An Indian Protocol for treatment of PLWHAs

[Guest guest]

Dear Forum members,

There are two components in any HIV / AIDS rehabilitation programme

that are extremely critical. " ACCEPTANCE & FREEDOM "

ABOUT FREEDOM FOUNDATION

Freedom Foundation is a care and support home for people with HIV & AIDS.

It is a 50 bed facility situated in Hennur Village. What began in 1992 as a

center for rehabilitation of people with problems of chemical dependency,

soon saw itself having to deal with an increasing number people testing +ve

for HIV. Even then HIV was still quite new and unheard of. Most of those

who knew about it seemed wary about dealing with people having HIV. The

growing numbers of +ve people and the intuition that they would require not

only medical care, but also some form of social support, made Freedom

Foundation start a care home for people living with HIV & AIDS.

Initially, there was difficulty in finding a place to set up the home.

Finally, in 1995 the HIV & AIDS center was started in Hennur village in a

rented and modified chicken shed. When Freedom Foundation first started, most of

the people who attended the clinic were men. The womens' ward was mostly empty.

That however, is not the case today.

Today, not only are the needs of adults taken care of, but we also have a

paediatric wing. In addition to the children who access the medical needs

on an inpatient or out patient basis, there are many children who are being

fostered by Freedom Foundation. All the needs of the children- which

include medical care, schooling and extra curricular activities- are taken

care of by the organization.

Within 2 years of initiation, NACO declared Freedom Foundation the model

center for care & support for PLWHAs. In 2001, UNAIDs declared the unit a

'best practice and center for excellence' for care & support of PLWHAs.

In addition to round the clock medical care for the inpatients, all the

care and support units consists of various other service components like,

short/long stay home, hospice, Laboratory, vocational unit, and a legal

cell. Freedom Foundation also provides counseling services and has a

hotline for counseling regarding HIV & AIDS. The counseling sessions are

either group sessions or on a one to one basis The Foundation also conucts

Training and Educational programmes on HIV/AIDS and Substance Abuse for

other NGOs, CBOs, schools, educational institutions and the corporate

sector. Added to this, there are community outreach programs where

awareness regarding hygiene, nutrition, sexually transmitted diseases etc.

are dealt with.

The Foundation's policy has been to link prevention activities with care

and support, Hense many specific prevention interventions are activitated

without trying to target any paticular communities.

Freedom Foundation has also been involved in training social workers and

community peer workers in dealing with HIV & AIDS related issues.

Freedom Foundation recognizes the need to address the dual problems of

chemical dependency and HIV & AIDS. Therefore, all HIV +ve persons who also

have problems of substance abuse are also provided with the option of going

through the de-addiction program.

Today, Freedom Foundation has opened up centers in Hyderabad and Bellary,

soon in Mangalore as well. The main objective is to provide a good quality

of care to people with HIV & AIDS.

______________________________________________

MEDICAL PROTOCOL FOR PLWHAs

Someone once said that only the brave venture into palliative care and only

the bravest venture into care for people living with HIV & AIDS.

The treatment of any person infected with HIV is 3- dimensional. It focuses

on the physical, psychological and the social aspects of the illness.

Caring for people with HIV is a team effort.

As care givers, we need to realize that there is no need for a specialized

degree inorder to care for people living with HIV & AIDS (PLWHAs). The

infections that are seen in HIV infected individuals are not peculiar or

unheard of. What we need to know is that their health problems are

complicated by the fact that they may have multiple infections and may

require prolonged treatment.

History : It was in 1981 in the U.S.A. that doctors began to notice an

increase in the number of people being diagnosed with PCP- pneumocystis

carnii pneumonia- which until then was quite rare. In the same year, there

was an increase in the number of cases reprting with Kaposi's sarcoma. The

intriguing factor was that these patients were all young men who had no

previous history of illness. Another common factor was that they were

homosexual men. Tests showed that these men were all immune-compromised.

In 1983, researchers in France and almost simultaneously in the U.S.

established the link between the immune-compromised states and a virus

which was later called the Human Immune Deficiency Virus - HIV.

It was in 1986 the first case of HIV was reported in India. It was found in

a group of commercial sex workers in Chennai.

Why do we need to be aware of HIV & AIDS?

India today has the highest number of HIV +ve people. Statistics report

that we have about 4 million HIV +ve people in the country today. What is

even more alarming is that studies reveal that 2 new HIV infections are

occurring every minute.

With these kind of numbers, it is obvious that medical practitioners and

health care workers ( HCWs) at some point in their careers are going to

come across people infected with the virus.

It is but natural that HCWs would be afraid of getting infected with HIV

while caring for an infected individual. This fear can be averted by being

well aware of the routes of transmission and the risk of infection involved.

The need for a protocol- The Freedom Experience:

So far, 90% of material available on HIV & AIDS is based on studies

conducted in the West. We do know that the HIV strains in the West are

different from those found in our population. The diseases seen and even

the drug reactions vary between the west and in Asia. For eg:

Hypersensitivity to Co-trimoxazole is more common in the Caucasians than

among the Indians.

The quality of nutrition, availability of drugs, etc. all play a role in

HIV management. Hence, we felt the need to have guidelines for doctors and

other care givers working with PLWHAs. In the Indian scenario, there are

more OIs to contend with than there are in the West. The availability of

drugs is also a cause for concern.

