Strategies, tools and policies to get the best
HIV treatment to more people, sooner

Contents
1. Where are we now?

1

2. Methods and results2

3. Timing is everything5

4. Strategies: reaching more
people with treatment

7

5. Tools: improving
quality of care

10

6. Policies: enabling affordable
and rapid scale-up

12

7. Conclusion

15

Annex 1

16

Annex 220

References

22

This document was produced with financial support of UNAIDS. The opinions expressed in this paper are those of theauthors and do not necessarily reflect the views, opinions and policies of the UNAIDS Secretariat or its Cosponsors.

Médecins Sans Frontières    Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner

1

Where are we now?
For over a decade, people living with HIV, treatment advocates, clinicians,
and health ministries have been grappling with how to ensure increased accessto quality antiretroviral therapy in resource-limited settings.

Although there have been enormous
strides over the past decade, constrained
budgets and sub-optimal policies thatare only slowly changing are impeding
the effort to reach all people in need.
In addition, too many people are stilldying because they do not know they
are living with HIV. And many people
are being diagnosed with HIV late orfall out of care before starting treatment.

The survey results provide a mixed
picture: 11 of 23 countries have reachedantiretroviral therapy coverage of 60%
or more. Some countries have alreadymade or are making strides towards theirown national targets of reaching 80% of
people in need with antiretroviral therapy.
On the other side of the spectrum,
six countries are still only reaching
one third of the people in need or less.
As the international norms for HIV movetowards better and earlier treatment
and technological advancements indiagnostics are becoming available, it isimportant to shore up and strengthen
the remaining key success factors thatrisk being compromised: political and© Zethu Mlobeli

This report outlines some of the strategies,
tools and policies that have supported thescaling up of treatment during the past
decade as well as those that can addresspersistent or new challenges. The results
are presented from a 23-country survey of
how consistently these strategies are being
implemented. (See Annex 1) The findings
demonstrate encouraging progress bysome health ministries in adopting manyof the enabling policies needed to facilitate

scale-up and improve care. Nevertheless,the adoption and implementation of thesestrategies, tools and policies are lagging insome countries.

financial support dedicated to addressing
and reversing the epidemic.
The last 12 years of antiretroviral therapy
in resource-limited settings have shown
that, when treatment is offered close
to home and before people get sick,their chances of survival increase.1, 2
In many countries, health facilities areoften overburdened and difficult to reach.
In response, several treatment strategies
were developed to provide care withincommunities, and these have shownpromising results. Such efforts to simplify
and decentralize treatment need toaccelerate to reach even more people withdurable, high-quality care.
To continue to make meaningful progress,
affected and donor countries will haveto fulfil commitments made at the 2011
United Nations High Level Meeting on HIV/
AIDS, when governments pledged to reach
15 million people with treatment by 2015.3
This target may well need to be revised
upwards if earlier initiation of antiretroviraltherapy for clinical benefit or for reductionof transmission becomes a global goal.
Nevertheless, current antiretroviral therapy
coverage is only halfway there: meeting
the goal means getting an additional
seven million people onto life-saving
treatment in the next three years andhelping them remain in care. Rapidly
increasing the number of people livingwith HIV receiving antiretroviral therapy
and supporting retention in care aremajor challenges, but the potential tostart reversing the epidemic by scaling up
treatment provides new motivation andrepresents an opportunity that must
be seized.

Teboho Haborone started antiretroviral treatment when his CD4 count was 25.
He now works at the clinic in Motsekuoa, Lesotho, as an HIV/TB lay counsellor
helping nurses with clinic tasks.

July 2012msfaccess.org

1

2

Methods and results
This survey examined 25 HIV indicators in 23 countries, 18 of which
are in sub-Saharan Africa.

Study
description
and methods
The data for this study were collected fromMarch to June 2012 with the objective ofassessing the status of key policies andoperational practices relevant to HIV andtuberculosis (TB) treatment programmes
in 23 countries.

In 2011, MSF published “Getting Ahead
Of The Wave: Lessons for the Next Decadeof the AIDS Response”4, providing facts
and figures on the implementation andprogress of HIV treatment policies in
16 countries. The present report is anattempt to enlarge the scope of the abovementioned publication. The 25 indicators
included in the study were assembled
with input from MSF and UNAIDS. Data
were collected mostly from national
government sources, primarily the healthministry and HIV programme coordinating
bodies. Documents included national
HIV and TB guidelines as well as national
programme updates from departments
responsible for the programmes related
to HIV, TB, preventing mother-to-childtransmission or human resources for health.
Alternatively, where reliable data were
not obtained from national documents,
MSF teams conducted interviews withnational authorities and/or used verifiable
information sourced locally.

2© Brendan Bannon

Médecins San Frontières (MSF) is an
emergency
medicalhumanitarianorganization that works in more than
60 countries worldwide and that currently
provides HIV treatment to 220,000
people in more than 20 countries.
Of the countries included in this survey,
MSF has HIV projects in 16. MSF fieldteams collected data for the countries
where MSF has HIV projects. Data for theremaining seven countries were collectedfrom similar national and internationalsources with the support of UNAIDS.

Brian, seven years old, is enrolled in the HIV/AIDS programme in Epworth,an urban settlement outside Harare, Zimbabwe.

For countries where MSF does not have
HIV operations, UNAIDS was asked
to assist in the process of informationcollection and validation. The maininternational source was the Global
HIV/AIDS response: epidemic update andhealth sector progress towards universal
access, Progress report 2011.5 Citations
for the sources of survey results as well
as a more detailed methodology can befound at www.msfaccess.org.

in reliable national and international

The information presented is thus largely
reported by governments and publishedpurview to validate officially reported

sources. In some cases there is a delay
between the establishment of normative
best practices and adopting and adapting
them into revised national guidelines.
Similarly, even when national guidelines
reflect

newnormative

standards,

implementation may lag.
As an emergency medical humanitarianorganization, it is not within MSF’s
figures or data.

Médecins Sans Frontières    Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner

UNAIDS, the Joint United Nations
Programme on HIV/AIDS, has endorsed
robust goals for continuing the rapid
expansion of antiretroviral therapy toachieve universal access by 2015 and,as well, to eliminating new HIV infections
among children and keep their mothers
alive. Achieving these goals depends
on several factors, including mobilizing
sufficient resources from domestic andinternational sources, adopting national
policy frameworks that are consistent
with international best practices andnormative guidelines and innovating
service delivery to facilitate greatly
expanded HIV care and treatment inlow- and middle-income countries.

UNAIDS, as well as other partners, iscontinuing to support the mobilizationof resources and the innovations thatare embedded in Treatment 2.0, the
WHO/UNAIDS programmatic approach,structured on five pillars: optimizing
drug regimens; developing point-of-careand simplified laboratory platforms;
innovating service delivery; reducing
costs; and mobilizing communities.
These activities are occurring inmany venues, including research anddevelopment, international forums andsupport for and the dissemination of
innovative best practices.

UNAIDS therefore supported MSF in
surveying 23 countries facing high-burden
HIV epidemics, focusing on the status of
implementation of national policies thatfacilitate the implementation of Treatment
2.0 and eliminating new HIV infections
among children. The outcomes of thecurrent publication provide a clear pictureof the national policy framework andimplementation status of the domains
important to monitor and advocate forpolicy and programme change and growth.
We hope that it serves as a powerfultool for policy-makers and programmemanagers to inspire them in scaling up
antiretroviral therapy (ART).

 f the 18 countries surveyed inO
sub-Saharan Africa, 11 allow nurses
to initiate antiretroviral therapy.
Six of these countries changed theirpolicies to allow nurses to initiate
antiretroviral therapy in the past two
years. Only 13 of the 23 countries
have policies allowing nurses toprescribe and provide TB treatment.


Only
eight countries’ guidelines
allow for multiple (two or three)month refills, rather than monthly,for people in stable condition.

Key results
 f the 23 countries surveyed, nine haveO
antiretroviral therapy coverage below
50%. The coverage rates of services
for preventing mother-to-childtransmission of HIV are greaterthan 80% in six of the countries
surveyed, but eight are still below
50% coverage. Only eight of the
20 countries for which data wasavailable provide antiretroviraltherapy in 30% or more of publicsector facilities.

Almostall countries are in accordancewith WHO-recommended protocols
for antiretroviral therapy initiationand first-line drug regimens, althoughimplementation in some countries
has faltered due to funding gaps.

 f the 23 countries surveyed, fourOrequire viral load before switching
to second-line or further regimens,
but the technology is only widely
available in four countries.

In many countries, policies are still notin place to support the provision ofbasic HIV-related tasks by lay workers:
only 14 of 23 countries allow lay
workers to provide HIV counselling andtesting and adherence counselling.

