Introduction

    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

Pharmacotherapy

Truvada +
Isentress or Tivicay*
(first-line)		Truvada +
Prezista + Norvir		Stribild
(guideline alternative)		Genvoya
Generic Combinationtenofovir DF 300mg /
emtricitabine 200mg
+
raltegravir 400mg or
dolutegravir 50mg		tenofovir DF 300mg /
emtricitabine 200mg
+
darunavir 800mg
+
Ritonavir 100mg		tenofovir DF 300mg /
emtricitabine 200mg /
elvitegravir 150mg /
cobicistat 150mg		Tenofovir alafenamide 10mg /
emtricitabine 200mg /
elvitegravir 150mg /
cobicistat 150mg
MechanismNucleoside reverse transcriptase inhibitor (x 2) + integrase inhibitorNucleoside reverse transcriptase inhibitor (x 2) + protease inhibitor (x 2)Nucleoside reverse transcriptase inhibitor (x 2) + integrase inhibitor + cytochrome P450 inhibitorNucleoside reverse transcriptase inhibitor (x 2) + integrase inhibitor + cytochrome P450 inhibitor
AdministrationTruvada daily
+
Isentress BID or Tivicay daily
(2-3 tabs per day)		Truvada, Prezista, and Norvir daily
(3 tabs per day)		Daily
(1 tab per day)		Daily
(1 tab per day)
Length of Therapy28 Days
ConsiderationsAll regimens require adjustments for renal dysfunction. Not all products are safe for pregnancy
Price for treatment course
(with GoodRx coupon)		Truvada: $1,825.63
Isentress: $1,639.03
Tivicay: $1,810.03		Truvada: $1,825.63
Prezista: $1,750.12
Norvir (generic): $53.11		$3,359.20$3,202.66
PAP available?Truvada: YES: Gilead Advancing Access
Isentress: YES Merck
Tivicay: YES ViiV Connect		Truvada: YES: Gilead Advancing Access
Prezista: Possible through outside organization
Ritonavir: NO		POSSIBLY
Through hospital-specific programs		YES
Gilead Advancing Access

*It is important to note that many patients will not meet requirements for a PAP, especially if they have any type of primary insurance coverage
*Even if patient has insurance coverage, brand-name medications may not be covered by plan and alternatives may need to be considered

Table 5. Preferred and Alternative Antiretroviral Medication 28-Day Regimens for nPEPa,b

Age groupPreferred/alternativeMedication
Adults and adolescents aged ≥13 years, including pregnant women, with normal renal function (creatinine clearance ≥60 mL/min)PreferredA 3-drug regimen consisting of
tenofovir DF 300 mg and fixed dose combination
emtricitabine 200 mg (Truvadac) once daily
with
raltegravir 400 mg twice daily
or
dolutegravir 50 mg once daily
AlternativeA 3-drug regimen consisting of
tenofovir DF 300 mg and fixed dose combination
emtricitabine 200 mg (Truvadac) once daily
with
darunavir 800 mg (as 2, 400-mg tablets) once daily
and
ritonavirb 100 mg once daily
Adults and adolescents aged ≥13 years with renal dysfunction (creatinine clearance ≤59 mL/min)PreferredA 3-drug regimen consisting of
zidovudine and lamivudine, with both doses adjusted to
degree of renal function
with
raltegravir 400 mg twice daily
or
dolutegravir 50 mg once daily
AlternativeA 3-drug regimen consisting of
zidovudine and lamivudine, with both doses adjusted to
degree of renal function
with
darunavir 800 mg (as 2, 400-mg tablets) once daily
and
ritonavirb 100 mg once daily

CDC. 2016 nPEP Guideline Update. Footnote markers a, b, c appear on the source table but their definition text was not present on the source PDF page — see Clinical Flags.

Evidence

Author, yearDesign/ sample sizeIntervention & ComparisonOutcome
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/cobicistat group (15%, 9% and 49%, respectively). 1 seroconversion was observed in the elvitegravir/cobicistat 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