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3 Preparation for antiretroviral treatment

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Contents

Objectives

When you have completed this chapter you should be able to:

  1. List the indications for antiretroviral treatment.
  2. Refer a patient for antiretroviral treatment.
  3. Give the reasons for postponing antiretroviral treatment.
  4. State the risks of starting antiretroviral treatment too early or too late.
  5. Prepare a patient for antiretroviral treatment.
  6. Describe the first and second screening visit.
  7. Explain the role of lay counsellors.
  8. Describe ‘treatment readiness’.

Indication for antiretroviral treatment

3-1 When should antiretroviral treatment be started?

Antiretroviral treatment (ART) is best started when a patient’s immune function is still good. Ideally a patient should start ART soon when they are diagnosed with HIV, regardless of the CD4 count. Priority should be given to those patients who are not well (HIV stage 4) and those who have a CD4 count of 200 cells or less.

Antiretrovirals should also be started immediately in all pregnant or breastfeeding women to prevent mother to child transmission of the virus.

ART should preferably be started as soon as possible after a person is diagnosed with HIV, regardless of CD4 count.

3-2 Which clinical signs indicate that antiretroviral treatment should be started?

In 2016, South Africa adopted the Universal Test and Treat Strategy. All people living with HIV should be counselled and encouraged to start ART, regardless of how well they are or of their CD4 count.

ART should be started as soon as possible after HIV diagnosis.

Antiretroviral treatment should start as soon as possible after the diagnosis of HIV infection is made.

3-3 What CD4 count is an indication to start antiretroviral treatment?

ART should be started regardless of the CD4 count, even if the clinical stage is still 1 or 2. The aim of ART is to prevent the CD4 count dropping in order to maintain good health. Also, a suppressed viral load reduces transmission of HIV (‘treatment as prevention’).

3-4 Should patients be asked whether they are ready for antiretroviral treatment?

Yes. It is a major decision to start ART as these patients will have to take drugs every day for the rest of their life. The patients must be fully counselled and given time to consider all the implications. Their opinion is very important and they must agree before treatment is started. They must understand the implications, the benefits and the side effects. Patients must be prepared and ready to start ART. Treatment will fail if the patient is not ready and willing to start.

Patients must be fully informed and willing to start antiretroviral treatment.

3-5 What are the combined medical and personal criteria for preparing a patient for starting antiretroviral treatment?

ART requires commitment to lifelong treatment. Therefore both medical and psychosocial factors are important in deciding when a patient should start ART. People living with HIV (PLWHIV) who have a low CD4 count or who are ill should be prioritised.

Both medical and personal factors must be considered before starting antiretroviral treatment.

Referral for anti­retroviral treatment

3-6 Who should refer a patient for antiretroviral treatment?

As soon as a patient is diagnosed with HIV, whether that is by a lay counsellor at an outreach testing station or by a nurse at a primary care clinic, they should be referred to their local HIV clinic. The decision to start ART is often complex, and patient preparation is so important, the assessment to start ART should be done at an antiretroviral clinic if possible. If a patient with a high CD4 count is not ready to start treatment, they can be referred to the local wellness clinic for regular CD4 testing and counselling in order to encourage them to start ART.

3-7 How should patients be referred to the antiretroviral clinic?

Patients should be sent to the antiretroviral clinic with a full referral letter. A standardised referral letter is helpful. Send the latest CD4 count if available. The patient should take the referral letter to the local ART clinic to get a date for initial screening. Unless the patient is sick, they will usually not be seen on the same day, but will have to return on their date for screening. Keeping appointments is a good index of patient reliability.

Patients should take their referral letter to the local ART clinic to get a date to be screened.

3-8 Who makes the final decision whether a patient should be given antiretroviral treatment?

Ideally it should be the multidisciplinary team at the antiretroviral clinic. The team would consist of the doctor, nurse, counsellor and community care worker. This will ensure that patients are psychosocially ready to start treatment. This is not always possible and many patients are started by the clinician i.e. doctor or NIMART (Nurse Initiated Management of Antiretroviral Therapy) trained nurse without consultation with counsellors or community care workers.

All the important management decisions should ideally be made by a multidisciplinary team.

Problems with starting antiretroviral treatment

3-9 What happens if the criteria for antiretroviral treatment are not met?

