TRUVADA is approved for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults at high risk. Clinical trials showed that PrEP reduced the risk of HIV infection by 44-92% in men who have sex with men and 75-90% in heterosexual couples where one partner had HIV. However, PrEP was only effective if taken consistently as prescribed. TRUVADA must be used as part of a comprehensive prevention strategy including condom use, knowledge of HIV status, and regular testing for HIV and STIs. Important safety information and drug interactions are provided. Resources for patients and providers on PrEP are listed.

1. Factsheet: TRUVADA for Pre-Exposure Prophylaxis (PrEP)
TRUVADA is indicated in combination with safer sex practices for PrEP to reduce the risk of sexually acquired
HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at
high risk for HIV-1 infection and in heterosexual serodiscordant couples. Contains tenofovir & emtricitabine.
Uninfected individuals at high risk for sexually acquired HIV-1 infections include:
• Individuals with HIV-1 infected partner(s)
• Individuals who engage in sexual activity in a high prevalence area or social network and have one or
more of the following: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs),
exchange of sex for commodities (money, food, shelter, drugs), use of illicit drugs or alcohol dependence,
incarceration, and/or sexual partners of unknown HIV status with any of the above risk factors.
Several studies showed that PrEP reduced the risk of getting HIV infection:
• MSM who were given PrEP medication were 44% less likely to get HIV infection than were those men who
took a placebo. This was an average that included men who didn’t take the medicine every day and those
who did. Among the men who said they took most of their daily doses, PrEP reduced the risk of HIV
infection by 73% or more, up to 92%.
• Among men and women in couples in which one partner had HIV infection and the other partner initially
did not (“serodiscordant” couples), those who received PrEP medication were 75% less likely to become
infected than those who took a placebo. Among those who said they took most of their daily doses, PrEP
reduced risk of HIV infection by up to 90%.
• In one study of men and women who entered the study as individuals, PrEP worked for both men and
women: those who received the medication were 62% less likely to get HIV infection; those who said they
took most of their daily doses, were 85% less likely to get HIV infection.
• In another study, only about 1 in 4 women (<26%) had PrEP medication found in their blood when it was
checked. This indicated that few women were actually taking their medication and that study found no
protection against HIV infection.
Important Safety Information
Discontinuation
Test client for HIV:
• If positive, document results of resistance
testing and establish a linkage to care.
• If negative, establish linkage to risk reduction
support services if necessary.
• If patient is positive for hepatitis B: Consider
an alternative medicine for treatment. Liver
function (AST, ALT, bilirubin) should be
closely monitored as hepatitis B flares can
occur.
Strategies to reduce HIV-1 infection:
TRUVADA is not always effective in preventing the
acquisition for HIV-1; therefore, use TRUVADA for
PrEP only as part of a comprehensive prevention
strategy that includes:
• Safer sex practices (consistent and correct
use of condoms)
• Knowledge of their HIV status and that of
their partner(s)
• Regular testing for HIV-1 and other sexually
transmitted infections
Every 1–3 months
• Discuss side effects and adherence.
• Discuss HIV risk reduction practices and
include condom distribution and education
in every visit. Re-test client for HIV.
• Re-test for kidney function. (If kidney
function is stable, testing every 3–6 months
is adequate.)
• Assess for STI symptoms. Re-test every 3–
6 months even if asymptomatic. Site-based
testing (vaginal, urethral, rectal, pharyngeal
swabs) now available in our lab formulary,
including for uninsured patients.
• Re-assess client’s pregnancy status/plans.
Prescription should be renewed after client re-tests
HIV negative and re-assess if prescription is
working for client.
Prescribing considerations:
TRUVADA for PrEP must be prescribed as part
of a comprehensive prevention strategy.
• Uninfected individuals must strictly
adhere to their dosing schedule. The
effectiveness of TRUVADA in reducing
the risk of acquiring HIV-1 is strongly
correlated with adherence.
• HIV-1 negative status must be confirmed
prior to initiating TRUVADA and at least
every 3 months thereafter.
• If clinical symptoms of acute HIV-1
infection are present and recent
exposures (<1 month) are suspected,
delay initiating TRUVADA for at least 1
month until negative HIV-1 status is
reconfirmed.

