Re: Urgent need to introduce second-line ARVs in government-supported ART centers

[Guest guest]

Dear group

I am treating HIViers since 1994. I think the urgency of need for second line

ART as concerned by INP+ is clinically not evidence based.

Less than 0.5 % PLHA's may require PI based regimens at time of diagnosis

itself. Less than 1% require 2nd line after a period of 7-10 years after 1st

line due to several factors including adherence.

Let US first be secure about 1st line and its equitable distribution free of

charge and dispel the myth that HIV care is ART delivery and thus compromising

on other components of HIV CARE .

Adherence counselling to 1 st line ART is very important right now.

Any premature allocation to 2nd line may retrograde the still unfinished

earlier steps.

Dr .Umesh M.S

CIVIL SURGEON

DISTRICT hospital

pathanamthitta

kerala.

e-mail: <ummusen1957@...>

[Guest guest]

Dear FORUM,

Dr. Umesh Sankaran's statement is false and highly misleading.

(/message/6753)

I don't know what regime Dr. Umesh Sankaran is providing to his (presumably)

private patients.

We have to remember that NACO provides only five ARVs. AZT, 3TC, Nevirapine,

Efavirenz, and d4T. So what does Dr. Sankaran mean by first and second line?

And what about salvage therapy, which is " beyond " second line.

For example, Honduras, a country poorer than India by all indicators, is

providing Abacavir, Ddi, Kaletra, Indinavir, and Ritonavir to people who

require ARV access, so physicians have a much wider menu of ARVs to choose

from, when people have problems with clinical failure, resistance or side

effects.

It is simply and TOTALLY untrue that 99 percent of all patients can survive for

7 -10 years on just these 5 ARVs that NACO is providing without either clinical

failure, virological resistance (which is not measured in India) or side effects

that are sometimes dangerous or even fatal.

If Dr. Sankaran would like to cite the studies on which he bases his claims,

I will be glad to forward them to the International AIDS Society, and other ARV

experts for their comments.

But, without such studies, I think what he is saying is very unfair to the

Indian PLWA who must depend on the public sector for their treatment, many of

whom are already experiencing clinical failure after only two years of ARV

treatment.

As for adherence, of course, better adherence will lead to better results. But

not in all cases.

Adherent individuals can still develop clinical failure, resistance, and side

effects.

Sometimes even the best intentioned of individuals also fail (or have temporary

lapses) in adherence due to economic factors, such as the inability to pay for

long journeys to ARV treatment centers. We have seen this in Central America,

and India is many times larger geogrpahically than Central America. People

should not be " blamed " or " punished " for issues related to adherence, they need

counseling and support.

ARV delivery is only part of comprehensive care, as Dr.Sankaran states. But

allowing people to die when their medications are no longer working, is not

comprehensive care.

Stern

e-mail: <rastern@...>

[Guest guest]

Dear Forum,

This has reference to Dr.Umesh's reaction to INP+ letter.

" I am treating HIViers since 1994. I think the urgency of need for

second line ART as concerned by INP+ is clinically not evidence

based, " says Dr. Umesh.

Earlier I have shared with the forum about my body's failing

response to first line ARV. I am grateful to all who wished me good

luck and encouraged me to keep up the hope. Till four days before I

was trying hard to postpone my need to go for the second line drugs.

I was hesitant because I am still not sure how far I will be able to

adhere to second line once I start it. Now I reached a stage that I

cannot survive anymore with out taking second line drugs and

gathered courage to purchase the second line medicines prescribed by

Dr.Manoj of Civil Hospital (ARV Centre) Ahmedabad.

It became possible because a gentle man doctor, a Cancer patient himself offered

the cost of my second line ARV medicines for few months that he may be able to

afford, hoping that in due course we may be able to find some source to avail

the medicines in Kachchh. I am very much grateful to him and personally feel a

ray of hope.

We are very much indebted to the lost lives of our friend Govardhan

Bhai of Kachchh NP+ and many others, for our efforts could not bring

them any help.

I think NACO need to; urgently take notice of people like us who are

failing to first line ARV, assess the situation and present the

problem before the government and donor agencies to find provisions

for people who otherwise will be missing from the national ARV

rollout programme.