Before we go onto medical management, it is important to familiarize

ourselves with the other factors concerned with HIV & AIDS.

Who is this protocol meant for?

Even though most of the material here is more technical and from the

clinical point of view, we have tried to keep it very simple so that all

those interested in working with HIV+ve people can understand and use the

information given.

This could mean clinicians, nurses, counselors, volunteers and care givers.

Transmission:

1. Blood transfusion: There is a 90% risk of infection through transfusion

of HIV infected blood. This involves blood products like plasma, platelets,

etc.

2. Mother to child transmission: There is a 25-30 % risk of transmission

from an infected mother to her child. This transmission can occur during

pregnancy or during delivery. The virus can also be transmitted to the

child during lactation.

3. Through sexual intercourse: The risk of getting infected through

unprotected sex with an infected partner is about 1%. This risk is

especially high among homosexual men since anal penetration is involved and

this means that there is a chance of sustaining mucosal injury. Amongst

hetero-sexuals, the women is at more risk of infection that the man. This

is because the vagina is in contact with the semen for a longer period of

time. In addition, injury to the vaginal mucosa is also a possibility

during intercourse.

4. Risk to health care workers: There is no risk of getting infected by

touching an HIV infected individual. There is no risk of infection if

infected blood is to come in contact with intact skin. The risk of getting

infected due to a needle stick injury is between 0.3 - 1 %.

This risk can be minimized further is we follow a few simple steps that

safe guard us.

Any care giver for people with HIV or Hepatitis B needs to be aware of the

Universal precautions: These are steps that have to be followed by the

health care workers ( HCW) with every single patient.

· washing of hands before and after checking up a patient. Just soap and

water is enough. This is a very basic precaution and yet we seem to forget it.

· while dealing with any person with open wounds or discharging wounds, always

wear gloves.

* while performing any invasive procedure like incision and drainage,

pleural tap, etc, the doctor and the assistant should be protected with gloves,

a mask and goggles. In addition the doctor needs to be protected with a

disposable apron.

· all infected material like blood, vomitus, etc should be disinfected with

bleaching powder or 5% hypochlorite solution.

· all needles and syringes, infected dressing material should be

disinfected with hypochlorite solution before being disposed.

· all suction tubes, endo-tracheal tubes etc. need to be disinfected with

glutaraldehyde solution before re-using.

* always make sure to have on foot wear.

Disposal of medical waste: All infected material like syringes, dressing

material, or other material infected with blood or other body fluids first

needs to be disinfected in hypochlorite solution. Only after disinfection

for about 5 hours, can all the medical waste be disposed. This then needs

to be incinerated. Sanitary napkins need to be burned.

The care givers team at a center for HIV & AIDS:

1. The doctor

2. The counselor

3. PLWH trained to be counselors and care givers

4. Nurses. ( The ideal ratio would be 1 nurse to 5-6 beds.)

5. Social worker ( for house visits & for awareness programs)

The aims of treatment in PLWHAs:

The treatment given is to ensure that the person has a QOL (quality of

life) that is acceptable to him/her as is the right of any person.

1. To make the person aware of his HIV status and counsel him about

stopping risk Behaviour.

2. To provide treatment for the opportunistic infections.

3. To provide symptom control and reduce any distress in the patient.

At Freedom Foundation, we aim to provide people with not only an improved

quality of life, but also dignity during death.

4.Social acceptance and family acceptance of the person.

STEPS INVOLVED IN ASSESSING A PATIENT:

Counseling is part of the work of any doctor working with HIV +ve people

and he needs to be sensitive to the issues affecting HIV +ve people.

a. PRE- TEST COUNSELLING: ( sample of pre-test form enclosed)

1. Information about HIV to be given to the person. The modes of

transmission, Issues of confidentiality, etc. have to be discussed. The effects

of HIV, any questions the patients may have regarding his/her health etc, need

to be answered.

2. Testing is done only after the patient consents to test his blood and he

signs the pre-test form.

b. POST - TEST Counselling: ( sample of post-test counseling forms

enclosed)

Has to be done regardless of the outcome of the HIV test. Disclosure of

the status, followed by reassurance of confidentiality, care and support.

1. HIV -ve: - information and reassert the importance of stopping risk

behaviour.

- Condom demonstration.

- Counselling regarding admission to a de-addiction center, if required.

2. HIV +ve: - allow time for the result to be understood, once again

explain the implications of HIV.

- give patient time to realize the emotional impact

- observe for feelings of shock, denial, anger, etc.

- assess and reassure

- assess whether the patient requires inpatient or out patient treatment.

- The person may require more than one to two sessions. After that we

always let the person know that we are available for any kind of guidance

that they need.

- At Freedom Foundation, we not only have sessions with the counselors and

HIV+ve people, but also sessions with only +ve people so that they form

their own peer support groups.

TESTING:

The present reliable tests available in India are anti-body based tests.

- ELISA

- Rapid spot test

- Western Blot

There are other tests like PCR & viral culture which test for the virus

itself. The problem with the viral tests are that they are very costly and

sometimes are that the reliability of the tests are not assured.

Time for testing: - The anti-body tests are reliable only when the person

has passed the window period.

