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Discover how you can help protect your patients who are at risk of HIV

Help protect your patients with TRUVADA FOR PrEP(R)

The only medication approved to significantly reduce the risk of sexually acquired HIV-1 in individuals at risk, in combination with safer sex practices.^1,2

Help protect your patients from HIV with TRUVADA FOR PrEP, one tablet taken each day—as part of a comprehensive prevention plan.¹

HIV‑1–negative status must be confirmed immediately prior to initiating TRUVADA FOR PrEP and at least every 3 months thereafter.

Dear Dr. John Doe,

I appreciate you taking the time to meet.

In preparation for our meeting, I am sending you some important information about TRUVADA FOR PrEP.

TRUVADA FOR PrEP (pre-exposure prophylaxis) is indicated to reduce the risk of sexually acquired HIV‑1 in adults and adolescents (≥35 kg) who are at risk for HIV, when used in combination with safer sex practices. HIV‑negative status must be confirmed immediately prior to initiation

•

If clinical symptoms of acute HIV-1 infection are present and recent exposures (<1 month) are suspected, delay initiation for at least 1 month until HIV-negative status is reconfirmed. Alternatively, confirm HIV-negative status with a test cleared by the FDA to aid in the diagnosis of acute HIV-1 infection

Individuals at risk for sexually acquired HIV‑1 may include those:

•	With HIV-1 infected partner(s), or

•	Who engage in sexual activity in a high prevalence area or social network and have additional risk factors, such as: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs), exchange of sex for commodities, use of illicit drugs or alcohol dependence, incarceration, or sexual partners of unknown HIV status with any of these risk factors

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

•	TRUVADA FOR PrEP must only be prescribed to individuals confirmed to be HIV‑negative immediately prior to initiation and at least every 3 months during use. Drug‑resistant HIV‑1 variants have been identified with use of TRUVADA FOR PrEP following undetected acute HIV‑1 infection. Do not initiate if signs or symptoms of acute HIV‑1 infection are present unless HIV‑negative status is confirmed

•	Severe acute exacerbations of hepatitis B have been reported in HBV‑infected patients who discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow‑up for at least several months in patients with HBV after discontinuing TRUVADA. If appropriate, initiation of anti‑hepatitis B therapy may be warranted

Please click to view full Prescribing Information for TRUVADA FOR PrEP, including BOXED WARNING.

Proven reduction in HIV‑1 acquisition in uninfected individuals taking TRUVADA FOR PrEP in 2 pivotal trials in adults

iPrEx Trial: Men and Transgender Women Who
Have Sex With Men at High Risk of HIV-1 Infection

Across all trial participants taking TRUVADA FOR PrEP¹:
42^%
RISK REDUCTION in HIV‑1 acquisition vs placebo (CI: 18%-60%)

HIV‑1 seroconversion was observed in¹:

•	48 out of 1251 subjects in the TRUVADA group
•	83 out of 1248 subjects in the placebo group

In participants with detectable drug levels (post‑hoc analysis)^1,3*:

92^%

RISK REDUCTION
in HIV‑1 acquisition in TRUVADA users with detectable drug levels vs those without detectable drug levels

Among TRUVADA users who became infected with HIV‑1, 31 out of 34 did not have detectable drug levels³

Partners PrEP Trial: Serodiscordant Heterosexual Couples

Across all trial participants taking TRUVADA FOR PrEP¹:
75^%
RISK REDUCTION in HIV‑1 acquisition vs placebo (CI: 55%-87%)

HIV‑1 seroconversion was observed in^1,2:

•	13 out of 1576 subjects in the TRUVADA group
•	52 out of 1578 subjects in the placebo group

In participants with detectable drug levels (post‑hoc analysis)^1,2*:

90^%

RISK REDUCTION
in HIV-1 acquisition in TRUVADA users with detectable drug levels vs those without detectable drug levels

Among TRUVADA users who became infected with HIV‑1, 9 out of 12 did not have detectable drug levels⁴

*	These results were based on a post-hoc case control study of detectable plasma and intracellular drug levels in about 10% of subjects. Risk reduction appeared to be the greatest in subjects with detectable intracellular tenofovir levels.^1-3

