penciclovir and Herpes-Labialis

Topics: Acyclovir; Administration, Oral; Administration, Topical; Antiviral Agents; Guanine; Herpes Labialis; Humans; Valacyclovir; Valine

Topics: Acyclovir; Antiviral Agents; Clinical Trials as Topic; Fatty Alcohols; Guanine; Herpes Labialis; Humans; Ointments

Topics: Acyclovir; Administration, Topical; Antioxidants; Antiviral Agents; Butylated Hydroxytoluene; Drug Therapy, Combination; Guanine; Herpes Genitalis; Herpes Labialis; Herpesvirus 1, Human; Herpesvirus 2, Human; Humans; Interferon-alpha; Vidarabine

Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Famciclovir; Guanine; Herpes Genitalis; Herpes Labialis; Herpes Simplex; Herpes Zoster; Herpesvirus 3, Human; Humans; Immunocompromised Host; Prodrugs; Simplexvirus; Virus Replication

Subjects received topical penciclovir for 4 days during successive episodes of recurrent herpes labialis. Isolation of herpes simplex virus (HSV) was attempted from lesions obtained before initiation of treatment and on each day of therapy. Isolates remained sensitive to penciclovir when tested by a plaque reduction assay, and there was no significant change in sensitivity during any treatment course or between successive treatments. The proportion of nucleoside-resistant variants present within a subset of these isolates was further investigated using a more-sensitive plating efficiency assay. Although the proportion of antiviral-resistant HSV variants increased on successive days, it invariably remained a minor subpopulation. Moreover, isolates from successive episodes obtained before treatment showed no change in the proportion of resistant HSV variants. We conclude that antiviral-resistant variants, which are readily detected in HSV isolates from peripheral lesions, do not accumulate in the sensory ganglia of immunocompetent patients receiving multiple courses of nucleoside analogues.

Topics: Acyclovir; Adolescent; Adult; Antiviral Agents; Drug Resistance, Viral; Female; Guanine; Herpes Labialis; Herpesvirus 1, Human; Humans; Male; Time Factors; Viral Plaque Assay

Two randomized, double-blind, parallel-group clinical trials were conducted in Europe and North America to compare the efficacy and safety of topical 1 percent penciclovir cream with a placebo cream.. A total of 4,573 immunocompetent people with a history of recurrent herpes simplex labialis, or HSL, with three or more episodes a year that typically manifested as classical lesions, were enrolled and prospectively dispensed medication-either 1 percent penciclovir in a cetomacrogol cream base or a matching placebo. Patients self-initiated treatment and were required to apply study medication six times per day for the first day and every two hours while awake for four consecutive days.. Of 4,573 enrolled patients, 3,057 initiated treatment (1,516 with penciclovir and 1,541 with placebo). Combined data from two trials revealed that penciclovir recipients lost classical lesions 31 percent faster than did placebo recipients (hazard ratio, or HR, = 1.31; 95 percent confidence interval, or CI, 1.20 to 1.42; P = .0001) and experienced 28 percent faster resolution of lesion pain (HR = 1.28; 95 percent CI, 1.17 to 1.39; P = .0001). Significant benefits were achieved with penciclovir use whether treatment was initiated in the early stages (P = .001) or later stages (P = .0055).. The largest data set currently available on the treatment of recurrent HSL revealed that penciclovir cream significantly outperformed the placebo in healing classical lesions and resolution of pain.. The authors found that penciclovir cream positively affects recurrent HSL, and dose frequency is vital to topical treatment. Even when penciclovir was applied late, it was effective in favorably altering the course of recurrent HSL.