The window period is time from the time of HIV infection to the time the

anti-bodies to the virus shows up in blood tests. This could vary from 3

months to 6 months.

The window period is important since during this period the persons test

shows HIV -ve and during this time he/ she may continue risk behaviour or

donate blood and thus infect another person.

How would we define AIDS?

Earlier on we had the major and minor criteria, however this was very

confusing at times. Today as per the WHO clinical AIDS in a person has to meet

the two main (A + criteria given below.

A. Positive test for HIV preferably done by two different tests.

At Freedom Foundation, we do a rapid test and follow it up with an ELISA,

before confirming that the person is HIV+ve.

B. Any one of the given criteria:

1. >Weight loss of 10% body weight which is related to HIV infection and

not due to any other condition.

Ø Chronic diarrhoea of one month's duration either intermittent or constant.

2. Miliary or extrapulmonary or disseminated T.B.

3. Oral / oesophageal candidiasis.

4.Neurological impairment restricting daily activities which is not due to

conditions unrelated to HIV (eg. Trauma)

5. Kaposis sarcoma

This means that for a person to be identified as having clinical AIDS, the

person has to have a confirmed HIV +ve test report accompanied by one of

the conditions mentioned under B.

Other suggestive clinical signs would be:

a. Fever lasting for more than a month's duration.

b. Generalized lymphadenopathy

c. Past or present multidermatomal herpes zoster.

d. Hairy leukoplakia

e. Cytomegalovirus retinitis

f. Recurrent pneumonia

g. Recurrent severe seborrhoeic dermatitis.

h. Recurrent/ severe vulvo vaginitis

Criteria for admission: If a person has come in a with moderate to severe

physical symptoms, or he requires adequate counseling regarding his illness

he needs to undergo admission. The admission could be either a short stay of 1

week to 10 days or it could depend on the prognosis of the person. Sometimes

however, a patient might require a longer duration of stay incase of

abandonment, till we either work through with the family or we can find suitable

accommodation.

Testing for children: The anti body based tests are to be done only after

the child has crossed 18 months. It takes about 18 months for the viral

antibodies to be eliminated from the infant's system. On the other hand the PCR

can be done after 72 hours of birth. The PCR tests for the viral antigens

itself.

A detailed clinical history needs to be taken prior to starting any form of

treatment. The clinician needs to check for opportunistic infections and

this is why the various tests mentioned below are important.

Tests to be done at the time of patient assessment:

1. HIV spot for confirmation

2. ELISA at a governmental nodal centre

3. VDRL

4. HBs ag

5. Chest X-ray

6. Sputum AFB & Grams stain

** all care givers need to be immunized against hepatitis B.

Treatment of VDRL reactive cases:

* Drug of choice : Penidure 24 lakh units im to be given after test dose.

To be given once a week for 3 weeks.

In patients that can't tolerate a large dose, 12 lakh units once a week for

6 weeks can be given after test dose.

· In case of people who are sensitive to penicillin or in pregnancy, the

person needs to get Erythromycin stearate 500mg qid 2weeks.

· Counselling needs to be done for the partner as well.

Opportunistic Infection management:

** In children, the dosage needs to be adjusted as per the body weight.

** Drugs contra-indicated in paediatric age group are to be taken note of.

( Streptomycin, tetracyclines etc are not to be used in children.)

** All children need to be treated in co-ordination with an experienced

paediatrician.

1. Tuberculosis: About 90% of persons with HIV come in after they have

been diagnosed with tuberculosis. T.B. has gained notoriety due to the

fact that there is an increase in the number of sputum +ve cases and so

also in the numbers developing resistance to first line of treatment. It is

advisable to have a tie up with the district T.B. center and also the DOTS

centers. First it is important to assess whether the person has pulmonary Kochs,

whether he has AFB in the sputum, T.B. meningitis or extra pulmonary T.B.

For sputum +ve cases, the person needs to be on 4 drugs. If possible, it

is necessary to try and register with the DOTS center. It is important to

supervise the treatment. It is for the doctor to decide whether the patient will

abide with the DOTS 3 day regime or the daily regime.

DOTS: Drugs to be given only on Monday, Wednesday and Friday in the morning.

The intensive phase is for 2 months. The drugs given are:

Rifampicin 450 mg, INH 600 mg, Ethambutol 1200 mg, Pyrazinamide 1500 mg,

Pyridoxine 40 mg

The continuation phase is for given 4 months. The drugs given are:

Rifampicin 450 mg , INH 600 mg & Pyridoxine 40 mg.

Daily regime: The treatment is to be given every day without any breaks.

The intensive phase is INH 300 mg, R-cin 450 mg, ETM 800mg,

PZA 1500 mg, Pyridoxine 40 mg.

The continuation phase is INH 300 mg , R-cin 450 mg, pyridoxine 40 mg.

· During the intensive phase, sputum examination is to be done once a month

to see whether the patient is responding to the treatment.

· If at the end of 2 months, the person is still sputum +ve for AFB, they

need to be given Streptomycin 75 mg along with the 4 drugs. This needs to

be given for another 2 months and then the person goes through the

continuation phase with 2 drugs.