Umashankar Pandey

President

Kachchh Network of Positive People (Kachchh NP+)

C/o Export Packaging Unit

Sector 2, KAZEZ

Gandhidham, Kachchh District, Gujarat.370230

Mob:09328945146

e-mail: <kachchhnp@...>

[Guest guest]

Dear Dr.Umesh,

The concerns raised by INP+ is the voice of people living with HIV (not HIViers)

whose first line of treatment fail and their health gets deteriorated, and some

who die as they can't afford to purchase 2ndline of line treatment. What more

clinical evidence base

you want?

A person on treatment doesn't jump from 1st line to 2nd line by his choice, but

on the advise of treating physician, who examine them clinically.

True, INP+ nor any other agency in India may not have the exact figure on how

many people are in immediate need of secondline. I believe,thats the reason why

INP+ proposed:- Estimation of those PLHA who need second-line ARVs: Estimation

of the number of PLHA who are coming to government-supported ART centers and who

now need second-line ARV regimens.

INP+ is not fighting just for 1st line or 2ndline or 3rdline, but fighting to

avoid untimely or premature deaths of PLHA who otherwise would be save by

Antiretroviral treatment.

I wonder if any of the people in this group believes that HIV care is ART

delivery. But i have no doubt that everyone in this list support that ART

delievery is the most(not the only) important component in HIV care, as of today

ARV is the only life saving drugs(not cure) that we have.

The adherence level of the client plays a vital role in achieving the goal of

ART,avoiding resistance or for the success of any ART programme.So adhrence is

always important whether you are on 1st line,2nd line or salvage therapy.

Dr.Umesh please put yourself one minute in the shoes of who needs 2ndline. Would

you still say No!? Would you still say don't give me my 2ndline medication but

give to other people who may need 1st line?

Human biengs' life is the same, be it people who needs 1st line or 2nd line

treatment.

Lets join hands in saving precious human lives!

Regards

Loon Gangte (who is currently on 1st line ARV but hates to see his

friends dying in need of 2ndline).

e-mail: dnpplus@...

[Guest guest]

Dear group,

I am not hostile to second line, but hold that it is not the ranking priority

right now

I am part of a government sponsored free ART program as a civil surgeon in a

district hospital of Kerala state giving care to hiv patients within the orbit

of treatment guidelines of the project

This KSACS project is only 2 years of age.

There are several patients who started ART 8-10years earlier than when they were

enrolled in the project. Most of them are remaining asymptomatic. The

proximate cause of death of hiv patients on ART could be several like : Late

diagnosis, less than 50 pretreatment cd4, advanced pulmonary TB, malignancies,

immune reconstitution illness, continuing alcohol and substance use, broken

adherence, concomitant use other herbal remedies, adverse drug reactions , drug

failure, suicide etc..

A presumption of drug failure and switch on to second line without evidence is

not admissible for a public heath project.

For individualized care also there needs evidence

Any premature death or worsening of condition whether due to lack of access to

second line could be ascertained only after reliable information on viral load

and cd4 responses consistently. The project has limitations even in providing

cd4 testing regularly for all the needy patients in time.

We have no facility for PVL Estimation or resistance testing, even though

Kerala, is the first state in India to initiate a free ART program. , Full

implementation of our project components still escapes us. For example, the

district hospital where I work, supplies of drugs for opportunistic infections

are not regular.

There is no VCTC at this district hospital. Patients have to travel 15 km to

the nearby VCTC, We are still suffering several, severe deficits in many

components of HIV prevention and care as it happens in every other resourse poor

setting.

Assuring uninterrupted first line drugs of quality, Supply, maintenance,

servicing and upgrading of laboratory services are the ranking priorities of

this care project.

We have to strengthen the capacity of community health workers in adherence

counseling .and follow up of primary care needs of hiv patients. Our HIV -TB

coordination is still weak. A host of other challenges too.

The project is treading every step with firmness. Prioritizing still unfinished

agendas and probing further steps based on context specific research and

evidence is prudent for a project to account. Otherwise we have to suffer the

risk of extending the legs before sitting.

