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PubMed2000

Valaciclovir: a review of its long term utility in the management of genital herpes simplex virus and cytomegalovirus infections.

UNLABELLED: Valaciclovir is an aciclovir prodrug used to treat infections caused by herpes simplex virus (HSV) and varicella zoster virus, and for prophylaxis against cytomegalovirus (CMV). Oral valaciclovir provides significantly better oral bioavailability than oral aciclovir itself, contributing to the need for less frequent administration. Several studies have demonstrated the efficacy of long term (> 90 days) therapy with valaciclovir for the suppression of genital HSV disease in otherwise healthy individuals with HSV infection. In 1 randomised, double-blind trial, once daily valaciclovir (1000 mg, 500 mg and 250 mg) produced statistically significant suppression of disease recurrence, as did twice daily valaciclovir 250 mg and aciclovir 400 mg. Valaciclovir dosages of > or = 500 mg daily are recommended for suppression of genital herpes recurrences in immunocompetent individuals. This disease occurs frequently in patients with human immunodeficiency virus (HIV) infection and, in a single randomised double-blind trial, prophylactic valaciclovir (1000 mg once daily or 500 mg twice daily) and aciclovir (400 mg twice daily) were found to be of similar efficacy in the suppression of genital herpes. However, a higher than expected dropout rate indicated that more studies of valaciclovir in patients with HIV are required. In a randomised trial of patients undergoing renal transplant, valaciclovir 2 g 4 times daily for 90 days significantly reduced the incidence and delayed the onset of CMV disease: the incidence in valaciclovir-treated patients who were CMV-seronegative at baseline, and recieived a kidney from a CMV-seropositive donor, was 3% versus 45% for placebo after 90 days of treatment. Acute graft rejection was also reduced in the valaciclovir-treated group. A small study in heart transplant patients compared valaciclovir (2 g 4 times daily) with aciclovir (200 mg 4 times daily) and found a significant reduction in CMV antigenaemia favouring valacilovir at the end of the treatment period. Additional reductions in other indices of CMV in those given valaciclovir compared with aciclovir were also noted. In a preliminary study of prophylaxis for CMV disease in bone marrow transplant recipients valaciclovir (2 g 4 times daily) was superior to aciclovir (800 mg 4 times daily) in terms of time to CMV viraemia or viruria. Although valaciclovir (8 g/day for approximately 30 weeks) reduced the incidence and time to CMV disease compared with aciclovir (3.2 g/day) in patients with advanced HIV disease, valaciclovir was associated with more gastrointestinal complaints and an increased risk of death, leading to premature termination of the study. As yet, no trials comparing the efficacy of valaciclovir with famciclovir (the oral prodrug for penciclovir) in the suppression of recurrent episodes of genital herpes have been published, nor have direct comparisons been made, between valaciclovir with ganciclovir in patients with CMV disease. Valaciclovir is well tolerated at dosages used to suppress recurrent episodes of genital herpes (500 to 1000 mg/day) in immunocompetent and HIV seropositive individuals, with headache being reported most often. However, a potentially fatal thrombotic microangiopathy (TMA)-like syndrome has been reported in some immunocompromised patients receiving high-dose prophylactic valaciclovir therapy (8 g/day) for CMV disease for prolonged periods, and the risk of this syndrome appears to be higher in patients with advanced HIV disease. While the clinical benefits of valaciclovir in some immunocompromised patients may outweigh the risk of TMA, close monitoring for symptoms of TMA is indicated in all immunocompromised patients receiving high-dose valaciclovir. CONCLUSION: Oral valaciclovir is an effective drug for the suppression of recurrent episodes of genital herpes in immunocompetent and immunocompromised individuals. (ABSTRACT TRUNCATED)

Acyclovir↗
PubMed2000

Valaciclovir: a review of its use in the management of herpes zoster.