Efficacy was strongly correlated with adherence¹

The iPrEx Trial was a randomized, double‑blind, placebo‑controlled, multinational, clinical study evaluating TRUVADA (n=1251) versus placebo (n=1248) in HIV‑1–seronegative men or transgender women who have sex with men and with evidence of high-risk behavior for HIV‑1 infection. Participants were ≥18 years old and received monthly HIV‑1 testing, risk-reduction counseling, condoms, and management of STIs. The primary outcome measure for the study was the incidence of documented HIV seroconversion. The study included a 72% Hispanic/Latino, 18% White, 9% Black, and 5% Asian population, with a mean age of 27 years.^1,3

The Partners PrEP Trial was a randomized, double-blind, placebo-controlled, multinational, 3‑arm trial conducted in 4758 serodiscordant heterosexual couples to evaluate the efficacy and safety of TRUVADA (n=1583) and TDF (n=1589) versus placebo (n=1586) in preventing HIV‑1 acquisition by the uninfected partner. TDF alone is not approved to reduce the risk of sexually acquired HIV‑1. Participants were ≥18 years old and received monthly HIV‑1 testing, risk-reduction counseling, condoms, and management of STIs. The primary endpoint was HIV‑1 infection in an HIV‑1–negative partner receiving TRUVADA, TDF, or placebo. The HIV‑1–positive partner was not medically eligible for ART. The uninfected partners were predominantly male (61‑64% across study groups) and had a mean age of 33-34 years.^1,2

IMPORTANT SAFETY INFORMATION (cont'd)

Contraindications

•	TRUVADA FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Warnings and precautions: Comprehensive risk reduction strategies

•	Reduce HIV-1 risk: TRUVADA FOR PrEP is not always effective in preventing HIV-1. Use only as part of a comprehensive prevention strategy that includes safer sex practices, regular testing for HIV-1 and other STIs, and counseling on reducing sexual risk behaviors

•	Reduce potential for drug resistance: TRUVADA FOR PrEP should only be used in individuals confirmed to be HIV-negative immediately prior to initiation, at least every 3 months while taking TRUVADA, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA. TRUVADA alone is not a complete regimen for treating HIV-1

	•	HIV antibody tests may not detect acute HIV infection. If recent exposures are suspected or symptoms of acute HIV infection are present (e.g., fever, fatigue, myalgia, skin rash), delay initiating (≥1 month) or discontinue use and confirm HIV‑negative status with a test approved by the FDA for the diagnosis of acute HIV infection

	•	If a screening test indicates possible HIV-1 infection, convert the HIV-1 PrEP regimen to an HIV treatment regimen until HIV-negative status is confirmed

•	Counsel on adherence: Counsel individuals to strictly adhere to their dosing schedule, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling

To minimize the risk of resistance, TRUVADA FOR PrEP should only be prescribed to individuals confirmed to be HIV-1 negative¹

•	Of the individuals who had unrecognized/acute HIV-1 infection at the time of TRUVADA FOR PrEP initiation, resistance to the components of TRUVADA was observed in both pivotal trials^1-3

Common adverse reactions (>2% and more frequently than placebo) were headache, abdominal pain, and weight decrease¹

•	Overall, common adverse events (all grades; ≥2% in any treatment arm) with TRUVADA FOR PrEP were comparable to placebo in two pivotal trials^1†

†	Adherence in the TRUVADA arms of these two pivotal trials varied across participants.

Overall, discontinuation rates due to adverse events with TRUVADA FOR PrEP were comparable to placebo^2,3,5

•	iPrEx trial: TRUVADA FOR PrEP 6% (79/1251) versus placebo 6% (72/1248)

•	Partners PrEP trial: TRUVADA FOR PrEP 0.1% (2/1579) versus placebo 0.1% (1/1584)

•	One subject in the TRUVADA arm of the iPrEx trial discontinued from the study due to an increase in serum creatinine and another due to low serum phosphorus¹

•	Six subjects in the TDF-containing arms of the Partners PrEP trial discontinued participation in the study due to an increase in serum creatinine compared with no discontinuations in the placebo group¹

TRUVADA FOR PrEP Overview

A brochure providing information about TRUVADA FOR PrEP, including identifying appropriate candidates, trial designs, efficacy, resistance, safety considerations, and factors to consider when prescribing to individuals at risk.

