3 Preparation for antiretroviral treatment

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

Indication for antiretroviral treatment

3-1 When should antiretroviral treatment be started?

Antiretroviral treatment (ART) is best started when a patient’s immune function begins to decrease. This is indicated by either one or both of the following:

  1. The clinical symptoms and signs
  2. The CD4 count

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

Antiretroviral treatment should preferably be started before a patient’s immune system begins to fail.

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

The 2014 South African treatment guidelines recommend that antiretroviral treatment should be started when the patient reaches clinical stage 3 or 4 disease.

All pregnant and breastfeeding women and all patients with Hepatitis B or TB should start ART irrespective of their CD4 count.

Antiretroviral treatment should be started when stage 3 or 4 is reached.

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

Antiretroviral treatment should be started when the CD4 count falls below 500 cells/µl, even if the clinical stage is still 1 or 2. The aim of antiretroviral treatment is to prevent the CD4 count dropping further.

3-4 Are both the clinical stage and the CD4 count equally important indicators for antiretroviral treatment?

Yes. Both the clinical stage of HIV infection and the CD4 count should be considered when deciding on whether to start antiretroviral treatment or not. Either the clinical stage of HIV infection (e.g. stage 3 or 4) or the CD4 count (e.g. below 500 cells/µl) may be used as an indication to start treatment. Therefore, treatment is indicated in a patient who is stage 2 but with a CD4 count below 500 cells/µl. Similarly, treatment should be started in all stage 4 patients even if their CD4 count is still above 500 cells/µl.

Both the clinical stage of HIV infection and the CD4 count are used as independent indicators for starting antiretroviral treatment.

A low CD4 count is the most common scenario for starting antiretroviral treatment.

3-5 Should patients be asked whether they are ready for antiretroviral treatment?

Yes. It is a major decision to start antiretroviral treatment 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 antiretroviral treatment. Treatment will fail if the patient is not ready and willing to start.

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

3-6 What are the combined medical and personal criteria for preparing a patient for starting antiretroviral treatment?

Patients should have a CD4 count below 500 cells/µl or stage 3 or 4 disease plus a readiness and commitment to lifelong treatment. Therefore both medical and psychosocial factors are important in deciding when a patient should start antiretroviral treatment.

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

Referral for anti­retroviral treatment

3-7 Who should refer a patient for antiretroviral treatment?

The nurse at the HIV clinic or general primary-care clinic, if an HIV clinic is not available. As the decision to start antiretroviral treatment is often complex, and as patient preparation is so important, this assessment should be done at an antiretroviral clinic if possible. All HIV clinics should know the criteria for patient referral. Patients should not be referred for antiretroviral treatment before the criteria are met.

3-8 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. An appointment should be made. The patient must be told the venue, date and time of the appointment. Keeping appointments is a good index of patient reliability.

Patients who meet the criteria for treatment should be referred to the antiretroviral clinic.

3-9 Who makes the final decision whether a patient should be given antiretroviral treatment?

The multidisciplinary team at the antiretroviral clinic. The team consists of the doctor, nurse, counsellor and community care worker.

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

Problems with starting antiretroviral treatment

3-10 What happens if the criteria for antiretroviral treatment are not met?

The patient is referred back to their local clinic with a letter providing the reasons why the patient has not been accepted for antiretroviral treatment. The local clinic should follow these patients and refer them again to the antiretroviral clinic when the criteria (stage 3 or 4 or CD4 count below 500 cells/µl) have been met. Any psychosocial problems identified during screening should be addressed. Patients should be provided with counselling to encourage disclosure so that they can obtain social support.

3-11 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 antiretroviral treatment. Antiretroviral treatment is likely to fail if there are major psychosocial problems. Therefore, provided antiretroviral treatment 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.

3-12 What are the common causes for postponing antiretroviral treatment?

Antiretroviral treatment is postponed (deferred) if:

  1. The patient does not meet the medical criteria (staging or CD4 count).
  2. The patient is clinically well and not ‘treatment ready’, i.e. is not fully prepared for lifelong antiretroviral treatment.
  3. The patient has a major psychosocial problem which needs to be addressed first.
  4. The patient is unreliable and does not attend the clinic regularly.
  5. 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 100 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.

3-13 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
  4. Side effects

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

3-14 What may happen if antiretroviral treatment is started too late?

Patients may die of the complications of HIV infection if antiretroviral treatment is started too late. Therefore, the correct timing of starting treatment is very important and is a balance between the risks of poor adherence, drug resistance and side effects if started too early, and the risk of serious illness if started too late. If antiretroviral treatment is started too late (e.g. with a CD4 count below 100 cells/µl) the immune system may have been so badly damaged that full recovery is no longer possible.

