(human herpesvirus 3 or human herpes virus 3).tw. Given the initial sampling time point of 30 minutes post infusion, our Tmax estimate is likely prolonged in patients receiving IV acyclovir. Acyclovir (standard dose for herpes zoster ophthalmicus: 800 mg five times daily for seven to 10 days) and valacyclovir (standard dose for herpes zoster ophthalmicus: 1000 mg three times daily for seven days) have both been approved for the treatment of herpes zoster, and are widely used (Dworkin 2007). Her acyclovir exposure following the initial dose of valacyclovir was similar to the group mean at 4,615 uMmin. The Cochrane researchers searched for studies that had been published up to June 2016. Joshi L, 18. exp experimental design/ We included the following outcomes in the summary of findings table. The https:// ensures that you are connecting to the What are the main results of the review? 11. We assessed the certainty of the evidence for the selected outcomes using the GRADE approach. Mean ( SD) Cmax values for acyclovir following oral valacyclovir were 18.8 7 uM with a total exposure of 4106 1519 uMmin. Adverse effects eyelid or facial oedema, Adverse effects disseminated herpes zoster. No association between concomitant medications and clearance was noted. Comparative activity of selected antiviral compounds against clinical isolates of varicella-zoster virus. Gross G, Persistent ocular lesions after 6 months were observed in 2/56 people in the valacyclovir group compared with 1/54 people in the acyclovir group (risk ratio (RR) 1.93 (95% CI 0.18 to 20.65); very low certainty evidence. [13] The mean bioavailability of valacyclovir in this population was 64%, exceeding the mean value of 43% previously reported in pediatric patients,[11] but in a range reported in adults. Therefore, valacyclovir might be equal to intravenous acyclovir administration and possibly superior to oral acyclovir administration, resulting in less complications in patients with herpes zoster ophthalmicus. Some of the study authors were sponsored by the pharmaceutical company marketing valacyclovir, and it was unclear whether a conflict of interest existed. 20. exp control group/ FOIA Grade 1 nausea and emesis, which occurred in 5 patients was the only valacyclovir-related toxicity. #5 TS=varicella zoster Sutton AJ, As we could only include one study in this review, there might be a risk of publication bias regarding other conducted but not registered or published studies. #10 TS=(valacyclovir or valaciclovir or valciclovir or valcyclor or valcyclovir) However, it has become an increasingly common practice to substitute valacyclovir for acyclovir, highlighting the need for pediatric data with regard to pharmacokinetics, safety and efficacy. 22. or/1221 These three references, however, related to the same study (publication: Colin 2000 and two meeting abstracts: Cochener 1997; Colin 1997). This outcome summarizes ocular involvements being persistent till the end of the study (six months). In a couple of weeks, rock overlords Queens Of The Stone Age will return with their new album In Times New Roman; we've already posted the singles "Emotion Sickness" and "Carnavoyeur Andrei G, Sienaert R, McGuigan C, et al. In conclusion, valacylovir was well tolerated and showed favorable pharmacokinetics in pediatric patients at the dose studied. A recent systematic review showed that oral treatment with valacyclovir compared to acyclovir resulted in a significant reduction in risk of herpes zosterassociated pain up to 112 days in participants with herpes zoster, including ophthalmicus, but did not further evaluate ophthalmic complications (McDonald 2012). This was especially the case for severe complications, which however, were considered to be the most relevant reason for using aggressive antiviral medication in this condition. In addition, patients with herpes zoster ophthalmicus are at greater risk of developing postherpetic neuralgia and of developing persistent neuropathic pain that lasts long after the initial rash has healed (Gross 2003). Lin HH, Both acyclovir and its prodrug valacyclovir are medications that are approved for the systemic treatment of herpes zoster. [14] The differences in bioavailability in the pediatric studies may reflect the different doses utilized, with decreased acyclovir bioavailability associated with the higher doses per body weight. 