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NANASI 13: April 2003

NANASI 13: April 2003

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In this issue of NANASI:

  • Q & A: Is counseling always required ?
  • Special course: "Setting up palliative care programs for the terminally ill"
  • ARV drugs available from MEDS
  • Update: ARV regimens and current prices in Kenya
  • Q & A: How important are CD4 tests ?

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Q & A: Is counseling always required?    

Situation: 
In a large hospital in Central Province, a visiting physician noted a comatose patient in the general medical ward. When asked what diagnostic studies had been done, the treating doctor listed a number of appropriate studies, but did not include an HIV test. The visiting physician asked why not; and the doctor replied that since the patient was comatose, no pre-test counseling could be done. Since the patient's family had not come to the hospital, no permission had been granted to test for HIV.

It is likely that this patient suffered from AIDS-related cryptococcal meningitis. No treatment had been started because no diagnosis had been made, because no permission had been given and no pre-test counseling could be done while the patient was in coma.

Question: 
Must pre-test counseling be done and permission obtained for all patients before testing for HIV? Such preliminaries are not required for other tests. It seems that waiting for pre-test counseling and permission can delay diagnosis and treatment to the detriment of the patient.  What do the guidelines say? What do the experts say?

Answer:
The above case illustrates an absurd, tragic and unintended interpretation of official guidelines on HIV testing.  Any patient in crisis should be tested without waiting for permission or counseling, if the test result will have a direct bearing on his care and well-being.  A person who enters hospital for diagnosis and treatment already is presumed to have given his consent to all tests necessary for his care.

The guidelines which recommend testing only after counseling and permission, while commendable, were never intended to subvert or impede the diagnosis and care of a sick patient.  For this misinterpretation of the intention of the guidelines, the above treating doctor could be guilty of medical negligence for NOT testing the comatose patient.

Four kinds of testing

Dr. Kevin DeCock, AIDS expert at CDC-KEMRI in Nairobi, points out the different circumstances in which one should test for HIV. In THE LANCET of 6 July 2002, Dr. DeCock distinguishes four types of HIV testing situations:

  1. Mandatory testing required for blood donations, candidates for the military and other special occupational groups.  No consent or pre-test counseling is required. The test is mandatory.
  2. Voluntary testing with counseling  (VCT) for persons in obvious good health, who wish to know their sero-status in order to change life styles and prevent infecting other persons.  Here permission and pre-test counseling are required.
  3. Delivery of prevention services for persons who, in a program where disease prevention is available, should be tested as part of a routine health assessment. This type of testing is desirable in ante-natal clinics where Prevention of Mother to Child Transmission (PMTCT) is available. Here HIV testing should be routine as is VDRL and hemoglobin testing. All clients should know that everybody is tested routinely for these conditions.  Consent is implied and openly assumed without the need for pre-test counseling.
  4. Diagnostic testing is required for persons who come for diagnosis and treatment of their illness. A proper diagnosis cannot be made nor adequate treatment instituted if certain common tests cannot be done without conditions such as special permission and counseling.  Such a withholding of medical procedures is incompatible with good or standard medical care anywhere. A sick patient who comes for care implicitly gives his consent for diagnostic tests.

In the case above, the treating doctor, who is responsible for the care of the comatose patient had failed to distinguish between Type 2 testing (Voluntary) and Type 4 (Diagnostic).


* * * * *    Update --  April 2003   * * * * *

ANTI-RETROVIRALS (ARVs) FOR ADULTS AND ADOLESCENTS

WHEN TO BEGIN ARVs

WHO stage I -- Healthy HIV-infected patients with no symptoms -- Do not start ARVs yet.
WHO stage II -- HIV-infected patients with mild symptoms or lymphocyte count >1,200
or CD4 count >200  - Do not start ARVs yet.
WHO stage III -- HIV-infected patients with advanced symptoms such as severe fatigue, persistent oral thrush, chronic diarrhea, tuberculosis or recurrent skin infections  --   Start ARVs.
WHO stage IV -- Bed-ridden HIV-infected patients with multiple symptoms  --  Start ARVs.

