Warning about the use of AZT + 3TC + EFV as a first line combination ART

[Guest guest]

Dear Forum Members,

I like to inform and warn about use of AZT as a first line

combination ART to all of you.

In last 6 months the follow up study of over 200 HIV patients

receiving combination ART viz AZT + 3TC + EFV have shown me alarming

findings.

These patients are on the said combination for more than 3

years (ranging between 3 to 7 years) and are most adherent as well

as immunologically and virologically well responded.

More than 50% of these patients have shown; 1 Dyslipidemia, 2. Lipodystrophy, 3.

Hyperglycemia, 4. Oesteoporosis, 5. Carotid artery narrowing more than 70% , 6

Three of them had acute mycardial infarction.

Two of patients were receiving AZT + 3TC + NVP also developed

above mentioned complications.

Other risk factors were carefully studied and taken into

consideration.

This means that we have lost; d4T, and now AZT as an ideal component

of 1st line combination ART in WHO ART rollout program.

There is again anticipated risk of coronary artery disease with use of Abacavir,

which is comparatively less potent especially for

patients with high HIV RNA copies, however risk of hypersensitivity

is comparatively low.

Even Tenofovir which is the answer for replacing AZT shall need long term

follow-up for risk of renal toxicities which I am observing in increasing number

of HIV patients receiving TDF + FTC +EFV combination. Where are we now ? Is

Raltegravir an answer ?

I wish health care providers and ART policy makers will make notice

of this observation

With greetings for Diwali and a Happy New Year

Dr. J.K.Maniar, MD

Consultant in HIV Medicine, Jaslok Hospital & Research Centre, Bombay

President, AIDS Society of India.

e-mail: <jkmaniar@...>

[Guest guest]

Dear Friends,

Re: /message/9593

I am afraid, although I do not have Dr. Maniar's level of experience, yet the

number of my patients on ART for last more than 4-5 years has started piling up

in terms of complications(as enumerated by Dr. Maniar).

Surely we are now heading towards a direction where we shall be left with

costlier regimens and lesser experience with them eg TDF. God forbid if you have

more HIV 2 than the treatment will be more cumbersum in all possible ways.

Can we do a sort of interplay of drugs for ARV naive patients---d4T for first 2

years, replaced by AZT for next 2 years and then TDF --the drugs to build the

regime of 3 ARV's around.

Can we try to force pharma industry to bring down the prices further.

Can NACO provide all types of trainings and drugs and involve experience of

people like Dr.Maniar at national level and like me at state level--who have

taken care of minimum few thousand PLHA already over more than a decade and a

half now.

Rakesh Bharti

Dr.Rakesh Bharti,

Bharti Derma Care and Research center,

27-D,Sant Avenue,The Mall,

Amritsar143001,Punjab INDIA

Email-rakesh.bharti1@...

9814044213  / 01832277822 /01832278522

[Guest guest]

Dear Dr. Maniar and the FORUM,

Re: /message/9593

Greetings and Thank you for your concern and findings.

 

NACP 3 has completely planned on reaching people living with HIV AIDS with

treatment in different categorised states.

But research in to such drug issues need to be strengthened as part of NACP 3

plans. More so, the ART impact in the lives of children living with HIV AIDS

needs to be given adequate importance in improving the quality of life of kids

to enjoy their childhood.

 

Also the ART Centers should provide adequate counseling in leading quality life

without ART as long as their physical conditions support, unfortunately people

living with HIV approaching ART centers are provided with ART even though their

CD 4 level and physical conditions are good enough.

 

We wish NACO will take appropriate measures to validate this finding and bring

in changes to the policy and guidelines in providing treatment services for

people living with HIV AIDS and their children.

 

regards

Jeyapaul Sundar Singh

e-mail: budsofchrist@...

[Guest guest]

Dear Moderator,

Re: /message/9593

This is with reference to Dr Maniar's warning to HIV Physicians.

He may be correct in his predictions.But in my opinion with regards to

d4T containing regimen is highly exaggerated by western journals,

clinicians as well as our physicians as an outdated one.

I am treating my patients in my private clinic with ART since 1999 onwards and

follow-up hundreds of HIV patients who are taking ART from Govt. ART centers as

a consultant to many NGOs.

To my experience, situation forced me to stop the d4T, 3TC, NVP combinations

were very very few.