UNLABELLED: Varicella zoster virus (VZV), the pathogen responsible for herpes zoster, belongs to the herpesvirus family and is sensitive to the antiviral drug aciclovir. However, the low oral bioavailability of aciclovir has to some extent limited its efficacy in the treatment of herpes zoster and has prompted the development of the more readily absorbed oral prodrug valaciclovir. In a large comparative study valaciclovir, (1000 mg 3 times daily for 7 days) was at least as effective as aciclovir (800 mg 5 times daily for 7 days) in controlling the symptoms of acute herpes zoster. Importantly, valaciclovir alleviated zoster-associated pain and postherpetic neuralgia significantly faster than aciclovir. A 14-day regimen of valaciclovir showed no significant advantage over the 7-day regimen. A smaller trial in Japanese patients focusing primarily on the cutaneous (rash) signs of herpes zoster confirmed the similar efficacy of valaciclovir and aciclovir in the 7-day regimen. This study did not follow all patients for a formal analysis of postherpetic neuralgia. Valaciclovir and aciclovir demonstrated similar efficacy for the control of cutaneous lesions and ocular complications in patients with zoster ophthalmicus. Preliminary results of a large controlled trial indicate that valaciclovir 1000 mg 3 times daily and famciclovir (the prodrug of penciclovir) 500 mg 3 times daily are of similar efficacy in speeding resolution of acute herpes zoster rash and shortening the duration of postherpetic neuralgia. Starting treatment later than 72 hours after rash onset did not significantly reduce the beneficial effect of valaciclovir on duration of zoster-associated pain (a continuum of pain that encompasses both acute pain and postherpetic neuralgia) in a large observational study, suggesting that valaciclovir might be effective when given later than previously thought. However, valaciclovir should ideally be given as soon as possible after symptoms appear. With the recommended regimen for the treatment of herpes zoster (1000 mg 3 times daily for 7 days) valaciclovir was well tolerated, with nausea and headache being the most commonly reported adverse events. The adverse events profile of the agent was similar to that seen with aciclovir or famciclovir. CONCLUSION: The efficacy of valaciclovir for the treatment of herpes zoster has been confirmed and extended by follow-up studies in herpes zoster ophthalmicus, in Japanese patients, and in the wider primary care setting. Valaciclovir is at least equivalent to, and better in certain parameters than, aciclovir and appears to have similar efficacy to famciclovir 500 mg 3 times daily. Valaciclovir is a well tolerated first-line therapy with an established place in the treatment of immunocompetent patients with herpes zoster.

Acyclovir↗
PubMed2000

Cost-effectiveness model of cytomegalovirus management strategies in renal transplantation. Comparing valaciclovir prophylaxis with current practice.

BACKGROUND: Cytomegalovirus (CMV) disease may occur following renal transplantation and has been shown to have health and cost consequences in this setting. OBJECTIVE: To compare the cost effectiveness of different CMV management strategies for renal transplant patients: prophylaxis with (i) oral valaciclovir or (ii) intravenous ganciclovir; viral testing for CMV followed by (iii) pre-emptive therapy with intravenous ganciclovir or (iv) adjustment of immunosuppression and intensive monitoring; or (v) waiting to treat when CMV disease develops. METHODS: A decision-tree model was constructed that included the different management strategies for the donor seropositive/recipient seronegative (D+R-) population. Clinical outcomes for the D+R- population came from clinical trials. Treatment algorithms and costs for CMV syndrome and tissue invasive disease were developed from published literature and UK physician interviews. One- and 2-way sensitivity analyses were performed. STUDY PERSPECTIVE: UK National Health Service. RESULTS: Prophylaxis with either oral valaciclovir or intravenous ganciclovir dominated (lower costs and fewer cases of CMV disease) the pre-emptive treatment and wait-and-treat strategies. The cost per patient was from 157 Pounds to 438 Pounds higher with oral valaciclovir prophylaxis compared with intravenous ganciclovir prophylaxis and the incremental cost per case of CMV disease avoided with valaciclovir prophylaxis ranged from 2243 Pounds to 8111 Pounds (1996 values). These results are sensitive to the efficacy of intravenous ganciclovir prophylaxis and CMV management costs. CONCLUSIONS: For D+R- renal transplant patients, prophylaxis is the dominant (more effective and less costly) management strategy compared with pre-emptive and wait-and-treat strategies. The cost per patient with oral valaciclovir prophylaxis compared with intravenous ganciclovir prophylaxis is slightly higher in our base case scenario, but may be lower under reasonable alternative assumptions.