12. exp clinical trial/ Smoothie. This report describes acyclovir pharmacokinetics following valacyclovir administration in immunocompromised pediatric patients, compares pharmacokinetic parameters following oral valacyclovir and IV acyclovir, and provides a limited assessment of efficacy in the setting of active herpes zoster infection. The process of first-pass metabolism also creates differences in how often these drugs must be dosed. Desmond RA, et al. There was a statistically significant difference across the means (p=0.03 for AUC; p=0.0004 for clearance). One study fulfilled the inclusion criteria. There was an increased exposure and decreased clearance with age. Schlichtenbrede FC, As a library, NLM provides access to scientific literature. A randomised controlled trial of valaciclovir versus acyclovir in the treatment of herpes zoster, Comparison between the efficacies of valaciclovir and acyclovir in the treatment of herpes zoster, Detecting skewness from summary information. Backonja M, We last searched the electronic databases on 13 June 2016. Persistent ocular lesions after six months were reported in 2/56 in the valacyclovir group and 1/54 in the acyclovir group (RR 1.93 (95% CI 0.18 to 20.65)) (Analysis 1.1). The method has a lower limit of quantitation of 10 ng/mL for acyclovir and valacyclovir using a 50-L aliquot of human plasma. Schuster AK, Mendoza N, Multicentre, randomised, doublemasked study that was conducted in France between 1 July 1994 and 16 October 1995. This allows for a patient to dose Valacyclovir less frequently while still achieving adequate antiviral levels in the body to treat various viral infections. There was no restriction to any type or location of the health service (primary, secondary and tertiary care). Another study of over 1,000 adults compared 7-day courses of valacyclovir and acyclovir for shingles. Food does not affect absorption. They made corrections and contributions to these paragraphs. We downgraded the certainty of the evidence due to concerns about study limitations (downgraded one level) and precision of the effect estimates (downgraded one or two levels) (Table 1). 8. human.sh. An official website of the United States government. Altman DG, Although acyclovir is prescribed in the management of herpes simplex encephalitis (HSE), the disease has a poor prognosis, particularly if the treatment is delayed, reaching mortality rates of 70% if left . AKS: None known. Although it is known that valacyclovir has an improved bioavailability and steadier plasma concentrations, it is currently unclear whether this finally leads to comparable treatment results and less ocular complications. The poor bioavailability of oral acyclovir necessitates frequent dosing and results in inferior drug exposure compared with intravenous administration. Murray A, They judged the certainty of the evidence to be very low because the study was small and there were some problems with the way it was reported. Pharmacokinetics of acyclovir suspension in infants and children. et al. editor(s). Smyth R, Taking into account the low number of events for severe complications overall, it must be assumed that the statistical power to detect differences was insufficient, and further research should be undertaken to investigate the effects of valacyclovir on the occurrence of rare but clinically relevant ocular complications. sharing sensitive information, make sure youre on a federal We calculated the 95% confidence intervals (CIs) for all outcomes. Stratum 1 of Study B enrolled patients with an acute herpes zoster infection ( 3 days of rash, limited to 3 or less dermatomes, and no evidence of dissemination). We did not use sample size, language, or publication status to determine whether or not a study was included. One of the top reasons to use valacyclovir vs. acyclovir for cold sores is because of its higher level of oral bioavailability. Metabolic fate and pharmacokinetics of the acyclovir prodrug valaciclovir in cynomolgus monkeys. There were statistically significant differences in exposure and clearance (p=0.02 for AUC; p=0.0003 for clearance) when the youngest (Group 1) was compared to the oldest (Group 3) patients. Herpesvirus 3, Human/ Valacyclovir provides enhanced acyclovir bioavailability in adults, but limited data are available in children. We reported categorical data descriptively. Aciclovir/ Colin J. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies. HoangXuan T, Drug was administered at least one hour before or after oral intake of food. A Mann-Whitney Rank Sum Test was used to evaluate demographic differences between the two study groups. It is characterised by greater bioavailability than acyclovir. Bethesda, MD 20894, Web Policies Valacyclovir, the L-valine ester prodrug of acyclovir, is rapidly and almost completely hydrolyzed to acyclovir by the liver and gastrointestinal tract and has higher bioavailability than . Eleven patients had pharmacokinetic sampling performed after both oral valacyclovir (mean dose 14.4 mg/kg) and IV acyclovir (mean dose 9.2 mg/kg) administration. We considered all randomised controlled trials (RCTs) in which systemic valacyclovir was compared to systemic acyclovir medication for treatment of herpes zoster ophthalmicus. [5, 6] In adult normal volunteers, valacyclovir has the same safety profile as acyclovir, with the most common adverse events being headache and nausea. Valacyclovir has three to fivefold greater oral bioavailability (about 55 percent) than acyclovir; it then undergoes rapid and extensive first-pass intestinal and/or hepatic hydrolysis to yield acyclovir and L-valine [ 2,3 ]. 