Acyclovir 5% ointment is an approved medication for treating herpes simplex virus infections. It is a topical antiviral treatment that can be used by both children and adults. It is particularly beneficial for immunocompromised individuals as it helps reduce the duration of herpes outbreaks and can be used as a preventive measure against reactivation of the virus.

Acyclovir is available in different forms, such as tablets, capsules, suspension, injection, as well as topical formulations like ointments and creams. The choice of formulation depends on factors like the patient's condition, location of the infection, age, and other existing health conditions.

When using Acyclovir ointment topically, some common side effects may occur. These include local skin irritation, which can manifest as pain, burning, or stinging at the site of application. However, the absorption of Acyclovir into the bloodstream through topical use is minimal, although it may occur in patients with compromised skin barriers.¹

It is important to note that while Acyclovir 5% ointment is FDA-approved for the initial treatment of genital herpes, the US Centers for Disease Control and Prevention (CDC) does not recommend this specific formulation for managing genital herpes due to limited clinical benefits.

Definitions

• Herpes Simplex Virus (HSV) is a highly infectious virus causing herpes, which can be transferred from one person to another via direct contact. Herpes infections predominantly manifest on the genitals or the oral region. The herpes simplex virus is categorized into two types:
• HSV-1: This variant is the primary cause of oral herpes, typically responsible for cold sores and fever blisters around the mouth and on the face. However, it can also cause genital herpes through oral-genital contact.
• HSV-2: This variant is mainly associated with genital herpes, but it can also cause oral herpes through genital-oral contact.
• Immunocompromised describes individuals with a weakened immune response, making them susceptible to infections, which may be more frequent or severe compared to immunocompetent individuals. Patients can become immunocompromised due to a variety of conditions such as autoimmune disorders (e.g., rheumatoid arthritis, multiple sclerosis, lupus), HIV, active cancer or those undergoing chemotherapy or radiation, organ transplant recipients, the elderly, and during pregnancy. Certain medications, like corticosteroids and other immunosuppressive drugs, can also render a person immunocompromised.

Medical Necessity Criteria for Authorization

The Plan considers acyclovir 5% ointment medically necessary when BOTH of the following criteria are met:

1. The member has a documented diagnosis of ONE of the following conditions:
   • Genital herpes, and the requested medication is being used in the treatment of the initial episode or recurrent outbreaks; or
   • Non-life-threatening, nongenital, mucocutaneous herpes simplex virus (HSV-1 or HSV-2) infections in immunocompromised adults;
   AND
2. The member is unable to use, or has tried and failed TWO of the following oral antiviral agents:
   • acyclovir (Zovirax); and/or
   • famciclovir (Famvir); and/or
   • valacyclovir (Valtrex).

If the above prior authorization criteria are met, acyclovir 5% ointment will be approved for up to 6 months.²

Experimental or Investigational / Not Medically Necessary

Acyclovir 5% ointment for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. Albrecht MA. Treatment of genital herpes simplex virus. Up to Date® Last Updated June 2021. Accessed Sept 2021. Available from: http://www.uptodate.com
2. Klein RS. Treatment of herpes simplex virus type 1 infection in immunocompetent patients. Up to Date®: Last updated September 2017. Accessed October 2017. Available from: http://www.uptodate.com.
3. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1
4. Zovirax ointment (acyclovir) [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC; October 2020.

Clinical Guideline Revision / History Information

Original Date: 10/14/2021

Reviewed/Revised: 12/01/2021, 06/23/2022, 06/29/2023