Side Effects of valganciclovir: A Synthesis of Findings from 22 Studies

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Original Abstract of the Article

Main Research Findings

Valganciclovir is recommended for ABO-incompatible kidney transplant patients as it significantly reduces CMV disease and infection. 18

Valganciclovir is a commonly used antiviral drug to treat or prevent acute HCMV infections, but its efficacy is limited because of toxicity, resistance issues, side effects and other problems. New drugs, such as letermovir and maribavir, with less toxicity and drug/cross-resistance have been approved and put on the market in recent years. 3

Neutropenia is associated with an increased risk of valganciclovir or MPA dose reductions or discontinuations, rejection, and hospitalizations. 5

Valganciclovir appears to be a safe treatment for congenital CMV infection for the mother and the fetus. 21

The use of valganciclovir is limited by side effects, such as myelosuppression as well as evolving resistance in CMV strains. 14

A number of studies have used Valganciclovir as a therapy for children with congenital CMV infection. 1

Extending cytomegalovirus prophylaxis from 6 to 9 months in high-risk lung transplant recipients reduces cytomegalovirus disease. 11

Oral valganciclovir is the recommended treatment in moderate or severe congenital CMV infections for a period of 6 weeks to 6 months. 12

Valganciclovir and ganciclovir are used for both prophylaxis and treatment of CMV infection in thoracic organ transplant recipients, but intolerance and treatment failure are common. 15

Valganciclovir and ganciclovir have successfully been used for prevention and treatment of CMV infections, although with serious side effects such as leucopenia and some development of resistance. 4

Reasons for Side Effects

Valganciclovir is a drug that suppresses CMV replication by inhibiting cellular DNA synthesis. However, this action can also affect normal cell DNA synthesis, which is thought to be the cause of side effects. 14

Common Side Effects

Leukopenia

One of the most common side effects of valganciclovir is leukopenia. This occurs because valganciclovir suppresses the bone marrow and reduces the production of white blood cells. 14 6 4 20

Thrombocytopenia

Valganciclovir can cause thrombocytopenia by reducing the number of platelets. 14 6

Renal Dysfunction

Valganciclovir can affect the kidneys and may cause renal dysfunction. 14 19

Gastrointestinal Side Effects

Valganciclovir can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. 14

Countermeasures for Side Effects

Countermeasures for Leukopenia

Countermeasures for leukopenia include reducing the dosage of valganciclovir or temporarily discontinuing administration. 6

Countermeasures for Renal Dysfunction

Countermeasures for renal dysfunction include reducing the dosage of valganciclovir or temporarily discontinuing administration. It is also important to stay hydrated. 19

Countermeasures for Gastrointestinal Side Effects

Countermeasures for gastrointestinal side effects include eating before taking valganciclovir or drinking plenty of fluids after taking valganciclovir. 14

Comparison Between Studies

Common Points of Studies

Many studies have shown that valganciclovir is effective in preventing and treating CMV infections. However, it has been pointed out that valganciclovir can cause serious side effects such as leukopenia. 18 6 20 4

Differences Between Studies

The dosage and duration of administration of valganciclovir, as well as the incidence of side effects, vary depending on the study. 18 20 16

Precautions for Applying to Real Life

Valganciclovir is an effective drug for preventing and treating CMV infection, but it is important to consider the risk of side effects. If you are taking valganciclovir, follow your doctor's instructions carefully and consult your doctor immediately if you experience any side effects. 18 6 20 4

Limitations of Current Research

Research on the side effects of valganciclovir is still insufficient. In particular, there are many points that have not been clarified about long-term side effects. 6 20

Future Research Directions

It is important to investigate the side effects of valganciclovir in more detail and clarify the mechanisms of side effect occurrence and preventive methods. It is also necessary to develop appropriate treatment methods for when side effects occur. 6

Conclusion

Valganciclovir is an effective drug for preventing and treating CMV infection, but it is important to consider the risk of side effects. If you are taking valganciclovir, follow your doctor's instructions carefully and consult your doctor immediately if you experience any side effects. 18 6 20 4

Literature analysis of 22 papers
Positive Content
19
Neutral Content
2
Negative Content
1
Article Type
1
1
2
8
22
1.

Role of Valganciclovir in Children with Congenital CMV Infection: A Review of the Literature.

Author: PataDavide, BuonsensoDanilo, Turriziani-ColonnaArianna, SalernoGilda, ScarlatoLucia, ColussiLara, Ulloa-GutierrezRolando, ValentiniPiero

Well tolerated
Moderately effective

This review evaluated the efficacy of Valganciclovir in preventing clinical sequelae in children with congenital cytomegalovirus (CMV) infection. The review found that neonatal antiviral treatments were only moderately effective in preventing clinical sequelae, and the therapy was well tolerated. The study concludes that randomized controlled trials are needed to establish the optimal dose and duration of Valganciclovir therapy for congenital CMV infection.

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

4.

Cytomegalovirus infection in transplant recipients: newly approved additions to our armamentarium.

