Clinician Updates

On July 7, 2022, the Food and Drug Administration (FDA) reported a shortage of erythromycin ophthalmic ointment, which is the only recommended regimen to prevent ophthalmia neonatorum caused by N. gonorrhoeae. If erythromycin ointment is unavailable, infants at risk for exposure to N. gonorrhoeae, especially those born to a mother at risk for gonococ15cal infection or with no prenatal care, can be administered ceftriaxone 25–50 mg/kg body weight IV or IM, not to exceed 250 mg in a single dose. Please see the CDC drug notice for additional guidance.

National HIV Testing Day is June 27. On this day, we take the time to remind everyone about the importance of HIV testing. It is important for a patient to know their HIV status. It allows them to stay healthy, regardless of what their status is. There are now more ways than ever to get an HIV test, including at routine medical appointments.

The Centers for Disease Control and Prevention (CDC) recommend that everyone between the ages of 13 and 64 get tested for HIV at least once in their lifetime. Some people should get tested more often. Read the most recent recommendations for HIV screening from the CDC at https://www.cdc.gov/hiv/clinicians/screening/index.html. These will help you better serve your patients that may benefit from routine HIV screenings, or have never previously received a test.

For Virginia-specific resources for health professionals in regards to HIV, STDs, and viral hepatitis, please visit our Health Professionals webpage at https://www.vdh.virginia.gov/disease-prevention/hcw/.

New Testing Recommendations for PrEP Patients

Based on the 2021 CDC Pre-Exposure Prophylaxis (PrEP) for the Prevention of HIV Infection in the United States, A Clinical Practice Guideline, VDH now recommends adding the qualitative HIV-1 RNA test to the HIV Ag/Ab 4^th generation test for those who:

- Have taken oral PrEP or Post-Exposure Prophylaxis (PEP) medications in the past three months, or
- Have received a cabotegravir injection in the past twelve months

Clinical trials found that the medications used for PrEP can suppress early viral replication, which can affect the timing of antibody development – a delay by a mean of 62 days in the cabotegravir group and by 34 days in the oral PrEP group. The HIV-1 RNA test detects HIV genetic material, not antibodies, so the results are not affected by taking PrEP medications.

For questions, please reach out to Jenny Calhoun, HIV/STD/Viral Hepatitis Nurse Consultant, at jenny.calhoun@vdh.virginia.gov, or (804) 864-7328.

To view the full 2021 CDC PrEP Guidelines, visit https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf.

Hepatitis Awareness Month is observed during May. Virginia Department of Health works with public health partners across the state to prevent and treat viral hepatitis. During the month of May, we shed light on this hidden epidemic by raising awareness of viral hepatitis and encouraging people to get tested.

Learn and Share the ABCs of Viral Hepatitis

While there are several different types of viral hepatitis, the three most common types in the United States are A, B, and C. Visit the online feature “the ABCs of Viral Hepatitis” from the Centers for Disease Control and Prevention (CDC). On this website you can learn more about hepatitis A, hepatitis B, and hepatitis C. Share the website so others can learn as well.

CDC has also provided a fact sheet that is specific to health professionals. This can be accessed in an online PDF table: https://www.cdc.gov/hepatitis/resources/professionals/pdfs/ABCTable.pdf.

CDC Recommendations for Hepatitis C Screening Among Adults

CDC now recommends one-time hepatitis C testing of all adults (18 and older) and all pregnant women during every pregnancy. CDC continues to recommend people with risk factors, including people who inject drugs, be tested regularly.

For more information, visit the full recommendations at CDC Recommendations for Hepatitis C Screening Among Adults — United States, 2020 | MMWR.

Updated Hepatitis B Vaccination Recommendations

The Advisory Committee on Immunization Practices (ACIP) recommends hepatitis B vaccination among all adults aged 19-59 years and adults 60 years and older with risk factors for hepatitis B or without identified risk factors but seeking protection.

Learn more by visiting the full recommendations: https://www.cdc.gov/mmwr/volumes/71/wr/pdfs/mm7113a1-h.pdf.

Share Your Passion

Virginia has a coalition of community members and health providers who work together to share their experiences and use their voice to eliminate viral hepatitis. If you are a provider that works with viral hepatitis and want to use your voice to make a difference, visit their website today at https://vahep.org/.

If you can’t commit to a coalition but still want to get involved, consider contributing to the needs assessment that VDH and the Virginia Hepatitis Coalition have put together. This assessment will identify barriers and service gaps in hepatitis services throughout the Commonwealth. Help us better serve our community and provide better services by participating: State of Viral Hepatitis in Virginia, 2022 Assessment.

The first long-acting injectable that prevents HIV has been approved by the U.S. Food and Drug Administration (FDA).