It is not a question of fancy menu of pharmaceutical molecules. It is a question

of evidence. Right now our evidence is incomplete due to lack of research due to

non availability of lab support in a resource poor setting.

Dr M.S. Umesh.

e-mail: <ummusen1957@...> wrote:

[Guest guest]

Dear FORUM,

Ref: the posting from esteemed Dr. Umesh challenging the need to introduce

second-line ARVs in government-supported ART centers

Why does India have to " re-invent the wheel " with respect to all of these

issues? Sub-saharan African countries that provide ARVs are all providing

second line medications, and many of these countries have than less three years

since they began their programs.

Apparently there is a reason for this, regardless of all the different

arguments presented by Dr. Umesh. These are countries that are poorer than

India, all of them.

So why does India needs its own evidence, when ALL other countries that I am

aware of, poor as well as rich already provide 2nd line medications. Does India

need its own evidence or can it not learn from the experience of others? This

just seems axiomatic. India shouldn't sit around trying to re-invent data that

already exists, especially at the expense of human lives. The evidence is

already out there for all to see.

Granted that there are differences between India and other countries, in fact,

all countries are different, but all other poor countries provide 2nd line

medications, to varying degrees, but ALL are providing them. So what has

created this incredible phenonemon that India is the ONLY one that doesn't.

If the real question is money, then say that! Please! But remember that there

is currently $70 million available from money that is available from Round 4 and

Round 6 Global fund grants specifically allocated for ARV purchase that has not

been touched.

I have discussed this in detail with Mrs. S. Rao, of NACO an unusual woman to

be admired for her courage and capabilities. But, she must now recognize the

wisdom of others as well, and apply her own skills and wisdom, even if there

are some pressures against her, in order to not leave Indian PLWA in this

terrible situation. This is the nature of courage, and what position requires

more courage and wisdom than directing the Indian National AIDS program?

Stern, Ph.D.

San , costa rica

e-mal: <rastern@...>

[Guest guest]

Dear FORUM,

Indian Network for People Living with HIV (INP+) appreciates the

initiatives by the National AIDS Control Organization (NACO) to

provide first-line Antiretrovirals (ARVs) in India.

With nearly fifty thousand People Living with HIV (PLHIV) getting

first-line ARVs in India by the end of October 2006, we now have the

challenge of rapidly scaling-up first-line ARVs to the remaining.

Additionally, we have to ensure equity in ARV access to various

marginalized populations. Moreover, various state and district level

PLHIV networks of INP+ are witnessing deaths of PLHIV because they

could not afford second-line ARVs. We feel this is not ethically

correct in this period of rapid progress made in economy and health

sector in India.

Also, INP+ has been following up at www.aidstreatmentaccess.org the

periodic reports like `Missing the target' series to track the

progress in ARV access in India.

One of the recommendations that have been consistently made in all

these reports as well as in the e-consultations during formulation of

the NACP-III strategy, and one in which not much progress has been

made is the urgent need to introduce second-line ARVs in government-

supported ART centers. Therefore, we need to think creatively and

devise mechanisms to raise resources and make second-line ARVs

available as soon as possible in government-supported ART centers

under the national ART program.

In order to assist NACO and other stakeholders in making decisions on

introducing second-line ARVs in government ART centers, INP+ is

preparing a discussion paper. In it, we are suggesting the following

simple steps as the way forward:

Estimation of those PLHIV who need second-line ARVs:

1.1 Estimation of the number of PLHIV who are coming to government-

supported ART centers and who now need second-line ARV regimens

1.2 Estimation of what proportion of PLHIV at any point in time might

need second-line ARVs so that this will be useful if we plan to use

the available resources to buy first-line and second-line ARVs

Reallocation of resources and negotiation with pharmaceutical

companies:

2.1 Possibility of reallocating resources from the global fund

round-4 and round-6 grants to buy second-line ARVs

2.2 Negotiation with pharmaceutical companies to bring down the

prices of second-line ARVs

Mobilising new resources:

3.1 Asking major donors and international agencies like Bill and

Melinda Gates Foundation and Clinton Foundation to support for

introduction of second-line ARVs in government-supported ART centers.