Author: KhawajaFareed, SpalloneAmy, KottonCamille N, ChemalyRoy F

CMV treatment
Resistance
Side effects

CMV infections pose a significant burden for transplant recipients, and while valganciclovir and ganciclovir have been effective, they also carry risks such as leucopenia and resistance. The development of new therapies that are both effective and well-tolerated is crucial.

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

5.

Outcomes among CMV-mismatched and highly sensitized kidney transplants recipients who develop neutropenia.

Author: BrarSandeep, BerryReyoot, RavalAmit D, TangYuexin, VincentiFlavio, SkartsisNikolaos

Kidney transplantation
Neutropenia

Neutropenia, a low white blood cell count, can occur after kidney transplantation. This study investigated the incidence and clinical outcomes of neutropenia in 572 kidney transplant recipients. Neutropenia was associated with an increased risk of medication changes, rejection, hospitalizations, and use of granulocyte colony stimulating factor.

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

6.

Therapeutic Drug Monitoring of Ganciclovir: Where Are We?

Author: MärtsonAnne-Grete, EdwinaAngela E, KimHannah Yejin, KnoesterMarjolein, TouwDaan J, SturkenboomMarieke G G, AlffenaarJan-Willem C

Cytomegalovirus prophylaxis
Cytomegalovirus treatment
Drug resistance
Myelosuppression

This review provides an overview of ganciclovir therapeutic drug monitoring (TDM).

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

Language : English

7.

Continuous-Infusion Foscarnet Facilitates Administration in Hematopoietic Stem Cell Transplantation Patients.

Author: DomingoWalter, NguyenIsabelle T, JohnsrudJoyce J, BrownJanice Wes

Herpesvirus treatment
Nephrotoxicity

This retrospective study compared continuous infusion foscarnet to intermittent infusion foscarnet in hematopoietic cell transplantation (HCT) recipients with resistant herpesvirus infections. Both infusion methods had similar rates of acute kidney injury (AKI), suggesting that continuous infusion may be a feasible option for outpatient treatment.

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

8.

Valganciclovir prophylaxis for cytomegalovirus infection in pediatric kidney transplant recipients: a single-center experience.

Author: IidaTakaya, MiuraKenichiro, BanHideki, AndoTaro, ShiraiYoko, IshiwaSho, ShiratoriAtsutoshi, KanekoNaoto, YabuuchiTomoo, IshizukaKiyonobu, TakaiwaMasanori, SuyamaKazuhide, HisanoMasataka, HattoriMotoshi

CMV infection treatment
Side effects

This study discusses the two approaches for treating cytomegalovirus (CMV) infection after kidney transplantation: preemptive and prophylactic therapy. The study highlights the need for more information about the appropriate dose and side effects of valganciclovir (VGCV) in children, particularly in Japan.

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

Language : English

10.

Efficacy and safety of valganciclovir in patients with symptomatic congenital cytomegalovirus disease: Study Protocol Clinical Trial (SPIRIT Compliant).

Author: MoriokaIchiro, KakeiYasumasa, OmoriTakashi, NozuKandai, FujiokaKazumichi, YoshikawaTetsushi, MoriuchiHiroyuki, ItoYoshinori, OkaAkira

Improved hearing
Improved neurodevelopment

Valganciclovir (VGCV) has demonstrated potential benefits for improving hearing and neurodevelopmental outcomes in infants with congenital cytomegalovirus (CMV) disease, despite lacking approval and insurance coverage in Japan and other countries.

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

11.

Extending cytomegalovirus prophylaxis in high-risk (D+/R-) lung transplant recipients from 6 to 9 months reduces cytomegalovirus disease: A retrospective study.

Author: HerreraSabina, KhanBasha, SingerLianne G, BinnieMatthew, ChaparroCecilia, ChowChung-Wai, MartinuTereza, TomlinsonGeorge, KeshavjeeShaf, HusainShahid, TikkanenJussi M

Reduced CMV disease
Side effects

Increasing the duration of CMV prophylaxis from 6 to 9 months reduced the incidence of CMV infection and disease in CMV-seronegative recipients receiving a seropositive allograft.

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

Language : English

12.

Outcome and management of newborns with congenital cytomegalovirus infection.

Author: NiclouxM, PetermanL, ParodiM, MagnyJ-F

CMV treatment
Neurosensory sequelae

This study reviews congenital cytomegalovirus (CMV) infection, the most common non-genetic cause of hearing loss and neurological disorder in children. CMV infection must be confirmed by polymerase chain reaction (PCR) before the 21st day of life. Oral valganciclovir is recommended for treatment.

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

13.

A double masked randomised 4-week, placebo-controlled study in the USA, Thailand and Taiwan to compare the efficacy of oral valganciclovir and topical 2% ganciclovir in the treatment of cytomegalovirus anterior uveitis: study protocol.

