According to the Apretude package insert last updated 12/2021, it is recommended to use the z-track injection technique to minimize medicine leakage from the injection site. Our administration at the VA would be utilizing our nursing injection clinic but we would not see any issues with administration at the community pharmacy as long as privacy is assured, local laws permit it and there is enough support for any serious adverse events. Current stipulation is via healthcare professional. We have not explored home care as an option as our patients have to be willing to comply with injections, labs and STI screening, but could be explored especially in rural setting. Great questions.

Answer By Dr. Tomasz Jodlowski 

Thank you for asking a great question. As you are probably aware, for IM Cabotegravir there is an optional oral lead-in with oral cabotegravir for 28 days. In that scenario, initiation injections should be administered on the last day of oral lead-in or within 3 days thereafter. There is no clear guidance from package insert regarding how long to achieve adequate protection nor how long oral PrEP (TDF/FTC or TAF/FTC) should be continued. Based on some early Cabotegravir PK data, it would be reasonable to continue taking oral PrEP for at least 7 days after first injection of Cabotegravir. With all of our PrEP patients, I encourage consistent condoms use, especially during the transition period form oral PrEP to IM PrEP.  Here is some more information regarding Cabotegravir PK Data Shaik et al. Br J Clin Pharmacol.2022;88:1667–1678. Please keep in mind that relationship between tissue/fluid concentrations and efficacy (correlate of protection) has not yet been clearly defined. Package insert (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215499s000lbl.pdf)

Answered by Dr. Minh Ho

In general, I manage their expectations regarding side effects up front at the first visit. We work closely with our pharmacists and have usually have follow up phone visit within a month of starting the medication, then we address their concerns. As you are probably familiar, common side effects to TDF often include GI such as diarrhea, abdominal pain, nausea. Based on my experience, diarrhea tends to be the one that is more likely to cause people to stop taking it. I usually recommend anti-diarrheal medications, feel free to choose your favorite.

Answered by Dr. Minh Ho

In general, patient should complete labs including HIV test and 30 day supply can be prescribed prior to the appointment without having to wait for the result. The remaining 60 days can be prescribed when that patient make the appointment. It is important to note that as long as patient takes 4 or more tablets per week, the risk of acquiring HIV is extremely low.1

1.Grant et al., Lancet Infect Dis. 2014

Answered by Dr. Minh Ho

From a provider’s standpoint, it is important to always ask if patients are taking their medication. If nonadherence has been identified, it is important to work through the possible reasons and together with the patient come up with a solution (eg prescribing a pillbox). 
From a patient’s standpoint, creating a routine (eg taking medication when brushing teeth, or mealtimes), set up an alarm, put a reminder, keep medication visible or carry extra doses are all helpful techniques to consider.

Answered by Dr. Minh Ho

Few antimicrobial agents reliably cure >90% of pharyngeal gonococcal infection. Test of cure should be performed around 14 days after initial treatment to minimize risks of false positive. Test of cure can be done using either culture or NAAT, though NAAT is most commonly used. If test is positive again, please make sure that this is not due to re-infection from same partner, if so would retreat with same dose. If there is concern of resistance, then local health department can be contacted to facilitate antimicrobial susceptibility testing. Patient should be instructed to abstain from sexual activity until the situation is resolved.2

2. CDC. (2021, November 24). Gonococcal Infections Among Adolescents and Adults. Centers for Disease Control and Prevention. Retrieved April 17, 2022, from https://www.cdc.gov/std/treatment-guidelines/gonorrhea-adults.htm

Answered by Dr. Minh Ho

Management steps to consider may include

1. Identify any new prescribed medications, over the counters, supplements, illicits, and/or herbals that may contribute to elevated SrCr. If identified, stop offending agent and repeat lab after to ensure improvement in SrCr.
2. Ask about changes in behaviors such as increasing or starting new workout regimen, decreasing water intake. If identified, then counseling should be provided to increase water intake and repeat lab after to ensure improvement in SrCr.
3. Repeat labs typical for workup of acute kidney injury and if elevation of SrCr is persistent can discuss options such as changing from TDF/FTC to TAF/FTC

Answered by Dr. Minh Ho

Great question. First, I would inquire more about the nature of the allergy or if it was a drug intolerance. More information about severity, mucus membrane involvement or other organ systems, need for hospital admission or treatment required is better. History of SJS/TEN would be quite problematic. This is noting that ceftriaxone and cephalexin do not share R-1 side chains, hence should have a low risk of cross-reactivity. If a severe IgE mediated reaction was clarified (hives/urticaria) or any other concerns, I would consider discussion with an allergist and if in agreement, administer in a monitored setting with observation for at least 1 hour. Additionally, I would consider reaching out to the National Network of STD Clinical Prevention Training Centerhttps://www.stdccn.org/

This is a very difficult decision as if patient wants to continue PrEP and is deemed at risk, all efforts should be made to continue. Suboptimal compliance, however, has consequences and although 4 tablets per week should be protective in MSM, this would not be true in females. Some ideas to explore would follow investigation of why? If rare sexual encounters, perhaps can consider 2-1-1 strategy. Perhaps IM PrEP? All efforts should be made without compromising effectiveness and safety. Would consider discontinuation if patient does not follow with routine labs and monitoring, if severe adverse reaction develops or patient has a seroconversion.

I think its important to discuss plans for pregnancy with PrEP patients at each visit as its part of the 5 Ps of good sexual health assessment. I would strongly encourage consultation with experts (OBGYN and Infections Diseases) in such scenario. The DHHS guidelines gives guidance as well that can be accessed at https://clinicalinfo.hiv.gov/en/guidelines. It is noteworthy that virological suppression of the HIV positive partner plays a major role. Thank you.

For oral PrEP (TAF/FTC or TDF/FTC), it is probably ok to forgo the HIV RNA PCR as long as the patient does not have signs or symptoms of acute HIV and has been taking PrEP daily as directed. For long acting injectable cabotegravir, there have been late seroconversions even in patients receiving their injections in a timely manner (though very rare). I would want the HIV RNA PCR for all patients on injectable PrEP.

Answered by: Helen King, MD

If I felt the patient would take doxycycline as directed without issue, I would opt for doxycycline. If I was concerned about adherence or the patient didn't want to take a longer course of antibiotics, I would prescribe azithromycin, since we know that azithromycin is still very effective at treating urogenital Chlamydia. It would be important to ask the woman whether she has receptive anal sex to ensure no concerns for rectal Chlamydia, since doxycycline is clearly superior in those cases. 

Answered by: Helen King, MD

For cis-gender men who have sex with women (and women who have sex with men), Chlamydia is not technically one of the indications for PrEP. However, the presence of a chlamydial infection would lead me to ask questions about sexual history to determine if they have other indications for PrEP. If the patient has multiple sexual partners, especially with condomless sex, that would be an indication for PrEP (even in men who have sex with women).

Answered by: Helen King, MD

Yes, when patients come for PrEP care, especially men who have sex with men and transgender women who have sex with men, they should be offered or referred for a monkeypox vaccine. 

Answered by: Helen King, MD

The recent reports from the DoxyPEP study of doxycycline post-exposure prophylaxis (PEP) show very exciting results with decreases in gonorrhea, chlamydia, and syphilis infections in people living with HIV and people on PrEP compared to those who did not use doxycycline PEP. Results of additional secondary analysis, including focus on development of drug-resistant infections, will be important to determine whether doxycycline PEP is appropriate for more standardized usage. This may be an important preventative intervention for patients on PrEP in the near future as more data becomes available.

Answered by: Helen King, MD