2. Adverse reactions: Common adverse reactions (>2% and more frequently than placebo) in PrEP clinical trials
were headache, abdominal pain, and weight decreased. No new adverse reactions were reported.
Drug interactions: Drugs affecting renal function: Coadministration of TRUVADA with drugs that reduce renal
function or compete for active tubular secretion may increase concentrations of emtricitabine and/or tenofovir
ICD-10: Z72.5, High-risk sexual behavior;
Z20.82, Contact with and (suspected) exposure to other viral communicable diseases
Medicaid: NC Medicaid does not cover Truvada for PrEP. CPHP Medicaid Select does cover it.
Paying Assistance for Truvada
With Insurance Without Insurance
Gilead Co-pay Program for Truvada
• Coverage is limited to $300 per month
• Does not cover those with Medicaid or Medicare
• No income requirement
• Issues a co-pay card for use at pharmacies
• $10 fee for 90-day supply through Piedmont
www.gileadcopay.com or 1-877-505-6986
Gilead U.S. Advancing Access® Program
• Provides assistance to patients in the US
who do not have insurance
• $10 fee for 90-day supply through Piedmont
Call 1-800-226-2056.
Application:http://services.gileadhiv.com/content/pd
f/gilead_enrollment_form.pdf
Patient Access Network (PAN) Co-pay Program
• $4,000 per year – may reapply, but program
funding will dictate response
• Does cover deductibles and co-insurance and is
designed for those who’s out-of-pocket costs are
not fully covered by the Gilead program
• Income below 500% of FPL
• Does not cover individuals with Medicaid, but it
does cover those with Medicare
• Most pharmacies should bill PAN directly
www.panfoundation.org/fundingapplication/welcome.php
or 1-866-316-PANF
Partnership for Rx Assistance (PPA) Program
• To find out if you qualify, call 1-888-477-
2669. You can visit the PPA Web site at
www.pparx.org
MAP for Truvada
• Income below 500% of the FPL and no
other sources for health insurance or
prescription coverage
• U.S. residency proof is required, but not
immigration legal status
• Drugs shipped to provider, may take 2 wks
Contact: 1-855-330-5479
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE
PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION, LACTIC ACIDOSIS/SEVERE
HEPATOMEGALY WITH STEATOSIS, and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B.
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the
use of nucleoside analogs, including tenofovir DF, in combination with other antiretrovirals.
• TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and
efficacy of TRUVADA have not been established in patients infected with HBV.
Warnings and Precautions:
• Do not use TRUVADA for PrEP in uninfected individuals with CrCl <60 mL/min. Reassess potential risks and
benefits of using TRUVADA for PrEP if a decrease in CrCl is observed during use.
• Use with other antiviral products: Do not coadminister with products containing emtricitabine, tenofovir DF,
lamivudine, or adefovir dipivoxil.
• Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia,
have been seen in patients treated with tenofovir DF. Consider monitoring BMD in patients with a history of
pathologic fracture or risk factors for bone loss.
• Fat Redistribution and accumulation has been observed in patients receiving antiretroviral therapy.
Use in specific populations:
• Pregnancy Category B: There are no adequate and well-controlled trials in pregnant women. Use during
pregnancy only if clearly needed. In uninfected women who become pregnant while taking TRUVADA for
PrEP, careful consideration about continuing TRUVADA should be given, taking into account the potential
increased risk of HIV-1 infection during pregnancy. Those taking TRUVADA for PrEP should be instructed not
to breastfeed because of the potential for serious adverse reactions in nursing infants and the potential for
HIV-1 transmission to the infant if HIV-1 infection is acquired.
References & Resources For Providers:
https://wwwn.cdc.gov/hivrisk/
http://betablog.org/getting-providers-comfortable-with-prep/
http://nccc.ucsf.edu/
www.cdc.gov/hiv/basics/prep.html
www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
Resources for Patients
http://www.projectinform.org/pdf/PrEP_Flow_Ch
art.pdf
http://myprepexperience.blogspot.com/p/paymen
t-support-for-prep.html
http://men.prepfacts.org/the-questions/