IMPORTANT SAFETY INFORMATION (cont'd)

Warnings and precautions

•	New onset or worsening renal impairment: Cases of acute renal impairment and Fanconi syndrome have been reported with the use of tenofovir disoproxil fumarate (TDF). TRUVADA is not recommended in individuals with estimated creatinine clearance (CrCl) <60 mL/min. Avoid concurrent or recent use with a nephrotoxic agent. Acute renal failure has been reported after initiation of high dose or multiple NSAIDs in patients at risk for renal dysfunction; consider alternatives to NSAIDs in these patients. Monitor renal function in all patients – See Dosage and Administration section

•	Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia associated with proximal renal tubulopathy, have been reported with the use of TDF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss

•	Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including TRUVADA. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations

•	Drug interactions: See Drug Interactions section. Consider the potential for drug interactions prior to and during use of TRUVADA and monitor for adverse reactions

Adverse reactions

•	Common adverse reactions (>2% and more frequently than placebo) of TRUVADA FOR PrEP in clinical trials were headache, abdominal pain, and weight loss

Drug interactions

•	Prescribing information: Consult the full Prescribing Information for TRUVADA for more information, warnings, and potentially significant drug interactions, including clinical comments

•	Hepatitis C antivirals: Coadministration with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir increases TDF exposure; monitor for adverse reactions

•	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

Pregnancy and lactation

•	Pregnancy: An Antiretroviral Pregnancy Registry (APR) has been established. Available data from observational studies and the APR show no increase in the rate of major birth defects for TRUVADA compared with a US reference population. Consider HIV prevention methods, including TRUVADA FOR PrEP in women due to the potential increased risk of HIV-1 infection during pregnancy and mother to child transmission during acute HIV-1 infection

•	Lactation: Emtricitabine and tenofovir have been detected in human milk. Evaluate the benefits and risks of TRUVADA FOR PrEP in breastfeeding women, including the risk of HIV-1 acquisition due to nonadherence, and subsequent mother to child transmission. Health benefits of breastfeeding should be considered along with potential adverse effects of TRUVADA on the child, which are unknown

Dosage and administration

•	Dosage: One tablet once daily with or without food

•	HIV screening: Test for HIV-1 infection prior to initiating and at least every 3 months during treatment

•	HBV screening: Test for HBV infection prior to or when initiating treatment

•	Renal impairment and monitoring: Not recommended in individuals with CrCl <60 mL/min. In all patients, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule. In patients with chronic kidney disease, also assess serum phosphorus

For more information about TRUVADA FOR PrEP, please see full Prescribing Information, including BOXED WARNING.

Please let me know if you would like any additional materials about TRUVADA FOR PrEP before we meet.

Best regards,

Gilead Gilead US
veeva@harrisonandstar.com
O: 212-555-1212
M: 917-555-1213

Learn more at
ww‍w.TRU‍VADA.c‍om/h‍cp

If your patients need assistance finding
an HCP in their area who can prescribe
TRUVADA FOR PrEP, direct them to
PrEPLOC‍ATOR.o‍rg

TRUVADA FOR PrEP has a Risk Evaluation and Mitigation Strategy (REMS). For further information, click here

ART=antiretroviral therapy; STIs=sexually transmitted infections; TDF=tenofovir disoproxil fumarate.

References: 1. TRUVADA [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2018. 2. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399‑410. 3. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):25‍87‍-‍25‍9‍9. 4. Baeten JM, Donnell D, Ndase P, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women [supplementary appendix]. N Engl J Med. 2012;367(5):3‍99‍-‍4‍10. ht‍tp://ww‍w‍.‍ne‍jm.o‍rg/doi/sup‍pl/10.105‍6/NEJMoa1108524/suppl_file/nejmoa1108524_appendix.p‍df. 5. Data on file. Gilead Sciences, Inc. 2016.

Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) tablets for PrEP (pre‑exposure prophylaxis)

TRUVADA, TRUVADA FOR PrEP, the TRUVADA FOR PrEP Logo, the TRUVADA Blue Pill Design, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks referenced herein are the property of their respective owners.