The only reason not to start patient on ART is if the patient is not ready to start treatment. If this is the case, and the patient is ill or has a low CD4 count, they should receive intensive counselling in the ART or wellness clinic until they feel ready to start. If the patient is well and has a high CD4 count, they should be retained in a wellness clinic where they will have 6-monthly CD4 count monitoring and counselling until they are ready to start ART. Any psychosocial problems identified during screening should be addressed in all patients. All patients should be provided with counselling to encourage disclosure so that they can obtain social support. Every effort should be made to start all HIV infected people on ART as soon as possible.

3-10 Should psychosocial factors be used as exclusion criteria for antiretroviral treatment?

No. However, psychosocial considerations (emotional, family and community problems) are very important when a patient is being assessed for ART. ART is likely to fail if there are major psychosocial problems. Therefore, provided ART is not urgently required for clinical reasons, it may be postponed until the psychosocial problems have been addressed.

Psychosocial problems are useful in predicting whether treatment is likely to be successful or not but should not be used as an exclusion criterion for antiretroviral treatment.

3-11 What are the common causes for postponing antiretroviral treatment?

ART may be postponed (deferred) if:

  1. The patient is clinically well and not ‘treatment ready’, i.e. is not fully prepared for lifelong ART.
  2. The patient has a major psychosocial problem which needs to be addressed first.
  3. The patient is unreliable and does not attend the clinic regularly.
  4. The patient has an HIV-associated infection (e.g. tuberculosis) which should be treated first.

Treatment however should not be delayed if the patient has a CD4 count below 200 cells/µl, has stage 4 disease, is pregnant or breastfeeding or has drug-resistant TB. In these instances extra counselling support should occur during the first weeks of treatment.

3-12 What problems may result if treatment is started too early?

Starting too early when a patient is not treatment ready may lead to:

  1. Unnecessary cost and inconvenience
  2. Poor adherence to treatment
  3. Drug resistance

Poor adherence and drug resistance will decrease the chances of a good response to ART when it is really needed.

3-13 What may happen if antiretroviral treatment is started too late?

Patients are often ill (HIV stage 3 or 4) and have a low CD4 counts. These patients may die of the complications of HIV infection because ART is started so late. If ART is started so late (e.g. with a CD4 count below 100 cells/µl) the immune system may have been so badly damaged that recovery to full health and normal CD4 count is no longer likely.

The timing of starting antiretroviral treatment is a balance between the risks of starting too early and the dangers of starting too late.

3-14 How long does it take to assess and prepare a patient for antiretroviral treatment?

Usually less than a week. During this time the patient is prepared for the start of ART.

It usually takes less than a week to prepare a patient for antiretroviral treatment.

3-15 Is starting antiretroviral treatment ever an emergency decision?

Starting ART is never an emergency but it is urgent. Wherever possible, patients must be fully prepared before treatment is started and this always takes time. Preferably do not rush the decision or force patients who are well to start ART before they are ready. Patients must show a commitment to take their medication correctly and follow instructions. However, in some cases the preparation may need to be as fast as possible, e.g. pregnant and breastfeeding women or patients with CD4 counts below 100 cells/µl or stage 4 disease.

Note
Patients with TB meningitis or Cryptococcal meningitis should have their ART delayed until 4-6 weeks after starting their treatment for TBM or CM. Staring ART earlier for these patients increases the risk of death due to immune reconstitution inflammatory syndrome (IRIS).

The decision to start antiretroviral treatment usually is not an emergency but an urgent one.

3-16 What psychosocial factors should be considered before starting antiretroviral treatment?

  1. Patients must show that they are both motivated and reliable. Otherwise adherence to treatment will be poor and they will not attend clinic regularly.
  2. They must accept their HIV status and have a good understanding of HIV infection and ART.
  3. There should be no unmanaged alcohol or drug abuse.
  4. They should not have untreated active psychiatric conditions such as depression.
  5. They are strongly advised to disclose their status to at least 1 person for social support.
  6. They must have access to an HIV clinic.
  7. They should have the support of their partner, a friend or family member.

Preparing for anti­retroviral treatment

3-17 Why is it important to prepare the patient starting antiretroviral treatment?

