From the Guidelines
Truvada, a combination of emtricitabine and tenofovir disoproxil fumarate, should be taken exactly as prescribed, once daily with or without food, and patients should not miss doses as consistent blood levels are crucial for effectiveness whether used for HIV treatment or pre-exposure prophylaxis (PrEP) 1.
Key Counseling Points
- Regular HIV testing is necessary before starting and during treatment to ensure patients don't have undiagnosed HIV, as Truvada alone isn't sufficient for HIV treatment.
- Potential side effects include kidney problems, bone density loss, and lactic acidosis, so patients should report symptoms like bone pain, muscle pain, or decreased urination to their healthcare provider immediately.
- Drug interactions can occur with medications like NSAIDs or other antiretrovirals, so patients should inform all healthcare providers about all medications they take.
- For PrEP use, patients should understand that Truvada reduces but doesn't eliminate HIV risk, so they should continue using condoms and other preventive measures.
- Women who are pregnant or breastfeeding should discuss risks and benefits with their healthcare provider.
- Regular monitoring of kidney function and bone density is essential during treatment.
Important Considerations
- Truvada works by inhibiting HIV viral replication, preventing the virus from making copies of itself in the body, which is why consistent daily dosing is critical for maintaining protective drug levels.
- Patients with osteopenia or osteoporosis should carefully weigh the risks and benefits of PrEP, and those with a creatinine clearance rate of less than 60 mL/min should not use Truvada-based PrEP 1.
- Vaccination against hepatitis A and hepatitis B viruses is recommended for those who are not immune 1.
- Patients should be screened for sexually transmitted infections, including syphilis, chlamydia, and gonorrhea, and any infections should be treated 1.
From the FDA Drug Label
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Severe Acute Exacerbation of Hepatitis B in Patients Infected with HBV Inform patients that severe acute exacerbations of hepatitis B have been reported in patients infected with hepatitis B virus (HBV) and have discontinued tenofovir disoproxil fumarate Advise patients not to discontinue tenofovir disoproxil fumarate without first informing their healthcare provider All patients should be tested for HBV infection before or when starting tenofovir disoproxil fumarate and those who are infected with HBV need close medical follow-up for several months after stopping tenofovir disoproxil fumarate to monitor for exacerbations of hepatitis [see Warnings and Precautions (5. 1)]. New Onset or Worsening Renal Impairment Inform patients that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of tenofovir disoproxil fumarate. Advise patients to avoid tenofovir disoproxil fumarate with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) [see Warnings and Precautions (5. 2)]. The dosing interval of tenofovir disoproxil fumarate may need adjustment in HIV-1 infected patients with renal impairment. Immune Reconstitution Syndrome Inform patients that in some patients with advanced HIV infection (AIDS) signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. Advise patients to inform their healthcare provider immediately of any symptoms of infection [see Warnings and Precautions (5. 4)]. Bone Loss and Mineralization Defects Inform patients that decreases in bone mineral density have been observed with the use of tenofovir disoproxil fumarate. Consider bone monitoring in patients who have a history of pathologic bone fracture or at risk for osteopenia [see Warnings and Precautions (5. 5)]. Lactic Acidosis and Severe Hepatomegaly Inform patients that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with tenofovir disoproxil fumarate should be suspended in any patient who develops clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5. 6)]. Drug Interactions Advise patients that tenofovir disoproxil fumarate may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other medication, including other HIV drugs and drugs for treatment of hepatitis C virus [see Warnings and Precautions (5. 7) and Drug Interactions (7)]. Dosing Recommendations Inform patients that it is important to take tenofovir disoproxil fumarate on a regular dosing schedule with or without food and to avoid missing doses as it can result in development of resistance [see Dosage and Administration (2)].
The main counseling points for Truvada are:
- Severe Acute Exacerbation of Hepatitis B: Patients should be informed of the risk of severe acute exacerbations of hepatitis B when discontinuing tenofovir disoproxil fumarate, and advised not to discontinue without first informing their healthcare provider 2.
- New Onset or Worsening Renal Impairment: Patients should be informed of the risk of renal impairment, and advised to avoid concurrent or recent use of nephrotoxic agents 2.
- Immune Reconstitution Syndrome: Patients should be informed of the risk of immune reconstitution syndrome, and advised to inform their healthcare provider immediately of any symptoms of infection 2.
- Bone Loss and Mineralization Defects: Patients should be informed of the risk of decreases in bone mineral density, and considered for bone monitoring if at risk for osteopenia 2.
- Lactic Acidosis and Severe Hepatomegaly: Patients should be informed of the risk of lactic acidosis and severe hepatomegaly, and treatment should be suspended if clinical symptoms suggestive of these conditions occur 2.
- Drug Interactions: Patients should be advised to report the use of any other medication to their healthcare provider, as tenofovir disoproxil fumarate may interact with many drugs 2.
- Dosing Recommendations: Patients should be informed of the importance of taking tenofovir disoproxil fumarate on a regular dosing schedule, with or without food, and avoiding missing doses to prevent development of resistance 2.
From the Research
Truvada Main Counseling Points
- Truvada, also known as emtricitabine-tenofovir disoproxil fumarate (FTC/TDF), is a highly effective medication for HIV pre-exposure prophylaxis (PrEP) 3, 4, 5
- The medication has been shown to reduce the risk of HIV acquisition among individuals at high risk, including men who have sex with men and heterosexual men and women 3, 6
- Truvada has been associated with some side effects, including renal dysfunction and bone mineral density loss, although these effects are generally mild and reversible 3, 7, 4
- Daily adherence to Truvada is crucial for its effectiveness in preventing HIV acquisition 3, 5
- Truvada has also been shown to reduce the risk of herpes simplex virus type 2 (HSV-2) acquisition among heterosexual men and women 6
- The cost-effectiveness of Truvada for PrEP has been assessed, and it is generally considered to be most cost-effective for individuals at highest risk of acquiring HIV 5
- Patient and provider acceptance, as well as patient adherence and retention in care, are critical factors in the successful implementation of Truvada for PrEP 5
- Concerns regarding the use of Truvada in healthy individuals, including the risk of medication adverse effects and the development of drug resistance, should be addressed through counseling and education 7, 5
- Alternative PrEP medications, such as emtricitabine-tenofovir alafenamide (F/TAF), may be available for individuals who experience adverse effects or have concerns about Truvada 4