HIV NPEP Access Toolkit > Prophylaxis & Follow Up
Prophylaxis & Follow Up
The decision to begin or withhold prophylaxis should be made by patients and healthcare professionals after patients have been adequately informed of the risks and benefit of prophylactic/preventative options.
Prophylaxis for HIV is a medication regimen that is given in an attempt to prevent a person from contracting HIV, assuming they were exposed. Like with other STIs, the medications used for HIV nPEP are also sometimes used to treat known HIV infection.
The CDC medication recommendations are below; however, it is recognized that some facilities may utilize alternate medications with similar mechanisms of action.
(Dominguez et al., 2016, p. 31)
For a patient in the first trimester of pregnancy OR who may become pregnant within the next 28 days: TDF/ FTC (Truvada) 300/200 mg 1 tab PO daily + EITHER dolutegravir (Tivicay) 50 mg 1 PO daily OR raltegravir (Isentress) 400 mg 1 tab PO twice a day is recommended.
- The use of dolutegravir at conception and in very early pregnancy has been associated with a small, but not statistically significant, increase in the risk of fetal neural tube defects (see package insert).
Truvada should not be used for those with a creatinine clearance less than 60 mL/min. An alternative regimen must be used in those circumstances.
Prior to administering HIV nPEP, baseline testing for HIV, Hepatitis B, Hepatitis C, Syphilis, as well as renal and liver function tests should be obtained, as per the CDC recommendations. These should be monitored throughout the course of nPEP and after by a qualified health care professional. Guidelines for testing and follow-up:
- Schedule an appointment with patients’ healthcare provider as soon as possible after the medical-forensic exam, but no later than 72 hours; and then 4 to 6 weeks later.
- HIV testing at time of exam, then again in 30 days and 3 months. Testing recommended at 6 months only if HCV infection was acquired during the original exposure; delayed HIV seroconversion has been seen in people who simultaneously acquire HIV and HCV infection (CDC, 2022b).
- Syphilis test at 4-6 weeks and 3-6 months after exposure.
- HBV and HCV serology tests at 6 months after initial non-reactive test if susceptible at baseline.
(CDC, 2021b)
Testing Assailant for HIV
Some patients may request that a known assailant be tested for HIV. The chart at the link below provides responses to patients’ most frequently asked questions (RAINN, 2020).
HIV/AIDS Testing of Offenders in PA (PDF)
Pennsylvania Requirements for Hospitals Providing STI Medications After Sexual Assault
With the patient’s consent, hospitals are required to provide an initial dosage of up to 72 hours of postexposure prophylactic treatment for sexually transmissible diseases, hepatitis and HIV. They must also provide the patient with information and prescriptions necessary to obtain the remainder of the treatment regimen.
28 Pa. Code § 117.54. Prevention of sexually transmitted diseases (2008).
(a) A hospital shall provide a sexual assault victim with an assessment of the victim’s risk for contracting a sexually transmitted disease, hepatitis and HIV. (b) The hospital shall base the risk assessment upon the following considerations: (1) Available information regarding the assault as well as the subsequent findings from medical examinations and tests that may be conducted. (2) Established standards of risk assessment, including consideration of recommendations made by the United States Department of Health and Human Services Centers for Disease Control and Prevention. (c) In addition to the assessment required in subsection (a), a hospital shall advise a sexual assault victim of sexually transmissible diseases, hepatitis and HIV, for which postexposure prophylaxis exists, and for which deferral of treatment would either significantly reduce treatment efficacy or would pose a substantial risk to the individual’s health. (d) Upon the victim’s consent, the hospital shall provide the victim with an initial dosage of up to 72 hours of postexposure prophylactic treatment for sexually transmissible diseases, hepatitis and HIV, and provide the victim with information and prescriptions necessary to obtain the remainder of the treatment regimen. A hospital will not be required to comply with this subsection when risk evaluation, adopted by the United States Department of Health and Human Services Centers for Disease Control and Prevention, clearly recommends against the application of postexposure prophylaxis.
Patient Access to Medications
Accessing prescribed medications can be challenging for patients. Some insurances may cover the full cost of nPEP, while others require copayments that can vary considerably in cost, rendering the medications unaffordable for some patients. Patient information, including contact information, insurance, and income will be required.
Common Patient Assistance Program Application (CPAPA)
In 2012, the Department of Health and Human Services (HHS), along with several pharmaceutical companies, National Alliance of State & Territorial AIDS Directors (NASTAD), and community stakeholders developed a common patient assistance program application (CPAPA) that can be used by both providers and patients. The CPAPA was updated in April 2022. Before 2012, patients and advocates had to complete different and separate sets of paperwork for each company. The CPAPA form helps simplify this process.
Companion Document to assist with form completion: https://nastad.org/sites/default/files/2022-04/PDF-NASTAD-CPAPA-Companio...
Application link: https://nastad.org/sites/default/files/2022-04/PDF-CPAPA-Form-Fillable-0...
Gilead’s (Truvada) Advancing Access Program (n.d.) is committed to helping individuals afford needed medication no matter their situation. Whether patients have insurance or not, Gilead will explore potential coverage options that might be right for any given situation.
- The Advancing Access Program can be reached at 1-800-226-2056 from 9 a.m. to 8 p.m. Monday through Friday with the exception of some holidays.
- An application can be completed on-line at any time at www.gileadadvancingaccess.com.
- Some patients may be eligible for a voucher which will cover the full cost of the medication.
- Patients with insurance coverage may be eligible for a coupon that will cover their copay.
- Gilead contracts with specific pharmacies, therefore it is important for patients to review availability at the pharmacy of their choice. The medication will be made available at the pharmacy for pick-up.
Merck (Isentress) (n.d.) has private and confidential programs that provide medication free of charge to eligible individuals, primarily the uninsured who, without assistance, could not afford needed medications. Individuals who do not meet the insurance criteria may still qualify for these programs if they attest that they have special circumstances of financial and medical hardship, and their income meets the program criteria.
- The Merck Patient Assistance Program can be reached at 1-800-727-5400 from 9 a.m. to 8 p.m. Monday through Friday with the exception of some holidays.
- An application may be completed on-line at www.merckhelps.com that must then be faxed to 915-849-1037 for a final determination on eligibility.
- If the application is approved, the medication can be shipped directly to the patient or their physician’s office.
Please note that these processes may take a few days, in particular during weekends and holidays. In the interim, it is important to provide enough medication at the time of the medical-forensic exam to accommodate this.
Teva Pharmaceuticals (n.d.) provides a generic option for Truvada (emtricitabine and tenofovir disoproxil fumarate), which may offer patients a cost-saving option. Additional information can be found at their website: https://www.tevahivgenerics.com/Truvada-generic/
In addition to these patient access programs, there are a number of organizations that provide coupons or vouchers enabling patients to receive medications at a reduced cost. These include but are not limited to: Prescription Prices, Coupons & Pharmacy Information - GoodRx; The Rx Advocates (patientassistanceprograms.com); Discount Pharmacy Prices (wellrx.com); https://www.singlecare.com/; Nurx: www.nurx.com