UNIT 10

INTRODUCTION TO
ANTIRETROVIRAL THERAPY
(ART)
 Unit Objectives

 Describe the benefits and general principles

regarding use of antiretroviral (ARV) therapy
 Identify possible adverse effects and drug
interactions with ARV use
 Explain why ARV resistance occurs in some
patients
 List factors affecting adherence to ARV therapy
 Describe nurse’s role in care of patients on ARV
therapy (ART)

2
 Important Terms

ART – AntiRetroviral Therapy

ARVs – AntiRetroVirals
HAART - Highly Active AntiRetroviral
Therapy
Triple Therapy - Three Antiretrovirals

These terms are all used interchangeably!

3
 How Do ARVs Control HIV?

• ARVs reduce
the ability of the As HIV
HIV virus to replication
replicate decreases

• In turn, this immune response

increases the increases
body’s ability to
fight disease
4
 Natural History of HIV
Infection Without ART
106
1000 HIV RNA
105
800

104
600
103

400 HIV Antibodies

102

200 CD4 + T cells 10

CD4
Count Window period
Viral
load
6 months Upto 10 years ? 2 years
Primary Asymptomatic Symptomatic AIDS 5
infection
 Benefits of ART

• Alters/reverses • Improves quality of

course of existing OIs life
• Decreases • Reduces HIV
hospitalizations transmission
• Increases survival • Benefits both adults
• Restores hope and children

ARVs change HIV from a terminal

(fatal) disease to a chronic disease
6
 Benefits of ART

Before ART
After ART

Courtesy: GHTM Jyothi’s Hope

7
 Limitations of ART

• Although ART dramatically improves the

health and life expectancy for PLHIV
-ART is NOT a cure for AIDS
- HIV is NEVER entirely eliminated from the
body
• HIV can still be transmitted to others, even
when the PLHIV is healthy and taking
his/her medication regularly
• ART is to be taken lifelong
8
 Common Classes of ARVs

• Nucleoside reverse transcriptase

inhibitors (NRTIs)

• Non-nucleoside reverse transcriptase

inhibitors (NNRTIs)

• Protease Inhibitors (PIs)

9
 Nucleoside Reverse Transcriptase
Inhibitors (NRTIs)
NRTIs inhibit activity of Reverse Transcriptase, a
viral DNA polymerase enzyme , that retroviruses
need to reproduce. They are:
– Zidovudine (AZT, ZDV)
– Lamivudine (3TC)
– Stavudine (d4T)
– Didanosine (ddI)
– Abacavir (ABC)
– Tenofovir (TDF)
– Emtricitibine (FTC)
10
 Non Nucleoside Reverse
Transcriptase Inhibitors (NNRTIs)

NNRTIs block Reverse Transcriptase by binding

at a different site on the enzyme, compared to
NRTIs

-Efavirenz (EFZ)
-Nevirapine (NVP)

11
 Protease Inhibitors (PIs)
Protease is a chemical, known as an enzyme,
that HIV needs, in order to make new viruses.
They are:
• Nelfinavir (NFV)
• Lopinavir/Ritonavir (LPV/R)
• Saquinavir ( SQV)
• Amprenavir( APV)
• Indinavir (IDV)
• Atazanavir (ATV)
• Ritonavir (RTV)- (Recommended as booster only)
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Drug regimens under the National AIDS
Control Programme

13
 Combination Therapy

ARVs must be given in a

3-drug combination

• This combination is referred to as the ARV

regimen – also known as a triple drug
combination

• Giving only 1 or 2 ARVs to treat HIV

disease is incorrect and ineffective
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Video of ART action

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Starting ART
 NACO Guidelines for
Starting ART

Classification of HIV- WHO CD4 test

associated clinical Clinical
disease stage

Asymptomatic 1 Treat if CD4< 250 ( if between 251

to 300, repeat CD4 count after 4
Mild symptoms 2 weeks)

Advanced symptoms 3 Treat if CD4 < 350

Severe/advanced 4 Treat irrespective of CD4

symptoms

17
 NACO Guidelines for
Starting ART
Specific situations
•HIV and TB - start Efavirenz based regimen
-Pulmonary TB & HIV: Start ART within 2 weeks
of initiation of ATT for all patients with CD4 <
350( for CD4 > 350, defer ART)

-Extra PTB & HIV : Start ART within 2 weeks of

initiation of ATT in all patients, irrespective of
CD4 counts ( special attention to monitor
Hepatotoxicity )
18
 NACO Guidelines for
Starting ART
Specific situations
•HIV and Pregnancy - Efavirenz to be
substituted with Nevirapine during the entire
pregnancy
-WHO stage I & II : start ART at CD4 < 250 ( if
between 251 & 300, repeat CD4 after 4 weeks)
-WHO stage III : start ART at CD4 < 350 ( with strict
monitoring of adverse effects of Nevirapine)
-WHO stage IV : start ART irrespective of CD4
counts
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 Factors to Consider
When Starting Therapy
• Concurrent health conditions -TB, Hepatitis B/C
• Drug interactions and side effects
• Potential for pregnancy
• PLHIV’s
– Readiness to start therapy
– Opportunity for follow up