Continued overleaf

July 2012msfaccess.org

3Policies and Progress in 18 Sub-SaharanAfrican Countries

Nigeria
CentralAfricanRepublic

Ethiopia

GuineaUgandaCameroon

Kenya

Democratic
Republic of
Congo
Tanzania
Malawi

Nurses can initiate TB treatment

ZambiaNurses cannot initiate TB treatment

Mozambique

Nurses can initiate ART
Nurses cannot initiate ART

Zimbabwe
Namibia

Botswana

ART coverage over 50%
ART coverage at or below 30%

Swaziland

PMTCT coverage over 50%
PMTCT coverage at or below 30%
Percentage of health facilities incountry offering ART over 50%

South Africa

Lesotho

Percentage of health facilities incountry offering ART at or
below 30%

4

Médecins Sans Frontières    Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner

3

Timing is everything
Recent scientific findings confirm that in addition to prolonging the lives
of individuals, HIV treatment is itself a key component of HIV prevention.
The landmark HPTN 052 study showed that providing HIV treatment earlier
helps to stave off opportunistic infections and reduces the risk of sexualtransmission to HIV-negative partners by 96%.2

Time is a critical factor: getting treatment
to people before their disease progresses
is important both for their own health andfor preventing further infections.
HIV treatment policy is quickly responding
to this new evidence. In April 2012, theWorld Health Organization (WHO) issued
two critical new pieces of guidance on
HIV treatment. Firstly, its April 2012programmatic update Use of antiretroviraldrugs for treating pregnant women andpreventing HIV infection in infants6 points

all pregnant women living with HIV for
preventing mother-to-child transmission
and for their own health. This protocol,
known as option B+, is easier to manage inmany settings than the current practice forpreventing mother-to-child transmissionof starting and stopping antiretroviraltherapy with each pregnancy. It is also
better for mothers and babies, especiallyin places where women have multiple
pregnancies but may not be accessing
services for preventing mother-to-childtransmission of HIV early enough.

for treatment and prevention in serodiscordant
couples7 recommends treatment for everyone
living with HIV who has an HIV-negative
partner (serodiscordant couples), regardlessof their CD4 count, to help prevent thesexual transmission of HIV.
These two interventions targeting specificpopulations, when considered in addition
to efforts based on growing evidence ofclinical benefit to reach others earlier in theirdisease progression, collectively constituteto the benefits and momentum behind

Second, WHO’s Guidance on couples HIV testinga care package referred to as accelerated

offering lifelong antiretroviral therapy toand counselling including antiretroviral therapy

antiretroviral therapy (see box).

Accelerated
antiretroviraltherapy includes:initiating antiretroviral therapy
at an early stage of disease(at CD4 count of 350 per mm3
or higher);
immediate
initiation of
antiretroviral therapy forpeople living with HIV whohave active TB;
 arly initiation of treatmentefor people living with HIV whohave HIV-negative partners(treatment as prevention)
which reduces the risk oftransmission by 96% forserodiscordant couples; andlifelong
treatment for pregnant
women and breastfeeding
mothers living with HIV,
regardless of CD4 count.

Accelerated treatment can result in A Decline
in New HIV Infections
Accelerated Scale-up
Base Case
140,000
120,000
100,000
80,00060,00040,00020,000
0
2010

2011

2012

2013

2014

2015

Under the scenario of today’s scale-up pace and treatment access rates, incident HIV
infections in Kenya are expected to remain relatively constant at or above 120,000
new cases per year. With accelerated treatment scale-up, new HIV infections could
be driven down to around 86,500 by 2015. Source: John Blandford, PhD, CDC

Continued overleaf

July 2012msfaccess.org

5Timing is everything continued

Scaling up antiretroviral therapy now would have significant benefits
both for individuals and communities:
 caling up treatment to meet theS“15 by 15” commitment would,
according to United Nations estimates,
prevent seven million people from dying
and 12 million people from acquiring
HIV by 2020.8
Every
1,000 people given treatment
per year averts 228 people dying,
61 people becoming newly infectedwith HIV through sexual transmission
and 26 infants from acquiring
infection.9

Accelerated
treatment is expected tohave a community-level impact andprovoke an even steeper drop in
the incidence of new HIV infections.
The United States Centers for Disease
Control and Prevention used datafrom Kenya to model treatment
acceleration and demonstrated that
extending HIV treatment to an
additional 323,000 Kenyans by 2015,
above the current pace, would reduce
the number of people newly infectedwith HIV by 31% by 2015 (see graph).9

 northern KwaZulu-Natal, SouthIn
African researchers found thatevery percentage point increasein antiretroviral therapy coverageamong adults living with HIV wasassociated with a 1.7% decline in
the risk of an HIV-negative adultacquiring HIV. People living in areas
with higher antiretroviral therapy
coverage (30 – 40%) were 38% lesslikely to acquire HIV than people in
low-coverage areas (coverage lessthan 10%).10

Progress in scaling up and implementing WHO-recommended improved treatment
protocols for earlier initiation varied across the 23 countries surveyed:Thecoverage rates of services forpreventing mother-to-child transmissionof HIV are greater than 80% in six of thecountries surveyed, but eight are still
below 50% coverage.

All
but one country surveyed haveadopted WHO recommendations to start
treatment at CD4 count of 350 per mm3
or lower and for all people coinfectedwith HIV and TB, irrespective of CD4.
Zambia has moved to provide early
antiretroviral therapy in cases ofserodiscordant partners regardless of
CD4 count; additional countries are
considering such a policy change.

 ll countries surveyed have adopted
A
protocols for services for preventing
mother-to-child transmission of HIV asrecommended by WHO:1 12 countries
implement option A; six countries
implement option B; two countries
allow either protocol; some of thesecountries are considering a change
to from option A to B or B+; only two
countries have option B+ as policy –as recommended by WHO in its April
2012 update,6 plus Kenya, where it isoffered as an option among all three
protocols for facilities to decide.
Althoughlimited data were available, themedian CD4 count when antiretroviraltherapy was initiated was less than
170 per mm3 in the six countries withavailable data.

Reachingchildren with treatment
continues to lag across many of thecountries surveyed. Children represent
an average of 7% of the people receiving
treatment in the 23 countries.

© Sven Torfinn

 the 23 countries surveyed, nine haveOf
antiretroviral therapy coverage below
50%. Botswana and Swaziland provide
antiretroviral therapy to 80% or more ofthose who need treatment.

Charles Sako, 41, started ARV treatment in 2005 and now lives with his partner and three-year old daughter in Kibera, Nairobi.

6

Médecins Sans Frontières    Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner

4

Strategies: reaching more
people with treatment

A major challenge in increasing access tocare is that most people with HIV do
not know their HIV status.11 Of the
23 countries in the study, 21 offer providerinitiated testing and counselling, which ismostly still conducted at the health facility
level. Implementation, however, lags behind.
A recent study from Malawi of clinic-based
HIV counselling and testing12 showed that
only 13% of clinic attendances included
HIV counselling and testing. A growing
number of countries16 now allow lay healthworkers to administer HIV testing, although
not all of these 16 have implemented thispolicy to the point of being standard practice.
Ensuring that treatment is available freeof charge is also essential. And althoughuser fees and other charges passed down
to service users are a documented barrier
to access,13 there is a risk that treatment
free of user charges might be reversed

if funding levels are not increased. According
to the survey results, all 23 countries havepolicies providing antiretroviral drugs for
free, but this policy is not being consistently
followed everywhere. For example, in the
Democratic Republic of the Congo, Central
African Republic and Zimbabwe, people arebeing charged according to MSF teams on
the ground. In two countries (Cameroon
and Myanmar), the policy of providing
drugs free of user charges does not include
the diagnostic and monitoring tests
required with care, and in three countries(China, Kenya, and Myanmar), the policy
does not include drugs needed to treat
opportunistic infections. In Mozambique,a nominal fee is charged to all outpatientsfor prescriptions and consultations.
In Zimbabwe, the government is proposing
charging people for antiretroviral therapy
to make up for funding shortfalls, sinceinternational donors have reduced support.

2) Scaling-up facility-based treatment
Getting treatment
into every clinic

Shifting healthcare tasks

Decentralization – getting care out ofcentralized hospitals and into community
clinics and local health posts – has been
the cornerstone of expanding access toantiretroviral therapy. Nevertheless, only eightof the 20 countries for which data wereavailable provide antiretroviral therapy in
30% or more public-sector facilities. Five of
the 16 countries with an adult prevalence of
HIV infection above 2% have decentralized
treatment and care to the extent that at least
40% of public-sector health facilities offer
antiretroviral therapy. Making treatment
available in more health facilities has allowed
more people to be reached in countries like
Lesotho, Malawi and South Africa, where facility
coverage is more than 60% and antiretroviraltherapy coverage is more than 50%.

