Click here to listen to Charles's and other VIRAMUNE patients' inspiring stories.

Adherence

Tolerability affects adherence [DHHS Guidelines]

Adverse events (AEs) are among the most common reasons for non-adherence.

  • Fear of or the experience of side effects of HAART, including metabolic and morphologic side effects can also cause inadequate adherence
  • Patients may have to switch or discontinue therapy due to AEs

Some of the patient factors associated with the risk of decreased adherence include:

  • Active substance abuse
  • Depression
  • Lack of social support

Assessing adherence

A patient's estimate of suboptimal adherence is a strong predictor and should be taken seriously. Patient self-reporting of complete adherence and the clinician's estimate of the patient's likelihood of adherence are unreliable predictors.

Early detection and prompt intervention for non-adherence can greatly reduce the risk of negative consequences.

Strategies to improve adherence

DHHS Guidelines recommend strategies to improve adherence

  • Establish readiness to start therapy
  • Provide education on medication dosing
  • Review potential side effects
  • Anticipate and treat side effects
  • Utilize educational aids, including pictures, pillboxes, and calendars
  • Engage family and friends
  • Simplify regimens, dosing, and food requirements
  • Utilize team approach with nurses, pharmacists, and peer counselors
  • Provide accessible, trusting healthcare team

You can make a difference in adherence

  • Talk with your patients
    • – Greater communication between patient and healthcare provider is associated with greater adherence to treatment
  • Screen for depression
    • – Depression is associated with nonadherence to ARV medications
  • Talk to your patients about side effects of drugs

INDICATION AND IMPORTANT SAFETY INFORMATION

VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial that demonstrated prolonged suppression of HIV-RNA and two smaller supportive studies.

Life-threatening and fatal hepatotoxicity has occurred in patients receiving VIRAMUNE. Any patient can experience hepatic events; however, female gender and higher CD4 counts at initiation of therapy place patients at greater risk. Women, including pregnant women, with CD4+ cell counts >250 cells/mm3 are at the greatest risk. VIRAMUNE should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk. Hepatic events are often associated with rash. Hepatic failure has also been reported in patients without HIV taking VIRAMUNE for post-exposure prophylaxis (PEP). Use of VIRAMUNE for occupational and non-occupational PEP is contraindicated.

Life-threatening and fatal skin reactions have also occurred, including Stevens-Johnson Syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction.

Patients should be intensively monitored for hepatic and skin reactions for the first 18 weeks of therapy with extra vigilance during the first 6 weeks, which is the period of greatest risk. Frequent monitoring should be performed throughout therapy with VIRAMUNE.

VIRAMUNE should be discontinued and not restarted in patients who develop signs or symptoms of hepatitis, hypersensitivity, severe skin reactions or any rash accompanied by constitutional findings. In some cases, hepatic injury has progressed despite discontinuation of treatment.

Patients with either hepatic fibrosis or cirrhosis should be monitored carefully for evidence of drug induced toxicity. VIRAMUNE should not be administered to patients with moderate or severe (Child Pugh Class B or C, respectively) hepatic impairment.

Other common side effects include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy.

The dose of VIRAMUNE for adults is one 200-mg tablet daily for the first 14 days (this has been shown to reduce the frequency of rash), followed by one 200-mg tablet twice daily. Any patient experiencing rash during the 14-day lead-in period should not increase dose until the rash has resolved. The lead-in dosing regimen should not be continued beyond 28 days.

INDICATION AND IMPORTANT SAFETY INFORMATION

VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial that demonstrated prolonged suppression of HIV-RNA and two smaller supportive studies.

Life-threatening and fatal hepatotoxicity has occurred in patients receiving VIRAMUNE. Any patient can experience hepatic events; however, female gender and higher CD4 counts at initiation of therapy place patients at greater risk. Women, including pregnant women, with CD4+ cell counts >250 cells/mm3 are at the greatest risk. VIRAMUNE should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk. Hepatic events are often associated with rash. Hepatic failure has also been reported in patients without HIV taking VIRAMUNE for post-exposure prophylaxis (PEP). Use of VIRAMUNE for occupational and non-occupational PEP is contraindicated.

Life-threatening and fatal skin reactions have also occurred, including Stevens-Johnson Syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction.

Patients should be intensively monitored for hepatic and skin reactions for the first 18 weeks of therapy with extra vigilance during the first 6 weeks, which is the period of greatest risk. Frequent monitoring should be performed throughout therapy with VIRAMUNE.

VIRAMUNE should be discontinued and not restarted in patients who develop signs or symptoms of hepatitis, hypersensitivity, severe skin reactions or any rash accompanied by constitutional findings. In some cases, hepatic injury has progressed despite discontinuation of treatment.

Patients with either hepatic fibrosis or cirrhosis should be monitored carefully for evidence of drug induced toxicity. VIRAMUNE should not be administered to patients with moderate or severe (Child Pugh Class B or C, respectively) hepatic impairment.

Other common side effects include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy.

The dose of VIRAMUNE for adults is one 200-mg tablet daily for the first 14 days (this has been shown to reduce the frequency of rash), followed by one 200-mg tablet twice daily. Any patient experiencing rash during the 14-day lead-in period should not increase dose until the rash has resolved. The lead-in dosing regimen should not be continued beyond 28 days.

Please see full Prescribing Information, including boxed WARNING, for VIRAMUNE.