Acyclovir↗
PubMed2003

Recurrent genital herpes treatments and their impact on quality of life.

Herpes genitalis is one of the most common viral sexually transmitted diseases in the world, with an estimated seroprevalence in the US of greater than 20%. Two viruses of the same family cause herpes genitalis: herpes simplex virus 1 and 2. After the resolution of primary infection, the virus persists in the nerve roots of the sacral plexus, often causing recurrent (though generally less severe) outbreaks. These outbreaks, as well as the infectious potential to the patient's sexual partners, results in significant psychological stress on the patient, and has a tremendous negative impact on QOL. Current treatment modalities may result in a reduction in the number of outbreaks and viral shedding, but no cure exists. Although studies have clearly demonstrated the negative impact of recurrent genital herpes on QOL, an assessment scale specific to herpes was not developed until recently. Earlier studies indicated that patients did not perceive a significant benefit from episodic treatment with antivirals, but studies using the Recurrent Genital Herpes Quality of Life Questionnaire (RGHQoL) have now demonstrated that suppressive antiviral therapy improves quality of life in patients with frequent recurrences of genital herpes. However, not all patients with recurrent genital herpes need suppressive therapy, and proposed factors to consider include frequency of recurrence, physical and psychological distress caused by recurrences, and the potential for transmission to the patient's sexual partner. Newer therapeutic modalities, including the topical immune response modifier resiquimod and herpes vaccines, may eventually be shown to further decrease the psychological morbidity of recurrent genital herpes.

2-Aminopurine↗
PubMed2002

Pharmacokinetics and safety of valaciclovir in children with Epstein-Barr virus illness.

OBJECTIVE: Valaciclovir has in vitro activity against Epstein-Barr virus (EBV) and, because of improved absorption with higher achievable serum concentrations, may be more effective than aciclovir in the treatment of EBV. No studies to date have evaluated the efficacy, safety or proper dosing of valaciclovir in children for the treatment of EBV infection. The objectives of this study were to determine the pharmacokinetics and safety of valaciclovir tablets and suspension in children with EBV illness. METHODS: 24 children with EBV illness were randomised to receive valaciclovir suspension 10 mg/kg or 20 mg/kg; eight children subsequently were crossed over and also received valaciclovir 500 mg tablets. Doses of either suspension or tablets were administered every 8 hours for four doses, and pharmacokinetic studies were performed to determine aciclovir serum concentrations. Samples for drug assay were obtained at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours. Samples were assayed by high performance liquid chromatography (HPLC) methods and aciclovir pharmacokinetics determined using non-compartmental analysis. RESULTS: Valaciclovir pharmacokinetic parameters (mean +/- SD) in children who received tablets and suspension (normalised to 500 mg dose) were: maximum serum concentration (C(max)) 3.16 +/- 1.30 and 2.42 +/- 0.74 mg/L, time to maximum serum concentration (t(max)) 1.88 +/- 0.99 and 1.31 +/- 0.53 hours, half-life (t 1/2) 1.72 +/- 0.41 and 1.94 +/- 0.60 hours, apparent total systemic clearance (CL/F) 20.01 +/- 6.61 and 15.58 +/- 3.34 ml/min/kg, volume of distribution/bioavailability (Vd/F) 3.04 +/- 1.26 and 2.58 +/- 0.81 L/kg, and area under the concentration-time curve (AUC) 10.13 +/- 3.47 and 8.59 +/- 2.52 mg x h/L, respectively. There were no statistically significant differences in the pharmacokinetics of valaciclovir tablets versus suspension. The relative bioavailability of the valaciclovir tablets compared with the suspension was 115 +/- 32%. Valaciclovir was well tolerated, with gastrointestinal disturbances and headache being the most common adverse effects in a small number of subjects. CONCLUSIONS: Valaciclovir is absorbed and achieves concentrations in children that appear to be effective for the treatment of herpes lesions. The pharmacokinetics of valaciclovir suspension and tablets are similar, and the pharmacokinetics of aciclovir after administration of valaciclovir to children are similar to historical observations of aciclovir pharmacokinetics in adults. Valaciclovir has a good safety profile and was well tolerated after oral administration in this group of children.