· If despite the streptomycin, after one month, the persons sputum still

shows the same sputum AFB count or the AFB count has increased, then a

culture sensitivity needs to be done to the first line drugs. The reports

for c/s take about 3 months. In the meantime, if the person can afford it

he may need to be started on Ciprofloxacin 500mg bd or Ofloxacin 200mg bd.

· All sputum +ve cases need to be isolated as they put other patients also

at risk of getting T.B.

· A decrease in the sputum AFB count and gain in weight is an indicator of

good response to the treatment.

Pulmonary T.B. If the person is not sputum +ve but has pulmonary T.B.,

then he needs to be put on 3 drugs during the intensive phase. The drugs

are INH, R-cin & ETM.

The dosage are the same as the ones mentioned above.

During the continuation phase, 2 drugs are given ie: INH, R-cin and

pyridoxine. The dosages remain the same.

T.B. meningitis: The treatment is to be given every day. 4 drugs are given.

INH 300 mg, R-cin 450 mg, ETM 800 mg, PZA 1500 mg, Pyridoxine 40 mg.

If the patient shows severe meningeal irritation with increase in intra

cranial tension then the person needs to receive mannitol once or twice a

day till there is an improvement in his condition. The continuation phase

may be maintained upto 2 years to prevent relapse.

Disseminated T.B. Is treated with 5 drugs ( INH, R-cin, ETM, PZA &

Streptomycin)

For 2 months and 2 drugs ( INH, R-cin ) for 4 months. Whether to follow the

DOTS regime or the daily regime is dependent on the doctor's assessment of

the patient.

Hyper- sensitivity reactions to T.B. medication:

1. INH : can cause peripheral neuropathy. This is usually managed by

increasing the dosage of pyridoxine.

2. R-cin: is hepato toxic. It can cause jaundice. In such a case, the

drugs need to be stopped till the jaundice is controlled and then

re-introduced one by one.

3. ETM: causes optic neuropathy.

4. PZA: can cause joint pains.

5. Streptomycin: causes oto- toxicity leading to giddiness, and

disturbance in gait. In this case, it is advisable to stop the

Streptomycin injections.

Sometimes, there may be hyper-sensitivity skin reactions. The medicines

need to be stopped. When the rashes disappear, then the drugs need to be

re-introduced one by one. At Freedom Foundation, we have seen

hypersensitivity reactions similar to 's sydrome. In such

severe reactions, steroids and topical soothening agents need to be given.

Atypical T.B.: It is very common in HIV +ve people. The clinical signs

are more or less the same. A definitive diagnosis is made usually by doing

a biopsy in cases of lymphadenitis. In cases of lung infection, an X-ray

and a sputum examination will be necessary.

In cases of atypical T.B. the drugs of choice are ETM 800mg, R-cin 450mg ,

Sparfloxacin 200 mg bd & Clarithromycin 250 mg bd.

Multi-drug resistant T.B. This could be due to defaulting on the T.B.

medication or the person could have acquired a resistant strain. In case

the history of defaulting is clear, we need to assess the period for which

he/she has not taken the medication. If it is a month or 2, we could

re-start the T.B treatment. Incase about 6 months have passed, we need to

use our judgement, do a repeat T.B work up and then start medication. Very

often, they would need 2nd line of drugs.

2. Oro - oesophageal candidiasis: It depends on the severity of the

candidiasis.

If the candidiasis is very mild, then usually they respond to Clotrimazole

oral application. In mild to moderate infection, they require 150 - 200 mg

Fluconazole once a day for 2 weeks.

In case of very severe infection where the person is unable to swallow, the

person needs to be put on i.v preparation of Fluconazole, 200mg twice

daily. Once the person begins to improve, then he can be put on to 200mg

orally for 2 weeks.

Once the infection subsides, the person needs to continue oral application

of Clotrimazole. In case of resistance to fluconazole , the person needs to be

started on Itraconazole 200mg twice daily. Itraconazole is to be taken with

food.

3. PCP: The diagnosis is usually based on clinical findings. High fever &

dyspnoea are visible signs. There will be a drop in the oxygen saturation.

The treatment is usually Trimethoprim 160mg + Sulphamethoxazole 800 mg

( co-trimoxazole) twice daily.

If it does not respond, then Dapsone 100mg once a day needs to added to the

regime. Incase it does not respond to that also, Clindamycin 600mg bd is proven

to be very effective with primaquine 30 mg.

The drug of choice if available is pentamidine.

4. Herpez - Zoster: Herpes in people with HIV usually occurs in more than

one dermatome.

The treatment of choice is Acyclovir 800 mg 5 times daily for 2 weeks.

Along with this, if the patient has pain, then NSAIDs need to be given. If

the herpetic neuralgia persists, imipramine or amitryptilline and in some

cases carbamazepine may be tried. Topical acyclovir ointment also gives the

person relief.