If the treatment is begun before the patient is ready to start treatment, there will almost certainly be poor adherence. The success or failure of ART often depends on whether the patients have been well prepared or not. One of the main reasons for treatment failure and poor co-operation from patients is inadequate preparation.

Inadequate preparation is an important cause of poor co-operation and treatment failure.

3-18 Why is excellent adherence so important?

It is very important that HIV patients take their correct medication on time every day. Poor adherence to taking medicine correctly leads to HIV resistance to 1 or more of the antiretroviral drugs (ARVs) being used. This reduces the drug options later in the course of the illness. The first regimen of ARVs is the easiest to take with the fewest side effects. Taking it correctly is the simplest way for the patient to be healthy and well for many years.

Excellent drug adherence is extremely important for the successful management of AIDS.

3-19 What are the aims of preparing a patient for antiretroviral treatment?

  1. The patient must have a good understanding of HIV infection.
  2. The names, dosing and timing of the antiretroviral agents should be learned. Patients should be taught to recognise their different drugs.
  3. The risks and symptoms of side effects must be known.
  4. The importance of excellent adherence must be understood and accepted.
  5. Disclosure to a partner, close family and friends should be encouraged.
  6. Social support is essential.
  7. The patient must learn a healthy lifestyle.
  8. The patient must accept regular follow-up care.

3-20 What issues should be discussed with patients before starting antiretroviral treatment?

  1. The purpose of giving ART is to give them a longer, healthier life and to reduce the spread of HIV.
  2. ART cannot cure HIV infection.
  3. They will still be infectious and be able to pass on HIV even while on treatment, but the risk is negligible if ART is taken properly and the virus is suppressed.
  4. Treatment is life long.
  5. The drugs must be taken correctly every day for the treatment to be effective.
  6. They will need regular blood tests and clinical check-ups.
  7. Side effects to the treatment may occur.
  8. They should find a treatment supporter.
  9. They need to consider the effects of daily treatment on their lifestyle.

Screening visits

3-21 What visits to the antiretroviral clinic are needed before treatment is started?

  1. The first visit is usually the patient’s first contact with the antiretroviral clinic. The patient should receive a clinical assessment at this visit, have baseline bloods taken and receive information on the pre-treatment counselling programme.
  2. The second visit may be used to prepare the patient for treatment and assess whether the patient is ready for lifelong ART. If the patient is ready to start, they would be started at this visit. This should be within 7 days of the 1st visit.

All patients should, ideally, be started on treatment on the same day or within 7 days of diagnosis unless there is a clinical or psychosocial contraindication to an early start. Treatment readiness sessions are done while they start ART.

3-22 What should be done at the first visit?

  1. A doctor or NIMART trained nurse should check the clinical or immunological criteria to see if the patient should be fast-tracked for ART or not. This requires a general medical screening examination.
  2. Identify any psychosocial problems.
  3. Make sure that tuberculosis has been excluded. This may require sputum tests and possibly a chest X-ray.
  4. Screen for Cryptococcus if the CD4 is less than 100 cells.
  5. Diagnose and treat any HIV-associated infection.
  6. The patient’s information record must be completed.
  7. The patient must meet or be referred to the counselling team for group education and/or individual counselling.
  8. Supply a 28-day supply of co-trimoxazole tablets, if required.
  9. Give the patient an appointment for the next visit (usually the second visit is in 1 to 2 weeks’ time).
  10. Arrange a home visit, if possible.

3-23 What general medical screening examination is necessary?

  1. Take a medical history.
  2. Obtain details of the patient’s social circumstances.
  3. Find out whether the patient has disclosed their HIV status to their partner and close family and friends.
  4. Ask what family and community support is available.
  5. Perform a full general physical examination.

3-24 What medical history is needed?

  1. Any symptoms or signs of HIV and associated infections.
  2. Recent weight loss.
  3. Recent hospital admissions.
  4. Recent history of TB.
  5. Any sexually transmitted diseases.
  6. General medical history including diabetes, hypertension, epilepsy.
  7. Current medication or allergies.

3-25 What social history is important?

  1. Age.
  2. Find out whether the patient understands what AIDS is and what the implications of the diagnosis are.
  3. Family structure and home environment.
  4. Sexual relationships and condom use.
  5. Whether women are on reliable contraception and if pregnancies are planned.
  6. Employment and family income.
  7. Available support.
  8. Disclosure.
  9. Alcohol or drug abuse.
  10. Severe emotional problems, e.g. depression.

