Module 3 Antiretroviral Therapy Adherence Sideeffects Resistance Monitoring Drugregimens

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Module 3Anti-retroviral TherapyAdherenceSide-
effectsResistanceMonitoringDrug-regimens

• KZN Department of Health
• Patient Drug-readiness Training

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Topics to be covered

• Adherence
• ARV side-effects
• ARV Resistance
• Laboratory monitoring
• Making a treatment plan
• Drugs for the KZN ARV programme

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Adherence
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What is adherence?

• Taking drugs exactly as prescribed
• On time
• Following dietary restriction
• No missed doses

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Why is adherence so important?

• Taking drugs exactly as prescribed
• On time ? ? ? ? ? ? good drug level
• Following dietary restriction ? ? good
  absorption
• No missed doses ? ? ? ? ? good drug level

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What happens if non-adherent?

• Taking drugs exactly as prescribed
• On time ? ? ? ? ? ? good drug level
• Following dietary restriction ? ? good
  absorption
• No missed doses ? ? ? ? ? good drug level
• Increased viral replication
• drug resistance !

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How does resistance develop

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How does resistance develop

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How does resistance develop

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Effect of missed doses

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Effect of missed doses

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Effect of missed doses

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Effect of missed doses

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Effect of missed doses

missed dose
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Effect of missed doses

Viral replication
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Failure to adhere

• Missing even a few doses can cause HIV to become
  resistant
• Resistant HIV ? ARV failure
• ARV failure ? viral load CD4
• 90-95 adherence mandatory

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What must you do to adhere?

• Give yourself time to get used the ARVs
• Prepare mentally for the side effects
• Develop a routine...work ARVs into your routine
• Near toothbrush
• Near bed-stand
• In work bag
• Develop good practices
• Take meds with you on day outings
• Take meds with you for weekends
• Never run out of supply at home
• Seek accept support

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What must you do to adhere?

• Give yourself time to get used the ARVs
• Prepare mentally for the side effects
• Develop a routine...work ARVs into your routine
• Near toothbrush
• Near bed-stand
• In work bag
• Develop good practices
• Take meds with you on day outings
• Take meds with you for weekends
• Never run out of supply at home
• Seek accept support

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What must you do to adhere?

• Give yourself time to get used the ARVs
• Prepare mentally for the side effects
• Develop a routine...work ARVs into your routine
• Near toothbrush
• Near bed-stand
• In work bag
• Develop good practices
• Take meds with you on day outings
• Take meds with you for weekends
• Never run out of supply at home
• Seek accept support

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What must you do to adhere?

• Give yourself time to get used the ARVs
• Prepare mentally for the side effects
• Develop a routine...work ARVs into your routine
• Near toothbrush
• Near bed-stand
• In work bag
• Develop good practices
• Take meds with you on day outings
• Take meds with you for weekends
• Never run out of supply at home
• Seek accept support

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What must you do to adhere?

• Give yourself time to get used the ARVs
• Prepare mentally for the side effects
• Develop a routine...work ARVs into your routine
• Near toothbrush
• Near bed-stand
• In work bag
• Develop good practices
• Take meds with you on day outings
• Take meds with you for weekends
• Never run out of supply at home
• Seek accept support

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Adherence tools

• Anything that can help you adhere tool
• Pill boxes standard
• Stickers / calendars pictures of pills
• Pill boxes with alarms / computer chips
• Set alarm-watch
• Friends to phone reminders
• Adherence buddy or partner
• Therapeutic counselor (home monitor)
• Pill counts
• Self report

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ARV adherence side effects

• Side-effects can make adherence difficult
• Most are mild and short lived
• If side-effects are affecting adherence
• ? you must tell your doctor or other clinic
  staff.

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ARV Side effects
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What is a drug side-effect?

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What is a drug side-effect?

• Unintended effect on the body
• Any drug can have side-effects
• Panado, penicillin, TB medications, etc.
• Most ARVs have side-effects
• Not everyone experiences side-effects
• It is difficult to tell who will have
  side-effects
• Most are mild short lived
• Some serious or even life threatening

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How serious are they?

• Nausea feeling tired most common
• Graded by your doctor
• 1 mild
• 2 moderate
• 3 severe
• 4 life-threatening
• EXAMPLES
• Vomiting mild
• Rash fever moderate
• Lactic acidosis / hypersensitivity severe
  (rare!)

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What must you do?