3.2 Asking Indian government to support for second-line ARVs

when budgeting for NACP-III

3.3 Asking state governments to support for both first-line and

second-line ARVs in their respective states

3.4 Proposing in the global fund round-7 grant application to

introduce second-line ARVs

Setting-up interim mechanisms: Since introduction of second-line ARVs

in government ART centers may take some time and we do not want to

loose lives because of the delay in this process, we suggest to setup

interim mechanisms to support those who urgently need second-line

ARVs. Some of these could be:

4.1 Introducing reimbursement system to reimburse the costs of

second-line ARVs purchased by PLHIV who come to the government-

supported ART centers

4.2 Funding the `Positive support fund' setup by INP+ to support

those PLHIV who need second-line ARVs

I would like to harness the collective wisdom of the members of the

FORUM to help me build, change and add to these steps.

In addition, do members know of any particular constraining factors

or areas of opportunity that might be taken into account?

Three years ago, NACO felt that introducing first-line ARVs was not

possible because it was afraid that the costs might be quite huge. We

guess NACO is now in a similar thinking mode when it comes to

introducing second-line ARVs. Nevertheless, we hope we can devise

ways to move forward and introduce second-line ARVs as soon as

possible.

We invite AIDS INDIA e FORUM members to send their suggestions so

that we can help NACO to help us.

Sincerely,

K.K. Abraham,

General Secretary,

Indian Network for People Living with HIV (INP+)

Chennai.

e-mail:<inp@...>

-----------------------------

Cross posting from the Solution Exchange

www.solutionexchange-un.net.in

[Guest guest]

Dear FORUM,

Ref: Dr. Stern's posting on " Urgent need to introduce second-line ARVs in

government-supported ART centers "

Without going into the merit of introducing of second line ART let me explain to

Dr. Stern, why people like Dr. Umesh insist on evidence rather than trusting

western experts who claim to prescribe what is good for India. If India had

blindly followed many of the presriptions of experts of Dr. Stern's ilk had

given us we would have been in much greater mess. As are many African and a few

South Asian countries are today.

I could name a few public health preseciptions which we were foolish enough to

follow without asking the right questions. So many of our youngsters would

insist on satisfying themselves before accepting gratutious advice and I think

many other developing countries would be better off following their example.

Fortunately Ms. Sujatha Rao knows enough of the political and economic agendas

of public health experts not to accept such prescriptions blindly. (I am not

saying you have any. But lots of people have). She has treated some other recent

presciptions also with caution and thank god for that. If one of her

predecessors had the sense not to be bulled into starting first line ART by the

" experts " without proper preparation the damange to Indian AIDS programme would

have been much less. ART would have started six months later but the coverage

would have been much larger and must more consistent.

Health decisions in a country like India with high burden of disease which

spends lesss than 1% of their GDP on health is always difficult. It is more so

for people like Dr. Umesh at the cutting edge who have to watch the misery of

people who can't afford the cost of essential treatment and watch their dear

ones succumb to diseases which they know could have been managed.

The solution to such a situaiton will come from political action in India. Not

by following prescriptions of people secure in the cocoon provided by economic

systems depending on exploitation of developing countries.

If their hearts bleed for the poor of such countries they could spend their time

persuading their govenments for better terms of trade for poor countries and

less arm twisting in the name of imposing democracy. This applies to some of

other gentlemen who have been favouring Indians with their prescriptions on this

forum.

Rajeev Sadanandan

e-mail: rajeev_sadanandan@...

[Guest guest]

Dear forum,

I canot agree more than what Loon has put up. I don't know why some people are

reading too much on the data/ statistics...well, I don't have anything against

research or any kind of good study which will help improve the quality of life

for all or for few people who deserved.

Second line ART of course need data and statistics but it should not be taken in

such a way that it ceased to be an area of primary concern. The simple rationale

should be clear in the minds of any people who are working with in this sector:

1. It is fact that PLHA are dying because of unffordabilty & unavialability of

second line ARV

2. The number of PLHA who will be needing second line ARV will be on the rise in

times to come

3. It is a fact that there are PLHA (although may be few) who are starting their

ART from second line ARV

4. There may be times when PLHA will be needing 3rd or 4th (or n number of

lines)

5. Giving choices of lines may not be a long time answer to the PLHA but one

cannot deny the fact that there is a strong relationship between providing

choices and empowering people (read PLHA)

....it is time we understand that some of the concerns cannot be divided into

primary/ immediate or secondary. It is time we realised that we may run out of

time.

