study from Brazil.

Author: LobatoCirley Maria de Oliveira, CodesLiana, SilvaGiovanni Faria, SouzaAécio Flávio Meirelles, CoelhoHenrique Sérgio Moraes, PedrosoMaria Lucia Alves, PariseEdison Roberto, LimaLeila Maria Soares Tojal de Barros, BorbaLuiz Augusto, EvangelistaAndreia Silva, RezendeRosamar Eulira Fontes, CheinquerHugo, KuniyoshiAline Satie Oba, AiresRodrigo Sebba, QuintelaEloiza Helena Dias, MendesLiliana Sampaio Costa, NascimentoFábio Carneiro Vosqui, Medeiros FilhoJosé Eymard Moraes de, FerrazMaria Lúcia Cardoso Gomes, AbdalaEdson, BittencourtPaulo Lisboa,

HCV treatment effectiveness

This study assessed the effectiveness and safety of hepatitis C virus (HCV) treatment with direct antiviral agents (DAAs) in a real-life setting in Brazil.

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

Language : English

6.

Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis.

Author: PoordadFred, SedghiShahriar, PockrosPaul J, RavendhranNatarajan, ReindollarRobert, LuceyMichael R, EpsteinMichael, BankLeslie, BernsteinDavid, TrinhRoger, KrishnanPreethi, PolepallyAkshanth R, UnnebrinkKristina, MartinezMarisol, NelsonDavid R

HCV treatment
Hemoglobin decrease

This Phase 3 study evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir + dasabuvir (OBV/PTV/r + DSV) with low-dose ribavirin for 12 weeks in genotype 1a-infected patients without cirrhosis. The SVR12 rate was 89.5%. Although noninferiority to the weight-based ribavirin regimen was not met, this regimen offers an alternative for patients who cannot tolerate full-dose ribavirin.

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.
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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Real-life results of treatment with ombitasvir, paritaprevir, dasabuvir, and ritonavir combination in patients with chronic renal failure infected with HCV in Turkey.

Author: YaraşSerkan, ÜçbilekEnver, ÖzdoğanOsman, AteşFehmi, AltıntaşEngin, SezginOrhan

Hepatitis C treatment
Renal failure treatment

This study presents the results of a treatment regimen using ombitasvir, paritaprevir, dasabuvir, and ritonavir for chronic hepatitis C virus (HCV) infection in patients with hemodialysis-dependent chronic renal failure (CRF).

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

8.

Direct acting anti-viral medications for hepatitis C: Clinical trials in patients with advanced chronic kidney disease.

Author: BruchfeldAnnette, LindahlKarin

CKD treatment
HCV cure

Direct-acting antiviral (DAA) therapies have proven highly effective in treating hepatitis C in patients with chronic kidney disease (CKD) including end-stage renal disease (ESRD). Cure rates of over 90% have been achieved with minimal side effects, highlighting the need to raise awareness of these treatment options.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

Hepatic Pharmacokinetics and Pharmacodynamics With Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir Treatment and Variable Ribavirin Dosage.

Author: TalalAndrew H, DumasEmily O, BauerBarbara, RejmanRichard M, OcqueAndrew, MorseGene D, LucicDanijela, ClohertyGavin A, KingJennifer, ZhaJiuhong, ZhangHongtao, CohenDaniel E, ShulmanNancy, PawlotskyJean-Michel, HézodeChristophe

HCV RNA decline
Pain

This study found that RBV coadministration had minimal impact on the plasma or liver kinetics of HCV RNA decline during the first 2 weeks of treatment, regardless of RBV dosing.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number 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.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Potential drug-drug interactions of OMBITASVIR, PARITAPREVIR/ritonavir ± DASABUVIR ± ribavirin in clinical practice.

Author: González-ColominasElena, LondoñoMaría-Carlota, MorillasRosa M, TorrasXavier, MojalSergi, LensSabela, LópezDulce, GallegoAdolfo, MariñoZoe, ArdèvolMercè, PagèsNeus, SolàRicard, CarriónJose A

Drug interactions

Drug-drug interactions (DDIs) are common in patients with chronic hepatitis C (CHC) receiving ombitasvir/paritaprevir/ritonavir with or without dasabuvir and with or without ribavirin (OBV/PTV/r ± DSV ± RBV). This study analyzed the prevalence and management of potential DDIs and adverse events (AEs) related to DDIs in clinical practice.

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

Language : English

11.

Anti-HCV treatment with ombitasvir/paritaprevir/ritonavir ± dasabuvir is associated with increased bile acid levels and pruritus.

Author: StauberRudolf E, FaulerGünter, RainerFlorian, LeberBettina, PoschAndreas, StreitAndrea, SpindelboeckWalter, StadlbauerVanessa, KesslerHarald H, ManggeHarald

HCV genotype 1/4 treatment
Well-tolerated
Pruritus

Ombitasvir/paritaprevir/ritonavir ± dasabuvir (OBV/PTV/r ± DSV) is a highly effective and generally well-tolerated treatment for HCV genotype 1 or 4 infection. However, pruritus, a unique side effect, has been observed in up to 20% of patients treated with this combination.

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

Language : English

12.

Real-Life Use of 3 Direct-Acting Antiviral Regimen in a Large Cohort of Patients with Genotype-1b HCV Compensated Cirrhosis.

Author: GheorgheLiana, IacobSperanta, CurescuManuela, BriscCiprian, CijevschiCristina, CaruntuFlorin, StanciuCarol, SimionovIulia, SporeaIoan, GheorgheCristian, IacobRazvan, AramaVictoria, SirliRoxana, TrifanAnca

HCV genotype-1b treatment

This study presents the first prospective Romanian cohort evaluating the effectiveness and safety of ombitasvir/paritaprevir/ritonavir/dasabuvir (OBV/PTV/r+DSV), a direct-acting antiviral (DAA) combination, in patients with HCV genotype-1b Child A liver cirrhosis.

