Serious side effects include allergic reactions such as hives, itching, and swelling of the face, lips, and tongue, and facial flushing. Rarely, a severe allergic reaction, including hives, difficulty breathing, swelling of the face, lips, or tongue; fever, itching, and swelling of the face, lips, or tongue; wheezing; chest pain; severe weakness; skin rash; urination problems; pain or swelling in the back, arms, shoulders, or lower chest; and itching or rash after application. Rarely, a skin rash, especially a rash that is watery or bloody, develops, especially in the face or neck area. Discontinued use: On discontinued use, contact your healthcare professional. If symptoms persist, it is important to discontinue use and seek medical attention immediately. If symptoms worsen, contact your healthcare professional immediately. If symptoms persist, they will continue to occur. When you stop use, any changes in skin color or texture will occur. If symptoms worsen, they will occur again.
Asymptomatic genital herpes simplex virus (HSV) infection is a common and distressing disease in both developed and developing countries. There is a paucity of information regarding the treatment of genital herpes simplex virus infection in women and men, but a number of effective treatments have been available, with the results of current treatments expected to increase the risk of genital herpes and other sexually transmitted infections (STIs) in men and women. The aim of this study was to evaluate the efficacy of herpes simplex virus (HSV) treatment in women with genital herpes and other STIs.
We conducted a randomized, double-blind, controlled clinical trial comparing oral aciclovir 400mg twice daily and a single daily dose of aciclovir 400mg twice daily in women with genital herpes with and without other STIs.
The aciclovir 400mg twice daily regimen resulted in a higher proportion of herpes simplex virus (HSV) infection compared with a single oral dose of aciclovir. This could be attributed to a higher incidence of genital herpes in women with genital herpes compared with other STIs. In addition, aciclovir was less effective than the single dose of oral aciclovir, with a higher proportion of genital herpes compared with other STIs.
The aciclovir 400mg twice daily regimen was more effective than aciclovir, and this may be due to a lower frequency of genital herpes in women with genital herpes compared with other STIs. However, the proportion of genital herpes was higher in women with HSV compared with men, and these differences were not statistically significant. We recommend that treatment with aciclovir 400mg twice daily be considered for women with genital herpes. This should include consideration of the potential side effects associated with aciclovir 400mg twice daily and oral aciclovir.
Citation:Kellis J, Hernstine C, Schulze A, et al. (2017) A randomized, double-blind, controlled clinical trial compares the efficacy and safety of herpes simplex virus (HSV) treatment in women with genital herpes and other STIs in two randomized, double-blind, placebo-controlled clinical trials. PLoS ONE 15(5): e0294026. https://doi.org/10.1371/journal.pone.0294026
Editor:Borat K. L. Kortmann, University of Pennsylvania, Philadelphia, United States of America
Received:January 10, 2017;Accepted:January 29, 2017;Published:February 23, 2017
Copyright:© 2017 Kellis et al. This is an open access article distributed under the terms of the, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability:All relevant data are within the paper.
Funding:This study received no specific funding for this project, and there is no other funding or funding for this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests:The authors have declared that no competing interests exist.
Genital herpes, an infection of the genitals that is spread by sexually transmitted infection (STDI), can have various causes, including immunosuppression, hormonal changes, and the immune system. HSV-2 is the most common cause of genital herpes in the United States, but is also found in people in Europe, Asia, North America, and Africa.
Genital herpes is caused by an HSV strain of the same virus called HSV-1 that causes genital herpes in both women and men. Both HSV-1 and HSV-2 are transmitted by sexual contact, and they are highly contagious. Genital herpes is often a cause of sexual dysfunction, and sexual transmission is associated with transmission of HSV to the genital area.
HSV-1 is a member of a group of genes known as herpes simplex viruses, which are highly infectious. The first known description of genital herpes, the first description of HSV-2, and the first description of genital herpes in men were published in the 1980s [,].
Background:Antiviral therapy ( antivirals ), the first FDA approved indication for the treatment of herpes simplex and herpes zoster infections, is recommended for the treatment of herpes zoster.
Objective:To evaluate the efficacy of aciclovir and famciclovir in the treatment of herpes zoster, the treatment of herpes zoster, and recurrence of the infection.
Design and setting:A prospective randomized, placebo-controlled trial, conducted on a multicenter, double-blind, randomized placebo-controlled trial in adults with herpes simplex and herpes zoster. A total of 539 patients aged between 18 and 35 years with herpes simplex and herpes zoster infections were included in this study.
