All Pharmacy Pearls

Introduction

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    Non-Occupational Post-Exposure Prophylaxis (nPEP) and Cost Considerations

    Introduction

  • Many medications for treatment and prophylaxis of are brand-name only and can come with a significant

    • cost for both insured and uninsured patients. Price may be a significant barrier for appropriate treatment and

    patient compliance.

    a. Patient Assistance Programs (PAP) are valuable resources that may help physicians make therapy

    decisions when cost is a significant barrier

    b. Not all guideline recommended therapies have patient assistance programs, and newer combination

    products designed to improve adherence that do not have FDA-indications for nPEP are being

Clinical Detail

Many medications for the treatment and prophylaxis of HIV are brand-name only and can carry a significant cost for both insured and uninsured patients. Price may be a significant barrier to appropriate treatment and patient compliance.

  • Patient Assistance Programs (PAP) are valuable resources that may help physicians make therapy decisions when cost is a significant barrier.
  • Not all guideline-recommended therapies have patient assistance programs, and newer combination products designed to improve adherence that do not have FDA indications for nPEP are being considered as alternative therapies, although data to support their use is lacking.

Pharmacotherapy Regimens

Regimen Generic Combination Mechanism Administration Length of Therapy
Truvada + Isentress or Tivicay* (first-line)tenofovir DF 300mg / emtricitabine 200mg
+
raltegravir 400mg or dolutegravir 50mg		Nucleoside reverse transcriptase inhibitor (x 2) + integrase inhibitorTruvada daily + Isentress BID or Tivicay daily (2–3 tabs per day)28 Days
Truvada + Prezista + Norvirtenofovir DF 300mg / emtricitabine 200mg
+
darunavir 800mg
+
Ritonavir 100mg		Nucleoside reverse transcriptase inhibitor (x 2) + protease inhibitor (x 2)Truvada, Prezista, and Norvir daily (3 tabs per day)28 Days
Stribild (guideline alternative)tenofovir DF 300mg / emtricitabine 200mg / elvitegravir 150mg / cobicistat 150mgNucleoside reverse transcriptase inhibitor (x 2) + integrase inhibitor + cytochrome P450 inhibitorDaily (1 tab per day)28 Days
GenvoyaTenofovir alafenamide 10mg / emtricitabine 200mg / elvitegravir 150mg / cobicistat 150mgNucleoside reverse transcriptase inhibitor (x 2) + integrase inhibitor + cytochrome P450 inhibitorDaily (1 tab per day)28 Days

Cost & Patient Assistance Considerations

Regimen Considerations Price for Treatment Course (with GoodRx coupon) PAP Available?
Truvada + Isentress or Tivicay*All regimens require adjustments for renal dysfunction. Not all products are safe for pregnancy.Truvada: $1,825.63
Isentress: $1,639.03
Tivicay: $1,810.03		Truvada: YES — Gilead Advancing Access
Isentress: YES — Merck
Tivicay: YES — ViiV Connect
Truvada + Prezista + NorvirAll regimens require adjustments for renal dysfunction. Not all products are safe for pregnancy.Truvada: $1,825.63
Prestiza: $1,750.12
Norvir (generic): $53.11		Truvada: YES — Gilead Advancing Access
Prestiza: Possible through outside organization
Ritonavir: NO
StribildAll regimens require adjustments for renal dysfunction. Not all products are safe for pregnancy.$3,359.20POSSIBLY — through hospital-specific programs
GenvoyaAll regimens require adjustments for renal dysfunction. Not all products are safe for pregnancy.$3,202.66YES — Gilead Advancing Access

*It is important to note that many patients will not meet the requirements for a PAP, especially if they have any type of primary insurance coverage.

*Even if a patient has insurance coverage, brand-name medications may not be covered by the plan and alternatives may need to be considered.

Recommendations are based on the CDC 2016 nPEP guidelines.

Evidence

Author, Year Design / Sample Size Intervention & Comparison Outcome
Valin 2016Prospective cohort
N = 234		Stribild tolerability in PEP92% of patients completed 28 days of therapy. 60% reported at least one ADR but were mild to moderate, with only 3 people switching regimens.
Mayer 2017Historical Control Comparison
N = 100		Completion rates of daily Stribild vs. historical treatment (BID)71% completed the course in the Stribild group vs. 57% and 39% in both historical control group regimens. No participants became HIV infected.
Inciarte 2017Prospective open randomized trial
N = 157		Truvada
+
lopinavir/ritonavir or elvitegravir/cobicistat		The lopinavir/ritonavir group had a higher PEP non-completion rate (33%), poor adherence (47%), and ADR rate (90%) than the elvitegravir/cobicstat group (15%, 9% and 49%, respectively). 1 seroconversion was observed in the elvitegravir/cobicstat group in a patient with multiple high-risk exposures before and after PEP.

Conclusions

    Any patient experiencing possible HIV exposure should be evaluated for appropriateness of nPEP

    a. Prophylaxis is only recommended if initiated within 72 hours of exposure

    b. Rapid Ag/Ab or antibody blood should be tested. Patients should not receive nPEP if HIV status is positive.

    c.

    All Patients should be treated with a minimum of a 3-drug antiviral regimen if they meet criteria for prophylaxis

    Patients’ financial situation should always be considered prior to prescribing therapy to ensure patients will be able to

    obtain access to treatment and prophylaxis. Addressing cost concerns prior to discharge may aid in patient compliance,

    even if alternative therapies need to be utilized.

References

    CDC. 2016 nPEP Guideline Update.

    Mayer KH, et al. J Acqur Immune Defic Syndr. 2017;15:75(5):535-39.

    Valin N, et al. BMC Infect Dis. 2016. doi: 10.1186/s12879-016-2056-3.

    Inciarte A, et al. J Antimicrob Chemother. 2017;72:2857-61.

    Micromedex [Electronic version].Greenwood Village, CO: Truven Health Analytics. Retrieved June 5, 2020, from http://www.micromedexsolutions.com/

Tags:PEP post-exposure prophylaxis HIV non-occupational exposure

Source PDF

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