Topics: Acyclovir; Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Confidence Intervals; Double-Blind Method; Female; Guanine; Herpes Labialis; Humans; Male; Middle Aged; Odds Ratio; Ointments; Placebos; Proportional Hazards Models; Prospective Studies; Recurrence; Reverse Transcriptase Inhibitors; Safety; Statistics, Nonparametric; Time Factors; Treatment Outcome; Virus Shedding; Wound Healing

Herpes simplex facialis/labialis (HSFL) is a common infectious skin disorder, caused mainly by herpes simplex virus (HSV) type 1, for which the topical application of a cream containing an antiviral agent for treatment of the disease has been widely utilized.. To explore the efficacy of the topical application of 1% penciclovir cream in the treatment of HSFL, and to compare its efficacy and safety with 3% aciclovir cream.. A total of 248 patients with a diagnosis of HSFL were randomly allocated to one of the two treatment groups (n = 124 each), using stratified randomization based on a table of random numbers. Before treatment (day 0) and at every visit (days 3, 5 and 7) during the study, the sign and symptom scores were recorded by the same doctor.. Excluding 23 patients (10 in the penciclovir and 13 in the aciclovir groups), 225 completed the study, and no severe adverse events were noted with any of the treatment regimens. Results show that an encouraging improvement in the clinical course was found simultaneously for patients with each episode type and each treatment assignment. There were no significant differences in terms of efficacy endpoint, clinical cure rate, and safety between the two treatment arms, but there was a trend towards a shorter time to resolution of all symptoms, cessation of new blisters, and loss of crust (p

Topics: Acyclovir; Administration, Cutaneous; Adolescent; Adult; Aged; Antiviral Agents; Double-Blind Method; Drug Administration Schedule; Facial Dermatoses; Female; Guanine; Herpes Labialis; Herpes Simplex; Humans; Male; Middle Aged; Ointments; Pruritus; Treatment Outcome

Acyclovir cream has been available for the treatment of herpes labialis in numerous countries outside the United States for over a decade. Evidence for its efficacy comes from a few small clinical trials conducted in the 1980s. To examine more comprehensively the efficacy and safety of this formulation, we conducted two independent, identical, parallel, randomized, double-blind, vehicle-controlled, large-scale multicenter clinical trials. Healthy adults with a history of frequent herpes labialis were recruited from the general population, screened for eligibility, randomized equally to 5% acyclovir cream or vehicle control, given study medication, and told to self-initiate treatment five times daily for 4 days beginning within 1 h of the onset of a recurrent episode. The number of patients who treated a lesion was 686 in study 1 and 699 in study 2. In study 1, the mean duration of episodes was 4.3 days for patients treated with acyclovir cream and 4.8 days for those treated with the vehicle control (hazards ratio [HR] = 1.23; 95% confidence interval [CI], 1.06 to 1.44; P = 0.007). In study 2, the mean duration of episodes was 4.6 days for patients treated with acyclovir cream and 5.2 days for those treated with the vehicle control (HR = 1.24; 95% CI, 1.06 to 1.44; P = 0.006). Efficacy was apparent whether therapy was initiated "early" (prodrome or erythema lesion stage) or "late" (papule or vesicle stage). There was a statistically significant reduction in the duration of lesion pain in both studies. Acyclovir cream did not prevent the development of classical lesions (progression to vesicles, ulcers, and/or crusts). Adverse events were mild and infrequent.

Topics: Acyclovir; Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Double-Blind Method; Female; Guanine; Herpes Labialis; Humans; Idoxuridine; Male; Middle Aged; Ointments; Pharmaceutical Vehicles

This study compares the effects of topical acyclovir and penciclovir in the treatment of recurrent herpes labialis. The study patients were a population of 40 patients with in excess of five recurrences annually, and were separated into four homogeneous groups each of 10 subjects. The antiviral creams were used to achieve total lesional cover, every 2 h during waking hours. The effects on the time to lesion crusting and to resolution of pain, were assessed. The results not only confirmed that aciclovir is ineffective, but confirmed that penciclovir is effective, and that penciclovir is superior to aciclovir.