Patients and methods:Inclusion and exclusion criteria were as follows: (1) Patients with a known history of herpes simplex or herpes zoster; (2) Patients with a known risk factor such as HIV, pregnancy, or current use of corticosteroids (sodium oxycort, dronedarone, dronedarone-oral, acyclovir, or valaciclovir); (3) Patients who received at least one antiviral prophylaxis to treat an acute herpes zoster infection, including aciclovir, or famciclovir; (4) Patients who had a diagnosis of genital herpes or an acute herpes zoster infection; (5) Patients who received a diagnosis of recurrent genital herpes and had an active genital herpes infection; (6) Patients who received a diagnosis of recurrent herpes simplex and herpes zoster; (7) Patients who received at least one treatment for herpes zoster infection and had a diagnosis of recurrent herpes zoster; (8) Patients who received a diagnosis of herpes zoster infection and had a positive genital lesion test; (9) Patients who received a diagnosis of recurrent herpes zoster and had an active recurrence of a herpes zoster infection; (10) Patients who received a diagnosis of herpes zoster infection and had a positive recurrence of a herpes zoster infection; and (11) Patients who had an active infection of the urethra or cervix, and had a history of herpes zoster infection.
Main outcome measure:The primary outcome measure was the percentage of patients who reported their genital lesion as coming in to be treated with aciclovir and famciclovir.
Secondary outcome measures:The secondary outcome measures were the following: (1) the clinical cure rate, defined as a cure rate of at least 1% with at least 2 weeks of oral aciclovir or famciclovir therapy, or a cure rate of at least 2 weeks of oral famciclovir therapy; (2) the percentage of patients with the following outcomes: the number of patients with recurrent infections of the genital tract, and the number of recurrences: the number of patients who did not report their genital lesion to the prescriber in the first year of treatment and the number who reported the first episode; (3) the proportion of patients who reported the same symptoms of the recurrence of genital herpes to the prescriber in the first year of treatment and the number of patients who reported the same symptoms of the recurrence of genital herpes to the prescriber in the first year of treatment. The analysis was by intention to treat (ITT) and non-interventional variables.
Results:Of the 539 patients, 691 (72.8%) reported their genital lesion to the physician in the first year of treatment. In the first year of treatment, 77 (9.7%) of the 539 patients (69.8%) reported their genital lesion to the physician in the first year of treatment. The overall proportion of patients with recurrent infections of the genital tract, which included acute herpes zoster and recurrent genital herpes, was significantly higher in the aciclovir group (50.8% vs. 28.8%, p = 0.001, relative risk = 0.52; 0.52 vs. 0.40, respectively; p = 0.002). Among the aciclovir-treated patients, a higher proportion of patients reported their recurrent herpes infection compared with the aciclovir group (44.9% vs. 18.1%; p = 0.0003). In the subgroup of patients with recurrent genital herpes, the proportion of patients who reported their recurrent infection to the physician was significantly higher (32.5% vs. 9.5%; p = 0.001) than in the aciclovir group (23.3% vs. 8.1%; p = 0.001).
Aciclovir 400mg tablets are used to treat infections caused by viruses (which include herpes, cold sores, and genital herpes).
It is also used to treat symptoms caused by herpes simplex virus (HSV) in adults and children. It works by preventing the virus from multiplying in the body.
Aciclovir works by helping to decrease the production of the virus which causes herpes. It does this by stopping its production and preventing the virus from multiplying in the body.
Aciclovir 400mg tablets contain the active ingredient aciclovir which is an antiviral drug.
The active ingredient in Aciclovir 400mg tablets is a steroid. This means it is a medication used to treat different types of skin infections.
If you are pregnant or may become pregnant, aciclovir may not be safe to use while you are taking this medication.
Aciclovir 400mg tablets work by reducing the production of the virus that causes cold sores. It does this by inhibiting the production of an enzyme called H2R (the enzyme that causes viral replication).
The virus that causes cold sores also has a way of replication. This means that the virus that causes cold sores can reactivate and cause a cold sore.
If you have cold sores, your doctor may prescribe you aciclovir 400mg tablets as soon as you notice symptoms, such as:
If you have cold sores and are taking aciclovir, you may also need to take it daily.
You will not be able to take aciclovir without your doctor’s advice. This will make it less effective.
You can get aciclovir tablets with other medicines such as:
If you are taking any of these medicines, you should be aware of your health history and make sure you know which medicines are right for you.
If you take any of the medicines you are prescribed, your dosage will depend on what you are taking.
If you are taking Aciclovir tablets, you will need to be sure that the tablets are not broken or damaged. It is important to wash your hands after taking the tablets. This will help prevent the spread of infection.