31. The bioavailability of valacyclovir is 54% compared to approximately 20% for oral acyclovir. more Prescription only Valacyclovir is an antiviral prodrug that is rapidly converted into acyclovir in the body. The review authors found one relevant study from France. 23. Patients in Study A received a single 15 mg/kg valacyclovir dose (maximum dose 2 gm) in either the caplet or suspension form. MNJ: None known. From each trial, we selected the measure considered to be most appropriate for each of the predefined outcomes of this review. We thank Catey Bunce, Simon Taylor, and Stephanie Watson for their comments on the protocol and review and Jennifer Evans and Anupa Shah for their assistance throughout the review process. Twentythree participants had serious ocular involvement (keratitis, uveitis, iritis, corneal, or scleral involvement), while 28 participants had minor ocular involvement (conjunctivitis, 'red eye', or excessive lacrimation). The apparent Cmax and Tmax values were estimated by visual inspection of the measured plasma drug concentration-time data for each subject. 3. placebo.ab,ti. See: Appendices for details of search strategies for CENTRAL (Appendix 1), MEDLINE (Appendix 2), Embase (Appendix 3), CPCIS (Appendix 4), BIOSIS (Appendix 5), ISRCTN (Appendix 6), ClinicalTrials.gov (Appendix 7) and the ICTRP (Appendix 8). 11 or 24 or 31 32 and 48, #11 #8 AND #9 AND #10 Due to the low number of studies, we abstained from performing subgroup analyses or analyses of heterogeneity. Sterne JA, 6. trial.ab,ti. The included study reported a similar incidence of ocular complications, and comparable zosterassociated pain and rate of healing of skin lesions between the two study groups being treated with either valacyclovir or acyclovir. Cochrane researchers collected and analysed all relevant studies to answer this question and found one study. Blum MR, Liao SH, de Miranda P. Overview of acyclovir pharmacokinetic disposition in adults and children. In the case of acute herpes zoster ophthalmicus, the dermatome of the ophthalmic division of the trigeminal nerve is affected. Herpes zoster ophthalmicus is a painful itchy rash that appears on one side of the forehead. When this patient was excluded, the mean SD t (1.69 0.41 h) was shorter compared to previously reported values in adults (mean range 2.32.44 h),[5][14][6] but was similar to that reported in immunocompromised children (1.8 0.38 h). 46. 21. or/1320 Jarczok MN, If only a very small number of trials had met the inclusion criteria, we had planned to report the results descriptively and not perform a metaanalysis. Chickenpox/ Patients in stratum 2 received a single dose of valacyclovir as outlined in Study A. In this multicentre, randomised doublemasked study carried out in France, 110 immunocompetent people with herpes zoster ophthalmicus, diagnosed within 72 hours of skin eruption, were treated, with 56 participants allocated to the valacyclovir group and 54 to the acyclovir group. Machida H. Comparison of susceptibilities of varicella-zoster virus and herpes simplex viruses to nucleoside analogs. Smith JR, Pros Available as a lower-cost generic Can be used in adults and children for cold sores Can be made into an oral liquid by the pharmacy for people having trouble swallowing the tablets Not many interactions with other medications Cons Doesn't cure viral infections Still have risk of future outbreaks 4. Balimane PV, GRADE considers the following criteria: study limitations, indirectness, imprecision, inconsistency, and publication bias. The ophthalmic examination focused on the frequency, severity and duration of ocular complications. Sufficient information is not given by the authors. Due to concerns about imprecision (small number of events and large confidence intervals) and study limitations, the certainty of evidence using the GRADE approach was rated as low to very low for the use of valacyclovir compared to acyclovir. Federal government websites often end in .gov or .mil. There was no declaration of interest among the primary researchers. Doctors can treat herpes zoster ophthalmicus with acyclovir. Taylor SR, If no methodological or clinical reasons could be found to explain strong statistical heterogeneity,we would not have proceeded with the metaanalysis. Based on the one included study, there is uncertainty in evidence that valacyclovir as systemic treatment option for herpes zoster ophthalmicus is different or comparable to acyclovir. Food does not affect absorption. Plasma pharmacokinetics of acyclovir after intravenous administration of acyclovir (mean dose= 9.2 mg/kg) and oral administration of valacyclovir (mean dose 14.4 mg/kg). 