One of the key obstacles to decentralized
treatment has been reluctance on the partof some policy-makers to shift health caretasks from doctors to nurses and nurses tolay health workers. Nevertheless, this haschanged in some countries.
In Malawi, an estimated one million people
are living with HIV, but there are just
1.2 doctors and 28 nurses for every
100,000 people. To cope with thiscritical shortage, the government started
shifting tasks such as initiating treatment
from physicians to non-physicians,
including nurses. The results are positive.
In Chiradzulu district, three-year treatment
outcomes for people whose treatment
was initiated by nurses were comparable© Pierre-Yves Bernard1) Making testing andtreatment accessible“I train nurses who work inlocal health clinics and areable to start patients on
antiretroviral treatment andalso TB treatment. In many
clinics where the nurses work,
there is no doctor available
so task-shifting allows patientsto be seen every day.”
Nolitha Mabandlela, Nurse mentor,
Khayelitsha, South Africa

to those initiated by clinical officers
and medical assistants; in fact, people
started on treatment by non-physicians
were more likely to remain in care.14
A randomized trial in South Africa15
found task-shifting of HIV treatment fromdoctors to nurses to be safe and effective.
Of the 18 countries surveyed in subSaharan Africa, 11 allow nurses to initiate
antiretroviral therapy. During the past two
years, six of these countries have changed
their policies to allow nurse-led initiation:
Kenya, South Africa, Swaziland, Uganda,
Zambia and Zimbabwe. Three of theseven African countries that do not allow
nurses to initiate antiretroviral therapy
do allow them to provide follow-up
Continued overleaf

July 2012msfaccess.org

7

Shifting health care tasks continued
for people on antiretroviral therapy.
Of the countries surveyed, Mozambique isthe one with the highest HIV prevalence
that has yet to allow nurses to initiate
and manage antiretroviral therapy, eventhough it suffers from a severe humanresources crisis and nurses comprise
70% of the health workforce. Medical
technicians (tecnicos de medicina) are theonly non-physicians permitted to performthese tasks but are not often found at the
primary care level.
Similarly to policies that allow the taskshifting of treatment initiation, policies thatallow lay workers to dispense antiretroviraldrugs support scale-out by easing the strain
on the health system. A study in western
Kenya showed that lay workers livingwith HIV successfully provided adherence
screening and antiretroviral drug refills
to people in the community, and thegovernment is considering replicating
this strategy throughout the country.16
A randomized trial, also done in Kenya,showed that outcomes were equivalent
under lay worker surveillance and clinicbased care but required half the numberof clinic visits, easing the burden on boththe people living with HIV and the system.
In many countries, however, policies still
do not support lay workers providing
basic HIV-related tasks: only 14 of the 23
countries allow lay workers to provide HIV
testing and antiretroviral therapy adherence
counselling. Seven of the 23 do not allow
lay workers to provide HIV testing.

Integrating
antiretroviral therapy
with other healthservices
Optimizing antiretroviral therapy delivery
also requires providing treatment withinsettings where people can have theirbroader health care needs addressed at thesame time, in one location, and from thesame health worker. This means addressing
health needs beyond HIV.
Integration with TB care. In Lesotho andSouth Africa, integrating HIV and TB at the
primary health care level has shown improved
case-finding and better outcomes17 as well as
reducing half the delay in starting antiretroviraltherapy for people newly diagnosed with
TB.18 Despite growing recognition that HIV
and TB integration is the preferred approachto tackling the twin epidemics in settings
with a high burden of HIV infection and TB
disease, and despite resulting policy changes,
integration is lagging in practice across manyof the countries surveyed, and full one-stopcare remains rare.
In several of the countries surveyed, thepolicies that establish where antiretroviraltherapy and TB treatment can be provided
and by whom make decentralization andintegration difficult. Of the 16 countries inwhich MSF provides HIV treatment, only six
were free from policy barriers that preventthe same primary health care worker
from providing HIV and TB treatment. In
Cameroon, for example, nurses can initiate
TB treatment but not antiretroviral therapy.

In Lesotho, although more than 90% of
public-sector facilities are reported to beproviding antiretroviral therapy and nurses
can provide both antiretroviral therapy and
TB treatment, the initiation of TB treatment
is not decentralized to the primary carehealth centres. In Uganda, the reverse
situation – nurses are not allowed to provide
antiretroviral therapy and TB treatment
is more decentralized than antiretroviraltherapy – gives the same result: integrating
decentralized HIV and TB care is moredifficult. Of the 23 countries, only 13 havepolicies allowing nurses to prescribe andprovide TB treatment.
Integration with prenatal and infant care.
New WHO guidance on option B+ forservices for preventing mother-to-childtransmission of HIV – in which all pregnant
women living with HIV are to be offeredcontinuous antiretroviral therapy, instead ofstarting and stopping antiretroviral therapy
with each pregnancy – can greatly simplify
the provision of prenatal and infant care. Thisapplies especially to regions with high fertility,
since it should reduce attrition between
pregnancies. An MSF study from Thyolo,
Malawi showed that, during the expansion
and integration of HIV services with prenatal
and infant care, the use of reproductive
health services increased, and the outcomesof infants born to mothers living with HIV
improved. Of the countries surveyed, only
Malawi and Uganda have option B+ as
policy, and Uganda only plans to implement
the policy if it is successful in securing
additional funds from international sources.
Other countries such as Mozambique arealso considering switching to this protocol.

Strategies to address the HIV care cascade
HIV Testing• Improved HIV rapid
tests (e.g. oral tests)

Pre-ART
regularclinic care• Home andcommunity-based
counseling and testing• Strong referral andlinkage to care• HIV testing bycommunity and lay
health workers• Provider-initiated HIV
testing and counselingand integration withprimary care
• Targeted mobile
testing for hard toreach groups at
schools, taxi ranks,
farms, workplaces8• Free HIV care
& treatment• Point of care CD4count testing• Rapid diagnosis
and treatment of TB• Regular visits, TB
and PCP prophylaxis• Support tools (mobile
messages, patient held
appointment cards)

Early ART
retentionin care• Timely and / or earlier
ART initiation

Long-term
ART andundetectableviral load

• Adapted adherence
support• Simplified clinicaland refill schedules• Decentralization,
primary care integration• Community-based,
peer-supported ART• Task-shifting• Viral load-triggered
adherence support• Non-toxic robust drugs;
once-daily fixed-dose
combinations• Viral load monitoring• Out of clinic care

• Reliable drug supply,
multiple month refills• Defaulter tracing

Médecins Sans Frontières    Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner

3) Managing
treatment at thecommunity level
With the continuing shift away from
specialised clinic HIV care, antiretroviraltherapy programmes are increasingly
looking towards newer models for chronic
disease management, whereby thecommunity manages people living with HIVwith a stable condition and interventions to
support treatment adherence. This further
decentralization and task-shifting involves
strategies such as peer antiretroviral therapy
groups, which can boost adherence andrelieve the burden on people living with HIV
and health systems. Other policies can help
reduce the number of required clinic visits,
simplify clinical appointments and/or reduceburdens by providing people with several
months of medicines in one refill visit.19, 20
In the Democratic Republic of the Congo,
community organizations of people livingwith HIV run antiretroviral drug distribution
points throughout Kinshasa, providing refills,
adherence counselling and basic healthfollow-up. People spent an average of 12
minutes to pick up their refills at these points,
compared with 85 minutes at the hospital.21© Brendan Bannon

MSF has piloted community-based
programmes in several high-prevalencesettings. For example, in Tete, Mozambique,community antiretroviral therapy groups ofsix people on antiretroviral therapy take turns
going to the clinic every month to pick up
medicine refills for the whole group. This peer
management also helps people to motivate
one another to adhere to treatment and helps
prevent loss to follow-up.22 This was rolled

HIV treatment in conflict settings and among
mobile populations
Access to treatment has increased instable environments but is less available
in conflict or post-conflict settings.26
Given competing medical priorities,
severe human resource and funding
constraints and a lack of priority given
to HIV-related health needs in countries
in conflict, the international community
has been reluctant to engage. One
major concern is that treatment
will be interrupted in an unstableenvironment, leading to possible drug
resistance. In these contexts, simplified
recommendations and implementation
procedures that anticipate the possibilityof sudden population movements are
essential, as is the integration of HIV withother health services. MSF’s experience intreating HIV in post-conflict settings, suchas in Bukavu, Democratic Republic of theCongo, has shown results comparable tothose in stable settings, with programmes
rarely disrupted by conflict.26

out in 20 health facilities in Tete Province,and only 0.1% of the 4,410 people enrolled
in 1,023 groups between February 2008 andDecember 2011 have been lost to follow-up.
In response to this success, the Governmentof Mozambique is scaling up the strategy
nationwide, and health ministry delegations
from Malawi, Swaziland and Zimbabwe
have visited the project to assess whether themodel could be replicated in their contexts.
Malawi’s health ministry has started a pilot“I’ve found so many advantages tobelonging to the community group.
Firstly we all support one anotherlike a family and if someone in
the group is sick we help them –maybe we fetch water or we clean
or cook for them. Then anothergood thing is that we only need tosend one person in the group eachmonth to the clinic to collect the
medicine refills for everyone else in
the group. Now we only have to go
individually to the clinic once every
six months. That means for me that
I can stay home, getting essential
things done around the houseand my shop.”
Carmen Jose-Panti, 32 years old,
HIV positive, Tete, Mozambique