Today's cheapest, WHO-approved, first-line 3-drug ARV regimens available from MEDS in Nairobi. Prices are low because MEDS purchases WHO-approved generic formulations whenever possible. MEDS pharmacy consultants certify all generic formulations for effectiveness and safety.

PLEASE NOTE: The price of a regimen does not indicate the effectiveness of that regimen; a higher priced regimen does not mean a better regimen. Different regimens sometimes are dictated by side effects (e.g., skin rash) or by physical state (such as pregnancy or liver disease) or by other drugs being taken (for example, Rifater). If one regimen is already being taken, usually it is best to keep taking that regimen, even if it costs more. Changing regimens without a clear medical indication leads to the development of drug resistance.

Regimen A
weight <60 kg.    
stavudine  30 mg. bid KSh 310
lamivudine 150 mg. bid KSh 944
nevirapine 200 mg. bid KSh 1,551
total cost per month = KSh 2,805

weight >60 kg.
stavudine 40 mg. bid KSh 351
lamivudine 150 mg. bid KSh944
nevirapine 200 mg. bid KSh 1,551
total cost per month = KSh 2,846

Regimen B
weight <60 kg.             
stavudine 30 mg. bid KSh 310
didanosine 250 mg. daily KSh 1,650
nevirapine 200 mg. bid KSh 1,551
total cost per month = KSh 3,511

weight >60 kg.
stavudine 40 mg. bid KSh 351
didanosine 400 mg. daily KSh 2,130
nevirapine 200 mg. bid KSh 1,551
total cost per month = KSh 4,032

Regimen C
weight < 60 Kg.   
stavudine 30 mg. bid Ksh 310
lamivudine 150 mg. bid KSh 944
efavirenz 600 mg, nocte KSh 2,625  
total cost per month KSh 3,879

weight > 60 Kg.
stavudine 40 mg. bids. KSh 351
lamivudine 150 mg. KSh 944
efavirenz 600 mg. nocte KSh 2,625
total cost per month KSh 3,920

Regimen D
weight <60 Kg.
stavudine 30 mg.bid KSh 310   
didanosine 250 mg daily Ksh 1,650
efavirenz 600 mg. nocte KSh 2,625
total cost per month KSh 4,585

weight > 60Kg
stavudine 40 mg. bid KSh 351
didanosine 400 mg. daily KSh 2,130
efavirenz 600 mg. nocte KSh 2,625
total cost per month Ksh 5,106


Regimen K
all adult weights
zidovudine+lamivudine (300/150mg.) 1 tab bid. KSh 2,228          
nevirapine  200 mg. bid KSh  1,551                        
total cost  per month KSh 3,779

  • Based on WHO document: "Scaling up ARV therapy in resource-limited settings"   


How to know if the ARV regimen is effective:

  • the patient gains weight
  • the patient feels better and appetite returns
  • skin and mouth lesions improve
  • gastro-intestinal symptoms improve

How to know if the ARV regimen is failing:

  • the patient's condition deteriorates and diarrhea worsens
  • the patient's appetite remains poor and weight falls
  • skin and mouth lesions become worse
  • the main cause of a failing ARV regimen is the patient's failure to take ARV drugs as prescribed.

What to do if the initial ARV regimen fails:

  • The patient should stop all ARV drugs of the initial regimen and start three new drugs of a second-line regimen. NEVER change just one drug of a failing regimen.