5. Cryptococcal meningitis: The treatment of choice is Amphotericin B.

0.7 mg/ kg to start with and gradually increase to 1 g / day, till the LP

is negative for cryptococci. However, the Indian population needs upto

0.1-0.2 mg/kg body weight. Initially, we start with 0.1mg/kg and slowly

increase it to 0.2mg/kg. It is given as a slow infusion in

5% Dextrose. It needs to be titrated and regular electrolyte monitoring

needs to be done. So, usually this is done in a hospital set up. We have

found that Amphotericin (in the doses we have mentioned) when given for 2

weeks along with Fluconazole 200mg bd is as effective as giving higher

doses of Amphoterecin and the same time,we can minimize the adverse effects

of Amphoterecin. Continuation therapy with Fluconazole 200mg bd is given

till there is a sustained improvement in the patients condition. This takes

about 6 weeks. Maintainance dose with fluconazole 200mg od is given.

or Fluconazole 400 mg twice daily for 8 weeks. Then maintainance, 200mg od is

continued.

6. Lower Respiratory Infection: If there is any expectoration, we can do

a Gram stain and start the person on anti-biotic treatment as per the Gram

stain result.

Lower respiratory infection is to be, managed as with other people.

7. Urinary tract infection: Rule out sexually transmitted diseases. Check

for ulcers, discharge and lymph node involvement which is suggestive of STDs.

Incase STDs are ruled out, we can start them on urinary anti-biotics. Norflox,

Co-trimoxazole, or Ciprofloxacin can be used as per the recommended dosages.

In case there is no response to the usual anti-biotics, we can do a culture

sensitivity test and proceed as per the sensitivity report.

8. Diarrhoea: We need to know that the HIV may itself cause viral enteritis.

Find out the nature of the diarrhoea. If it is mucous stained and foul

smelling it is indicative of amoebiasis. In this case, metrogyl 400 mg tid

is usually the drug of choice, to be given for 5 days. Other wise,

tinidazole 400 mg bd, or secnidazole forte 2 grams stat to be given.

If despite this the diarrhoea persists, start on furazolidine 200 mg tid

for 5 days. The furazolidine is to be given along with metrogyl.

In case of watery diarrhoea, shigella dysentery is suspected. For this,

Co-trimoxazole in double strength is the drug of choice. Nalidixic acid

600mg tid for 5 days is also used. Usually this is given along with

metrogyl in the usual dosage is given.

9. Fever: All the causes for fever need to be ruled out. Typhoid,

malaria, T.B., LRI, UTI all need to be ruled out.

Typhoid: Tab Chloremphenicol 400 mg qid for two weeks is the drug of

choice. Then the dosage is halved for another week.

In case the person does not respond, then other lines of drugs like

Ciprofloxacin 500 mg bd / Inj Gentamycin 80 mg bd/ one of the

cephalosporins need to be given in combination with chloremphenicol.

We have come across multi-drug resistant strains of typhoid as well. In

such cases, a combination of 3 drugs has proved effective.

Malaria: The treatment is Chloroquin 600mg initially, followed by 300mg

after 6 hours and then 300mg once a day for 3 days.

In cases of recurrent malarial attacks, 2 tablets with a combination of

Pyrimetahmine 25mg + Sulphamethopyrazine 500mg needs to be given as a

single dose.

The management of T.B. LRI & UTI have been mentioned.

10. Toxoplasmosis: The drug of choice is pyrimethamine. 200 mg stat

followed by 50- 100 mg /day. Folinic acid 10 mg /day is to be given along with

this. Sulfadiazine 4- 8g / day or Clindamycin 900 mg /day, may be added to the

regime if there is no response.

11. Syndromic management of STDs:

Sometimes, identifying the exact organism of an STD is difficult,

especially in cases where they are HIV +ve. Hence an approach where all the

expected STDs are taken care of, is done. Partner treatment is also required.

a) Urethral discharge:

i. Tab Ciprofloxacin 500 mg single dose along with

Doxycycline 100 mg bd for 1 week.

ii. Inj Ceftriaxone 250 mg sd.

Vaginal discharge:

i. Tab Ciprofloxacin 500 mg single dose along with

Doxy 100mg bd and Metrogyl 400 mg bd for 1 week may be accompanied with

clotrimazole ointment or vaginal tabs. Or In pregnancy

ii. Inj Ceftriaxone 250 mg single dose

Or

iii. Tab Erythromycin 500mg qid for 1 week

c) Inguinal swelling:

Doxycycline 100mg bd for 15 days.

d) Lower abdomen pain: Doxycycline 100 mg for 15 days and Metrogyl 400mg

for 1wk

e) Genital ulcers: Inj Benzathine penicillin 24 lakh units im once a week

for 3 weeks after test dose.

f) Herpes: Tab acycovir 200 mg 5 times a day for 1 week.

g) Scrotal swelling: Tab. Doxycycline 100 mg bd for 15 days.

At a care & support unit for HIV:

** Every month deworming has to be done for adults with 400mg Albendazole.

** Every month blanket treatment for scabies needs to be done. Bezyl

benzoate application is very effective.

** Cotrimoxazole double strength once a day is given as a prophylaxis for

many infections such as toxoplasmosis, diarrhoea, PCP,etc.

PAIN MANAGEMENT IN PLWHAs: Pain in people with HIV and AIDS is

unfortunately not recognized. Unlike people with cancer, where pain is

given utmost importance, pain / symptom management in AIDS is yet to gain

importance and momentum in advocacy.

We need to realize that a person is in pain when he says so. As doctors,

our part is to find the cause of the pain and ease his pain.

As with any care and support facility, we need to remember that they have a

right to a quality of life that they find acceptable.

