Objective:To compare the efficacy of aciclovir and placebo for the treatment of genital herpes (Herpes Simplex Virus (HSV) type 1 and HSV type 2) in women with genital herpes compared with oral and topical aciclovir.
Design:Randomized, double-blind, placebo-controlled clinical trial. One hundred and fifty-six women with genital herpes who were randomly assigned to aciclovir or placebo were enrolled. Outcome measures were genital herpes symptoms (HSV-1 and HSV-2), laboratory results (including serum C reactive, anti-coagulant antibodies, and anti-viral tests), and clinical efficacy. There were no significant differences between the two groups in either of the clinical laboratory tests (all except for serum C reactive and anti-coagulant antibodies) or the laboratory results (all except anti-viral tests) as measured by the Clinical Global Impressions-Treatment Response Scale (CGI-TRS) at baseline (all except for anti-coagulant tests).
Setting:Intensive care unit. Women were randomized to receive either aciclovir or placebo. All women were treated with oral aciclovir 400 mg twice daily for 1 week, then twice daily for 7 days, then daily for 2 weeks. For the first week, women were treated with aciclovir 400 mg twice daily for 4 weeks, then daily for 7 days, and then twice daily for 2 weeks, then twice daily for 3 weeks, followed by the second week by aciclovir 400 mg twice daily for 3 weeks. In the following week, women were treated with aciclovir 400 mg twice daily for 5 days, and then daily for 4 weeks. All treatment was discontinued on day 3 of the study. All patients were discharged with a baseline visit. The primary efficacy endpoint was genital herpes severity score (SFS) at week 2, day 4, and week 8.
Main outcome measures:Mean genital herpes SFS (mL) was evaluated at baseline (baseline SFS), week 2, day 4, and week 8, and at week 2, day 4, and week 8. Change from baseline in SFS at baseline and at week 2, day 4, and week 8 were evaluated using log-transformed data. A secondary analysis was performed using the Kaplan-Meier method for the incidence of genital herpes at week 2, day 4, and week 8. Safety analysis was performed using the Kaplan-Meier method with a cut-off point of 50% reduction in SFS.
Results:A total of 112 women completed the trial, with 55 women being assigned to aciclovir or placebo at baseline. At week 2, 55 women (75%) were randomized to aciclovir or placebo, and 35 women (61%) were randomized to aciclovir and placebo. At week 8, 56 women (74%) were randomized to aciclovir or placebo. At baseline, 58 (82%) women were randomized to aciclovir, and 34 women (59%) were randomized to placebo. All patients received the oral aciclovir 400 mg twice daily for 3 days. At week 2, the aciclovir group had an SFS of 49.8 mL (range 15.0-104.5) compared with 49.7 mL (15.0-121.0) in the placebo group. SFS at week 2 was similar between the two groups (50.3 mL (15.0-119.5) vs 49.7 mL (15.0-121.0); p=0.16).
Conclusions:Aciclovir was more effective than placebo in the treatment of genital herpes in women with herpes simplex virus infection.
Inhaled corticosteroidsThe use of corticosteroids for treatment of genital herpes is a common problem, particularly in immunocompromised patients. The World Health Organization (WHO) guideline for the management of herpes simplex virus infections, published in 2001, recommends that patients on corticosteroid therapy should be evaluated for genital herpes as early as possible in order to minimize the risk of transmission to others. The authors state that it is essential that patients be treated with antiviral drugs that have proven effective in preventing transmission to others.
Treatment with topical corticosteroids has been shown to reduce the frequency of recurrences of herpes simplex virus infection.
Zovirax is a prescription medicine that belongs to a class of drugs called antivirals. Zovirax contains aciclovir as its active ingredient and has potent antiviral activity. This medication is mainly used for the treatment of viral infections like genital herpes, cold sores, and chickenpox.
If you are diagnosed with the herpes virus, start the therapy as soon as possible or at the first sign of an outbreak. Your doctor may prescribe you Zovirax tablets depending on your age and medical condition. The tablets are taken orally with or without food.
Take the medication at the same times every day for maximum benefit. Do not skip any dose, or stop this medication early without consulting your doctor. Always drink enough water while taking Zovirax to prevent the chances of dehydration and kidney damage.
Patients may experience some common side effects after taking Zovirax, including:
Contact your doctor immediately if you notice any serious side effects, including:
The
on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.
ACICLAVIR contains aciclovir and is an antiviral medicine used to treat infections caused by certain types of herpes simplex viruses (HSV) and varicella-zoster viruses (VZV). It is also used to treat cold sores (herpes labialis), chickenpox (varicella), and shingles (herpes zoster).
ACICLAVIR is used to prevent or treat outbreaks of genital herpes, chickenpox (varicella), and shingles caused by HSV-1 and HSV-2 viruses.
Talk to your doctor, nurse or pharmacist if you have any questions.
Do not take ACICLAVIR if you have ever had an allergic reaction to it, have kidney disease or if you have had a serious reaction to aciclovir (it is used for treating cold sores, chickenpox, shingles and genital herpes).
Talk to your doctor if you have any of these serious side effects:
Tell your doctor immediately if you become pregnant, have breast cancer, have any kind of breast infection or ulcer, or take any other medicines, including medicines you take regularly.
If you are breast feeding or are pregnant, tell your doctor immediately. You must not breastfeed while taking this medicine.
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may affect the way other medicines work, other medicines other than ACICLAVIR can affect how well or how well other medicines work. This may affect how well or how well other medicines work or other medicines other than ACICLAVIR will work. It is important you inform your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription.
Things you should do | Tell all your doctors and other health care providers that you are taking ACICLAVIR if you are pregnant, planning to become pregnant or are breastfeeding. Tell all your doctors and other health care providers that you are taking ACICLAVIR if you are taking any of the following medicines:
|
|---|---|
Things you should not do | Do not take ACICLAVIR if you are pregnant, planning to become pregnant or breastfeeding. |
Zovirax is a prescription medicine that belongs to a class of drugs called antivirals. Zovirax contains aciclovir as its active ingredient and has potent antiviral activity. This medication is mainly used for the treatment of viral infections like genital herpes, cold sores, and chickenpox.
If you are diagnosed with the herpes virus, start the therapy as soon as possible or at the first sign of an outbreak. Your doctor may prescribe you Zovirax tablets depending on your age and medical condition. The tablets are taken orally with or without food.
Take the medication at the same times every day for maximum benefit. Do not skip any dose, or stop this medication early without consulting your doctor. Always drink enough water while taking Zovirax to prevent the chances of dehydration and kidney damage.
Patients may experience some common side effects after taking Zovirax, including:
Contact your doctor immediately if you notice any serious side effects, including: