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In this asynchronous online activity, we will be exploring timely clinical topics related to caring for people living with HIV.


Rapid Start in the Naïve Patient

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Consider the Following Case:
Martin, a 34-year-old African American male, presents after being diagnosed with HIV.  He has no past medical history.  He takes a multivitamin daily and for occasion heartburn he takes over the counter antacids including Tums and Rolaids. He was diagnosed at his primary care provider’s office 2 days prior and he was sent to you for evaluation/treatment. The testing was done as part of routine primary care. His last HIV test was 2 years ago and it was negative.  He is currently asymptomatic.

Data:

  • BP: 110/70 mmHg
  • HIV antigen/antibody screening test: reactive
  • HIV antibody-reactive
  • Labs drawn and pending including HIV-1 genotype
  • Pt is ready to start treatment

Questions for Discussion:

  1. Would you start him on treatment today prior to his lab work coming back?
  2. What treatment option would you start and why?

34 thoughts on “Rapid Start in the Naïve Patient

  1. Jason Schafer says:

    I think that I would consider initiating ART today using a shared decision making approach with the patient and close follow up. I would ask whether or not the he had received PrEP recently (within the past 2-3 months) as that might influence my choice of regimens. Otherwise, TAF/FTC + DTG, BIC or DRV/cobi would be reasonable in my opinion. Anyone agree or disagree with starting ART today? If using a rapid start approach, is there a regimen that you favor?

  2. William Short says:

    Thanks Jason for getting this conversation started. I totally agree with you and I would favor starting today as long as the patient is willing to start. I would draw baseline labs including genotype and I agree with your choice of regimens.

    Would anyone do anything different?

    Are you concerned with starting ART without baseline labs and a genotype?

    • Eileen Donaghy says:

      I agree with Bill and Jason and I think it’s reasonable to start treatment today with any of the choices Jason listed when following a rapid start method.
      BUT-
      I would like to have some more information regarding his risk factors and his ability to commit to chronic treatment so soon after being diagnosed.
      Given those choices of regimens, the pt would likely choose BIC (small, 1 tablet).
      How would you counsel the patient regarding daily dosing?
      When would you bring him back to the office?

    • Lorena Cavazos says:

      Ok, I have to admit that I am completely new and I want to learn more about how to care for patients with HIV, so I have a lot of reading to do but I wanted to post before too late. From what I have read he can be started on ART even while waiting for the result of the genotype as treatment can be adjusted later. I agree that asking if he was taking PrEP is important. I am looking at the different pictures available on the medications but I am not understanding all the combinations that Jason wrote. From my understanding he should have a combination of 3 different medications, ideally in 1-2 capsule/tablet to encourage compliance and hopefully reduce cost as well. Does he have good insurance coverage or does he qualify for some of the phamaceutical company discounts?
      As far as labs: CBC, CMP, lipid panel, viral load, LFT, HepBsAg if at risk??

      • William Short says:

        Lorena
        Thank you for your comment. You are correct about labs but I might add that all patients should be screened for hepatitis B and C prior to starting treatment. This is important because the NRTIs (TDF, TAF, FTC, 3TC) have activity against Hepatitis B. I would also do a genotype (NRTI, NNRTI, PI) on all patients but there is no need to screen for integrase resistance given the prevalence is low.

        Jason’s comment about drug combination really focused on what is recommended by the guideline panels and those where providers would feel comfortable starting without having a genotype back.

        This is the prefect forum to ask questions about drug combinations. We are here to help assist you. So please feel free to ask away-no question is a bad one.
        Bill

      • Stacey Draper says:

        The labs that you listed are a great starting point, Lorena, as well as screening for Hepatitis B and C and a genotype, which William listed. I like to test for both HepB Ab and HepB Ag so we can see if patient has immunity to Hep B and can immunize if he does not. I also like to get a Hep A Ab to check immunity so that, again, we can immunize if patient does not have immunity.

        Other labs that are a good starting point: urinalysis, gonorrhea, chlamydia, syphilis, trichomonas, HLAB5701, G6PD. Pregnancy test if patient is female.