First, we need to rule out any treatable cause of pain. For eg. Dysphagia

due to oral candidiasis is treatable. Once the infection is under control,

then the pain also disappears.

Incase the pain is not due to a treatable cause, then the 3 step WHO ladder

of pain management needs to be followed. As per the ladder, pain management

starts with NSAIDs starting with the optimal prescribed effective dosage

(ie: the pesron is relieved of pain with that dosage and that dosing is the

maximally permitted dose of the drug.). Sometimes, NSAIDs along with

adjuvants like anxiolytics, anti-depressants or sedatives are required.

The next step is to progress to weak opiates. Only then should we progress

to strong opiates.

The list of drugs mentioned below are those commonly available in India.

* Before venturing onto pain management, it is important to know the

maximum effective dosage of the drugs.

I . The NSAIDs commonly used are :

i. Paracetamol

ii. Nimesulide

iii. Diclofenac

iv. Bruphen

v. Piroxicam

vi. Ketorolac ( a very potent analgesic, needs to be used with discretion,

preferable to start with the common analgesics first, before trying ketorolac)

II. The weak opioids are: i. Propoxyphene

III. The moderately strong opioids are : i. Tramadol

IV. The strong opioids are Morphine and Buprenorphine.

Today there are more potent analgesics like meloxicam and pyricoxib

available. The cost factor usually is a limitation.

** Morphine is still not available for use in homes for PLWHAs. There are a

lot of hurdles involved in obtaining liscence for morphine usage.

Buprenorphine, however is available to registered institutions.

** Pain management should be given round the clock. Ie: bd or tid dosage as

per the bio-availability and efficacy of the drug.

** Wherever possible, it is important to try and treat the cause, as in

T.B., candidiasis,etc.

** Sometimes, where there is no specific treatment, then the pain alone

needs to be managed.

** Don't jump from one NSAID to another. NSAIDs in combination can be used.

Eg Nimesulide + Paracetamol. But refrain from using one NSAID then trying

another and then another. If an NSAID or a combination of NSAID in optimal

dose doesn't provide relief, then it is unlikely that another one will do

the trick.

** A weak opioid needs to be used with a non-opioid analgesic, not

separately.

** In case of AIDS, where the person is obviously in his last, we need to

respect the person's wishes to have a pain free end.

Anti-retro viral treatment

At FF, we have noticed the enormous impact that Anti-retro-viral (ART) has

on improving the health and therefore the QOL of HIV +ve people. Prior to

starting the treatment, the doctor needs to be very aware of the dosage,

the expected side effects, the costs and the availability of the drugs.

The doctor needs to be aware that under dosing can lead to resistance in

the virus. Also, the doctors need to be aware that these drugs are to be

given life long and is not a short course.

Anti-retro viral treatment in the Indian scenario: The need for assessment

of the patient and counselling

Most people can't afford anti-retro viral treatment in India. Any person

opting for ART therefore needs ample counseling prior to starting

medication. The counseling in this case needs to emphasize the cost factor,

the need to take the drugs life long, the side effects, and the fact that

the drugs are not a cure. The person also does need re-assurance that if

he/ she is able to afford ART, then there will be an improvement in the

quality of life of the person. ( for eg: the risk of falling prey to

opportunistic infections decreases, appetite improves, etc.)

At present, the government is yet to take a stand and subsidize the rates

of ART. While in the west, ART is paid for by the insurance companies or by

the public health services, in India, we are still looking at

affordability. We also need to look at complete exemption of taxes for

these medicines.

ART makes economic sense: Once a person is started on ART, it is but

obvious that his CD-4 count is going to increase. A good CD-4 count means

that his immune system is going to improve and be able to defend himself

against OIs. This is a two-pronged weapon where the cost of OI management

can be saved and at the same time, the QOL of the person is improved. As

the persons health improves, he is able to work and thus earn a living to

support himself and his family. Good health also means lesser hospitalization.

In our set up,we have seen that ART not only boosts the health of the

person, but also the morale of the person.

Doctor Patient relationship: This can-not be over emphasized. The patient

needs to be able to confide and trust the doctor with his/her problems.

There are a lot of side effects to ART at the time of starting. The

patients needs to be informed of these. He also needs to know that there

may be times when at the time of starting ART, there may be fever due to

the bouncing back of the immune system. At such times, the patient may be

under a lot of stress and hence requires a lot of re-assurance.

Tests to be done prior to starting treatment:

· Ideally, a viral load needs to be done prior to starting anti-retro-viral

treatment. However, due to the cost factors involved, we don't usually do it.

The other tests that need to be done are:

1. CD 4 count: a count less than <350 is an indicator for starting treatment.

2. Complete blood picture : Check for nutritional anaemia, bone marrow

depression, High ESR, etc.

3. LFT: Any abnormalities in LFT needs to be noted.

4. Serum urea & creatinine.

Any abnormalities in the test results need to be taken account of and

corrected prior to starting treatment.