Disfigurement due to lypodystrophy is not a lifethreatening

condition. Severe peripheral neuritis which warrents for a switch

over also with a handful of cases only in our patients. But for the

resistance acquired with some longterm patients who are on this

combinations more than 4-5 years,this combinations are working well

in controlling viral load and regaining immunity.

Dyslipidimia and dysfigurement in our poor patients where there are not much

options and rare Lactic acidosis are not warrantig us to switch over often.

Whereas drugs like AZT and NVP poses more severe life threatening

illness like bone marrow depression, very severe anaemia,

thrombocytopenia with AZT and severe liver failure with NNRTIs

warrant the physician to stop the drugs immediately.

Moreover, Abacavir, Teofovir, Emtricitacin are not within the reach of our

patients both in private and Govt.set up as far as our country is concerned.

About raltegravir ,we canot dream for it at present. It has

to be introduced in the Indian market and should be within the reach

our patients.

So in a country like ours and for our patients still d4T Combinations should not

be forgotton as a first line of drugs.

Dr. S.Murugan

e-mail: <muruganyes@...>

[Guest guest]

Dear Forum and Dr Maniar,

Re: /message/9593

What I am telling is what happened to me under Dr Micheal Saag, and since he

does keep us patients informed as to what is happening to us, I will repeat of

what happened to me. But it is a single case; mine.

In 1999, in Birmingham, Alabama, I was put on didanosine ddi EC 400mg , combovir

(lamiduvine/zidovudine 150mg/300mg) and efarvirenz 600mg.

I had recently had HPV virus- caused- cancer, and had a permanent colostomy bag

put on after.

I took all my medicines as prescribed, everyday.

In 2006, I had a bad case of neuropathy on my feet and extremities and the

sensitivity test showed that none of the medicines were effective anymore.

Next Dr Saag tried Truvada(emtricitabine/tenofovir 200mg/300 TDF), and

zidovudine 300mg along with ritonovir.

I had lacticacidiosis and Dr Saag stopped all medications for two weeks or a

month till my liver recovered. Dr Saag did get mad at me for refusing to take

Fuzeon as he had suggested earlier.

It was then that I went on Fuzeon (enfuritide 90mg twice a day),

along with saquanavir mesylate 4x200mg plus one 100mg plus ritonovir booster.

The whole procedure was cumbersome and I was afraid if I moved to India, I might

develop infection from needle pricks and contaminated water, and had to wait

till all solid enfuride would dissolve in before injecting it.

So as soon as raltegravir came out, I asked to be put on a trial and with

saquanavir and ritonovir booster (Dr Saag's combination).

The only good think is that whereas my viral load had never dropped to below 200

copies, it did, after I started raltegravir trial, and it has remained there

(<50 copies)for over a year now.

If a single case has any validity (I am a statistician) then I am presenting my

case.

Sincerely,

Priyadarshi Datta.

e-mail: <pdatta@...>

[Guest guest]

Dear All,

Re: /message/9593

 

Without commenting on the usefulness(or otherwise) of continutation or

modification of any extant ÂART regimen,I would request all to keep the

principle of basing our decisions on 'evidence' only.

Anecdotal data does have an important  role but it is largely a properly sampled

data (of appropriate sample size) analysed for statistical significance which

forms concrete and adequate evidence to modify the guidelines.

We must analyse the information from the ART centres/physicians managing AIDS

patients,initiate multi-centric studies and carry out metanalysis to ensure

early and appropriate modifications.

Best wishes,

 

Dr.Rajesh Gopal.

Dr. Rajesh  Gopal,MD

Joint  Director,

Gujarat  State  AIDS  Control  Society (GSACS),

O/1 Block, New  Mental Hospital  Complex,

Meghaninagar, Ahmedabad,

Gujarat. PIN 380016

Phone (O) 079-22680211--12--13,22685210 Fax 079-22680214

e-mail: <dr_rajeshg@...>

[Guest guest]

Dear Moderator and the Group:

Re: /message/9593

Working off the impressions I gather from the postings made by Dr. Maniar, I

have 3 questions for the clinicians on this list serve:

 

1. To clinicians in the non government / private sector: What percentage of PLHA

that come to you for clinical services are truly ART naive, ie; have not been

exposed to any of the anti retrovirals?