On December 20, 2021, the U.S. Food and Drug Administration (FDA), approved Apretude® (cabotegravir) for HIV pre-exposure prophylaxis, or PrEP. The medication is approved for adults and adolescents - 15 years old and older - weighing at least 77 pounds, and who are at risk of getting HIV through sexual activity. All other options have been oral tablets. In approving the new medication, the FDA noted that an injectable could make it easier for patients to maintain adherence, a key factor in the effectiveness of PrEP as an HIV prevention strategy.

Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Potential patients may take an oral lead-in for four weeks to assess tolerance for the medication. Side effects include: injection site reaction, headache, pyrexia, fatigue, back pain, myalgia and rash. Manufacturer’s warnings also include precautions regarding hypersensitivity reactions, hepatotoxicity and depressive disorders.

For more information, visit the press release from the FDA.

STI Treatment Guidelines, 2021 Update

CDC has issued updated guidelines for the treatment of sexually transmitted infections (STI). Following adjustments to gonorrhea treatment practices (published in late- 2020), the new guidelines include other notable updates:

- Updated treatment recommendations for chlamydia, trichomoniasis, and pelvic inflammatory disease
- Updated treatment recommendations for uncomplicated gonorrhea in neonates, children, and other specific clinical situations (e.g., proctitis, epididymitis, sexual assault) which builds on broader treatment changes published in Morbidity and Mortality Weekly Report.
- Information on FDA-cleared diagnostic tests for Mycoplasma genitalium and rectal and pharyngeal chlamydia and gonorrhea
- Expanded risk factors for syphilis testing among pregnant patients
- Recommended two-step serologic testing for diagnosing genital herpes simplex virus
- Harmonized recommendations for human papillomavirus vaccination with the Advisory Committee on Immunization Practices
- Recommended universal hepatitis C testing in alignment with CDC’s 2020 hepatitis C testing recommendations

Key resources are available on the CDC website.

**Please note: the summary above is not comprehensive; refer to the updated guidelines for the complete set of recommendations, including alternative treatment regimens and treatment regimens for special populations.

2020 Update to CDC's Treatment for Gonococcal Infections

First Ever STI National Strategic Plan

STI Diagnostic Kit and Supply Shortage

FDA Reports Azithromycin Shortage

Increased Reports of Disseminated Gonococcal Infection (DGI)

DGI occurs when the sexually transmitted pathogen Neisseria gonorrhoeae invades the bloodstream and spreads to distant sites in the body. Infection leads to clinical manifestations like septic arthritis, polyarthralgia, tenosynovitis, petechial/pustular skin lesions, bacteremia, or, on rare occasions, endocarditis or meningitis. Cultures from disseminated sites of infection are often negative, and mucosal sites of infection (e.g. urogenital, rectal, or pharyngeal) are often asymptomatic and not tested before empiric antimicrobial treatment is started, despite having a higher diagnostic yield. As a result, DGI is usually a clinical diagnosis without microbiologic confirmation, which likely contributes to underdiagnosis and delays in treatment and reporting. If there is clinical suspicion for DGI, nucleic acid amplification test (NAAT) and culture specimens from urogenital and extragenital mucosal site(s), as applicable, should be collected and processed, in addition to culture specimens from disseminated sites of infection (e.g., skin, synovial fluid, blood, or cerebrospinal fluid [CSF]). All N. gonorrhoeae isolates in DGI cases should be tested for antimicrobial susceptibility, which requires culture. Management of DGI cases should be guided by the CDC STD Treatment Guidelines. Hospitalization and consultation with an infectious disease specialist are recommended for initial therapy.

What You Can Do

To better understand the magnitude of DGI in Virginia and the US, providers should take the following actions:

- Continue to report confirmed DGI cases to CDC as gonorrhea via routine case notification mechanisms; if there are positive laboratory results from multiple anatomic sites, prioritize the sterile site (i.e., blood, CSF, or other aspirate) as the reported specimen source when reporting the case. Regardless of clinical manifestations, isolation of gonorrhoeaefrom a sterile site (e.g., blood, synovial fluid, or CSF) would constitute confirmed DGI.
  - gonorrhoeaeisolates from sterile sites should be reported to VDH within 24 hours. Report electronically here.
  - Any laboratory confirmed or clinically suspected cases of DGI, including those empirically treated without laboratory evidence of gonorrhoeae, should be reported to VDH within 24 hours. Report electronically here.
  - Obtain NAAT and culture specimens of genital and extragenital sites (if exposed) before initiating empiric antimicrobial treatment for patients with clinical findings suggestive of DGI.
- Facilitate submission of any culture isolates from sterile and/or genital and extragenital sites to CDC. Instructions on isolates submission can be found here.