Acyclovir↗
PubMed2006

Viral infections affecting the skin in organ transplant recipients: epidemiology and current management strategies.

Viral skin infections are common findings in organ transplant recipients. The most important etiological agents are the group of human herpesviruses (HHV), human papillomaviruses (HPV), and molluscum contagiosum virus. HHV that are important in this group of patients are herpes simplex virus (HSV) types 1 and 2, varicella-zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), HHV-6 and -7, and HHV-8, which causes Kaposi sarcoma (KS). HSV infections are characterized by their ability to establish latency and then reactivate at a later date. The most common manifestations of HSV infection in organ transplant recipients are mucocutaneous lesions of the oropharynx or genital regions. Treatment is usually with acyclovir, valaciclovir, or famciclovir. Acyclovir resistance may arise although the majority of acyclovir-resistant strains have been isolated from AIDS patients and not organ transplant recipients. In such cases, alternatives such as foscarnet, cidofovir, or trifluridine may have to be considered. VZV causes chickenpox as well as herpes zoster. In organ transplant recipients, recurrent herpes zoster can occur. Acute chickenpox in organ transplant patients should be treated with intravenous acyclovir. CMV infection occurs in 20-60% of all transplant recipients. Cutaneous manifestations, which include nonspecific macular rashes, ulcers, purpuric eruptions, and vesiculobullous lesions, are seen in 10-20% of patients with systemic infection and signify a poor prognosis. The present gold standard for treatment is ganciclovir, but newer drugs such as valganciclovir appear promising. EBV is responsible for some cases of post-transplant lymphoproliferative disorder, which represents the greatest risk of serious EBV disease in transplant recipients. HHV-6 and HHV-7 are two relatively newly discovered viruses and, at present, the body of information concerning these two agents is still fairly limited. KS is caused by HHV-8, which is the most recently discovered lymphotrophic HHV. Iatrogenic KS is seen in solid-organ transplant recipients, with a prevalence of 0.5-5% depending on the patient's country of origin. HPV is ubiquitous, and organ transplant recipients may never totally clear HPV infections, which are the most frequently recurring infections in renal transplant recipients. HPV infection in transplant recipients is important because of its link to the development of certain skin cancers, in particular, squamous cell carcinoma. Regular surveillance, sun avoidance, and patient education are important aspects of the management strategy.

2-Aminopurine↗
PubMed2002

Genital herpes simplex virus infection in the adolescent: special considerations for management.

Genital herpes simplex virus (HSV) infections are increasingly common among adolescents. In developed countries, during the 1990s, adolescent HSV type 2 seroprevalence rates ranged from 4 to 30% depending on the population studied. The clinical diagnosis of genital herpes may be unreliable and laboratory testing is recommended. Aciclovir, valaciclovir, and famciclovir are three antiviral drugs that have proven efficacy in the treatment of genital herpes. These drugs can be used in the treatment of the first episode or for recurrent infections, or can be used long term to suppress recurrent infections. Once or twice daily administration regimens are preferable for adolescents for reasons of adherence, and because it avoids the need to take medication at school. Unproven remedies are used commonly and can be harmful. In addition to antiviral therapy, proper management of the adolescent with genital herpes should also include developmentally appropriate explanations of the diagnosis, treatment and potential complications, recommendations for symptomatic relief, screening for other sexually transmitted infections, and discussion of safer sexual practices. All adolescents should have follow-up visits to complete education and counseling and to assess compliance with antiviral therapy.

2-Aminopurine↗
PubMed2000

Acute and chronic herpes zoster. An ancient scourge yields to timely therapy.

With the US population aging steadily, herpes zoster represents a growing contributor to diminished quality of life. Dermatologic manifestations appear as immunity declines with age but rarely pose a significant threat, except in instances when ocular structures are involved. Pain is of more concern, because it usually accompanies and may even precede and persist after acute eruptions. In most young patients, pain is transient and bearable. Unfortunately, in the elderly--who are at highest risk for herpes zoster--pain is often more prolonged and more intense. In spite of a wide spectrum of interventions, palliative efforts remain rather ineffectual. At present, intervening as early as possible, ideally within 48 to 72 hours of disease onset, offers the greatest chance of minimizing neurologic sequelae. Inoculation with varicella vaccine in patients between ages 55 and 65 may prove to boost cell-mediated immunity sufficiently so that recrudescence of the varicella virus can be relegated to the annals of history.