Author: TakharJaskirat S, JoyeAshlin S, SomkijrungrojThanapong, LaovirojjanakulWipada, LinChang-Ping, LietmanThomas M, PorcoTravis C, KeenanJeremy D, GebreegziabherElisabeth A, SeitzmanGerami D, Rose-NussbaumerJennifer, DoanThuy A, AcharyaNisha R, GonzalesJohn A

CMV anterior uveitis treatment
Ganciclovir efficacy
Valganciclovir efficacy
Bone marrow suppression
Corneal endothelial damage
Glaucoma
Renal failure

This study explores the potential benefits of topical ganciclovir solution for CMV anterior uveitis. Topical ganciclovir may be a safer, more cost-effective, and convenient treatment option compared to oral valganciclovir.

Clinical Trial ProtocolA plan for conducting a clinical trial. It describes in detail the purpose, design, methodology, and statistical considerations of the trial, ensuring the transparency and consistency of the trial.
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

14.

New treatments for cytomegalovirus in transplant patients.

Author: CoppockGaia M, BlumbergEmily

CMV prophylaxis
CMV treatment
CMV resistance
Myelosuppression

This review discusses novel advances in prophylaxis and treatment of CMV in kidney transplant recipients. It highlights the limitations of current antiviral therapies and explores emerging options to address side effects and resistance.

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

15.

Single-center experience with use of letermovir for CMV prophylaxis or treatment in thoracic organ transplant recipients.

Author: AryalShambhu, KatugahaShalika B, CochraneAdam, BrownAnne Whitney, NathanSteven D, ShlobinOksana A, AhmadKareem, MarinakLauren, ChunJessica, FregosoMargaret, DesaiShashank, KingChristopher

Prevent CMV infection

Letermovir has been shown to be effective in preventing CMV infection in allogeneic hematopoietic cell transplantation. However, there is currently no data on its efficacy in thoracic organ transplant recipients.

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

Language : English

16.

Efficacy and Safety of Ultra-Low-Dose Valganciclovir Chemoprophylaxis for Cytomegalovirus Infection in High-Risk Kidney Transplantation Patients.

Author: LeeJin Ho, KimHee Yeoun, LeeDong Yeol, KimYoon Ji, LeeHee Ryong, OhJoon Seok, SinYong Hun, KimJoong Kyung, HwangSeun Deuk

CMV prevention

Ultra-low dose, short-duration valganciclovir (VGCV) is a promising strategy to prevent CMV infection in kidney transplant recipients.

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

Language : English

17.

The use of CMVIg rescue therapy in cardiothoracic transplantation: A single-center experience over 6 years (2011-2017).

Author: SanthanakrishnanKarthik, YonanNizar, CallanPaul, KarimiEbrahim, Al-AloulMohamed, VenkateswaranRajamiyer

CMVIg rescue therapy
Viral replication control
CMV disease
CMV infection

CMV hyperimmune globulin (CMVIg) rescue therapy was safe, well tolerated, and effective at controlling CMV replication in cardiothoracic transplant recipients.

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.

Language : English

19.

Effect of Low-Dose Vs Standard-Dose Valganciclovir in the Prevention of Cytomegalovirus Disease in Kidney Transplantation Recipients: A Systemic Review and Meta-Analysis.

Author: HwangS D, LeeJ H, LeeS W, KimJ K, KimM-J, SongJ H

CMV prevention
Leukopenia

The 450-mg dose of valganciclovir effectively prevented post-transplantation CMV infection and decreased drug-induced side effects such as leukopenia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

20.

Hematologic Adverse Events Associated With Prolonged Valganciclovir Treatment in Congenital Cytomegalovirus Infection.

Author: ZivLiron, YacobovichJoanne, PardoJoseph, Yarden-BilavskyHavatzelet, AmirJacob, OsovskyMicky, BilavskyEfraim

Hearing improvement
Neurodevelopmental outcome
Neutropenia

Valganciclovir, a medication for cytomegalovirus infection, improved the hearing and development of babies with the infection. The only reported side effect was a low white blood cell count.

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

Language : English

21.

Intrauterine therapy of cytomegalovirus infection with valganciclovir: review of the literature.

Author: SeidelVera, Feiterna-SperlingCornelia, SiedentopfJan-Peter, HofmannJörg, HenrichWolfgang, BührerChristoph, WeizsäckerKatharina

This review discusses the use of ganciclovir (GCV) and valganciclovir (VGCV) during pregnancy for the treatment of congenital cytomegalovirus (CMV) infection. The review found limited evidence on the safety of these drugs for both the mother and fetus. Two case reports of intrauterine treatment of fetal CMV infection with VGCV are presented, suggesting that VGCV may be a safe and effective treatment option for this condition.

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.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

22.

The chemical class of quinazoline compounds provides a core structure for the design of anticytomegaloviral kinase inhibitors.

Author: HuttererC, HamiltonS, SteingruberM, ZeitträgerI, BahsiH, ThumaN, NaingZ, ÖrfiZ, ÖrfiL, SocherE, StichtH, RawlinsonW, ChouS, HauptV J, MarschallM

HCMV infection treatment
Drug resistance

Novel quinazolines Vi7392 and Vi7453 show high antiviral activity against HCMV laboratory and clinically relevant strains, including maribavir- and ganciclovir-resistant variants.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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