The dosages of the Drugs are given below:

DRUGS Adults Paediatric

Adverse effects

a. Nucleoside analogues

.. AZT 300mg bd 360mg/sqm/day

neutropenia

divide tds

neonates: 2mg/kg anaemia, myopathy

6th hourly nausea, headache

i.v. 120mg/sqm 6th hrly

.. Lamivudine 150mg bd 4mg/kg bd

pancreatitis, peripheral

neonates: 2mg/kg bd neuropathy, nutropenia

abnormal LFT

.. Stavudine <60kg: 30mg bd 2mg/kg/day in two headache,

GI upset, rashes

>60kg: 40mg bd divided doses peripheral neuropathy,

pancreatitis

.. Didanosine 200mg bd 180-240 mg/sqm/day

pancreatitis, peripheral

in two divided doses neuropathy, diarrhoea,

retinal pigmentation,

abnormal electrolytes

DRUGS Adults Paediatric

Adverse effects

.. Zalactabine 0.75mg tid 0.03mg/kg/day

Headache, GI upset

divide bd rashes, peripheral

neuropathy, pancreatitis,

hepatic toxicity

.. Abacavir 300mg bd 16mg/kg/day

Hypersensitivity reaction,

divide bd fever, malaise, Incase of

mucositis with or without

rashes stop the drug

immediately.

b. Non-nucleoside reverse transcriptase inhibitors:

.. Nevirapine 200mg od 120mg/sqm/day od Rashes,

Stop incase of

for 1st two weeks for 1st two weeks & Syndrome,

and then increase and then increase Abnormal LFT

to bd to bd

.. Efavirenz 600mg od 10-15 kg: 200mg od

Rashes, abnormal dreams,

15-20kg: 250mg od CNS toxicity

20-25kg: 300mg od

25-33kg: 350mg od

33-40kg: 400mg od

Delavirdine 400mg tid Not known

Headache, fatigue, rash

c) Protease Inhibitors:

.. Indinavir 800mg tid 500mg/sqm/dose

Abnormal LFT, Nausea,

given tid Renal Stones, haemolytic

anaemia, abnormal glucose

metabolism.

.. Saquinavir 6*200mg tabs tid 100mg/kg/day

Increased bleeding

in 3 divided doses tendencies in

DRUGS Adults Paediatric

Adverse effects

Haemophiliacs, Abnormal

Glucose & lipid metabolism

.. Ritonavir 600mg bd Start with 250mg/sqm/dose

Increased bleeding

12th hrly and increase tendencies

over 5 days to in hemophiliacs,

800mg/sqm/day in Abnormal lipid & glucose

two divided doses metabolism, GI upset,

rashes, headaches

.. Nelfinavir 750 mg tid 90-110mg/kg/day

Diarrhoea, vomiting, rash,

in three divided doses abnormal lipid & glucose

metabolism.

.. Amprenavir 8*150mg bd 20mg/kg/day in two

Abnormal lipid &

divided doses Glucose metabolism, GI

upset

The ideal combination is a 3 drug regimen which could be 1NNRTI + 2NRTIs or

1 protease inhibitor with 2 NRTIs.

The fact that the virus could turn resistant to any of the regiments has to

be kept in mind and explained to the patient. Only with his consent can the

drugs be started.

· Hydroxyurea given along with Stavudine or Didanosine, increases the

efficacy of these drugs.

· AZT and Stavudine are not given together.

· Instead of giving 18 tablets of Saquinavir a day, where compliance may be

a difficulty, the patient can be asked to take just 8 tablets of 200 mg

Saquinavir in the morning along with one tablet of Ritonavir 600mg. This

not only brings down the cost of the drugs, but also decreases the drug

load on the patients.

Advice to be given to a patient starting ART:

Nutrition:

The person needs to be adviced regarding good nutrition. The importance of

nutrition on health needs to be reiterated. Infact, certain drugs like

didanosine etc. have better absorption when taken after taking after a

gastric stimulant such as a chocolate drink or an orange juice.

It is important to take 4 square meals a day. The emphasis of quality food,

boiling water before drinking, etc. need to be made.

At Ff, we usually make it a point to give the person a list of health foods

that will do him/her good. In addition, we also do advice on meal timings,

and reduction of highly spicy or oily food.

Blood Tests in order to monitor persons on ART:

Initially for the first 1 month every week, Hb% and SGOT, SGPT needs to be

checked. This is so that any initial reactions can be foreseen. Then the same

tests need to be done fortnightly for another month.

Then, we need to do the Hb% regularly every month.

In children, the initial monitoring with the tests need to be done every week.

Any drop in the Hb%, or elevation of hepatic enzymes needs to be paid

attention to and taken care of.

We also need to note that in India, nutritional anaemia is quite common an

hence, we sometimes start ART in people with Hb% of 9g% also. We put the

person simultaneously on oral haematinics.

We need to also pay to attention to all other specific side effects that

could occur eg: pancreatitis in cases of people taking stavudine &

didanosine, renal failure in case of those taking Indinavir, -

syndrome in case of Nevirapine.

This is why we need to be aware of all the adverse effects of the

medication when we prescribe them.

* CD4 counts need to be repeated every 3 months. This is only so that the

doctor has an idea of the immune status of the patient.

Incase the Hb drops suddenly to below 9g % or the person develops jaundice,

then the anti-retro-viral treatment needs to be stopped. In case of a drop

in Hb, then a TC DC needs to be done inorder to check for bone marrow

depression. In such cases, the drugs will need to be stopped for some time

till the side effects are corrected and then the combination of drugs

changed. In order to do this, the doctor needs to be well aware of the

various drugs and the side effects of the same.