3-26 What physical examination is required?

  1. Full general physical condition.
  2. Any signs of weight loss.
  3. Clinical signs of HIV and associated infections.
  4. Assess the clinical stage of the patient.

3-27 Who should prepare a patient for antiretroviral treatment?

This is best done by the multidisciplinary staff of the health centre where ART is started. The doctor, nurse, counsellor, and pharmacist all play an important role in preparing a patient for ART. Sometimes patients are referred for special treatment readiness classes.

Patients should attend a treatment readiness programme, if their ART clinic provides one.

3-28 What are the steps in preparing a patient for antiretroviral treatment?

  1. Education
  2. Counselling

3-29 What education is needed?

The patient needs to:

  1. Understand what HIV infection is
  2. Understand what antiretroviral treatment is
  3. Know the names and appearance of the ARVs to be used
  4. Know the dose and how to take these drugs correctly
  5. Know the symptoms and signs of the side effects
  6. Know about the common HIV-associated infections
  7. Know that a good diet and a positive lifestyle are important

The trade name and appearance of the drugs may change depending on which generic is being provided at the clinic at the time. It is important that patients can recognise the generic name of the drug in case the trade name and appearance change. If patients are not sure if they are being provided the correct treatment, they should be encouraged to ask why the name and appearance of the medication has changed.

Patients need to understand antiretroviral treatment (‘patients must know their meds’). It is particularly important that patients accept that excellent adherence is essential and that they understand that resistance is dangerous, and that failure of treatment and emergence of resistance are usually due to poor adherence.

Patients need to know about the drugs they will be taking.

3-30 How is education provided?

  1. During individual counselling sessions
  2. In group education classes or waiting room education
  3. With pamphlets on HIV infection and ART
  4. Posters and videos are helpful
  5. A treatment chart illustrating the drugs, timing of doses and possible side effects

3-31 What counselling is needed?

The patient may need help in accepting their HIV status and the importance of ART. They may also have difficulty disclosing their HIV status and finding someone who can support them. All patients preparing for ART should be encouraged to join a support group. Patients need an opportunity to talk about their fears and concerns. Counselling empowers patients to make the best decisions for themselves and take control of their lives. It helps them understand, accept and make choices.

Disclosure and support are very important for successful treatment.

3-32 Why and for whom is co-trimoxazole prophylaxis started?

Co-trimoxazole provides protection against pneumocystis pneumonia, toxoplasmosis, malaria, many bacterial infections and some causes of chronic diarrhoea.

The 2015 South African ART Guidelines advise co-trimoxazole for those adults who are WHO stage 2, 3 or 4 or have a CD4 of 200 cells or less. It is safe to use in pregnancy and children.

3-33 How and when is co-trimoxazole prophylaxis given?

The dose of co-trimoxazole is 160/800 mg daily. This can be given as 2 single-strength tablets or 1 double strength tablet per day. The most common side effect is a maculopapular rash. Continue the co-trimoxazole if the rash is mild. Stop immediately if the rash is severe or blistering, the mucous membranes are involved, or the patient becomes ill with fever or develops hepatitis.

Since the side effects of co-trimoxazole and ART are similar, they should not be started at the same time. Co-trimoxazole should be started at the first visit.

Co-trimoxazole can be stopped when the patient is well on ART and can be restarted if any new opportunistic infections develop.

Note
Dapsone can be used if patients have severe side effects to co-trimoxazole but the protection it gives is not as good as co-trimoxazole.

3-34 Can the degree of drug adherence be assessed before starting antiretroviral treatment?

Yes, as patients who are not adherent to prophylactic co-trimoxazole will probably not adhere to ART. Patients should bring their unused tablets to each clinic visit. These should be counted to assess adherence. If all the tablets needed have not been taken, the patient should be counselled to find out why adherence is poor. The advantages and importance of excellent adherence must again be stressed.

Adherence to co-trimoxazole is a good indicator of adherence to antiretroviral treatment.

3-35 Is a home visit always needed?

A home visit is very helpful to assess the home circumstances and family support, and whether the patient has provided the correct contact and social details. A reliable home address is essential and a telephone contact number is useful. A home visit also helps to determine whether the patient has disclosed their HIV status.

