Q And A Forum: HIV Prevention Tips For Grass Root Organizations

1. Know Your Epidemic
2. Know Your Social Services
3. Know Your Marginalized Population
4. Know Your Needs
5. Know Your Reporting Mechanisms

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PROACTIVELY PROTECT YOURSELF FROM HIV, BRING DOWN THE VIRUS WITH TRUVADA FOR PrEP—ONE TABLET, ONCE DAILY

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

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U.S. AND GLOBAL HEALTH GUIDELINES RECOMMEND TRUVADA FOR PrEP IN COMBINATION WITH SAFER SEX PRACTICES TO HELP REDUCE THE RISK OF SEXUALLY ACQUIRED HIV-1 IN INDIVIDUALS AT RISK

ARV Provider Organizations should:

Provide criteria for determining a person's risk of HIV infection and for TRUVADA FOR PrEP use

Include TRUVADA FOR PrEP as a prevention option for HIV-1–negative individuals at risk for HIV infection

Emphasize the importance of counseling on adherence and comprehensive HIV risk reduction

Recommend confirming HIV-1–negative status prior to starting PrEP

Recommend that ongoing use of TRUVADA FOR PrEP be guided by regular risk assessment

Health guidelines recommend TRUVADA FOR PrEP and emphasize the importance of counseling on adherence and HIV-1 risk reduction strategies.

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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

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

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