20
 Factors to Consider
When Starting Therapy
Co-existing infections/ Drugs to Avoid
conditions
• NVP during first 2 months
• TB of Rifampicin ATT
• Anaemia • AZT / ZDV
• Hepatitis/Chronic liver • NVP
disease
• Pregnancy • EFV in first trimester

If patient has concurrent infection – treat

infection before starting ART (i.e. stabilize
patient first) 21
 Factors to Consider
When Starting Therapy
• Knowledge and belief about ART
• Ability to access care:
• transportation
• financial resources
• family support

Starting antiretroviral medication is not an

emergency!!
22
 Immune Reconstitution
Inflammatory Syndrome (IRIS)
• When ARV therapy is initiated, you may
see:
– Worsening of previous symptoms due to
flaring of subclinical OIs, e.g. TB, CMV
• Nurses’ role
– Assess and report for signs of IRIS
– Manage symptoms
– Inform patient the need to discontinue all
ART would arise only in most severe cases
after consulting doctor
If patient has concurrent infection – treat
infection before starting ART (i.e. stabilize
patient first) 23
 ART Case Scenario:
Exercise
A lady comes to you with Oesophageal candidiasis
and is HIV infected. Which of the following steps you
would like to take:
• Think the patient is ready to be started on ART today?
• Tell her she is OK, treat her candidiasis and ask her to
return for a check up in 3 months?
• Treat her candidiasis, begin to explore her knowledge
around HIV, assess her social support, link her with a
clinic-based educator, and have her come back
whenever she feels she is ready to start treatment?
• Do all the steps given above but ask her to return to the
clinic in 1-2 weeks?
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 Small Group Exercise - Quiz

1.How do ARV drugs affect HIV disease?

2.Name the three main classes of ARV drugs?
3.What are the two main enzymes which
current ARV drugs inhibit?
4.What is the main goal of ARV therapy?
5.What are the main advantages of ARV
drugs?
6.When should ARV drugs be started?
7.What main factors are taken in to
consideration before starting patients on
ARV drugs?
ART & Side Effects
 Nurse’s Role:
Educate PLHIV on ART
Short term side effects (3-4 wks)
– Headache
– Vomiting
– Nausea
– Diarrhoea
– Abdominal pain
– Bloating
– Fatigue

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 Nurse’s Role:
Monitoring for Side Effects and Toxicities

• Look for:
– Rash
– Jaundice
– Abdominal pain
– Numbness or pain in extremities
– Pallor
• Report laboratory abnormalities
– Liver function
– Hemoglobin
– Lipase 28
 Nurse’s Role: Monitoring for Serious
Adverse Effects of NRTI’s

Lactic acidosis/Fatty Liver All NRTIs, esp. d4 T & ddl

Anemia ZDV
Pancreatitis ddl
Hypersensitivity Reaction ABC
(Steven-Johnsons Syndrome)
Potentially life threantening
Loss of subcutaneous fat All NRTIs,espd4T
Lipoatrophy
Myopathy ZDV
Neuropathy ddl/d4T

Ascending motor weakness d4T

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 Nurse’s Role: Monitoring for Serious
Adverse Effects of NNRTI’s (contd…)

Hepatitis All NNRTIs,

Potentially life threatening

Hypersensitivity Reaction All NNRTIs,

(Steven-Johnsons Nevirapine
Syndrome)
Potentially life threatening
Central nervous system Efavirenz
symptoms

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Steven-Johnson’s Syndrome

31
 Nurse’s Role: Monitoring for Serious
Adverse Effects of PI’s

Kidney Stones IDV (Indinavir)

Jaundice ATV ( Atazanavir )

Diarrhoea NFV (Nelfinavir ),

RTV (Ritonavir )

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 Exercise 3

1. List the five ARVs used to treat HIV patients in India

2. List the main side effects of each medication –

2.1 Side effects that require immediate attention

2.2 Side effects that can be relieved by the patient at

home

(As the participants call these out, write them up on

a flipchart)
Divide the side effects between 2 groups 33
 Nurse’s Role:
Monitoring ART

• Performing patient self appraisal

• Clinical Examination: e.g. weight

gain, rash,

• Laboratory Testing: e.g. CD4

count monitoring, LFT, Creatinine
34
 ART Case Scenario:
Monitoring
• Mr. X has been on ARV treatment for 3 months. He
missed his last monthly appointment and you contact
the NGO that is helping him

• You learn that he has to travel a long distance to the

ART centre to get his medications. It is difficult for
him to find the time and money to come to the centre

• The last time he visited the centre, he felt that some

staff were judgmental and discriminatory

• He does not want to come back

What would you do? 35
Treatment Failure
and Resistance
 Indications of
ART Treatment Failure