2 We downgraded 2 levels for imprecision as there were few events and very wide confidence intervals. There were no significant differences in skin healing between the two medications. As the chosen medication was administered systemically, we analysed participants based on their randomisation to treatment type, and not on individual eyes. Lau J, 1 We downgraded 1 level for risk of bias, as the authors did not report on random sequence generation, allocation concealment and masking of staff, and the extent to which bias had been avoided was largely unclear (1). #12 #10 or #11 A double blind randomized trial to compare safety and efficacy of valaciclovir and aciclovir for treatment of herpes zoster ophthalmicus, Investigative Ophthalmology and Visual Science. Gupta N, Cochener B, Rolland B, Sullender WM, Arvin AM, Diaz PS, et al. Oral valacyclovir (500 mg twice a day for 5 days and 1 g once a day for 5 days) has been shown in placebo-controlled and head-to-head studies to match acyclovir in terms of decreasing episode length, viral shedding, and healing time. scleritis, uveitis, vasculitis, optic neuritis, chorioretinitis, acute retinal necrosis; time point: 12 months after infection). Sinko PJ. et al. Three serious adverse events were observed, two in the valacyclovir group (rectorrhagia, kidney stone; Analysis 1.3; Table 3) and one in the acyclovir group (disseminated zoster; Analysis 1.3). Acyclovir is routinely used in the prophylaxis and treatment of HSV and VZV infections in immunocompromised pediatric patients. Complete eligibility criteria for both studies are included in Appendix I. Valacyclovir was supplied by GlaxoSmithKline as 500 mg and 1 gm caplets. Key messages In our study, one patient had a markedly prolonged terminal elimination half-life following i.v. Andersen PL, The time point of most outcome measures was defined as 12 months after primary infection, defined as a period of six to 18 months. Due to concerns about imprecision (due to small number of events and large confidence intervals) and relevant study limitations (random sequence generation, allocation concealment and masking of staff), the certainty of evidence was downgraded from high to low and very low. In your body, valacyclovir becomes the anti-herpes medicine, acyclovir. Hoglund M, Ljungman P, Weller S. Comparable aciclovir exposures produced by oral valaciclovir and intravenous aciclovir in immunocompromised cancer patients. Blinding of participants and personnel (performance bias), Blinding of outcome assessment (detection bias). Therefore, an uptodate systematic review is warranted to compare the effects of valacyclovir versus acyclovir for the systemic antiviral treatment of herpes zoster ophthalmicus. #14 #9 and #12 and #13, 1. randomised controlled trial.pt. New drugs--reports of new drugs recently approved by the FDA. Esta actitud por parte del paparazzi . #8 shingles Characteristics of patients included in the pharmacokinetic analysis are outlined in Table I. 21 and 24 and 26 Jones DR, A review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in herpesvirus infections. [11][12] The mean SD t was shorter (1.45 0.48 h) in children than in adults who received a comparable dose based on body weight (mean values between 2.63.3 hours). Children 1 month through 5 years of age with or at risk for herpesvirus infection received a single 25 mg/kg dose of extemporaneously compounded valacyclovir oral suspension (n = 57 ), whereas children 1 through Pediatr Blood Cancer. Valacyclovir. Dostal M, 9 not (9 and 10) Valacyclovir is available only with your doctor's prescription. One study fulfilled the inclusion criteria and compared valacyclovir to acyclovir in immunocompetent patients with herpes zoster ophthalmicus. Arora A, Oral valacyclovir is a prodrug that undergoes the first-pass intestinal and/or hepatic metabolism to produce active-moiety acyclovir and L-valine at a high bioavailability that is several times greater than that obtained from oral acyclovir []. Comparison 1 Valacyclovir versus acyclovir, Outcome 3 Adverse effects. No primary participant data. The mean plasma acyclovir concentration-time profiles following administration of intravenous acyclovir and oral valacyclovir are shown in Figure 1. Nevertheless, one trial showed an improved effect in immunocompetent adults having herpes zoster (Beutner 1995), while another reported no difference in patients with herpes zoster ophthalmicus (Colin 2000). Treatment with intravenous acyclovir requires either hospitalization, or extensive use of home health services, each with attendant expense and inconvenience. Wood MJ, Healing of skin lesions was comparable in both groups. FCS: None known. Data were only available on persistent ocular lesions after 6 months. de Miranda P, Burnette TC. This study compared valacyclovir 1000 mg taken three times a day for seven days with acyclovir 800 mg taken five times a day for seven days. Primary ocular complications in