2-Aminopurine↗
PubMedDate not supplied

Herpes simplex virus keratitis after laser in situ keratomileusis.

PURPOSE: To report two cases of herpes simplex virus (HSV) keratitis after laser in situ keratomileusis (LASIK). METHODS: Interventional small case series. Two patients underwent uneventful LASIK. History of herpes labialis in one patient and herpetic eye disease > 10 years prior to intervention in the other patient was reported. Both patients developed stromal herpetic keratitis 6 weeks and 2 years after the procedure, respectively. RESULTS: Treatment consisting of topical steroid drops and topical and systemic antiviral therapy was administered. Recurrences of the herpetic keratitis were seen after tapering of the topical steroids; four and three recurrences were observed, respectively. Final visual acuity was > 6/9 in both cases. CONCLUSIONS: Herpetic keratitis after LASIK is an uncommon, possibly under-reported, entity. Even patients without history of herpetic eye disease can present with this complication. Oral antiviral prophylaxis may be appropriate when performing LASIK on patients with a history of ocular or systemic HSV infection.

Acyclovir↗
PubMed2000

Update on antiviral therapy for genital herpes infection.

For the primary infection of genital herpes, antiviral therapy with acyclovir is the gold standard. For recurrences, there are two options: antiviral treatment of each outbreak as it arises, or suppression of outbreaks with daily oral therapy. Patients tend to prefer the latter because it can decrease the number and severity of outbreaks, but it increases asymptomatic viral shedding and, therefore, the risk of unwittingly transmitting herpes simplex virus to uninfected sexual partners.

2-Aminopurine↗
PubMed2004

[Arcuate keratotomy to correct residual astigmatism after stromal herpetic keratitis].

CLINICAL CASE: A woman with a history of recurrent herpes simplex keratitis in the left eye developed endothelial and stromal keratitis after cataract extraction. Because of the resultant corneal distortion a high regular astigmatism appeared. An arcuate keratotomy was performed to improve her visual acuity. DISCUSSION: Corneal astigmatism can appear after herpetic keratitis. An arcuate keratotomy was effective in this case to decrease astigmatism and improve her vision. Keratitis reactivation is possible so antiviral prophylaxis is advisable. Our good results show that arcuate keratotomy can be a useful technique for these patients.

Acyclovir↗
PubMed1999

[Drug clinics. How I treat zona].

The treatment of herpes zoster relies on the intravenous or oral administration of antiviral drugs. Oral aciclovir for shingles is hindered by its low bioavailability. New antiviral drugs with improved oral bioavailability (famciclovir and valaciclovir) allow a better efficacy. The opportuneness of treating herpes zoster is different in the immunocompetent and immunocompromised patients, and during childhood and pregnancy.

2-Aminopurine↗
PubMedDate not supplied

The use of antiviral medications in the treatment of herpes simplex virus infections of women.

Over the last decades, major basic and clinical research in the field of antiviral therapy has allowed the health care provider to treat and prevent the morbidity and mortality of many viral infections. The health care provider is faced with challengers in the diagnosis, prevention, and treatment of viral STDs in women. A number of antiviral compounds can be used for the treatment of acute infection. In addition, these medications have been proven to be safe and effective when administered over long periods of time to treat and suppress such viral infections as genital herpes. Another therapeutic way of using these antiviral medications is to reduce viral shedding in infected patients thus preventing transmission of the disease. The use of antiviral medications as postexposure prophylaxis is another area in which the clinician needs current information. The mechanism of action, the spectrum of activity, and the pharmacokinetics of these antiviral compounds are important in selecting appropriate therapy for patients. The standard of care has changed with the availability of safe and effective antiviral medications. The FDA after careful and controlled clinical trials has approved several antiviral compounds to treat viral STDs. Appropriate use of antiviral compounds in the nonpregnant and pregnant woman significantly improves the morbidity and mortality associated with herpes simplex virus infections and may influence transmission rates to sexual partners and the newborn.

2-Aminopurine↗