All N. gonorrhoeae isolates from sterile sites should be submitted to CDC for comprehensive antimicrobial susceptibility testing (AST) using agar dilution and whole genome sequencing (WGS). Resources

- CDC Health Alert
- Virginia Disease Reporting and Control Regulations

Erythromycin (0.5%) Ophthalmic Ointment Shortage

On March 5, 2019, the Food and Drug Administration (FDA) released a report on a shortage of erythromycin (0.5%) ophthalmic ointment. This is a serious problem for a number of reasons. Erythromycin (0.5%) ophthalmic ointment is the only antibiotic ointment currently recommended and the only drug cleared by the FDA for the prophylaxis of gonococcal ophthalmia neonatorum. Furthermore, gonorrhea ocular prophylaxis of newborns is mandated by law in most states and is considered standard neonatal care. This prophylaxis was recently reaffirmed by the USPSTF. If erythromycin ointment is not available, CDC recommends that neonates at risk for exposure to N. gonorrhoeae during delivery (especially those born to a mother at risk for gonococcal infection or with no prenatal care) be administered ceftriaxone 25–50 mg/kg IV or IM, not to exceed 125 mg in a single dose. For more information, please see the 2015 STD Treatment Guidelines and if questions, please contact Roxanne Barrow, MD, MPH, Medical Epidemiologist, (rbarrow@cdc.gov; 404-639-8503). Other topical medications are not recommended:

- Tetracycline ophthalmic ointment and silver nitrate are no longer available in the United States;
- Gentamicin was associated with chemical conjunctivitis during the last erythromycin shortage;
- Povidone-iodine has limited data on its benefits and harms.

It is important to remember that prenatal screening is the best method for preventing gonococcal ophthalmia neonatorum among newborns! All pregnant women < 25 years of age and women > 25 at increased risk should be screened for N. gonorrhoeae at the first prenatal care visit and again at the third trimester if risk continues during pregnancy. Also, all females treated for gonorrhea should be retested 3 months following treatment. Please notify health care providers, hospitals and pharmacists of the shortage of erythromycin (0.5%) ophthalmic ointment so they are aware and remind them of gonorrhea screening recommendations for pregnant females. As we have recommended with previous shortages, please ask providers, hospitals and pharmacists to report to you any challenges in procuring product and alert CDC of any problems. Current information regarding the availability of erythromycin (0.5%) ophthalmic ointment is available at the FDA Drug Shortage Website.

Ceftriaxone Diluents Update

Penicillin G benzathine (Bicillin L-A ®) and Penicillin G procaine Update

There is good news related to the supply of Penicillin G benzathine (Bicillin L-A®) and Penicillin G procaine in the United States. As mentioned in earlier letters, Pfizer is the sole manufacturer of Penicillin G benzathine (Bicillin L-A®) and Penicillin G procaine in the United States. After a protracted shortage, Penicillin G benzathine (Bicillin L-A®) is back to normal supply levels and has been moved by the FDA to a resolved shortage status. As supply can be fragile when there is only one manufacturer and Penicillin G benzathine is the only recommended treatment for syphilis in adults in the 2015 CDC STD Treatment Guidelines we encourage the following:

- Ask health care providers and pharmacists to continue to report to you any challenges in procuring Penicillin G benzathine product and report these challenges to CDC. We need to keep ahead of supply problems given the unprecedented current levels of syphilis in the United States.

Note: Doxycycline is an alternative treatment for non-pregnant patients and only if a medical contraindication exists such as an IgE mediated allergy to penicillin. Efficacy of doxycycline has not been well-studied, is considered inferior to penicillin and if utilized close follow-up of the patient is indicated.

- If a patient is unable to afford Penicillin G benzathine (Bicillin L-A®) out of pocket or because of co-pays, please contact the local or State STD Director in your jurisdiction for assistance.
- Encourage clinicians with questions about STD clinical management to contact the on-line National Network of STD Clinical Prevention Training Centers (NNPTC) STD Clinical Consultation Network (https://www.stdccn.org).

After an even more protracted shortage, Penicillin G procaine is now available at normal supply levels and the FDA has recently moved it to the resolved shortage status. Penicillin G procaine is an alternative regimen for outpatient treatment of neurosyphilis and congenital syphilis. As with Penicillin G benzathine, we encourage the following:

- Notify health care providers and pharmacists of the availability of Penicillin G procaine so they are aware that product is available.
- Ask them to report to you any challenges in procuring product and report these challenges to CDC.

Drug Shortage: Erythromycin Ophthalmic Ointment

National HIV Testing Day

New Resources for Expedited Partner Therapy (EPT)

Hepatitis Awareness Month

New HIV PrEP Option Approved by FDA

STI Treatment Guidelines, 2021 Update

**Please note: the summary above is not comprehensive; refer to the updated guidelines for the complete set of recommendations, including alternative treatment regimens and treatment regimens for special populations.

Archived Updates