Re: Query: Second line treatment of HIV

[Guest guest]

Detailed Recommendations for Switching to Second-Line ARV Regimens in Adults and Adolescents

August 2006

Source: World Health Organization, Antiretroviral Therapy for HIV Infection in Adults and Adolescents in Resource-Limited Settings: Towards Universal Access - Recommendations for a Public Health Approach, August 7, 2006.

Detailed Recommendations for Switching to Second-Line ARV Regimens in Adults and Adolescents

First-Line Regimen

Second-Line Regimen

RTI Component

PI Component a

Standard Strategy

AZT or d4T + 3TC b + NVP or EFV

ddI + ABC or TDF + ABC or TDF + 3TC (± AZT) c

PI/r d

TDF + 3TC b + NVP or EFV

ddI + ABC or ddI + 3TC (± AZT) c

ABC + 3TC b + NVP or EFV

ddI + 3TC (± AZT) c or TDF + 3TC (± AZT) c

Alternative Strategy

AZT or d4T + 3TC b + TDF or ABC

EFV or NVP ± ddI

a - NFV does not need refrigeration and can be used as a PI alternative in places without a cold chain.

b - 3TC and FTC are considered interchangeable because they are structurally related and share pharmacological properties and resistance profiles.

c - 3TC can be considered to be maintained in second-line regimens to potentially reduce viral fitness, confer residual antiviral activity and maintain pressure on the M184V mutation to improve viral sensitivity to AZT or TDF. AZT may prevent or delay the emergence of the K65R mutation.

d - There are insufficient data to detect differences among currently available RTV-boosted PIs (ATV/r, FPV/r, IDV/r, LPV/r and SQV/r) and the choice should be based on individual program priorities (see report). In the absence of a cold chain, NFV can be employed as the PI component but it is considered less potent than an RTV-boosted PI.

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[Guest guest]

Dear FORUM,

It is very common in developing countries for people to be switched from first

line to second line treatment without a viral resistance study.

Either CD4 or Viral Load test are sufficient, although perhaps less precise. But

no one should have to die because of lack of a viral resistance study.

Also, even where neither CD4 or Viral Load tests confirm resistance,

physicians should begin 2nd line treatment if the PLWA is clearly failing a

first line regime as evidenced by development of Clinical Symptoms. WHO

guidelines for resource poor settings make this clear.

2nd line drugs are cheaper than ever, as a result of new discounts announced by

the Clinton Foundation. Also, UNITAID has offered to pay for 2nd line treatment

in the public sector for two years, meaning that the Government of India would

not be responsible for the cost. And there are millions of dollars of unused

Global Fund money still available for 2nd line treatment, if NACO was motivated

to access it .

It's a tragedy, given the drop in prices and the availability of funds from

outside sources, that NACO is apparently still not providing 2nd line treatment.

In a previous posting

/message/7180

I have summarized some of our findings in relation to 2nd line treatment in

India, after spending five weeks there late in 2006.

Stern

San , Costa Rica

E-MAIL: <rastern@...>

[Guest guest]

Dear Members,

Re: /message/7424

The WHO's 3 by 5 initiative without proper ground work have lead to

10- 15% of resistance to first line drugs within 2- 3 years. If NACO

without proper clinical experience & lab support starts 2 nd line

drugs no one will save the disastrous out come.

NACO should first prepare the monitoring methods rather than pushing second line

regimen in hurry as done in First line drugs.

Sureshkumar.

E-MAIL: dsk_1973@...

[Guest guest]

Dear Suresh Kumar & Forum,

Re: /message/7424

I think with the best monitoring and adhearence also 10-15% of people who are on

ART may develope resistance in 2-5 years, due to the nature of human body or the

virus itself, nothing to do whith WHO or NACO.

You and i may not require 2nd line now, but there are real people who needs

2ndline here and now! Do you ever put yourself in their shoe?

I agreed with you that NACO has to prepare a proper monitoring methods, ensure

uninterupt supplies of drugs and lab.support along with a provision of 2nd line

regimen but NEVER at the cost of delaying 2ndline.

Loon Gangte

Delhi Network of Positive Poeple (DNP+)

House No. 64, Gali No. 3

Neb Sarai, New Delhi - 110068

Ph: 91-11- 29535239/65242332

DNP+ <dnpplus@...>

[Guest guest]

Dear Forum members,

The idea of raising good ground work before second line through NACO

was not a delaying tactics but with good intent to support large

number of PLWHA who might need 2 nd line regimen shortly due to our 3

by 5 initiative.

If you need more advise on 2 nd line ART i'll happy to respond.

Regards

Sureshkumar

e-mail: <dsk_1973@...>

[Guest guest]

Dear All,

Dr. Suresh Kumar has a point here. Raising good ground work is

indeed necessary here. We shouldn't repeat the same mistake now.

We all know how this so called 3 by 5 was initiated throught out

the globe. And particularly for India things was not at all as we

all have expected and this may probably be (or will likely be in

near future) the cause for the ART regime to fail.

However, it is high time that NACO include its provision in its

phase III implementation.

Somehow, I don't understand how NACO functions. In the earlier draft of PIP for

phase III there were so many essential provisions that were included.

But now in its final copy some of these essentials have totally been excluded.

For example Oral Substitution Therapy for IDUs. I would like to raise here WHY?

Regards

Ronny Waikhom

e-mail: <ronny_waik@...>