Gay Thongamba

e-mail: <gthongamba@...>

[Guest guest]

Dear forum,

It was a critical clinical question which expected responses from medically

trained persons ,but such was not forthcoming.

Sri.Rajeev sadanandan's pointblank critique on the whole politics of invasionary

prescriptions is an outcome of lessons learnt.

There were enough examples where a successful program is traded for another or

scarce resourses are squandered on unsound practices. Regarding politics of

treatment of HIV patients, what is witnessing now is a tragicomedy in which

pharma companies and treatment activists have succeeded in destroying the last

pretences of rational drug use and regulations.

Any drug, no matter how toxic, no matter how inappropriate. No matter how

lacking in benefits, is considered better than doing nothing. This dictum

amounts to a mass insanity better termed " pharmaco mania " . We know that this

kind of manic activism led to the demise of traditional drug trials like double

blind placebo controlled trials, the gold standard of drug testing.

Abandonment of evidentiary standards of drug approval in the name of expanded

access, accelerated approval and parrallel tracking led to a plethora of drugs

inadequately studied, without their benefits clearly demonstrated , entering

markets. It is known that ddi,and ddc got approval within record time.

Some of the treatment activists may be sincere persons. Others are undoubtedly

paid tools of the pharma companies, the only beneficieries of treatment

activism. When the pharma industry is allowed to bypass relevant evidentiary

trials for the sake of expanded access , it is shirking its responsibility to

carry out adequate post marketing studies.

It is also noticeable that the infected activist community is not vehement

regarding preventive vaccines, more efficient Anti.TB drugs or other

microbicides. It is worthwhile for activists to examine whether all these are

done in the best interests of HIV patients.

We doctors prefer to err on the side of caution.

Dr.Umesh

e-mail: <ummusen1957@...>

[Guest guest]

Dear FORUM,

Re: Urgent need to introduce second-line ARVs in government-supported ART

centers

[/message/6865]

Perhaps Dr. Umesh would like to disclose the amount and sources of his own

income, the perrks and benefits he receives from the medical representatives.

This seems relevant given that he is insinuating that some treatment activists

are " paid tools of pharma. "

I wonder if this particular Dr. has even the slightest ability to grasp what it

is like to be poor and faced with a life threatening illness. I wonder,

actually, how he can be so bold as to question the benefits of ARV therapy, when

Doctors around the world are prescribing anti-retrovirals to over 2 million

people in over 150 countries.

On the other hand, the kind of logic he finally chooses to apply is perhaps not

even worthy of further discussion or replies.

Stern

San , Costa Rica

e-mail: <rastern@...>

[Guest guest]

Friends

while we are emphasisng the need for second lines,I feel even the first lines

ART is not properly provided. The latest example is from my place where ART

center has hardly started catering to about 150-200 patients for last couple of

months and has already run short of emrti40(d4T+3TC+NVP combination). The people

managing the center then either start giving emtri30 in place thus reducing the

disage of d4T.

Not only that for no reason NNRTI efaviranez is replaced by NVP in ppl on that

drug for years together. When enquired I was told we have such instructions

nthat if a patient on ATT and ARV is stopped ATT then EFV should be replace by

NVP. I in practice have been doing the same but for economic reasons only.

I think there is no rationale to change or reduce the dosages of drugs unless

there are solid reasons for the same. When ARV are rolled out free then

definitely economy can not be the reason for change/reduction of dosages.

I feel by no being able to continually supplying the exact combination and right

dosages we are causing more harm to the control of disease.

Change of ARV's is a serious matter and even the experts have to spend sometime

themselves and with the poatient before doing so. The people who have been few

months training and have seen barely some patients should be instructed to seek

the help of seniors in whatever set up before doing so.