Clinical Failure New or recurrent WHO Stage 4

condition, after at least 6 months of
ART
Immunological  Fall of CD4 count to pre-therapy
Failure baseline (or below); or
 50% fall from the on-treatment peak
value(if known); or
 Persistent CD4 levels below 100
cells/mm3
Virological Plasma viral load > 10,000 copies/ml
Failure

37
 Factors Contributing
to ART Failure

• Suboptimal ARV regimen

• Suboptimal drug level

• Side effects and drug toxicity

• Lack of proper adherence to therapy

38
 Reasons to Change ART

• Reasons to consider ARV drug

substitution:
– Intolerance
– Drug toxicity
– Occurrence of active TB
– Pregnancy
• Reasons to consider ARV regimen
switch:
– ARV treatment failure
39
 What Is Resistance?
• HIV reproduces very rapidly

• The virus often makes errors while copying itself

• Each new generation of viruses differs slightly from the

one before
– This is called mutation

• These mutant forms of HIV may not be sensitive to ARVs

.
• In other words, the ARVs are no longer able to control
HIV.
40
 A Big Concern!

If resistance develops:
• Drugs start failing and the virus is able to replicate
• As virus replicates, immune system is damaged
• OIs occur, progressing to AIDS

Also, there are only limited drug options

available!

41
Development of
Drug Resistance

42
 Nurse’s Role:
Reducing ART Resistance in PLHIV

• Provide adherence support

• Work with patients and their families to minimize

barriers to medication adherence

• Ensure that patients are on triple therapy

• Instruct patients that if ARV medications are to

be discontinued, to stop all drugs at the same
time
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 Jyothi’s Hope Video

Please click on the video above to start the playback.

Adherence
 Compliance vs. Adherence

• Compliance: patient acts in accordance to

instructions given by provider

• Adherence: patient participates and

understands plan of care and treatment
– Implies understanding, consent, and
partnership
– Includes both adherence to
care and adherence
to medications
46
 What is ART Adherence?

• The the patient takes his/her

medications exactly as prescribed:
– Right drug
– Right dose
– Right way
– Every time
• Must be taken more than 95%
of the time
• ARVs must never be shared
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 Barriers to Adherence

Brainstorm with participants what

are some barriers to adherence

48
 Barriers to Adherence

Personal Factors
• Feeling well – PLHA • Forgetting to take pills
doesn’t think he/she • Does not understand
needs the medication purpose of therapy
anymore • No belief in treatment
• Too ill to take efficacy
medications • Debilitating symptoms
• Taking other
• Poor self-esteem,
medications
depression, and
• mental illness
49
 Barriers to Adherence

Socioeconomic Factors
• Expense related to • Cultural or religious
care beliefs (fasting,
• Competing priorities mourning, traditions)
—work, family, food • Substance abuse
access
• Lack of social support
• Stigma & disclosure
issues
•
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 Barriers to Adherence

Medication Factors
• Drug interactions • Pill fatigue/tired of
• Complex regimen taking medicines for
• months/years
Difficult to swallow
• Side effect/s
• Interference with daily
life

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 Barriers to Adherence

Institutional Factors
• Location of centre is • No appropriate
inconvenient, difficult education provided
or expensive to get to • Language &
• Inadequate staffing, communication
insufficient time barriers
• Attitude of clinician &
care team

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 Remember

Maintaining adherence is the

MOST IMPORTANT
factor for successful ARV treatment
and improved health status

Healthcare providers are often unable to

predict who will adhere correctly

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Nurse’s Role in ART
 Nurse’s Role:
Care of a Patient on ART
• Patient education about
ART
• Counselling
• Assessing ART
readiness
• Monitoring ART
• Adherence support
• Communicating with the
Multidisciplinary Team
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 Nurse’s Role:
At ART Centre
• Dispensing Drugs in the absence of
Pharmacist
• Counselling patients on ART adherence
• Assisting and maintaining records and
reports of HIV+ patients
• Ensuring the provision of PEP to health care
workers
• Supervising the Infection control practices
• Management of the ART Centre
• Nursing care and follow-up of patients
admitted in the hospital 56
 ART Case Scenario: Patient
Education & Counselling
Ms. Y is about to start ARV therapy
• She works as a housekeeper from early
morning until the late evening.
• She has not told her employer about her HIV
status, her husband is the only family member
who knows
• She has 3 children and an extended family to
care for

How would you counsel her?

57
 Key Points

• ART is not a cure for HIV/AIDS

• HIV can still be transmitted, even when an
individual is on ART or when HIV viral load are
below the limits of detection
• ART can significantly reduce HIV-related
mortality and morbidity
• For therapy to be effective, patient readiness
must be assessed and triple ARV medications
must be used
• Patients on ART require close monitoring and
frequent evaluation
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 Key Points

• Adherence is a critical component of

ART
• Poor adherence is the most frequent
cause of treatment failure and the
development of resistant strains of HIV
• Nurses play an essential role in all
aspects of ART, including managing side
effects and the promotion of successful
adherence
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Thank You!