• Learn about the side-effects of your ARVs
• Learn what is mild ? moderate ? serious
• Prepare yourself mentally for short duration
• Know your body will adjust
• Report all side-effects to your clinic
• Learn what helps (ex peppermint for nausea)

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What if they dont go away?

• Some side-effects can be dealt with or treated
• Nausea ? anti-emetics / home remedies
• Rash ? steroid cream / anti-histamines
• Feeling tired ? take dose near bedtime
• Loss of appetite ? small frequent meals
• Tingling/burning in feet or hands ? medications
• Kidney stones ?drink plenty of water
• Report them to the clinic
• ? do not stop ARVs on your own!

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Serious side-effects?

• All serious side-effects must be evaluated
• Serious side-effects are uncommon
• One ARV can be switched IF due to
  side-effects you can tell which ARV is at fault
• Switching must be closely supervised
• Never stop any ARVs on your own!

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ARVResistance
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What is resistance?

• When DRUGS stop working against HIV
• ARVs slow down the reproduction of HIV
• It does not stop completely
• Low level reproduction still occuring
• When reproducing, HIV makes mistakes
• Mistakes where ARVs work, leads to resistant
  virus
• If not maximally slowed, the number of resistant
  HIV increases

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What causes resistance?

• Main reason for resistance is non-adherence
• Missing doses means lower amount of ARV in blood
• Lower levels of ARV in the blood allows HIV
  reproduction
• More resistant HIV is made
• ARVs no longer are effective
• Viral load goes up / CD4 goes down

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Avoiding resistance

• Strict adherence
• If serious side-effects occur, your doctor will
  decide which drug(s) should be changed or stopped
• One ARV might be changed, but you will always
  take 3-drugs
• If you are having trouble adhering for ANY
  reason, you must talk to the clinic staff!
• Your clinic should support you as part of a
  partnership but the commitment is yours!

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Infection with drug-resistant HIV

• People can become infected with a drug-resistant
  strains of HIV
• This occurs if they are infected by a person who
  has taken ARVs ? been non-adherent ? developed
  resistant virus.
• Once your HIV is resistant, your treatment
  options become limited
• It is dangerous for the individual and from a
  public health stand point.

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Protect yourself

• It is critical for you to protect yourself and
  practice positive living
• This means embracing the opportunity you are
  being given (access to treatment) allowing you to
  become healthy and live a full life
• You must protect yourself through safe sexual
  practices (so you dont become re-infected)
• and protect others from becoming infected by you
  as well.

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ARV Monitoring
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Clinical Monitoring

• Looking for signs or symptoms of drug
  side-effects (rash, nausea, headache, etc)
• Done at the clinic by doctor and/or nurse
• Done at home by the patient
• Done at home by the home-based carer

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Lab Monitoring for EFFICACY

• Efficacy how well drugs are working
• CD4 count stable or going up
• Viral load down by 1-2 logs in weeks

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CD4 count

• Measures the number of CD4 cells in blood
• ARVs slow viral replication
• Lowering the viral load allows CD4 to increase
• CD4 will come up slowly over many months
• The lower the count, the longer the recovery
• Check if change in clinical picture
• Check 6-monthly if affordable

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Viral Load

• Measures the amount of HIV in the blood
• Will come down rapidly with HAART (weeks)
• Goal is to get VL to undetectable
• Check once before starting treatment
• If affordable, check 1-month after starting tx
• If not, check 6-monthly or yearly
• Once undetectable, VL can rise if ARV failure
• Most common reason is non-adherence
  
  
  
  
  
  
  
  

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Lab Monitoring for SAFETY

• Safety (or toxicity) labs may be taken before
  starting ARVs and at intervals while taking ARVs
• These tell us how your body is tolerating the
  ARVs
• UE ? how are the chemicals in your body doing
• Liver enzymes (ie ALT)? how is the liver doing
• FBC ? how is your blood doing

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Safety Monitoring depends on which drugs you take

• EXAMPLES
• Nevirapine ? liver toxicity (check ALT)
• TB treatment ? liver toxicity (check ALT)
• AZT ? causes anemia (check FBC or Hb)
• Protease Inhibitor ? cholesterol or diabetes

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Making a Treatment Plan
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Making a treatment plan

• Treatment plan ? patient clinic staff
• Personal situation
• Partner/family support - Stress?
• Employment? - Responsibilities (children)?
• Enough food at home? - Transport?
• Lifestyle
• Wake-up
• Meal times
• Bedtime
• Return to clinic monitoring schedule
• Home visits / support