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

Language : English

13.

Safety of the 2D/3D direct-acting antiviral regimen in HCV-induced Child-Pugh A cirrhosis - A pooled analysis.

Author: PoordadFred, NelsonDavid R, FeldJordan J, FriedMichael W, WedemeyerHeiner, LarsenLois, CohenDaniel E, CohenEric, MobasheryNiloufar, TatschFernando, FosterGraham R

HCV treatment

This review summarizes clinical trial data on the all-oral direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir (OBV/PTV/r±DSV), in patients with Child-Pugh A cirrhosis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin is safe and effective in HCV-infected patients in a real-life cohort from Latin America.

Author: MendizabalManuel, HaddadLeila, GallardoPatricia E, FerradaAlejandro, SozaAlejandro A, AdroverRaul, AravenaEdmundo, RobleroJuan P, PrietoJhon, VujacichClaudia, RomeroGustavo, MuñozAlberto, AndersMargarita, HernándezNelia, CoccozellaDaniel, GruzFernando, ReggiardoMaria V, RufAndres E, VarónAdriana, CartierMariano, Pérez RavierRoberto, RidruejoEzequiel, PeraltaMirta, PoncinoDaniel, VorobioffJulio, Aballay SoterasGabriel, SilvaMarcelo O

Treats HCV Infection
Hepatic Decompensation

This real-world study evaluated the safety and effectiveness of ombitasvir/paritaprevir/ritonavir/dasabuvir ± ribavirin (OBV/PTV/r/DSV ± RBV) therapy for genotype 1 chronic hepatitis C infection in Latin America. The treatment was highly effective in patients without cirrhosis or with Child-Pugh A cirrhosis, but adverse events were more frequent in patients with Child-Pugh B cirrhosis or previous hepatic decompensation.

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

15.

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

16.

Real life experience with direct-acting antivirals agents against hepatitis C infection in elderly patients.

Author: Rodríguez-OsorioIria, CidPurificación, MoranoLuis, CastroÁngeles, SuárezMarta, DelgadoManuel, MargusinoLuis, MeijideHéctor, PernasBerta, TabernillaAndrés, PedreiraJosé D, MenaÁlvaro, PovedaEva

HCV treatment
AE
Dose reduction

Direct-acting antivirals (DAAs) were found to be effective in treating elderly patients with hepatitis C virus (HCV) infection, achieving high sustained virological response (SVR12) rates of 88.3%. However, adverse events (AEs) were frequent (65%), particularly when protease inhibitors (PIs) were used.

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

17.

Universal Sustained Viral Response to the Combination of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with/without Ribavirin in Patients on Hemodialysis Infected with Hepatitis C Virus Genotypes 1 and 4.

Author: AbadSoraya, VegaAlmudena, HernándezEduardo, MéridaEvangelina, de SequeraPatricia, AlbalateMarta, MacíasNicolás, MillaMonica, López-GómezJuan M

This study investigated the efficacy and safety of a combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, direct-acting antivirals (DAAs), for treating hepatitis C virus (HCV) infection in patients on hemodialysis. The study found that this DAA combination was well-tolerated and achieved high rates of sustained virological response (SVR) in both HCV monoinfected and HIV/HCV co-infected 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.

Language : English

18.

Effectiveness and safety of ombitasvir, paritaprevir, ritonavir ± dasabuvir ± ribavirin: An early access programme for Spanish patients with genotype 1/4 chronic hepatitis C virus infection.

Author: PerellóC, CarriónJ A, Ruiz-AntoránB, CrespoJ, TurnesJ, LlanerasJ, LensS, DelgadoM, García-SamaniegoJ, García-ParedesF, FernándezI, MorillasR M, RincónD, PorresJ C, PrietoM, Lázaro RíosM, Fernández-RodríguezC, HermoJ A, RodríguezM, HerreroJ I, RuizP, FernándezJ R, MacíasM, PascasioJ M, MorenoJ M, SerraM Á, ArenasJ, RealY, JorqueraF, CallejaJ L,

Effective HCV treatment
Hepatic decompensation
Serious adverse events

This study investigated the effectiveness and safety of a combination therapy for hepatitis C virus (HCV) infection in clinical practice. The study found that ombitasvir/paritaprevir/ritonavir±dasabuvir was highly effective in achieving sustained virological response (SVR), with a 96.2% success rate. While serious adverse events (SAEs) were reported in 10.3% of patients, the therapy was generally well tolerated.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Direct-acting antivirals in hepatitis C virus (HCV)-infected and HCV/HIV-coinfected patients: real-life safety and efficacy.

Author: MilazzoL, LaiA, CalviE, RonziP, MicheliV, BindaF, RidolfoA L, GervasoniC, GalliM, AntinoriS, SollimaS

High SVR12 rates
Similar response in HCV/HIV

All-oral direct-acting antiviral (DAA) regimens for chronic hepatitis C virus (HCV) infection resulted in high SVR12 rates in both HCV monoinfection and HCV/HIV coinfection. SVR12 rates were 96% in HCV monoinfection and 91% in HCV/HIV coinfection. No predictors of SVR12 were identified.

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

22.

Working together to tackle HCV infection: ombitasvir/paritaprevir/ritonavir and dasabuvir combination.

Author: GamalN, AndreoneP

HCV treatment

Ombitasvir/paritaprevir/ritonavir co-packaged with dasabuvir is a new all-oral regimen for the treatment of genotype 1 HCV infection. The regimen is safe and well tolerated, with high rates of sustained virologic response.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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