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

3-15 How long does it take to assess and prepare a patient for antiretroviral treatment?

Usually two to four weeks. During this time the patient is prepared for the start of antiretroviral treatment.

It usually takes two to four weeks to prepare a patient for antiretroviral treatment.

3-16 Is starting antiretroviral treatment ever an emergency decision?

Starting antiretroviral treatment is never an emergency. But sometimes the indication to start may be urgent and treatment should not be unnecessarily delayed. 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 antiretroviral treatment 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 100cells/µl or stage 4 disease.

Starting antiretroviral treatment becomes urgent when the patient is demented or very weak and ill. In many of these cases the patient will die if treatment is delayed until they are fully prepared.

Patients with TB meningitis or Cryptococcal meningitis should start ART within 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 and must not be rushed.

3-17 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 antiretroviral treatment.
  3. There should be no unmanaged alcohol or drug abuse.
  4. They should not have untreated active depression.
  5. They are strongly advised to disclose their status to at least one person.
  6. They must have access to an antiretroviral centre and HIV clinic.
  7. They should have the support of their partner, a friend or family member.

Preparing for anti­retroviral treatment

3-18 Why is it important to prepare the patient before 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 antiretroviral treatment 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.

3-19 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 one or more of the antiretroviral drugs being used. This reduces the drug options later in the course of the illness. Taking the first regimen of antiretroviral drugs correctly is the best chance the patient has to be healthy and well for many years.

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

3-20 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 must 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.

3-21 What issues should be discussed with patients before starting antiretroviral treatment?

  1. The purpose of giving antiretroviral treatment is to give them a longer, healthier life.
  2. Antiretroviral treatment cannot cure HIV infection.
  3. They will still be infectious and be able to pass on HIV even while on treatment.
  4. Treatment is lifelong.
  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

3-22 What visits to the antiretroviral clinic are needed before treatment is started?

Usually two treatment readiness visits are needed, followed by the final visit when 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.
  3. At the third visit, a final decision is made and, if the patient is ready, treatment is started.

Usually two visits are needed to fully assess a patient for antiretroviral treatment.

3-23 What should be done at the first visit?

  1. A doctor or ART trained nurse should confirm that the clinical or immunological selection criteria for antiretroviral treatment have been met. This requires a general medical screening examination.
  2. Identify any psychosocial problems.
  3. Make sure that tuberculosis has been excluded. This may require a chest X-ray and sputum tests.
  4. Diagnose and treat any HIV-associated infection.
  5. The patient’s information record must be completed.
  6. The patient must meet or be referred to the counselling team for group education and/or individual counselling.
  7. Supply a 28-day supply of co-trimoxazole tablets.
  8. Give the patient an appointment for the next visit (usually the second visit in two weeks’ time).
  9. Arrange a home visit, if possible.

3-24 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 his/her 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.

3-25 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. Current medication or allergies.

3-26 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.

3-27 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.

3-28 Who should prepare a patient for antiretroviral treatment?

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

Patients need to attend a treatment readiness programme.

3-29 What are the steps in preparing a patient for antiretroviral treatment?

  1. Education
  2. Counselling

3-30 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 antiretroviral drugs 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 patient needs to understand antiretroviral treatment (‘patients must know their meds’). It is particularly important that the patient accepts that excellent adherence is essential and understands that resistance is dangerous, and that failure of treatment and resistance are usually due to poor adherence.

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

3-31 How is education provided?

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

3-32 What counselling is needed?

The patient may need help in accepting their HIV status and the importance of antiretroviral treatment. They may also have difficulty disclosing their HIV status and finding someone who can support them. All patients preparing for antiretroviral treatment 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 needed for successful treatment.

3-33 Why is co-trimoxazole prophylaxis started?

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

3-34 How is co-trimoxazole prophylaxis given?

Two single-strength tablets daily (i.e. 80/400 mg). The commonest 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.

Dapsone can be used if patients have severe side effects to co-trimoxazole.

3-35 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 antiretroviral treatment. 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.

3-36 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 his/her HIV status.

3-37 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.

3-38 What are the benefits of lay counsellors?

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

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 antiretroviral treatment is started. Tracing patients that fail to collect their medicines regularly or miss a clinic appointment is an important function.

Lay counsellors are valuable members of the treatment team.

3-39 Should patients have their own counsellor?