        • Eileen Donaghy says:

          This is all great information for someone starting to navigate the care of a newly diagnosed patient. Just want to address Lorena’s comment/question regarding insurance/pharma assistance programs. In the State of PA. we have a very generous Ryan White/ADAP program- Special Pharmaceutical Benefits Program (SPBP). Patients qualify based on income and in recent years the level has increased to close the gap between those patients who don’t qualify for Medical Assistance but can’t afford private insurance. The other benefit of SPBP is that immigration status is not a qualifying factor. The application can be found at https://www.health.pa.gov/topics/Documents/Programs/HIV/Special Pharmaceutical Benefits… Additionally, most HIV pharmaceutical companies offer patient assistance cards which cover the copay expense generated by private insurance companies.

  3. Stacey Draper says:

    As patient is relatively healthy with no major comorbidities, I would be inclined to start him on ART today (as long as he feels psychologically ready to start and continue medication). I am not concerned with starting ART without baseline labs and a genotype, assuming his is ART naive (including not having previously used Truvada for PrEP).

    I agree that is its important to discuss the available medication options with patient. I tend to favor Biktarvy for its small pill size, lack of booster, and lack of food requirement, and patients tend to prefer this as well.

    As labs have been drawn, I would bring patient back in a week to discuss results of testing and to assess his adjustment to both medication and how he is coping with diagnosis.

    • William Short says:

      Stacey thank you for your comments and I think we are all on the same page regarding rapid starts. If he was currently uninsured would that change anything in terms of labs you are able to draw or what you start?

      • Stacey Draper says:

        If he is uninsured, he may qualify for Ryan White benefits based on his income. If he does qualify, he should be able to have 7-day benefits available which would allow him to have labs drawn.

        As far as medication choice, there are options. If he is deemed to be a good candidate for Symtuza (ie he is not on any medications or substances that we worry about being boosted by cobicistat), there is a 30-day voucher available that he could use immediately. If he is not a good candidate for Symtuza, we could start the process for a patient assistance program (PAP) for another medication (most likely Biktarvy). There is usually an option to get same-day PAP, or we can wait to start medication until we can find some sort of coverage for him. However, I favor utilizing same-day PAP services so that patient can start medications immediately.

  4. Melissa Badowski says:

    I would agree with the importance and need to verify that the medication is covered by insurance. In certain PAPs, there is a certain period of time that the patient has access to medications (i.e. 30 days, 1 year, etc.). All too many times medications are prescribed and the ARV combination may require a prior authorization, is not covered by the patient’s insurance, or the patient cannot afford the medication due to co-pays (for which there are co-pay cards that need to be activated). The number one reason I see a patient unable to start/continue medication is due to the inability to access medications and we do not learn of this until they follow-up in 3-4 months or are discharged from the hospital with prescriptions but no one ever verifies the patient can access ART. While I am all in favor of rapid start initiation due to the various medical benefits and easing the patient’s anxiety level, we need to ensure consistent access to the medications.

  5. Gwen Verlinghieri says:

    I like this case, but I must admit, most of my patients don’t have a PCP. This patient has a PCP which leads me to think he does have insurance, has been given his test results and he is ready to start HIV medications. I would discuss with the patient that he can start HIV medications today, even before his labs are resulted. I like to show patients the single tablet regimens that are available using a pill chart so he can see the size of each pill. I discuss any short term or long term side effects of the medications. Because this is a naive patient, I would consider starting him on either dovato or biktarvy. Our site is fortunate to have case management onsite to assist with insurance issues if they arise, Therapists and an onsite lab. It has been my experience that most patients are willing to take the first dose of HIV medication in the clinic, on the same day.

  6. William Short says:

    Would anyone consider using Dovato (a new FDA approved 2 drug combination of 3TC and DTG) in this patient if it was readily available on drug formularies? Why or why not?

    • Jason Schafer says:

      Right now, I would be less comfortable using DTG/3TC as opposed to a 3-drug combination. Transmitted NRTI resistance is uncommon in the US, but not rare (http://www.croiconference.org/sites/default/files/posters-2019/1430_McClung_0526.pdf). If 3TC resistance is present at baseline and DTG/3TC is started, the patient is essentially receiving DTG monotherapy. If the genotype results return quickly and we are able to adjust DTG/3TC to another regimen quickly in the setting of 3TC resistance, that may be ok. If not, the patient may experience a poor outcome and be at risk for developing INSTI resistance (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057516/). As a result, I would probably take a more conservative approach initially, start a three drug regimen and consider switching to the two drug regimen in the future. I’m definitely interested in hearing other peoples thoughts…is this approach overly conservative?

