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Antimicrobials during Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
Valganciclovir is used to prevent CMV infection in those with HIV infection. It is an FDA category C drug. The manufacturer reported that rabbits given this drug during organogenesis at 2 times the usual human dose had offspring with an increased frequency of birth defects. The manufacturer advises against use during pregnancy citing a possible risk of birth defects.
HIV and Its Complications and Needlestick Injuries
Published in Miriam Orcutt, Clare Shortall, Sarah Walpole, Aula Abbara, Sylvia Garry, Rita Issa, Alimuddin Zumla, Ibrahim Abubakar, Handbook of Refugee Health, 2021
Cytomegalovirus retinitis usually occurs with CD4 count <50 cells/μl but can occur at higher CD4 counts. Patients present with decreased visual acuity, blurred vision, scotomata (blind spot), floaters and flashing lights. Complications include retinal detachment and IRIS. Fundoscopy shows ‘brushfire’ or ‘pizza pie’ retinitis. Treatment is with 900 mg valganciclovir orally twice daily for 2–4 weeks and then once daily until immune recovery and established on ART with CD4 >100 cells/μl for at least 3 months. Monitor for bone marrow suppression on valganciclovir.
Anti-Infective Agents
Published in Radhwan Nidal Al-Zidan, Drugs in Pregnancy, 2020
Risk Summary: Due to the carcinogenic and mutagenic effects of Valganciclovir in animals and the potential for fetal toxicity, some experts recommend that Valganciclovir should only be used during pregnancy for immunocom-promised patients with major CMV infections, such as retinitis or for life-threatening disease.
The use of antiviral drugs in children
Published in Journal of Chemotherapy, 2022
Marco Antonio Motisi, Agnese Tamborino, Sara Parigi, Luisa Galli, Maurizio de Martino, Elena Chiappini
The treatment of congenital CMV infection was standardized in 2003, when Kimberlin and the CASG (Collaborative Antiviral Study Group) demonstrated that treatment with ganciclovir (GCV) was associated with improved hearing function at six months of age and with reduced cognitive impairment. Treatment with ganciclovir, at a dose of 6 mg/kg intravenously every 12 hours for six weeks, requires the maintenance of venous access for long periods of time and, consequently, a long stay in hospital. This has led to the introduction of valganciclovir (V-GCV), a mono-valyl-ester and pro-drug of GCV, administered orally, which is already approved for the treatment of CMV retinitis in adults with HIV immunodeficiency. Valganciclovir is to be taken on a full stomach at 16 mg/kg/dose by mouth every 12 hours [19].
Individualized management of cytomegalovirus in solid organ transplant recipients
Published in Expert Review of Precision Medicine and Drug Development, 2021
Huma Saeed, Matthew Thoendel, Raymund R Razonable
It is important to emphasize that valganciclovir and ganciclovir dosing is customized based on individual renal function, aiming for a balance between efficacy and safety. It is critical to maintain systemic ganciclovir levels to prevent drug-associated toxicity and subtherapeutic dosing associated with drug resistance and treatment failure [80,81]. However, therapeutic drug monitoring has not been shown to be useful in daily clinical practice [82]. It is however recommended that antiviral dosing be adjusted based on renal clearance, as estimated using Cockcroft-Gault formula, although other methods such as Modified Diet in Renal Disease formula and Chronic Kidney Disease Epidemiology Collaboration may be used. However, practitioners have to be cognizant of using renal clearance based on ideal body weight as this may underestimate the renal function in overweight individuals and this could result in underdosing [83].
Optimization of Ganciclovir use in allogeneic hematopoietic cell transplant recipients – the role of therapeutic drug monitoring
Published in Expert Review of Anti-infective Therapy, 2021
Su Ann Ho, Monica Slavin, Jason A. Roberts, Michelle Yong
TDM has a well-established role in dose optimization of certain antimicrobial agents such as aminoglycosides and vancomycin due to a known narrow therapeutic window and risk of nephrotoxicity. This is, however still a contentious issue in the prescribing of ganciclovir and valganciclovir. Currently, there are no data correlating in vitro susceptibilities with in vivo pharmacokinetic parameters to provide a defined target PK/PD ratio for these antivirals [37]. PK studies have shown total body clearance of ganciclovir is correlated with creatinine clearance (CrCl) [32]. Some have argued, because of this predictability, TDM is unnecessary [25,32,37]. The tolerability profile of ganciclovir has been difficult to assess, given recipients are immunocompromised with a degree of disease contributing to myelosuppression, in addition to potential concurrent nephrotoxic agents. However, neutropenia has been consistently reported in most published studies and appears to be dose-related which resolves on cessation of the drug [53]. The rates of myelosuppression are approximately 20 to 50% during induction therapy [38,46,54] resulting in the need for cessation of the drug or concomitant administration of granulocyte colony-stimulating-factor.