Providing antiretroviral therapy formobile populations requires adapted
operational strategies to deliver
treatment. Migrants (especially those
who are undocumented) can be
reluctant to seek care for fear ofdeportation, and likewise, clinics canbe reluctant to deliver care for migrants
out of fear that they will not adhere totreatment or be able to access refills.
Through a weekly mobile HIV and TB
clinic service, MSF provides HIV care
to Zimbabwean migrant farm workers
in South Africa in Musina. They receivea three-month supply of antiretroviraldrugs if they plan to return home fora period, as well as a health “passport”
that serves as a record of their care if theyneed to transfer to another antiretroviraltherapy provider. Models that accountfor population mobility could benefit
other HIV treatment programmes.27

project. A similar strategy in Khayelitsha,
South Africa offers streamlined health visits
for people in stable condition in adherencegroups, who receive check-ups as a group andget refills within two hours. A lay adherence
counsellor leads the group, providing
support to long-term service users who
sometimes experience adherence fatigue.
Retention in care was significantly higher forgroup members compared with people notin groups (97% versus 85%).23 Among the
23 countries surveyed, only Mozambique
has an explicit policy allowing antiretroviraldrugs to be dispensed outside facilities andmobile clinics.
Routine multiple-month refills and simplified
clinical appointments have been implemented
in many programmes and settings. Such
practices are showing good outcomes forpeople in their first year of antiretroviral therapy
in Zimbabwe.24 In Chiradzulu, Malawi, 97%of those in a programme offering clinician
appointments every six months for people instable condition, and antiretroviral drug refills
every three months from health surveillance
assistants, remained in care after one year.25
Of the 23 countries surveyed, eight explicitly
allow in the treatment guidelines for multiple(two or three) month refills for people instable condition, a policy that is also accepted
standard practice, although not reflected in
the guidelines, in three additional countries.
Drug supply problems, however, can be abarrier to implementing such strategies.

July 2012msfaccess.org

9

5

Tools: improving
quality of care
Getting the best possible treatment to the most people possible – andretaining them in care – requires securing access to the best medicines
and tools needed to monitor HIV treatment and properly and timely
diagnose TB. These must be affordable. But limited budgets should notstand in the way of ensuring the best possible treatment and monitoring
options are available.

Better drugs
In 2006, WHO recommended a shift
away from stavudine; WHO’s 2010

“To make sure my treatment is effective, the clinic takes a blood
sample to check my CD4 count and viral load. My latest viralload count, taken in June 2011, was undetectable. Antiretroviraltreatment is life-long so it’s encouraging to be told that thetreatment is working well for me.

guidelines recommended that it bephased out entirely and be replaced infirst-line treatment by either zidovudineor tenofovir. The current best option forfirst-line therapy is the combination of It helps to know that whatever the difficulties, I am controlling thevirus. I am proud that my viral load is undetectable, and I tell others
about it. It helps me plan for tomorrow and I am confident I will
live a normal life in the future.”

tenofovir + lamivudine + efavirenz, whichis available as an adherence-friendly onepill-once-a-day formulation.
Of the countries surveyed, all had

Fanelwa Gwashu, 40, HIV positive, Khayelitsha, South Africa

adopted alternatives to stavudine into
policy, be it tenofovir (eleven countries)
or zidovudine (seven countries) or either

Given the development of new drug classes

five years on antiretroviral therapy30. Thisand new generations of well-tolerated andcompromises people’s care and reduces

easy-to-use drugs, first-line regimens are

the impact of antiretroviral therapy at the

expected to improve further. Second-line

community level because of increased

treatment whether for people initiating

regimens should also be revised to include

illness and transmission.

therapy, or people already receiving

more powerful protease inhibitors andantiretroviral therapy, or to roll it out on a

integrase inhibitors.

of the two options (five countries).
However, in several countries, funding
constraints have resulted in decisions todelay the implementation of improved

partial basis only.

load

monitoringcanimprovetreatment by indicating when a person
may need to switch regimens. Viral

providing robust and potent antiretroviral

Viral loadmonitoring

drugs with as few side effects as possible

Treatment failure, where HIV develops drug

targeted adherence support to stave off

will help long-term adherence, which

resistance, goes mostly underdetected andthe emergence of drug resistance anddelays the need to switch to more costly

underdiagnosed in low- and middle-income

treatment failure, so that they can continue

second-line regimens. New treatments

countries; according to WHO, only 3% ofon the same regimen. In Khayelitsha,

will need to be easy to take and should

the people receiving antiretroviral therapy

South Africa, where routine viral load

be offered in fixed-dose, once-daily

aretreatment,

testing identified detectable viral load in

combinations. They also must not be

although the need is greater given theclinic attendees, all were given targetedcounterindicated with other medicines

rate of failure:

one study of almost

adherence support. Of that group, 71%

routinely taken for coinfections and20,000 people in South Africa found that

had an undetectable viral load at the next

should be safe for use in pregnancy.

10% needed second-line treatment after

check three months later.31

As more people are placed on treatment,

10

Viral

load monitoring also helps preventively,
as it can identify people who need28

receiving

second-line
29

Médecins Sans Frontières    Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner

Nevertheless, most programmes inAfrica do not have access to viral load
testing – primarily because of its highcost and because the complexity ofthe technologies make them ill-suitedfor resource-limited settings. At best,
viral load monitoring is reserved for
confirming treatment failure once people
already show clinical or immunologicalsigns of failure – not to guide targeted
adherence counselling that can preventthe emergence of resistance in the firstplace. Of the 23 countries surveyed,nearly all recommend using viral load
testing to confirm treatment failure.
Six of the countries’ guidelines requireviral load testing before switching
regimens, and routine monitoring ofviral load is recommended in somecountries and required in four of them.
Nevertheless, of the countries surveyed,
the tools necessary for viral load are only
widely available in four countries.
There is an urgent need for simple
and affordable viral load technologies
that are adapted to resource-limited
settings and that could be used in
district laboratories, clinics and at thecommunity level.32,33 A number of pointof-care tests are expected to become
available starting in 2013,34 and several
laboratory-based tests in the pipeline
could also be simple enough for use at the
district level.35 Although cost currently
limits the use of viral load testing,donors and national governments should
support its implementation, since this willdraw multiple producers to the market,
fostering price-reducing competition.
Similarly, additional simplified tools
could help in overcoming existing humanresource constraints towards greater
implementation of viral load monitoring.

TB diagnostics
TB continues to be the main killer of people
living with HIV,36 with at least 350,000
people dying from HIV-associated TB eachyear. A key factor behind this persistently
high death rate is the difficulty ofaccurately diagnosing TB among people
living with HIV. The most commonly used
test, sputum smear microscopy, detects
only half of all TB cases among people
living with HIV.37“When my TB treatment
was completed, I felt as if
I had got a new life. I could
now live for my children
and do some work. Now
I stitch blouses, dresses,
alteration work. People ofmy neighbourhood support
me a lot. They give mework and I am able to earn
good money from my work.”

There is still an urgent need for affordable
and easy-to-use tests that can detect
TB without referral for more specialized
testing. Many people living with HIV are
harder to diagnose with the usual sputum
test. Developing a new test or technology
to diagnose TB that does not rely on
sputum but on other samples such as
urine or blood offers the best solution.

Veena Panchal, HIV positiveand previously co-infectedwith MDR TB, Mumbai

New TB molecular testing
A new rapid molecular test, Xpert
MTB/RIF, represents an important
advance. Not only does it speed up
diagnosis (giving results in two hours
versus up to two months with othermethods) and therefore significantly
shortens the time from TB test to
initiating TB treatment, improving
chances of survival for people livingwith HIV who have TB, it also screensfor drug-resistant TB and improves
TB detection among people whohave falsely tested negative throughsputum smear (prominent amongpeople living with HIV who have TB).

smear microscopy, but of the remaining

A study by MSF in Zimbabwe showed
that, of 1,672 sputum samples, 184
were positive for TB using sputum

for a new price of US$ 9.98 per cartridge)

38

negative 1,488 samples, Xpert MTB/
RIF detected TB in a further 116, which
had been missed by microscopy. After
implementing Xpert MTB/RIF, themedian time from diagnosis of smearnegative TB among people living withHIV who have TB to the initiation oftreatment was reduced from 18.5 days
to seven days38.
Although Xpert offers new potential
in TB diagnosis, it has a number ofdrawbacks including its relatively highprice (120 countries will be soon eligible
and its reliance on a stable electricity
supply and controlled temperature.