    • Eileen Donaghy says:

      I’m glad the topic of dovato came up in this conversation. If we go back to the initial question regarding starting treatment prior to all labs resulting, we have to be very careful about using dolutegravir/lamivudine without knowing one’s Hep B status. Thoughts??
      Regarding Jason’s conservative comment, I am becoming more comfortable with the thought of using Dovato initially- in 2015 the AIDS Clinical Trials Group conducted a phase II, open-label study, A5353, which enrolled 120 naïve participants and provided all participants with dolutegravir and lamivudine, the combination was found to be effective in 90% of study participants. The Gemini 1/2 pooled data impressively shows similar results and noninferiority to a 3 drug regimen. These studies enrolled nearly 1500 participants. BUT, I would start Dovato after obtaining a baseline genotype/genosure. So, not in this case.
      Is “less” better?

  7. William Short says:

    I would feel comfortable starting Dovatao if someone had chronic hepatitis B and I was unaware because I started ART before the labs were back. Lamivudine does have activity against hep B but the concern is the development of resistance which usually develops over years. By the time your hepatitis serologies come back and if the person has chronic HBV–I could change the regimen to add tenofovir.

    • Stacey Draper says:

      I think my hesitancy to start Dovato is simply because using two drugs for the treatment of HIV is still such a new concept. I know that Juluca is available as a switch regimen for patients who have shown that they can remain undetectable for at least 6 months, but I have only switched a couple patients to Juluca due to fear of non-compliance with ART. I work with four other NPs and no one has started a new patient on Dovato yet, and everyone’s hesitancy stems from not knowing the patient well and not knowing how their adherence will be.

  8. Melissa Badowski says:

    Other 2DR, such as Juluca, may be considered down the road but I would be leery to start this patient on this since he does have heartburn and would have to ensure separation from Tums/Rolaids due to the rilpivirine component of Juluca. This could be something we discussed down the road when he was virologically suppressed but in terms of rapid initiation, I would prefer a 3DR.

  9. Idalina Afopa says:

    We have already established that we would not delay treatment but rather start him on ART the same day. I would check a social history to have a better sense of the new pt and educate on importance of adherence, rx side effects including bone loss, metabolic problems and renal problems. As far as labs, although the pt is ART naïve, never used Truvada, he could be infected with a virus that is resistant to an ART. Therefore I would include a baseline HIV genotypic resistance profile, CrCL & hepatic profile (r/o impairment), rule out coinfections (HBV, HCV, TB).
    Single tab regimen with a once-daily dosing is preferred. Clinicians should not prescribe two-drug regimens as initial therapy. In this case, I would prescribe INSTI-based regimens as they are generally the best option for most patients particularly given its tolerability and lack of drug-drug interactions. In addition, no resistance has been reported in ART-naive patients treated with dolutegravir when used as part of combination therapy.

    • William Short says:

      I don’t quite understand your comment about not using Truvada. I always use Truvada or Descovy in my initial regimen. It is preferred by both sets of guidelines. the M184V mutation occurs in < 1% of patients and the K65R is rare as well so I have no concerns starting a Truvada based ART regimen.

    • Stacey Draper says:

      I agree with William about the Truvada. It is approved for use as part of an initial regimen. Also, if patient were to be part of the <1% who has the M184V mutation (which is most common in ART-experienced individuals), he could be switched to a new regimen after the genotype comes back.

  10. Rod Gordon says:

    One question or theoretical concern I would have, based on my experience as a pharmacist who works with patients at all stages of their disease [I work in community specialty retail pharmacy setting and we rarely get to see lab results], is what about that patient who is treatment naive and is a candidate for a rapid start approach, but his baseline CD4 count or % results are not back yet, and he doesn’t look as immune suppressed as he actually is [his CD4 count is actually below 100]. I understand that up to 30% of patients who are severely immune suppressed and Serum CrAg+ may be asymptomatic [no headache/nausea/lethargy/mental status changes] may also be CSF CrAg+ and culture + for crypto; Isn’t it true that one would want to delay ART and initiate CM treatment first and then start ART after completing the consolidation phase [at least the first two weeks of CM treatment]? Is this just a theoretical concern, since CM is a rare condition, or should we at least want to see the CD4 count before starting ART? Just curious if this crosses anyone’s mind?