Precautions and common side effects to watch for:

stavudine (d4T)

  • Do NOT use in combination with zidovudine (AZT, ZDV)
  • Be alert to possible liver failure
  • Be alert to peripheral neuropathy and paresthesias
  • Calculate dose by patient weight: < 60 kg give 30 mg. bid; > 60 kg give 40 mg. bid

lamivudine (3TC)

Seldom gives side effects, but resistance develops rapidly

didanosine (ddI)

  • Should be taken on an empty stomach, e.g. before breakfast or 30 minutes before supper.
  • Be alert to liver failure and pancreatitis.
  • Calculate dose by patient weight: <60 Kg. give 250 mg. daily;  >60 Kg give 200 mg. daily.

nevirapine (NVP)

  • Always start nevirapine 200 mg. od for 2 weeks, then increase to 200 mg. bid.
  • Rash is common: If mild, continue nevirapine at initial od dose.  If severe, stop nevirapine.
  • Efavirenz is a good substitute if the patient is not pregnant .
  • To minimize risk of liver toxicity in patients taking Rifater anti-TB treatment, do not  give nevirapine. Give efavirenz instead.*
  • Nevirapine lowers the effectiveness of oral contraceptives**

efavirenz (EFZ)

  • Give at bedtime (nocte) to reduce common CNS side-effects.
  • May cause foetal malformations if taken in first trimester of pregnancy.**
  • Use nevirapine instead.
  • if used in TB patients taking Rifater, then increase dose to 800 mg nocte*.
  • Efavirenz lowers the effectiveness of oral contraceptives**.

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*NOTE: If the person has tuberculosis, it is best to complete the initial two months of  Rifater therapy before starting ARV drugs. But if the patient is very sick and must be on ARVs early, it is safer to use efavirenz than nevirapine. The dose of efavirenz should be increased to 800 nocte for TB patients on Rifater. After finishing two months of Rifater, one can change from efavirenz to nevirapine, which is cheaper.

* NOTE: it is best for an HIV-infected woman to avoid all pregnancies.


Q & A: HOW IMPORTANT ARE CD4 TESTS?

QUESTION from a clinical officer of a health program in Western Province: Many of our AIDS patients have difficulty paying for their CD4 tests. How important is it to have a CD4 count on our patients who are taking ARVs?


ANSWER:
It is always good to have a CD4 count on AIDS patients who begin ARVs and to follow the patient's progress with CD4 counts while they are under treatment. However, in resource-poor settings such as you have in Western Province, the World Health Organization (WHO) maintains that CD4 counts are not absolutely necessary.

Most mission hospitals which serve poor people begin ARV treatment only when the patient becomes symptomatic (e.g., diarrhea, pneumonia, tuberculosis, weight loss, oral thrush).  If the patient is symptomatic from AIDS, then WHO guidelines encourage one to begin ARV treatment regardless of the CD4 count.  Therefore one could conclude that a CD4 count is not necessary to begin symptomatic patients on ARVs.

If the patient has few or no symptoms of AIDS, but is interested in starting ARV therapy, then a CD4 count would be advisable.  However, there is little to be gained in length or quality of life by starting ARVs before serious symptoms arise.  ARV drugs have their own risks and side effects and sometimes they make a well patient feel sick.

In order to follow the course of ARV treatment, a CD4 count is not required either.  In resource-poor settings, one should use expensive laboratory tests only for making action decisions, and not to "follow the patient".  For patients taking ARVs, only three decisions are required:

  • To keep taking the same ARVs
  • To stop taking the same ARVs
  • To change to other ARVs

A CD4 count is not required to make these decisions; good clinical monitoring is adequate.  If the patient gains weight, increases appetite and feels stronger, then one should continue the same ARV regimen.  If the patient loses weight, is nauseated, has persistent diarrhea and feels bad, then one should consider stopping the ARV regimen and selecting another.  Sadly, in resource-poor settings, very few patients can afford a second-line regimen, and even fewer can bear the expense of a CD4 count to help decide if they need a second-line regimen.

In summary, for poor patients in Western Province, it is best to rely on patient history, physical examination and good clinical judgment.  You will not be remiss in not ordering CD4 counts.

ARV Medicine available from MEDS (April 2003)

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