July 2012msfaccess.org

11

6

Policies: enabling affordable
and rapid scale-up
Bringing to scale the strategies outlined in this report could help dramaticallyaccelerate the scaling up of antiretroviral therapy. Countries hard hit by the
epidemic have a responsibility to implement health policies that serve the needsof people living with HIV, even in an environment of tight budgets. But these
efforts must be backed up by sustained international donor commitment andpolicies that promote access to affordable antiretroviral drugs.

Donors mustre-engage
Funding for global HIV treatment has
been lagging during the past several
years. Although there has been somerenewed political commitment to support
the scaling up of HIV treatment and care,such as the AIDS-free generation policyof the United States Government, many
international donors continue to leave
their financial commitments unfulfilled.
An estimated US$ 22 – 24 billion will
be needed each year to reach the goalof reaching 15 million people with
antiretroviral therapy by 2015, but donors
are falling short of this, by half.

3

One consequence of reduced global
donor funding was the unprecedented
cancellation of a funding round in late2011 by the Global Fund to Fight AIDS,
Tuberculosis and Malaria.39 Some donor
countries’ bilateral programmes havealso reduced funding. Both of theseleave countries more vulnerable andless equipped to scale up antiretroviraltherapy.
Although

low-

and

middle-income

countries cannot pay for the responseon their own,40 national governments
do need to increase domestic HIV
and health funding. Some countries
are considering innovative strategies
to identify new revenue streams. But
these have limitations: an assessment in
Malawi concluded that a combinationof new strategies such as an airline andtelecommunication levy would cover only

12

17% of the HIV funding gap.41 Further,
extra revenue should not come at theexpense of people: although Zimbabwe israising an AIDS levy, it is still consideringa change to its policy of providing
HIV treatment free of charge and may
introduce user fees.

However, patent barriers and restrictive

Nevertheless,innovative
fundingmechanisms, if applied in multiple
countries, could add up to a substantial
amount to supplement national anddonor
governments’contributions.
UNITAID, an international organizationthat generates funds for HIV, TB andmalaria through an airline tax, is an
important example of how a small tax canhave an ongoing and important impact
on health. Mechanisms able to generate
long-term, predictable revenue, such as
through a financial transaction tax, could
raise substantial revenue and should be
implemented. Although the feasibility ofa financial transaction tax is now largely
accepted in many government circles,
especially in Europe, whether or to what
extent the revenue raised from such a tax
will be dedicated to global health remains
an unanswered question.

in which medicines were not patented,

licensing agreements often prevent many
low- and middle-income countries fromaccessing the most affordable prices for
medicines (see box, page 14).
Competition

among

multiple

generic

pharmaceutical manufacturers in countries
especially India, is what has reduced thecost of HIV treatment by 99% since 2000.
The lack of pharmaceutical patents in India
until 2005 additionally allowed for the
production of fixed-dose combinations,which both support adherence and are
crucial to the simplification of treatmentthat has been central to the global scaling
up of treatment. India has thus been called
the pharmacy of the developing world:
more than 80% of donor-funded purchasesof antiretroviral drugs for use in low- andmiddle-income countries from 2003 to2008 were manufactured in India, andmore than 80% of the antiretroviral drugs
MSF uses are sourced from India.43
When India did introduce pharmaceuticalpatents, it designed a patent law thatis strict about what merits a patent,
reserving these only for medicines that

Antiretrovirals
must beaffordable

show therapeutic benefit over products

Sustained access to the best treatment
options at affordable prices is essential
so that money goes as far as possible.
The most powerful tool to bring
medicine prices down is market
competition among multiple producers.42

granted. This measure has led to several

that already exist. India has also put inplace a system that allows patents tobe opposed before and after they are
antiretroviral drug patents being rejected
in India, keeping the door open for pricereducing generic competition. Other
countries should consider designing
patent laws that have similar clauses.

Médecins Sans Frontières    Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner

But increased drug patenting in key
production countries, especially India, isstarting to block price-reducing genericcompetition

for

newer

antiretroviraldrugs. If increased patenting and otherintellectual

propertymeasuresmeanthat generic competition cannot catalyse
reductions in the prices of medicines,
tomorrow’s battle for access to affordable
antiretroviral drugs will require more
systematic use of compulsory licences
and

other

policies

to

bring

pricesdown or through voluntary licensing

arrangements that respond to publichealth needs.
When drugs are patented, genericcompetition can only happen throughcompulsory licences or voluntary licences.
Compulsory licences can open up themarket to competition by overriding
patents to lower prices and increase access.
Several countries have issued compulsory
licences for antiretroviral drugs, whichhave led to significant cost savings andhave set an important precedent foraccess to medicines that have been“Affordable ARVs made in India have played a vital role in scaling
up ART to eight million people in developing countries over the last
decade. But this ‘safe haven’ for the production of low-cost, quality
generic medicines is under threat: local generic production of anumber of newer antiretroviral medicines is being blocked becauseof patents and new threats are emerging.
 If we want to scale up treatment to those in need, we must keep thesesources of affordable medicines open.”© Mudit Mathur

Leena Menghaney, MSF Access Campaign, Delhi

Demonstrators against the India-EU FTA on the streets of New Delhi.

priced out of reach. Low- and middleincome countries should ensure that they
have the ability to issue such licences intheir legislation.
In issuing a voluntary licence, a patent
holder authorizes a generic manufacturer
to produce and export a generic version
of a medicine, often in exchange forroyalty payments. Several antiretroviraldrugs are now being produced under
different forms of licensing agreements
betweenoriginatorandgeneric
producers. However, the terms of theselicences are critical: they often exclude
many low- and middle-income countries
with sizeable burdens of HIV; they often
contain clauses that limit competition
by restricting where licensees can
produce and the sources of the active
pharmaceutical ingredient; and theyoften are a de facto way of preventing
compulsory licences by preventing
licensees from supplying a country if
it issues a compulsory licence. Further,
the terms and conditions of voluntary
licences are not publicly available,
meaning that their potential contribution
or threat to public health benefit
cannot be scrutinized. Mechanisms thatencourage transparent licensing, suchas the Medicines Patent Pool, should be
supported. The Medicines Patent Poolmanages intellectual property collectively
in the interest of public health rather
than through secret bilateral agreements
between companies.
Other policies also threaten affordable
medicines. Bilateral free-trade agreements
and poorly drafted anti-counterfeiting
legislation often seek levels of intellectual
property
protection
that
exceedrequirements in international trade
rules.43 Examples include the European
Union–India
free-trade
agreement
currently being negotiated, the AntiCounterfeiting Trade Agreement andContinued overleaf

July 2012msfaccess.org

13

Antiretrovirals must be affordable continued

the Trans-Pacific Partnership Agreementthat the United States is negotiatingwith Pacific Rim countries. The leaked
Trans-Pacific Partnership Agreement text
has shown that the United States is seeking
to impose intellectual property provisionsat levels yet unseen that would restrict
access to life-saving medicines.
Ensuring that more affordable genericversions of newer-generation antiretroviraldrugs can be produced and accessedis therefore critical. Low- and middleincome countries should enact and use
all the public health flexibilities allowed
in international trade rules. Ensuring that
excessive intellectual property provisions
are kept out of both free-trade agreements
and anti-counterfeiting agreements will
also be essential to sustaining long-term
access.44 Low- and middle-income countries
should refrain from pushing measuresthat impose even greater intellectual
property protection than international
trade rules require.

Antiretroviral drug prices and the 23 countries
Annex 2 illustrates how qualityassured generic manufacturers charge
significantly less for the key fixed-dose
combination (tenofovir + lamivudine+ efavirenz) recommended for firstline treatment in comparison withthe price charged by the originator.
Matrix/Mylan sells tenofovir + lamivudine+ efavirenz for US$ 172 per person per
year. In contrast, Merck charges certain
low- and middle-income countries
US$ 613 per person per year for thetherapeutically equivalent regimen
tenofovir + lamivudine + efavirenz and
US$ 1033 per person per year in otherlow- and middle-income countries.
Two additional generic sources ofquality-assured tenofovir + lamivudine+ efavirenz are expected to reach themarket within the next 12 months,
which should lower the genericprice even further.
Annex 2 also shows that certain
per person per year countries are
excluded from originators’ discountpricing schemes and/or are unable toaccess medicines manufactured undervoluntary licence because of territorial
restrictions. India, for example, is not
eligible for Merck’s discounted price,although it may purchase from bothcurrent generic suppliers. In contrast,
Brazil and China are excluded fromboth the discount prices offeredby Merck and from purchasefrom Mylan because of voluntary
licence restrictions.