2. To the clinicians / program officials in the National AIDS Control Program:

What percentage of PLHA that come to the ART centres are truly ART naive, ie;

have not been exposed to any of the anti retrovirals? If there is history of

exposure to the one or more of the anti-retrovirals (irrrespective of

combination / duration), is there a treatment triage done for probability of

drug resistance?

 

3. To both sets of clinicians: Do you factor in the presence of Tuberculosis as

a treatment modifier? And for those that have TB, what percentage of PLHA are TB

treatment naive, ie; not exposed to any prior TB treatments?

 

Thank you for your responses.

 

Warm regards,

 

Dr. Bobby

Global Health Advocates / Center for Sustainable Health & Development

e-mail: bj@...

[Guest guest]

Dear Forum

Re: /message/9593

The mail by one of our most respected HIV physician of India should be seen

seriously.

 

But I feel the information available in this message is very limited and Dr

Maniar will publish the data in a peer reviewed journal soon and thus will get

scrutinised by peers. Also this will help is disseminating this information into

the scientific community and the rest of the world.

Personally i feel it is good practice to go to media and forums like this after

a  scrutiny. (I write this with an impression that this information is not

published). If published or submitted I request Dr Maniar to disseminate the

detailed data so that people like me can be more informed.

This responce is no way meant to see the information given by respected Dr

Maniar as inferior .

 

Regards

 

Dr Ajith

Dr Ajithkumar.K

Asst Professor In Dermatology and Veneriology

Medical college Chest Hospital

MG Kav, Trichur, Kerala, India

Ph 04872333322 (res) 9447226012

e-mail: <ajisudha@...>

[Guest guest]

Dear Moderator,

 

Re: /message/9604

This is in reference to Dr.S.Murugan with regards to d4t contain regimen is

highly exagerated by western journalist and clinician. Moreover ABC,TDF and FTC

are not within the reach of pvt and govt. patient.

I am not Doctor, but i have seen many of my friends with d4t disrupting their

quality of life. They may still have respectable CD4 count and undetectable

viral load, but many of them suffer the side effect of lypodystrophy, it's not

life threathening but it surely deshaping their face and other part of the body.

I have a friends who runs a cosmetic shops, but he don't want to sit in his shop

as people often ask him, " what happen to your sunken face? " His life is not

threathening but he lives the life of embarrassment and always want to be away

from people. This certainly is not the goal of ARV.

The goal of ARV is not just bring down the VL and push up CD4 count but also " To

improve the quality of life " Yet people on d4t their life is not threathening

but certainly compromise of the quality of life.

I have many friends from the west, but none of them are on d4t and very very

very few on AZT.I don't think this just because someone exageration but there

are ample studies on d4t and AZT side effect- a scientific and evidence base

info.

More over Indian Generic Pharma Co. produced a varieties of ARVs, why should we

continue to use those outdate ARVs like d4t and AZT?

We always claim India is " pharmacy of the developing countries " but we continue

to prescribe and take, the lowest,cheapest and nasties ARVs. Why?

 

Indian PLHIV  wants to live a productive and quality live not with sunken face

or elephant hump. Down with d4t and AZT. Time for newer drugs for Indian PLHIV.

 

Thanks Dr. Maniar for bring up this important issue.

 

Regards,

Loon Gangte

on AZT/3TC/NVP for the last 6 years.

e-mail: <dnpplus@...>

[Guest guest]

Dear Forum Members

 

Re: /message/9593

I'm a doctor working in HIV since 8 years (4 in Italy, 2 in China and 2 in

India).

Honestly I didn't understand very well all these concerns about AZT and d4T.

The side effects of these medicines are very well known and like any other

medicines they need to be replaced when the side effects are severe and cannot

be managed. But this is for all medicines.

I really think that all alternative drugs (TDF, Emtricitabine, PIs and new

classes) need to be used ONLY when it is absolutely necessary, especially here

in India where they are not yet availible on large scale and where the price is

unaffordable for most of the people.

In our clinic in Mumbai we have altreantive medicines (TDF, ABC, ddI, LPV/r,

IDV) but we keep them for the patients with confirmed need, keeping in mind that

it is probebly the last option for our patients and we have the responsability

to not to waste it.

Thank you,

 

Dr Chiara Montaldo MD

Project Coordinator

MSF B - HIV/AIDS Mumbai

Chandni Bunglow, 1rst floor

Union Park, Off Road

Tel +91-22-2 6055515

Mobile +91-9870729525

E-mail:MSFB-Mumbai-aidscare@...