Topics: Acyclovir; Administration, Topical; Adolescent; Adult; Antiviral Agents; Child; Female; Guanine; Herpes Labialis; Humans; Male; Middle Aged

The purpose of this study was to further define the therapeutic value of penciclovir cream in the treatment of sunlight-induced herpes labialis by comparing its efficacy and tolerability with those of an inactive control (purified water).. In this randomized, double-blind, placebo-controlled, parallel-group clinical trial, lesions were induced by exposure to sunlight. Treatment was self-initiated within 1 hour of development of the signs or symptoms of a recurrence.. Healthy male and female patients (mean age, 38.3 years; range, 18 to 81 years) who had a history of sunlight-induced herpes labialis (mean of 6 recurrences in previous 12 months) applied either penciclovir cream (n = 266) or purified water (n = 275). Penciclovir cream significantly decreased the time to lesion healing (P < 0.001), with a reduction in median time of up to 2 days. The efficacy of penciclovir cream was further supported by a significant reduction in maximum lesion area (P = 0.008), a faster loss of lesion-associated symptoms (P = 0.026), and significant reductions in daily assessments of pain (P < or = 0.040), itching (P < or = 0.032), burning (P < or = 0.028), and tenderness (P < or = 0.026) as moderate or severe. These effects were reinforced by the results of the daily self-assessment of lesion attributes, with significantly fewer severe/extreme assessments of lesion size (P < or = 0.003), noticeability (P < or = 0.003), amount of scab/crust (P < or = 0.003), raised/ swollen area (P < or = 0.040), soreness/tenderness (P < or = 0.043), and overall severity (P < or = 0.001) throughout the study period.. Penciclovir cream has demonstrated efficacy for a broad range of clinically important outcomes. Significant effects on lesion area, lesion symptoms, and other lesion attributes extend the clinical efficacy of penciclovir cream beyond lesion healing.

Topics: Acyclovir; Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Double-Blind Method; Female; Guanine; Herpes Labialis; Humans; Male; Middle Aged; Ointments; Sunlight

To compare the safety and efficacy of topical 1% penciclovir cream with vehicle control cream (placebo) for the treatment of a recurrent episode of herpes simplex labialis (cold sores) in immunocompetent patients.. Randomized, double-blind, placebo-controlled, patient-initiated, 2-armed, parallel clinical trial. Patients were prospectively dispensed study medication, and treatment was self-initiated by the patient within 1 hour of the first sign or symptom of a recurrence.. A total of 31 ambulatory clinics in the United States in a variety of settings, including private practices, public health facilities, and universities.. Otherwise healthy individuals with a history of frequent episodes of herpes simplex labialis. A total of 2209 patients were enrolled and given study medication, and 1573 initiated treatment for a recurrence.. Topical 1% penciclovir cream or vehicle control cream. Subjects applied treatment every 2 hours while awake for 4 consecutive days.. Lesion healing was the primary efficacy variable. Secondary end points included time to loss of lesion pain and time to cessation of viral shedding.. Healing of classical lesions (vesicles, ulcers, and/or crusts) was 0.7 day faster for penciclovir-treated patients compared with those who received vehicle control cream (median, 4.8 days vs 5.5 days; hazard ratio [HR], 1.33; 95% confidence interval [CI], 1.18-1.49; P<.001). Pain (median, 3.5 days vs 4.1 days; HR, 1.22; 95% CI, 1.09-1.36; P<.001) and lesion virus shedding (median, 3 days vs 3 days; HR, 1.35; 95% CI, 1.10-1.64; P=.003) also resolved more quickly for penciclovir-treated patients compared with patients who applied the vehicle control. The efficacy of penciclovir cream was apparent when therapy was initiated early (prodrome or erythema lesion stage) and when initiated late (papule or vesicle stage). The incidence of adverse events was comparable between penciclovir and placebo groups.. Penciclovir cream is the first treatment to clearly demonstrate an impact on the course of recurrent herpes labialis in immunocompetent patients. Efficacy was seen in all clinical and laboratory measures of the disease (lesion healing, pain resolution, and cessation of viral shedding). Faster healing and pain resolution occurred both among patients who first applied penciclovir cream in the prodrome and erythema stages and among those who started treatment in the papule and vesicle lesion stages.