A personal counsellor is a great advantage if it is possible to have one. Often the success of antiretroviral treatment 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.

3-40 What should be done at the second clinic visit?

The second visit is usually arranged for one to two weeks after the first visit. During this time the patient has had time to consider the implications of antiretroviral treatment. 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 education and information session is provided.
  3. The patient is again counselled about the importance of excellent adherence.
  4. The co-trimoxazole tablets are counted (pill count) to assess adherence.
  5. Blood results are checked and tests are repeated if necessary.

The second visit is followed by a multidisciplinary team discussion.

3-41 What is the multidisciplinary team discussion?

Following the second visit the patient must be assessed for readiness for antiretroviral treatment by a multidisciplinary team. This is done by the whole treatment team and not just one person. All the available information must be ready for the discussion (clinical assessment, results of the two educational and counselling sessions and a home visit report if possible). This is the final check that the patient is fully prepared for treatment.

Patients who are ready for treatment should be given an appointment to start their antiretroviral treatment.

3-42 What is a treatment plan?

The treatment plan is the formal guide to the patient’s future management. Each patient must be fully aware of their own treatment plan. Usually the treatment plan is given to each patient as a printed form.

It is essential that each patient has a clearly understood treatment plan.

3-43 When are patients ‘treatment ready’?

  1. They show a willingness for treatment.
  2. They demonstrate insight into their illness.
  3. They accept that lifetime treatment is required.
  4. They understand the possible side effects of antiretroviral treatment.
  5. They recognise the importance of excellent daily adherence.
  6. They have preferably disclosed to a family member or friend who can support them.
  7. They are able to attend the clinic regularly.
  8. They must know the names and recognise which drugs are to be taken.
  9. They must know the symptoms and signs of common side effects.

If patients are not treatment ready yet and are clinically well, the start of antiretroviral treatment may be postponed until they are ready and all the requirements have been met.

3-44 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. Haemoglobin level (Hb) and differential white count (or full blood count) if AZT (zidovudine) is used
  2. Serum ALT (alanine aminotransferase) if nevirapine is used
  3. Fasting serum glucose, cholesterol and triglyceride if ‘PIs’ such as lopinavir/ritonavir (Aluvia/Kaletra) are used
  4. Creatinine for creatinine clearance if tenofovir (TDF) is being used
To calculate creatinine clearance: (140 – age in years) × weight in kg / serum creatinine concentration (× 0.85 in women)

Other routine baseline blood 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.
Patients with a positive CLAT and no symptoms of meningitis should be treated with 800mg fluconazole by mouth daily for 2 weeks, then 400mg daily by mouth for 8 weeks, then 200mg per day until the CD4 count is below 200cells/µl for at least 6 months.

3-45 What should be done when patients are ready for treatment?

They should be asked to continue their co-trimoxazole prophylaxis and be given an appointment for their next visit in one to two weeks when antiretroviral treatment will begin.

Once it is agreed that antiretroviral treatment should be started, the drug regime and doses must be decided on and the drugs should be ordered from the pharmacy. It is helpful to have a system which maintains a close check on medication collected.

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, as her CD4 count is below 500 cells/µl. This indicates that her immune function is depressed and she is at high risk of contracting an opportunistic infection unless she receives antiretroviral treatment.

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.

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

No, as she has psychosocial problems. She is not happy about starting treatment and has not disclosed her status to either her partner or family.

4. Should psychosocial factors exclude her from treatment?

No, but she should be counselled and be helped to become ‘treatment ready’. Without disclosure, support and a firm commitment to daily medication, she will almost certainly not succeed with antiretroviral treatment.

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 antiretroviral treatment 2 to 8 weeks after starting treatment for tuberculosis.

Case study 2

A patient who meets both the medical and psychosocial 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?

No. It is always important to make sure that the patient is well prepared before starting treatment. Starting antiretroviral treatment is not an emergency.

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

A careful history should be taken and a full physical examination done to confirm that all the criteria for treatment have been met. Counselling and education sessions must be arranged and co-trimoxazole started.

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. 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 his drugs’. 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 antiretroviral treatment.

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 the clinic.

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

They sometimes are HIV positive and well managed on antiretroviral treatment. 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 antiretroviral treatment.

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.

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 to the clinic for treatment readiness classes.

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:

2. When are patients ‘treatment ready’?

When they are willing to accept that treatment is for life and excellent adherence is the key to successful treatment. They must understand how to take their medication correctly and know what side effects to expect. They should also be able to attend clinic regularly, have preferably disclosed their HIV status and have good home support.

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

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