3-36 Who does the home visit?

This is usually done by a lay counsellor who has taken on the role of community care worker or home based carer.

3-37 What are the benefits of lay counsellors?

Some lay counsellors are on ART themselves. They have a personal understanding of what it means to be living with HIV and to successfully adhere to treatment. As a result, these lay counsellors are good role models for patients starting ART.

Lay counsellors undergo careful training which provides them with the knowledge and skills to function in their new role as counsellors and educators. Without lay counsellors, most antiretroviral clinics would not be able to function. They are essential members of the treatment team as they know the community well, usually speak the patients’ home language and help to maintain close contact between patients and the clinic.

Lay counsellors promote a healthy lifestyle and often follow up the patient once ART is started. Tracing patients that fail to collect their medicines regularly or miss a clinic appointment is another important function.

Lay counsellors are invaluable members of the treatment team.

3-38 Should patients have their own counsellor?

A personal counsellor is a great advantage if it is possible to have one. Often the success of ART depends on the help and support of a lay counsellor. The counsellor should develop a special, caring relationship with the patient. They can perform the home visit, meet the patient at each clinic visit and act as the contact between the patient and the clinic team.

It is a great advantage if each patient can have a personal counsellor.

3-39 What should be done at the second clinic visit?

The second visit is usually arranged within 7 days of diagnosis. During this time the patient has had some time to consider the implications of ART. The following should be done at the second assessment visit:

  1. If the patient is unwell, a clinical assessment should be repeated.
  2. A second group or individual education and information session is provided.
  3. The patient is again counselled about the importance of excellent adherence.
  4. The co-trimoxazole tablets may be counted (pill count) to assess adherence.
  5. Blood results are checked and tests are repeated if necessary.

The second visit should be followed by a multidisciplinary team discussion, if this service is available.

3-40 What baseline blood tests are needed?

The baseline CD4 count has usually been done before the patient is referred for treatment consideration and, therefore, need not be repeated. If the CD4 count was not measured, this should be done at the screening visit.

Special blood tests depending on the likely side effects of the specific drugs being used:

  1. Creatinine for creatinine clearance if tenofovir (TDF) is required.
  2. Haemoglobin level (Hb) and differential white count (or full blood count) if AZT (zidovudine) is required.
  3. Serum ALT (alanine aminotransferase) if nevirapine is required.
  4. Fasting serum cholesterol and triglycerides if a PI such as lopinavir/ritonavir (Aluvia) is required.
Note
To calculate creatinine clearance: (140 – age in years) × weight in kg / serum creatinine concentration (× 0.85 in women)

Other routine baseline tests:

  1. RPR to check for syphilis if not done by referring clinic.
  2. Cryptococcal latex agglutination test (CLAT) should be done on all patients with a CD4 below 100 cells/µl to identify patients who require cryptococcal meningitis prophylaxis with fluconazole.
  3. Urine pregnancy test in all women of reproductive age.
  4. Screen for hypertension by checking blood pressure.
  5. Screen for diabetes by checking for glycosuria on urine dipstix.
  6. All women who have not had a pap smear in the last 3 years should also have a pap smear, or have a booking for a pap smear made.
Note
Patients with a positive CLAT and no symptoms of meningitis should be treated with 800 mg fluconazole by mouth daily for 2 weeks, then 400 mg daily by mouth for 8 weeks, then 200 mg per day until the CD4 count is below 200 cells/µl for at least 6 months.

3-41 What should be done when patients are ready for treatment?

Once it is agreed that ART should be started, the drug regime and doses must be decided on and the patient should start ART within 7 days of diagnosis. It is helpful to have a system which maintains a close check on medication collected as this helps to assess adherence.

Case study 1

A patient who has had symptomatic HIV infection for the past year is referred to an antiretroviral clinic for treatment. Her CD4 count is 150 cells/µl and she has been clinic­ally graded as stage 4. She is unhappy about starting treatment as she does not want to disclose her HIV status to her partner and family. She has a chronic cough.

1. Does her immunological status meet the criteria for antiretroviral treatment?

Yes, ART is started regardless of immunological status. Her CD count also indicates that her immune function is depressed and she is at high risk of contracting an opportunistic infection unless she receives ART.