At my place I can offer my services, if need be- in case SACO thinks to utilise

and the bottomline is it will be in the interest of ailing community and as

ussual I am willing to do this transfer of knowledge free of cost to anyone

needing.

Punjab AIDS Control Society if you are reading this ,feel free to

involve me- I charge nothing

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 Moderator & Forum Member,

I was following and listening to this debate and discussion right from the

begging of the first posting till today.

All through this time what I heard is more of “Why we should provide 2nd line

ARV” versus “Why we should not provide 2nd line”. This makes me very sad because

if we go on this direction it will never end and we will keep on debating and

talking, in the mean time many people who needs 2nd line will die or people who

are on 1st line will develop resistance.

If we have to talk lets talk on “WHY WE MUST PROVIDE SECOND LINE”. This way we

can come to conclusion soon and saves more lives, if our intention is to save

lives from premature or untimely death of PLHA due lack of access to treatment.

I heard people saying we can not provide 2nd line because of cost factor/economy

or lack of infrastructure /capacity or some say we don’t have enough trained

health care worker or how can we do this when we still need so many people on

1st line etc. etc. etc.

I respect all what people said and its an ideal things but I don’t agreed that

if we have to wait for all these to be in place after we can only provide 2nd

line then.

Because after 20 years from now, our Doctors will still needs to be updated,

there will still be poor people or CD4 count/Viral load/resistance test will not

be everywhere or Treatment literacy will still be needed.

So it will never end and we will never get 2nd line ARV.

HIV is human virus. So let’s talk humanly.

You are earning hardly Rs.6000 months to look after your family. Suddenly one

fine day, Doctor tells you that your wife/husband/children/mother/father or love

one is suffering from a heart disease or Cancer. You are told you have to spend

minimum 1.5 lakhs NOW to save his/her live.

What did you and I do? Did we say NO doctor let me pay my children school fees

and uniform first, or let me complete my kitchen sink or

leakage in the roof or let my wife go to beauty parlor or repair my bike or do I

say let me study first exactly how and when did s/he got this disease.

I believe inspite of all other needs we have to attend, our first thought is “ O

my God! Where will I get the money to save his/her lives??? We ask ourselves

should I ask my dad, mom or my boss or take a bank loan or sold my plot or do

all. I don’t even remember how and

where I got the money, by after noon I handover 1.5 lakhs to my Doctor and say

save his/her lives NOW!!!

I believe if we think “WE MUST PROVIDE SECOND LINE ARV” we have think in a

similar ways and takes things on a war footing steps.I am never against building

public health system, I believe health care workers

needs to be train and update, 1st line ARV coverage must be expand, we need to

have efficient supplies and distribution system, treatment literacy is priority,

I am waiting Indian economy to be boom, I would love to see CD4 machine in all

district and ART Clinic all Taluks, Viral load test in every state and Resistant

test in every region, I want the Patent Controller rejects all Patent

application utilizing TRIPS flexibilities according to Doha declaration nor I

don’t mind taking branded drugs provide everyone who needs have access to it, I

am looking forward a day when I go and collect my ARV the counselor politely

tells me about the importance of Adherence and how to avoid side effect,

everyday I am praying let there be no more drug supply interruption at ART

clinic and also lets do a study/research on how many people exactly need 2ndline

and why people do develop resistance et al.

If YOU are the one who needs 2nd line would you like to have your medication or

would still lobby that things should be in place first. Or are we going to wait

until we get infected with HIV, take 1st line get resistance then only we are

going to demand???

Be it 5 or 500 or 50000, today there a real people who urgently requires 2ndline

so let’s come together deliberate “WHY WE MUST PROVIDE SECOND LINE”.

Denying Treatment is denying the rights to life. That’s the biggest form of

DISCRIMINATION.

Treatment is not a provision but it a RIGHT.

Loon Gangte

Regional Coordinator

Collaborative Fund for HIV Treatment Prepapredness

South Asia

INP+

B-5/140,1st Floor

Safdarjung Enclave,New Delhi-1100 29

Phone-+91-11-413 549 36, & 37

Fax- +91-11-413 549 38

Mobile-+91-11-98710 29 514

Email.-loon_gangte@...