Spotlight: low HIV Treatment coverage
Democratic Republicof the Congo

their child; the country’s Global Fundthe country has a fully comprehensive

Round 11 proposal aimed to increase

health care system. A total of 40,000

The vast majority of people living

the coverage of services for preventing

people receive antiretroviral therapy, lessmother-to-child transmission of HIV, butthan a quarter of the estimated 125,000

the funding round was subsequently

who urgently need it.45 Between 15,000

antiretroviral therapy. This is because

cancelled. In 2013, the Global Fundand 20,000 people living with HIV dieof a lack of political commitment

will be, again, the main ARV purchaser

every year in Myanmar because of theon the part of the government,in the country. The PMTCT program

lack of access to life-saving antiretroviralcompounded by the withdrawal of

supported by PEPFAR purchases ARV

therapy. Despite 9,300 new casesinternational donors. An estimated one

treatment for mothers that are eligibleof drug-resistant TB every year, by

million people are living with HIV andfor lifelong treatment, up to 18 months

the end of 2011, only 300 people

435,000 need antiretroviral therapy,

only. By 2015 the ART coverage is

had been started on treatment.46

with only 12% of those in need

forecast to be 22%, a best-case scenario.

Life-saving treatment for both HIV andwith HIV in the Democratic Republicof the Congo do not have access toreceiving treatment. In 2011 funding

14

drug-resistant TB urgently needs toshortfalls led to a cap on the number

Myanmarof new treatment slots. Nationally,

Myanmar is the least developed country

country has led to greater international

only 6% of mothers living with HIV

in South-East Asia. Although there areengagement, providing an opportunity

have access to antiretroviral therapy

expectations of an increase to theto give priority to access to treatment

to prevent transmission of HIV tohealth budget, it will be years before

for people living with HIV and TB.

be scaled up. Political reform in the

Médecins Sans Frontières    Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner

Conclusion
Recent research results along with novel treatment models provide a
genuine possibility to both reduce the number of people acquiring HIV
infection and ensure long-term survival for people already living with
HIV. National governments, donors, and other key actors must seize
this opportunity to turn around the epidemic.
Research results presented in this reportshow that critical progress has been
made in ensuring policies are put in placethat allow more people to be reachedwith treatment. Antiretroviral therapy isgetting decentralized further and further
into communities, people are being
reached with treatment earlier in theirdisease progression, and more individuals
are being provided with better-tolerated
drugs that allow them to stay on theirregimens longer.

treatment further into the community,

At the same time, much more needs tobe done to reach even more people withtreatment and care: several countries
are still resisting policies to allow thetask-shifting necessary to decentralize

The experience of the past decade hasoffer integrated HIV at the lowest-level
facilities and offer simplified treatment
outside of facilities. It is crucial to movetreatment to the community level toreduce the burden of multiple clinic visitson people with HIV and decrease theworkload at over-stretched health facilities.
This approach also allows people with HIV
greater autonomy and responsibility for
managing their own care.

shown that treatment costs can and

Nevertheless, the right policies must be
in place. Policies should be promotedthat support the production of affordable
medicines and the development of medical
tools that enable massive scale-up andsustainable long-term treatment provision.
Further, international donors mustre-engage and recommit to HIV globally.
If they continue to withdraw support, theprogress achieved over the last decadeof investing in global HIV treatment risks
being unravelled.

Governments and donors:“Pay now, or pay forever.” 47

will decrease when tools are simplified,treatment is decentralized and measures
are supported to reduce medicine prices.

“When I first found out
I was HIV positive,
I didn’t believe for aminute that I would behere today. Everyone in
my family was upset andcrying. But now I am on
treatment and working
again. In the future I
would like to have asewing machine to
make clothes for myhusband, my kids andmy neighbours.”© Brendan Bannon

Ivone Culimbica,
HIV positive, Mozambique

July 2012msfaccess.org

15Annex 1. Survey results: strategies, tools and policies
MSF field teams provided data for the first 16 countries shown here where MSF has HIV projects. Data for the remaining
seven countries were collected from national and international sources with the support of UNAIDS.

Cameroon

CAR †

DRC ‡

Ethiopia

Population (millions)

20.1

5.10

73.6

93.8

Prevalence of HIV infection among adults (%)

4.3

4.9*

2.6

1.5

% of pregnant women living with HIV receiving services for preventing
mother-to-child transmission

53* a

24* a

5.6 b

24 b

% of people in need who receive antiretroviral therapy

46.4

26.1

12.3

86 h

Number (%) of public-sector facilities offering antiretroviral therapy

108(4.4%)

76

222 l

743

Children (<15 years) as a % of people receiving antiretroviral therapy

4.2

5.4*

11.6

6

Provider-initiated testing and counselling is national policy

Yes

Yes

Yes

Yes

Antiretroviral therapy offerred free of charge in outpatientpublic facilities

Yes, butnot labs

Yes, but
not inpractice

Yes, but
not inpractice

Yes

WHO-recommended protocol for services for preventing mother-to-childtransmission is national policy

A

A

A

A

WHO-recommended protocol for initiating ART is national policy

Yes

Yes

Yes

No w

AZT or TDF

AZT

AZT

AZT or TDF% of people on ART on a d4t-containing regimen

0◊

N/A

N/A

59*

% of pregnant women receiving single-dose NVP

13.4

N/A

43.4

N/A

Protocol includes third-line antiretroviral therapy or salvage treatment

Yes

No

No

No

TB prophylaxis (isoniazid preventive therapy) for all people living with
HIV is national policy

Yes (LTD)

No

No

Yes

VL testing to confirm treatment failure

Optional

Optional

OptionalNo

Routine VL testing of people on antiretroviral therapy

Optional

No

No

No

LTD

LTD

LTD

LTD

Follow-up
only

Yes

No

Yes

Nurses can initiate TB treatment (drug-sensitive)

Yes

No kk

Yes llNo

Same health worker can provide TB and HIV treatment at PHC level

No

N/A

No

No mm

Adherence

Yes

No

Antiretroviral therapy coverage and availability

Best practices and WHO protocols as national policies

TDF or AZT is part of the preferred adult first-line regimen

Viral load (VL) testing in national protocols

VL testing is available for this purpose
Task-shifting allowed as national policy
Nurses can initiate antiretroviral therapy

Lay workers can provide HIV testing and antiretroviral therapy
adherence counsellingmm

Adherencell

Simplified antiretroviral drug dispensing allowed as national policy
2- to 3-month routine antiretroviral drug refills for people in stable condition

No

No

No

2

Antiretroviral drug refill dispensing at the community level

No

No

No

No

8.5*

8.5*

9.1*

13.5*

FUNDING FOR HIV & HEALTH% of government expenditure on health as % of general
government expenditure16

Médecins Sans Frontières    Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner

supporting the scaling up of treatment in 23 countries

Guinea

India

Kenya

Lesotho

MalawiMozambique

MyanmarSouth Africa

Swaziland

Uganda10.9

1,210.2

43

1.9

16.3

23.5

54.6

48.8

1.4

35.9

1.5

0.3**

6.2

23**

10.6*

11.5**

0.5

16.6

26◊

6.7

40.5 c27.8 d69.2 b78 c

48 b, e52* c54.3* c87.1 c87.5 c46.1 b

59.9

N/A i

72.1◊

61

57.7

45.5

33.4

52

80

54.3

41
(9%)

1,297
(3%)

1,242
(34.8%)

197(94%)*

487(80.4%) m

261
(22%)

100
(3.4%)*

2,552
(68%)

110
(42%)

1,424 n

4.8

5.8◊

9◊

7.3

8.9

8.4

7.5

8.5

9.1

7.9

Yes

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

Yes, but
not some
opportunistic
infections p

Yes

Yes

Yes, withrestrictions q

Antiretroviraldrugs, notopportunistic
infections/labs r

Yes

Yes

Yes

B

B

A, B, or B+

A

B+

A

A or B

A

A

B+ u

Yes

Yes

Yes

Yes

Yes

Yes

Yes x

Yes

Yes

Yes

AZT

AZT

TDF

TDF

TDF

AZT

AZT or TDF

TDF

TDF

TDF

N/A

t

24.9◊

N/A

81

7*

N/A z

40*

0◊

2

N/A

27.8

4.2

0*

14 b b

28

0

0*

0*

7.3

Yes

No

Yes

Yes

No

No

Yes

Yes

No

No

No

No

Yes (LTD)Yes

Yes (LTD)Yes (LTD)Yes (LTD) ee

Yes (LTD)Yes

Yes (LTD)