Topics: Acyclovir; Administration, Topical; Adult; Aged; Antiviral Agents; Double-Blind Method; Female; Guanine; Herpes Labialis; Humans; Immunocompetence; Male; Middle Aged; Ointments; Pain; Proportional Hazards Models; Recurrence; Virus Shedding; Wound Healing

Topics: Acyclovir; Administration, Topical; Antiviral Agents; Costs and Cost Analysis; Guanine; Herpes Labialis; Humans

Topics: Acyclovir; Antiviral Agents; Female; Guanine; Herpes Labialis; Humans; Male; Ointments; Recurrence; Reproducibility of Results; Treatment Outcome

Herpes labialis, caused by herpes simplex virus type 1, is usually characterized by painful skin or mucosal lesions. Penciclovir (PV) tablets are found to be effective against herpes labialis but suffer from poor oral bioavailability. This study aimed to combine the benefits of PV and lavender oil (LO), which exhibits anesthetic activity, in the form of a self-nanoemulsifying drug delivery system (SNEDDS) for the treatment of herpes labialis. Toward this purpose, LO (oil), Labrasol:Labrafil M1944 CS in the ratio of 6:4 (surfactant mixture), and Lauroglycol-FCC (co-surfactant, selected based on the solubility of PV) were evaluated as the independent factors using a distance quadratic mixture design. The formulation was optimized for the minimum globule size and maximum stability index and was determined to contain 14% LO, 40.5% Labrasol:Labrafil 1944 (6:4), and 45.5% Lauroglycol-FCC. The optimized PV-LO-SNEDDS was embedded in chitosan hydrogel and the resulting formulations coded by (O3) were prepared and evaluated. The rheological studies demonstrated a combined pseudoplastic and thixotropic behavior with the highest flux of PV permeation across sheep buccal mucosa. Compared to a marketed 1% PV cream, the O3 formulation exhibited a significantly higher and sustained PV release, nearly twice the PV permeability, and a relative bioavailability of 180%. Overall, results confirm that the O3 formulation can provide an efficient delivery system for PV to reach oral mucosa and subsequent prolonged PV release. Thus, the PV-LO-SNEDDS embedded oral gel is promising and can be further evaluated in clinical settings to establish its therapeutic use in herpes labialis.

Topics: Administration, Topical; Animals; Chemistry, Pharmaceutical; Chitosan; Delayed-Action Preparations; Drug Delivery Systems; Drug Liberation; Drug Stability; Emulsions; Glycerides; Guanine; Herpes Labialis; Hydrogels; Lavandula; Male; Nanoparticles; Oils, Volatile; Particle Size; Plant Oils; Rats; Rats, Wistar; Rheology; Sheep

Topics: Acyclovir; Administration, Cutaneous; Antiviral Agents; Guanine; Herpes Labialis; Humans; Randomized Controlled Trials as Topic

The antiherpesvirus agent penciclovir (PCV) shares an identical activation pathway and a similar mode of action with acyclovir (ACV). However, since PCV represents a relatively recent treatment option, the clinical resistance profile to PCV is less well known. A susceptibility program was established to assess the resistance profile for serial herpes simplex virus isolates from immunocompetent patients with recurrent herpes labialis obtained throughout a 4-day period of treatment with topical PCV (1% cream) or a placebo. Two isolates (2 of 1,035 [0.19%]), representing 0.34% of the patients (2 of 585), were confirmed to be PCV-resistant (Pcv(r)) herpes simplex virus type 1 by a plaque reduction assay in MRC-5 cells. These two viruses were highly resistant to PCV (50% inhibitory concentrations [IC(50)s], >55 micro g/ml) and were isolated less than 17 h after the start of patient-initiated treatment. However, subsequent isolates on days 2 and 3 from these patients were completely susceptible to PCV (IC(50)s, <2.0 micro g/ml). Thus, it is not clear whether the resistance to PCV for these two early-treatment isolates was directly associated with the 17 h of PCV treatment; several possible explanations are discussed. In an analysis of the distribution of IC(50) differences between the first and last isolates, there were three patients with minor IC(50) increases in the PCV-treated population and one in the placebo-treated group, although statistically, only the latter was an outlier. No patients were found to have Pcv(r) virus at the end of acute treatment, regardless of treatment group. Overall, the prevalence of Pcv(r) was found to be similar to the 0.3% Acv(r) reported for immunocompetent, untreated populations.