2. Is stage 4 disease a criteria for treatment?

Yes. Stage 4 HIV infection (i.e. AIDS), with or without a low CD4 count, is a criteria for treatment. She therefore meets both the immunological and clinical criteria for treatment. An urgent need to immediately begin ART is known as fast tracking.

3. Do you think she should start on antiretroviral treatment?

Not yet, as she has psychosocial problems. She is also not happy about starting treatment. She should be referred to the counsellor to get intensive counselling support. Also, she has a cough and so TB should be excluded before ART is initiated.

4. Should psychosocial factors exclude her from treatment?

No, but she should be counselled. Without disclosure, support and a firm commitment to daily medication, she will likely struggle with adherence to ART. A patient like this is difficult because the longer treatment is delayed, the greater her chance of dying from an opportunistic infection.

5. If she has tuberculosis should the antiretroviral treatment be postponed?

Yes, as she has a CD4 count above 50 cells/µl she should start ART 2 to 8 weeks after starting treatment for tuberculosis.

Case study 2

A patient who meets the criteria for treatment attends his first screening visit. He is very keen and wants treatment to start immediately.

1. Should he be offered treatment immediately as he wants to start straight away?

Yes. Treatment should be started either on the same day or within 7 days of diagnosis. HIV and treatment counselling should still happen while starting treatment.

2. What should be done at the first screening visit?

A careful history should be taken and a full physical examination done. Counselling and education sessions must be started and co-trimoxazole started if required. ART should be started on this visit, if there are no contraindications on assessment such as suspected TB or Cryptococcus infection.

3. Who should provide the counselling and education?

All the members of the multidisciplinary team play a role. Individual counselling is important. Pamphlets, videos and posters are helpful, if available. A group education course may be available.

4. What must the patient learn about antiretroviral treatment?

He must know what drugs are to be taken, the dose and timing of treatment, and the side effects. He must ‘know their meds’. The importance of excellent adherence must be stressed at every meeting. He must be aware of the risks and advantages of treatment.

5. Why should he start co-trimoxazole?

It prevents many of the infections associated with HIV. It is also a measure of the patient’s willingness to take regular medication. A ‘pill count’ assesses whether all doses have been taken. Taking all his co-trimoxazole tablets as prescribed suggests he will also adhere to ART.

6. What is the most important lesson to learn about taking antiretroviral drugs?

For successful treatment drug adherence must be excellent.

Case study 3

After the first screening appointment a home visit is arranged. This is done by a community care worker. The community care worker discovers that the patient is drinking heavily over weekends.

1. What is the aim of the home visit?

To help assess the home circumstances, especially disclosure and support. It is also important to confirm the home address and contact phone number.

2. Should the home visit not be done by a professional counsellor?

Usually there are not enough professional counsellors to do all the home visits. Therefore community care workers or home based carers often perform this function. They are well trained and employed by an organisation the specialises in providing this service to the clinic and community.

3. What are the advantages of a community care worker?

They sometimes are HIV positive and well managed on ART. As a result they have personal experience of the problems of HIV management. They come from the local community and have a good understanding of the social circumstances. Usually the community care worker can speak the patient’s home language. The community care worker is a good role model for the patient starting ART.

4. Would alcohol abuse be a contra­indication for starting antiretroviral treatment?

Yes, if uncontrolled. So would untreated active depression or drug abuse. These problems would need to be successfully managed before treatment could start. Discovering this problem stresses the importance of a home visit. The decision about when to start ART would need to be individualised on a case-by-case basis.

5. What other support can a lay counsellor provide?

They help with counselling and education. Lay counsellors keep close contact between patients and the clinic. They help promote a healthy lifestyle with a positive outlook.

Case study 4

A patient attends the screening visit. After she is seen by the doctor, blood samples are taken. She is assessed for treatment readiness and told to return within 7 days.

1. What blood tests are done at the screening visit?

A CD4 count is done if this has not already been checked. Additional blood tests are done depending on the drugs to be used:

  1. Serum creatinine for TDF
  2. A Hb (haemoglobin) test or full blood count for AZT
  3. Serum ALT for nevirapine
  4. Cholesterol and triglyceride for lopinavir/ritonavir.

2. Who decides when a patient is ready to start treatment?

The multidisciplinary team and the patient. The decision should not be taken by the doctor alone.