Optional

Required

Optional

Optional

Required

Optional

Optional

Required

Optional

Optional

No

No

No

No

No cc

Required dd

No

RequiredNo

Optional

LTD

LTD

Yes

LTD

LTD

No

LTD

Yes

LTD

LTD

Yes ff

No

Yes

Yes

Yes

No gg

No

Yes

Yes

Follow-up
only hh

No

No

Yes

Yes

Yes

No

No

Yes

Yes

Yes

No

No

No

Yes

Yes

No

qq

No

rr

Yes

Yes

No ss

nn

nn

oo

pp

y

HIV

Yes

Yes

Yes

Yes

HIV

No

Yes

Yes

Yes

No

2

2-3

No

2-3

No

No

3

3

No (Yes inpractice)

No

No

No

No

No

Yes tt

No

No uu

No

No

1.8*

3.6*

7.3*

13.4*

14.2*

12.2*

1*

11.9*

10.1*

12.1*

July 2012msfaccess.org

17

Zambia

Zimbabwe

Botswana

BrazilChina

Namibia

Nigeria

Tanzania

Ukraine

14.3

12.6

2.9

205.7

1,343.2

2.2

170.1

43.6

44.9

14.6**

13.1

25

0.6

05-0.07

13.5

3.4*

5.6**

1

84.5 b84* b93.98 c50.23 cN/A f

89.5 c15.9 c71.53 b

68 g

77.6

79.7

96.1 h71.9

46.8% j

74

29.8

76.2

13.4* k1784
(25.4%)*

590(36%) o(32.2%)

737(0.3%)

3.142(0.3%)

181(52.8%)(2.9%)*(17.4%)*

127(16.7%)

7.3

8.4

6.2*

2.7

1.84

10.2

5.7*

7.7*

8.5

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes, not inpractice
consistently

Yes, withrestrictions s

Yes

Yes, but notopportunistic
infections

Yes

Yes, withrestrictions t

Yes

Yes

A

A

B

B

B

A

A or B v

A

B

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

TDF

TDF

TDF

AZT

TDF

TDF

AZT or TDF

AZT

TDF

N/A

75.8◊

N/A

N/A

36.3

N/A

N/A

63* aa

4.6

11.4

8.6

0*

N/A

N/A

3.7

24.8*

18.2

4.3

Yes

No

Yes

Yes

No

Yes

Yes

No

Yes

Yes (LTD)Yes (LTD)Yes (LTD)

Yes

No

Yes

Yes (LTD)Yes (LTD)

Yes

Optional

Optional

Required

Required

Optional

Optional

Optional

Optional

Required

Optional

No

Required

Required

Optional

Optional

Optional

Optional

Optional

LTD

LTD

Yes

Yes

LTD

LTD

LTD

LTD

LTD

Yes

Yes ii

Yes jjNo

No

Follow-up
only

No

No

No

Yes

Yes ll

Yes

No

No

Yes

Yes

No

No

Yes

Yes

No

No

N/A

N/A

No

No

No

Yes

Yes

Yes

Adherence

Yes

Yes

Adherence

Yes

Adherence

3

No (Yes inpractice)No

No (Yes inpractice)

No (Yes inpractice)

NoNo

2 or more

No (Yes inpractice)

Yes vv

No

No

No

No

No

No

No

No

15.6*

N/A ww

17*

7.1*

12.1*

12.1*

4.4*

13.8*

9.4*

Legend and Footnotes continued overleaf

Annex 1: Legend and Footnotes
LEGEND
HIV programme and policy data are from2011 except where indicated:**2009 data; *2010 data, ◊2012 data.
†Central African Republic. ‡Democratic Republicof Congo Adult population means 15 – 49 years
old. TDF: tenofovir. AZT: zidovudine. NVP:
nevirapine. NA: not available. LTD: limited
availability or implementation. Adherence:
Antiretroviral treatment adherence counseling.
PMTCT and ART coverage: As reported
by governments or sources such as WHO,
these figures are based on the numbers ofpregnant women living with HIV receiving
intervention for PMTCT out of national
estimates of need.
PMTCT protocols include: option A(zidovudine from week 14, single-dose
nevirapine at birth, zidovudine + lamivudine
during labour and delivery and zidovudine+ lamivudine one week postpartum); option
B (triple-course antiretroviral therapy fromweek 14 of pregnancy through to one week
after breastfeeding); and option B+ (lifelong
antiretroviral therapy for all pregnant women
living with HIV).

j. Based on 2010 WHO estimates of national ART
need. The government-reported coverage figure(76.1%) is based on the actual reported numberof people in need of ART (such as those registeredin the HIV program) at the end of 2011.

dd. National protocol requires VL testing at
six months on ART, but this testing is not
generally available.

k. MOH reports 53% coverage, which isbased on the total number of people needing
ART and registered and enrolled in the MOH
health care system.

ff. Only under doctor’s supervision.

l. Government target is for 4,017 public andprivate ART facilities. In 2011, 444 public andprivate sites were operational, so current coveragebased on the government target is 11%.
m. Includes some Christian Health Associationof Malawi facilities, partly supported by the
MOH to provide ART.
n. Includes non-MOH facilities.
o. Number of facilities offering ART follow-up.
Initiation is provided at 141 facilities.
p. Free ART policy includes diagnostics andtreatment only for certain OI’s.
q. Patients pay a nominal fee for prescriptions(not including TB treatment and ART) andconsultations.

ee. Policy is in place, but implementation isstill at pilot stage.

gg. Only medical technicians (Tecnicos demedicina) can initiate and manage ART. A 2011
pilot program to train agents of medicine(agentes de medicina), general nurses (Nurses
Geral Medio) and general and PMTCT middle
nurses (Nurses Medio) to initiate and manage
ART is undergoing an evaluation by the MOH.
Basic nurses, who represent more than half thehealth workforce are not being considered toinitiate ART or provide follow-up.
hh. Nurses can start ART for HIV+ positive
pregnant women and provide ART follow-up.
ii. Registered General Nurses who received
training and mentorship can initiate ART
with verbal authorization from district healthofficials, although formal policies not yet
adopted. Primary Care Nurses cannot initiate
but can provide follow-up.
jj. Nurses can start ART for asymptomatic adults
with CD4>150 and not yet exposed to ARVs.

WHO recommended ART initiation protocol
includes CD4<350 per mm3, HIV/TB coinfection
and/or Stage 3 or 4.

r. Patients pay under a cost-sharing model
for labs and OI treatment. TB diagnosis andtreatment is free.

Footnotes

s. For citizens only.

ll. Nurses can start TB treatment only forsmear-positive patients.

a. Based on women receiving ARV drugs,
excluding single-dose NVP.

t. Includes CD4 monitoring but not other lab tests
and also not consistently offered free in practice.

mm. Nurses cannot initiate ART, but they canstart patients on TB treatment.

b. Includes pregnant HIV-positive women
who received a partial PMTCT protocol(e.g. single-dose NVP).

u. Option B+ adopted as national policy,
but roll-out deferred until early 2013 due tofunding shortfalls.

nn. HIV and TB treatment provided in separate
facilities or at different levels of care.

c. Does not delineate specific protocols forpreventing mother-to-child transmissiondelivered.

v. MOH recommends Option B for “facilities
with capacity to provide and monitor triple
ARV medication” and Option A for “facilities
with limited capacity (on–site or by referral) to
provide and monitor triple ARV medication.”d. Based on percentage of estimated 43,000
HIV poslitive pregnant women in 2010–2011,of whom 11,962 mother-baby pairs received
intervention for preventing mother-to-childtransmission.
e. Data from last quarter of 2011 only,
following change in PMTCT eligibility
protocol in mid-2011.
f. National estimate for the number of HIV
positive pregnant women not available.
Government-reported PMTCT coverage figure(74.1%) is based instead on the number ofpregnant women who tested positive for
HIV at ANC clinics received intervention forpreventing mother-to-child transmission.
g. Ministry of Health reports 95.5% coverage,
based on the number of pregnant women
who tested positive rather than on national
estimates of HIV positive pregnant women.
h. Based on CD4<200.
i. National estimate for the number of HIV+
people in need of ART is not available. The
government-reported ART coverage figure(33.8%) is based on the number of people
registered to be in need, a subset of theoverall population in need.

w. Pregnant women or people at clinical Stage
3 can start ART with a CD4<350. Otherwise,
ART initiation threshold for adults is CD4<200.
x. Latest guidelines include CD4<350 but haven’t
been implemented in parts of the country.
y. Full implementation delayed due to funding
shortfalls. The first phase of implementation
prioritizes HIV positive pregnant women,
people with TB/HIV co-infections, andpatients with severe d4T side effects (e.g.,advanced lipodystrophy). Other adults starton a d4t-containing regimen.
z. The majority of people on ART in Myanmar
are on d4t as the new guidelines stipulating
TDF-containing regimens for preferred first-line
treatment for adults are not in full effect yet.
aa. Estimates of people on ART are on a
d4t-containing regimen in 2011 are between
10-20%.