    • Eileen Donaghy says:

      Thanks Ron for your comment. In an asymptomatic HIV+ patient, a serum or CSF crypto Ag is not a typical baseline evaluation. The only CD4 guideline to remember when rapidly starting meds prior to all baseline labs returning is:
      * avoid using Rilpivirine- based regimens or Darunavir/ritonavir + Raltegravir -a higher rate of virologic failure has been found in patients with pretreatment CD4 counts <200
      If the patient is symptomatic and found to have an OI at the time of diagnosis, there are additional guidelines to follow including treatment recommendations and the timing of when to initiate ART following initiation of OI treatment.
      I think most would agree, with an asymptomatic patient, the CD4 would not guide the choice of ART keeping in mind the recommendation above.
      Wondering how we can wrap up this case and ensure our patient has lasting virologic suppression, remains STI-free and remains emotionally stable? What "out of the box" services do you have in your offices to assist these patients? Behavioral health counseling, nutrition counseling, social worker, case manager, support group, peer support, patient navigator, pharmacy counseling, research opportunities, etc.............

  11. William Short says:

    I do not wait for the CD4 count to come back before starting ART. You are correct that if someone has Cryptococcal meningitis you need to delay starting ART but it is rare. I do see it about once every 6 months. We recently had a case with increased intracranial pressure and he need daily LPs’ and eventually a drain. He did not survive.

    CNS Toxo and Cryptococcal meningitis are reasons to hold starting ART.

    • Stacey Draper says:

      Agree. I feel like you would know if your patient had crypto or toxo meningitis–he most likely would not be sitting in your office conversing with you. I would need to refer to the guidelines again, but I believe that for most OIs, guidelines state to begin ART right away upon diagnosis of the OI. If his CD4 comes back low, you can go ahead and put him on OI prophylaxis at that time.
      On that note, I mentioned above but didn’t discuss its significance–G6PD testing is important. If patient has a G6PD deficiency, we need to avoid dapsone and primaquine to avoid potential drug reaction (especially important to know if patient is allergic to Bactrim).

    • Stacey Draper says:

      I work in a specialized clinic that provides care to patients living with HIV and also offers prevention services. I am one of five nurse practitioners and we oversee medical care. However, we utilize a multidisciplinary approach in order to retain patients in care. We have three HIV clinical pharmacists who meet with patients at least twice upon entrance into our clinic; some have more extensive follow-up with our pharmacists while others do not. For example, those who have difficulty remembering to take their medication come in once a month to have their monthly pillboxes filled. Our pharmacists also assist with prior authorizations and we have a relationship with the outpatient pharmacy at our hospital.
      We have eight social workers and each patient is assigned to a social worker who helps them manage potential barriers to care (social, financial, insurance, etc.). Patients always see their NP and SW at each visit and the pharmacist prn.
      We have a counselor/therapist available every day as well as a psychiatrist, psych pharmacist, and an art therapist in our office twice a week.
      We recently began rapid start (June 1, 2019) and have had great success, especially so far with retention in care. Out of our 10 potential rapid starts (we have specific criteria at this point for patients who qualify with plans to expand later), 8 have come to their initial appointment and all have continued coming and have had an undetectable viral load at either their first or second follow-up appointment.
      At last check (beginning of the month), 91% of our patients have an undetectable (<20 copies) HIV viral load!

  12. Melissa Badowski says:

    We attempt to make our clinic a one-stop shop and cater to the needs of the patient, much like any clinic. Some patients would like to be seen more often while others would prefer to see us as little as possible! We have our patients engage in case management services so they know who to contact if they have an issue with their insurance. We have clinical pharmacists on site everyday and they know to contact us if they have a problem accessing their medications.

    Aside from a face-to-face clinic, I am part of an interdisciplinary telehealth clinic that manages prisoners living with HIV. The most effective way to keeping our patients engaged in care is having a physician, clinical pharmacist, nurse, and case manager all part of the patient’s care simultaneously. For 15 minutes for follow-up and 30 minutes for new or reincarcerated patients, we all are engaged simultaneously in the patients care, along with the patient, and make decisions as a team. In my opinion, this is the most effective way to provide care since we all hear what the patient is saying in real time.

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