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Making a treatment plan

• Treatment plan ? patient clinic staff
• Personal situation
• Partner/family support - Stress?
• Employment? - Responsibilities (children)?
• Enough food at home? - Transport?
• Lifestyle
• Wake-up
• Meal times
• Bedtime
• Return to clinic monitoring schedule
• Home visits / support

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Making a treatment plan

• Treatment plan ? patient clinic staff
• Personal situation
• Partner/family support - Stress?
• Employment? - Responsibilities (children)?
• Enough food at home? - Transport?
• Lifestyle
• Wake-up
• Meal times
• Bedtime
• Return to clinic monitoring schedule
• Home visits / support

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Making a treatment plan

• Treatment plan ? patient clinic staff
• Personal situation
• Partner/family support - Stress?
• Employment? - Responsibilities (children)?
• Enough food at home? - Transport?
• Lifestyle
• Wake-up
• Meal times
• Bedtime
• Return to clinic monitoring schedule
• Home visits / support

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Making a treatment plan

• Treatment plan ? patient clinic staff
• Personal situation
• Partner/family support - Stress?
• Employment? - Responsibilities (children)?
• Enough food at home? - Transport?
• Lifestyle
• Wake-up
• Meal times
• Bedtime
• Return to clinic monitoring schedule
• Home visits / support

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Making a treatment plan

• Treatment plan ? patient clinic staff
• Personal situation
• Partner/family support - Stress?
• Employment? - Responsibilities (children)?
• Enough food at home? - Transport?
• Lifestyle
• Wake-up
• Meal times
• Bedtime
• Return to clinic monitoring schedule
• Home visits / support

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Treatment Plan

• Each patient must make their own plan for how
  they are going to take their medications
• designed by PATIENT (with help from the clinic
  staff)
• It is based on THE PATIENTS lifestyle
• Each person must be realistic and consider all of
  the factors that will helpand hinder their
  adherence to ARVs

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ARVs for KZN roll-out
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Which ARV drugs will KZN use?

• ARV drugs will not selected 1 by 1
• They will be selected as a REGIMEN
• REGIMEN a set combination of 3 ARVs

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What regimens will KZN use?

• REGIMEN 1 (first-line)
• d4T
• 3TC
• NVP or Stocrin
• REGIMEN 2 (second-line)
• AZT
• ddI
• Kaletra (lopinavir/ritonavir)

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Why have 2 regimens?

• Most patients will be started on REGIMEN 1
• Patients who do not comply or cannot take REGIMEN
  1 ? will be started on REGIMEN 2

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What about Regimen 1?

• REGIMEN 1
• Potent
• Effective
• Easy to take
• 3TC NRTI twice daily
  tablet
• d4T NRTI twice daily tablet
• NVP NNRTI start 1x/day x
  14d
• Or
• Stocrin NNRTI 3 capsules at
  bedtime

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Regimen 1a 3rd drug Stocrin
MORNING (7am)
d4t
3TC
Bactrim
EVENING (7pm)
d4t
3TC
BEDTIME
Stocrin
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Regimen 1b3rd drug NVP
MORNING (7am)
d4t
3TC
NVP
Bactrim
EVENING (7pm)
3TC
d4t
NVP
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Details of first-line drugs
Larger dose (40mg) if weight more 60kg MAIN
SIDE-EFFECTS peripheral neuropathy
d4T
3TC
Very well tolerated
Start 1 daily for first 14 days, then 2x/day
MAIN SIDE EFFECTS rash liver toxicity
NVP
Taken at bedtime because causes sleepiness MAIN
SIDE EFFECTS rash liver toxicity, vivid
dreams, birth defects if taken in pregnancy
Stocrin
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Regimen 2 3rd drug Protease Inhibitor

• REGIMEN 2
• Potent
• Effective
• Easy to take
• AZT NRTI twice daily tablet anemia, muscle
  ache,
• fatigue
• ddI NRTI twice daily tablet peripheral neuropathy
• Kaletra PI twice daily increase cholesterol
• worsen diabetes

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What if a patient fails both?

• Very few other options at this time
• Critical for patients to adhere
• Stay on REGIMEN 1 for as long as possible!
• SALVAGE THERAPY (3rd line) not available
  currently

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Conclusion

• ARV treatment is lifelong
• ARVs have side-effects which are tolerable
• ARV treatment requires patient commitment
• It requires knowledgeable committed staff
• It requires a knowledgeable committed patients
• It requires a support network family, community
• Disclosure is very important to adherence
• Adherence is mandatory for treatment to work
• There are risks, but the benefit is life !