At Freedom Foundation, we have seen the Hb drop to 5g% within 10 days of

starting treatment. At such times, we stop treatment completely and give

the person blood transfusions till the Hb% develops.

Hence, we make it our responsibility to advice patients to do regular blood

check ups. This helps us see the progress of the patient and his compliance

to the medication.

In case of abnormal LFTs also, we need to stop the drug and monitor the

patient. Once the LFT normalises, then we start the medication again.

Clinical follow ups:

Any person on ART needs to take complete responsibility for his health.

Regular follow up visits to the doctor is very important.

How do we know that the drugs are failing?

This is why we do the CD4 counts atleast once in three months. A drop in

the CD4 count despite the medication is an indicator that the drugs are not

working.

Where ever possible, a viral load is beneficial. When the viral load starts

increasing despite the drugs, it is an indicator that the virus has

developed resistance to the drugs.

In such cases, we need to change the drugs to a more effective combination.

· Don't add a new drug to a failing regime.

· Once resistance develops, start a new combination all together.

When can we stop prophylaxis for OI ?

As already mentioned, all HIV +ve people with low CD4 counts need

prophylaxis with Co-trimoxazole. However, when the person is on ART and the

CD4 counts have gone well above 800 cells/cumm, then the physician can

think of stopping ART.

Prevention of Mother to Child Transmission:

The risk of transmission from mother to child during pregnancy, delivery

and lactation is about 40%. With interventions such as forceps, the risk of

transmission increases even further.

Any HIV+ve couple that opts to have a child, needs to be counseled. They

need to be told about the availability of PMTCT. The counselor needs to

explain to the couple the benefits of a cesarean section to reduce HIV

transmission from mother to child. The need to abstain from nursing the

child, to see to it that the mother goes in for PMTCT.

The AZT is started in the 38th week of pregnancy.

200mg tid till the onset of labour pains. Then 3 capsules of 300mg to be

given every 3 hours till the baby is delivered.

The neo-nate has to be given AZT syrup 7 hours after birth. The dose is

6mg/kg. This is continued for 6-8wks.

The other drug that is proven and also convenient is Nevirapine 200mg

single dose at the onset of delivery.

The neo-natal dose is 2mg/kg single dose.

Breast feeding is completely prohibited incase mother and child opt for

prophylaxis. The child needs to be artificial feeds.

Also, the mode of delivery needs to be discussed. A cesarean is preferred.

If they can't afford it, then during normal delivery other interventions

like forceps, etc. need to be refrained from.

Post exposure prophylaxis ( PEP ) :

The possibility of injury via needle stick is only about 0.3%.

PEP involves 3 steps: a. Reporting

b. Assessment of the risk of transmission

c. Prophylactic treatment where required

a. Any person who sustains an injury such as needle stick (used on an HIV

+ve person), injury from scissors or blades, needs to immediately report it

to the person incharge or the doctor.

The area needs to be cleaned first with soap and water and allow it to bleed.

Within 24 hours, the person who sustained the injury needs to be started on

prophylactic treatment.

b. Assessment of risk & prophylactic treatment:

The risk of transmission varies with kind of injury involved. If the injury

is through a needle, then the risk is mild to moderate. The drugs used in

this case is AZT 200mg tid (in an adult) in combination with Lamivudine

150mg bd. The treatment needs to be given for 6 weeks.

If the injury is very severe like that from a scalpel blade which was used

on infected tissue, then the person requires a three drug regimen is used,

of 2 NRTIs and a Protease inhibitor. The protease inhibotor generally used

is Indinavir 800mg tid is used. The treatment is given for 6 weeks.

A PCR is adviced at the end of 3 weeks.

Any person working with HIV +ve people is already working in a stressful

environment. An injury of this sort only adds to the stress. Therefore, the

person requires ample counseling and support from the rest of the staff.

Medical ethics in dealing with PLWHAs:

As doctors, we are taught to be non-judgemental and fair while rendering

service to people. However, as human beings, the fear of the unknown always

plagues us.

This is why we need to be aware and educated about HIV & AIDS. It does

exist in society and we will keep seeing an increasing number of HIV +ve

people. As medical care givers, if we take all the required precautions,

we are in no danger of getting infected by the virus.

Medical Rights:

* As doctors, we need to remember the right of a person to receive pre-test

counseling prior to testing for HIV.

* We also need to ensure the patients confidentiality regarding the result.

· The result can be disclosed to a third person only after obtaining

consent from the individual.

* There is no need for a special HIV ward in any hospital.

· All HIV +ve people have the right to undergo surgery or dental procedures if

they so require.

· No patient needs to be discharged from a hospital because he is HIV+ve.

As doctors, we need to remember that HIV +ve people are more vulnerable to

various illnesses and do require our care and support. As care givers, we

are not at risk of getting infected with HIV if we take adequate

precautions while doing invasive procedures.

The right to a good quality of life is the right of any person.

__________________________________________

Ashok Rau, Dr. Nirmala ,

The Freedom Foundation Trust

Email: freedom@... ; ashokrau@...

Web site: www.thefreedomfoundation.org

_________________________________________________