The second line of defence

[Guest guest]

The second line of defence

Despite its initial successes against HIV/AIDS, India must now invest in new

medication for patients

Loon Gangte and Leena Menghaney

Posted: Mon, Jun 8 2009. 9:35 PM IST

The cornerstone of India's AIDS treatment programme—thanks to strong leadership

from the National AIDS Control Organisation (Naco), public health experts and

civil society—is the implementation of a policy that mandates the provision of

antiretroviral (ARV) drugs that fight HIV itself, to all people living with

HIV/AIDS (PLHIV).

Barely five years after India started treating HIV/AIDS at only a few select

centres in government hospitals, it has the largest growing programme in the

world today.

Two hundred and twenty thousand PLHIV access treatment from 190 ARV therapy

centres across the country. Treatment includes access to doctors, diagnostics,

counselling, essential medicines including ARVs and those that treat

opportunistic infections—all free of cost.

The dramatic scale-up of India's treatment programme was enabled in large part

by the domestic production of affordable three-in-one fixed-dose combinations of

first-line ARV drugs by generics companies—made possible by India's refusal to

grant product patents on pharmaceuticals until 2005. The treatment is proving

effective even for those with advanced disease. With treatment, PLHIV are living

longer, healthier lives.

Yet, all this success is now at risk. HIV/AIDS is a lifelong disease. Over the

years, people on HIV treatment will inevitably develop resistance to their

first-line combination of ARVs. When this drug resistance develops, increasing

numbers of patients will need to switch to newer-generation, second-line ARVs.

This is something that " established " AIDS treatment programmes in other

developing countries such as Brazil, Thailand and South Africa have faced.

The need for access to newer combinations of ARVs has been evident from the

beginning of the government treatment programme. Yet, the government held back

from introducing second-line ARVs in the national AIDS treatment programme on

concerns about the spiralling prices of second-line ARVs. With the product

patent regime having been introduced in India in 2005, domestic generics

production that had so successfully brought down prices for first-line treatment

was unlikely to be replicated.

People living with AIDS, or PLHA, networks and public interest groups also saw

the danger of the possible patenting of these newer medicines, and of the high

prices that multinational pharmaceutical companies were likely to be able to

set. In order to ensure access to these life-saving drugs, they launched a legal

struggle to safeguard domestic generics production for second-line ARVs.

Starting from 2006, several oppositions to the grant of patents on second-line

ARVs have been filed before the Indian patent offices—on tenofovir, abacavir,

atazanavir and lopinavir/ritonavir, for example.

The need for newer drugs has been evident from the beginning of India's AIDS

programme

Encouraged by such moves, Indian generics companies followed up with the

generics production of second-line ARVs—at prices substantially lower than those

of multinational pharmaceutical companies.

Competition between multiple generics producers has further brought down these

prices over the last four years.

In 2008, at last assured of sustainable generics production of newer-generation

ARVs at affordable prices, India started to address the needs of PLHIV who had

developed drug resistance to first-line ARV regimens. Ten ARV therapy centres

across the country have begun providing second-line ARVs.

Under the criteria prescribed by Naco for accessing second-line ARV treatment,

the priority given to widows and children living with HIV will narrow the

disparities they face in accessing healthcare.

But this does not mean the battle has been won. PLHIV show that these same

criteria also restrict the access of those who most need the treatment. A key

criterion restricts access to second-line treatment to those living " below the

poverty line " . Another restricts access to those PLHIV who have been on the

government treatment programme for two years.

This leaves out patients whose conditions have already so deteriorated that they

are unable to wait for government-provided second-line ARVs and are forced to

seek treatment in the private sector. Others who are already failing first-line

but have been under treatment for less than two years in ARV therapy centres are

also ineligible.

Excluding PLHIV from second-line treatment based on these conditions means

driving them to the unregulated private medical sector, where the prescription

of irrational ARV regimens is common—a concern Naco itself has often expressed.

The refusal to treat spells immense hardship for PLHIV and their families, who

are forced to purchase second-line ARVs themselves from pharmacies at prices

significantly higher than those obtained by the government through bulk

purchases directly from the generics producers. Many will not be able to sustain

this expensive treatment, leading inevitably to further drug resistance,

continuous ill health, AIDS, and death.

If India is not to reverse the advances it has made in the past five years in

increasing access to ARV therapy, the concerns of PLHIV unable to access

second-line ARVs must be addressed urgently.

The battle to start providing ARV therapy in India has been won. The battle to

provide lifelong treatment to all is just beginning.

Loon Gangte is president of the Delhi Network of Positive People, and Leena

Menghaney is projects manager, India, Campaign for Access to Essential

Medicines, Medecins Sans Frontieres. Comment at theirview@...

http://www.livemint.com/2009/06/08213524/The-second-line-of-defence.html?h=B