the observation time (up to six months) were: conjunctivitis in 54% (30/56) of the valacyclovir group and 52% (28/54) of the acyclovir group (relative risk (RR) 1.03; 95% confidence interval (CI 0.72 to 1.47)), punctate keratitis in 39% (22/56) and 48% (26/54), respectively (RR 0.82 (95% CI 0.53 to 1.25), and dendritic keratitis in 11% (6/56 and 6/54) of each group (RR 0.96 (95% CI 0.33 to 2.81); Analysis 1.1; Table 2). The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews, Antivirals for management of herpes zoster including ophthalmicus: a systematic review of highquality randomized controlled trials, Management of herpes zoster ophthalmicus in people with HIV infection, Valaciclovir: a review of its use in the management of herpes zoster, Herpes zoster antivirals and pain management, Valaciclovir. Friedman DJ, Pharmacokinetics of the acyclovir pro-drug valaciclovir after escalating single- and multiple-dose administration to normal volunteers. Tsai HC, For testing the significance of heterogeneity, we would have considered the Chi statistic; P = 0.1 or less would indicate significant heterogeneity. Napumpujte ho antioxidantmi a vitamnmi! Due to the low number of studies, we abstained from combining studies in a metaanalysis and reported the results descriptively instead. Risk of selection bias was unclear as there was not sufficient information given by the authors. HoangXuan T. Treatment of herpes zoster ophthalmicus: a doubleblind trial to compare valaciclovir and aciclovir. Individual data were not provided in a way which would have allowed stratification into any occurrence of ocular involvement, or occurrence of simple or severe ocular manifestations. These data support the recommendation that further consideration should be given to the use of valacyclovir for the treatment of herpes zoster in clinically stable pediatric oncology patients or in the setting of HSV prophylaxis in pediatric patients undergoing bone marrow transplantation. 23. [2, 3] Unlike oral acyclovir which has a bioavailability of only 10% to 20%, valacyclovir is more completely absorbed[4, 5] In adults, similar plasma acyclovir exposures may be obtained following oral administration of valacyclovir as compared to those achieved with doses of intravenous acyclovir. For patients unable to swallow caplets, or to administer an exact dose, a 50 mg/ml suspension with Ora-Plus (50:50 v/v) vehicle was extemporaneously prepared by the pharmacy. (acyclovir or aciclovir).tw. As one of the most commonly used antiviral drugs, acyclovir represents the mainstay of antiviral herpes zoster treatment. Pain resolved significantly faster with valacyclovir (38 days) compared to acyclovir (51 days). Recommendations for examining and interpreting funnel plot asymmetry in metaanalyses of randomised controlled trials. The aim was to compare efficacy and safety of valacyclovir and acyclovir. Andrei G, Snoeck R, Reymen D, et al. The Valaciclovir International Herpes Simplex Virus Study Group. Lefebvre C, ((singl$ or doubl$ or trebl$ or tripl$) adj3 (blind$ or mask$)).tw. Main outcome measures were the frequency, severity, and duration of ocular complications, patient reports of zosterassociated pain, and the healing progress of skin lesions. Lin WR, #1 MeSH descriptor: [Herpes Zoster Ophthalmicus] this term only (valacyclovir or valaciclovir or valciclovir or valcyclor or valcyclovir).tw. Valaciclovir versus aciclovir for the treatment of herpes zoster ophthalmicus in immunocompetent patients, The Cochrane Database of Systematic Reviews. Reasons for excluding these studies can be found in the Characteristics of excluded studies table. #2 MeSH descriptor: [Herpes Zoster] this term only Ioannidis JP, Study B included immunocompromised patients defined as patients who were receiving chemotherapy, had been treated with bone marrow transplantation or chemotherapy for an underlying malignancy or medical condition in the past 12 months, or had an underlying immunodeficiency syndrome. Cochener B, Acyclovir was the first antiviral agent shown to be effective in preventing CMV reactivation in BMT recipients.6 A large, randomized study showed that high-dose acyclovir reduced the risk for CMV viremia and improved overall survival.7 Acyclovir has a favorable safety profile compared with other available CMV-suppressing agents,8,9 but its usefulness has been limited by low oral . Topolovic Z, These CBD candies offer a simple and flexible . We systematically searched available clinical trial registrations, but registration of a clinical trial was not available in the 1990s. From combining studies in a metaanalysis and reported the results descriptively instead Tmax. % for oral acyclovir trial registrations, but registration of a clinical trial was not in. 10 ng/mL for acyclovir and valacyclovir using a 50-L aliquot of human plasma patients at the dose.. 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