kk. No official policy adopted, but in practicenurses can prescribe TB treatment.

oo. TB treatment initiated at lower-level
health centers (II and III) than ART (mainlylevel IV and above), although the latter ischanging. Thus, TB and ART may soon beinitiated by the same PHC health worker.
pp. Policy supports task-shifting of ART and
TB treatment to nurses, but ART is being
more rapidly decentralized to PHC. Most
health centers still lack drugs and/or capacity
to initiate TB treatment.
qq. Nurses cannot initiate ART and TB
treatment but are the only medical staff
present in many PHC clinics. Cadres allowed
to initiate both treatments are not widely
available at PHC level.
rr. ART not available at MOH-supported PHC
facilities but new HIV/TB policies in development
are expected to support integrated HIV/TB care.
ss. TB treatment is decentralized further than ART.
Nurses can initiate ART only in pregnant women.
tt. Peers in community ART groups (CAGs)
can deliver ARV refills to other CAG members.
uu. MSF is piloting pre-packed ARVs dispensed
by lay counselors to CAGs in Khayelitsha.

bb. For the last quarter of 2011.

vv. Mobile ART clinics are part of national
HIV strategy.

cc. VL monitoring for patients on ART is
included in Malawi’s ART guidelines, butrollout deferred due to funding shortfalls.

ww. The Government of Zimbabwe allocated
9.3% of its 2011 budget to health. Healthexpenditure data is not available.

Annex 2. TDF-containing first-line regimen:
pricing eligibility in 23 countries
First-line treatment option of TDF/3TC/EFV 300/300/600 mg
or TDF/FTC/EFV 300/200/600 mg

COUNTRY

Quality-assured* generic
options for TDF/3TC/EFV
300/300/600 mg

Quality-assured* generic options for
TDF/FTC/EFV 300/200/600 mg

Quality-assured* originator
option for TDF/FTC/EFV
300/200/600 mg
Merck

Matrix (Mylan)
US$ 172

Matrix (Mylan)
US$ 197

Cipla
US$ 207 a

Eligible

Eligible d

Not eligible f

Cameroon

CAR, DRC, Ethiopia,
Guinea, Lesotho,
Malawi, Mozambique,
Myanmar, Tanzania,
Uganda, Zambia g

Category 1
countries
US$ 613 b

Category 2
countries
US$ 1033 c

Eligible for supply if patentbarriers overcome** d

Eligible d

N/ANot eligible f

Eligible for supply but
price unknown

Not eligible

Not eligible

Eligible

Eligible

Eligible for supply but
patent status unknown***

Eligible

N/A

Eligible

Eligible

Eligible

Eligible

N/A

China

Not eligible f

Not eligible f

Eligible for supply if patentbarriers overcome

Not eligible

Not eligible

India

Eligible

Eligible

EligibleNot eligible

Not eligible

Kenya

Eligible

Eligible

Eligible for supply if patentbarriers overcome dEligible d

N/ANamibia

Eligible

Eligible d

Eligible for supply if patentbarriers overcome dEligible d

N/ANigeria

Eligible

Eligible

Eligible for supply but
patent status unknown

Eligible

N/ASouth Africa

Eligible

Eligible

Eligible for supply if patentbarriers overcome

Eligible

N/A

Swaziland

Eligible

Eligible d

Eligible for supply if patentbarriers overcome dEligible d

N/AUkraineNot eligible f

Not eligible f

Eligible for supply if patentbarriers overcome

Eligible

N/A

Zimbabwe

Eligible

Eligible d

Eligible for supply if patentbarriers overcome dEligible d

N/ABotswana

Brazil e20

Médecins Sans Frontières    Speed up scale-up: Strategies, tools and policies to get the best HIV treatment to more people, sooner

© Brendan Bannon

LEGENDAll prices displayed in US$ per patient per
year, as quoted by companies.
*Quality-assured: The term quality assured
is used here to refer to products assured
by US FDA or WHO prequalification (asof June 2012). Currently Mylan is the only
quality assured source of this combination,
but additional manufacturers in India arein the process of submitting their products
for quality assurance. Prices should decrease
further as this competition is introduced.
**Eligible for supply if patent barriers overcome:Countries identified as ‘eligible for supply ifpatent barriers overcome’ are those territories
where a patent on one of the drugs or drug
combinations has been granted. Patent status
information taken from the Medicines Patent
Pool Patent Status database available at
http://www.medicinespatentpool.org/table/.
[Last accessed 18/06/12].
***Eligible for supply but patent status is
unknown: The patent status for TDF and
TDF combinations is unknown. Source:
http://www.medicinespatentpool.org/table/.
[Last accessed 18/06/12].

FOOTNOTES
a. Cipla does not manufacture TDF undervoluntary licence from Gilead, and are
therefore free to sell in any territory. However,where patents on TDF or TDF combinations
with FTC or EFV have been granted,
importation barriers may occur. Cipla has
negotiated higher prices separately for
10 Latin American countries.

b. The following list of category 1 countries
was provided by Merck for TDF/FTC/EFV
300/200/600mg:
Afghanistan;Angola;Antigua and Barbuda; Bangladesh; Belize;
Benin; Bhutan; Botswana; Burkina Faso;
Burundi; Cambodia; Cameroon; Cape Verde;Central African Republic; Chad; Comoros;
Congo; Congo (DRC); Côte d’Ivoire; Djibouti;
Dominica; Dominican Rep.; Equatorial Guinea;
Eritrea; Ethiopia; Gabon; Gambia; Ghana;
Grenada; Guatemala; Guinea-Bissau; Guinea;
Guyana; Haiti; Honduras; Jamaica; Kenya;
Kiribati; Laos; Lesotho; Liberia; Madagascar;
Malawi; Maldives; Mali; Mauritania; Moldova;
Mozambique; Myanmar; Namibia; Nepal;
Niger; Nigeria; Pakistan; Panama; Papua New
Guinea; Rwanda; São Tomé and Principe;
Senegal; Sierra Leone; Solomon Islands;
Somalia; South Africa; St Kitts and Nevis;
St Lucia; St Vincent and the Grenadines;
Samoa; Sudan; Suriname; Swaziland;
Tanzania; Timor-Leste; Togo; Trinidad andTobago; Tuvalu; Uganda; Ukraine; Vanuatu;
Yemen; Zambia; Zimbabwe.
c. The following list of category 2 countries
was provided by Merck for TDF/FTC/EFV 300/200/600mg: Bolivia; Indonesia;
Kyrgyzstan; Mauritius; Mongolia; Nicaragua;
Seychelles; Syria; Tajikistan; Uzbekistan;
Vietnam.
d. The Medicines Patent Pool patent status
database shows that a TDF combination
with FTC patent was granted (AP2089)
in the ARIPO region. Non LDC ARIPO
countries could technically see combination
patents on TDF with FTC enforced. Source:
http://www.medicinespatentpool.org/table/.
Last updated November 2011. [Last accessed
18/06/12].

e. There are several combination patents on TDF
filed in Brazil, but none are currently granted.
Source: http://www.medicinespatentpool.
org/table/. Last updated January 2012.
[Last accessed 18/06/12].
f. Matrix manufactures TDF under voluntary
licence from Gilead. Those countries marked
as ‘non eligible’ are countries not included in
the geographic scope for sale.
g. The World Trade Organization (WTO) Doha
Declaration, paragraph 7 states that leastdeveloped members do not have to implement
or enforce pharmaceutical patent protection
until January 1, 2016. List of 48 LDCs
Source: http://www.unohrlls.org/en/ldc/25/.
[Last accessed 18/06/12].

METHODOLOGY
The latest pricing data supplied by ARV
producers to MSF for the 15th edition of‘Untangling the web of antiretroviral pricereductions’ utw.msfaccess.org was crosschecked with the stated eligibility criteriaof these companies in order to determine
which of the 23 countries were eligible forsupply from each producer. Where genericcompanies had not included their own
eligibility restrictions through, for example,
specifying a list of eligible countries under
the terms of a voluntary licence, we used the
Medicines Patent Pool Patent Status databaseh t t p : / / w w w. m e d i c i n e s p a t e n t p o o l . o r g /patent-data/patent-status-of-arvs/ to identify
where patents on these ARVs had been filed
or granted. Where we identified patentbarriers we noted them. Such barriers may
be overcome, but the importing country
will need to take specific action in this case.

July 2012msfaccess.org

21

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