Topics: Acyclovir; Antiviral Agents; Autoradiography; Drug Resistance, Viral; Frameshift Mutation; Guanine; Herpes Labialis; Herpesvirus 1, Human; Humans; Microbial Sensitivity Tests; Protein-Tyrosine Kinases; Recurrence; Viral Plaque Assay

In a general population survey in the United States, the prevalence of antiviral-agent-resistant herpes simplex virus was very low among more than 1,000 isolates from individuals with an episode of recurrent herpes labialis not treated with topical antiviral agents. Two isolates had borderline resistance to acyclovir (0.2%), and all were susceptible to penciclovir.

Topics: Acyclovir; Administration, Topical; Adult; Animals; Antiviral Agents; Cells, Cultured; Drug Resistance, Viral; Female; Guanine; Herpes Labialis; Herpesvirus 1, Human; Humans; Male; Population; Rabbits; Recurrence; United States

Topics: Acyclovir; Administration, Topical; Antiviral Agents; Guanine; Herpes Labialis; Humans; Recurrence

Topics: Acyclovir; Antiviral Agents; Fatty Alcohols; Guanine; Herpes Labialis; Humans; Recurrence; Simplexvirus; Stomatitis, Herpetic; Virulence; Virus Activation; Virus Shedding

There are 3 new topical treatments for herpes labialis that have either been approved by the US Food and Drug Administration (penciclovir cream [Denavir] and n-docosanol cream [Abreva]) or recently undergone extensive clinical evaluation (acyclovir cream). The relative efficacy of these products is unknown.. To compare the efficacy of penciclovir cream, acyclovir cream, n-docosanol cream, and acyclovir ointment in an experimental animal model of cutaneous herpes simplex virus type 1 (HSV-1) disease.. The backs of guinea pigs were infected with HSV-1 using a vaccination instrument. Active treatments and corresponding vehicle controls were applied for 3 to 5 days beginning 24 hours after inoculation.. After completion of treatment, the animals were killed and the severity of the infection assessed from the number of lesions, the total lesion area, and the lesion virus titer.. Penciclovir cream effected modest reductions in lesion number (19%), area (38%), and virus titer (88%) compared with its vehicle control, and each of these differences was significantly greater (P<.05) than the reductions effected by acyclovir ointment (0%, 21%, and 75%, respectively). The acyclovir cream effect (reductions of 4%, 28%, and 77%, respectively) was less than that of penciclovir cream, and this difference was confirmed by 2 additional head-to-head experiments. Two experiments with n-docosanol cream failed to show statistically significant differences by any parameter between n-docasonol cream and vehicle control-treated sites or between n-docosanol and untreated infection sites.. In this model, the efficacy of penciclovir cream was greater than acyclovir cream, acyclovir cream was greater than or equal to acyclovir ointment, and acyclovir ointment was greater than n-docosanol cream. Since our model was designed to evaluate compounds that function primarily through antiviral activity, the negative findings with n-docosanol in these studies do not exclude that it might work clinically through other mechanisms.

Topics: Acyclovir; Administration, Topical; Animals; Disease Models, Animal; Fatty Alcohols; Female; Guanine; Guinea Pigs; Herpes Labialis; Herpesvirus 1, Human; Humans; Treatment Outcome

Topics: Acyclovir; Administration, Topical; Animals; Antiviral Agents; Disease Models, Animal; Fatty Alcohols; Guanine; Guinea Pigs; Herpes Labialis; Humans; Ointments; Treatment Outcome

Topics: Acyclovir; Antiviral Agents; Guanine; Herpes Labialis; Humans

Topics: 2-Aminopurine; Acyclovir; Antiviral Agents; Famciclovir; Guanine; Herpes Labialis; Herpes Zoster; Humans; Valacyclovir; Valine