Geneva, 14 October 2009Dr Alice Maida, Mr. Joseph Njala, Dr Frank Chimbwandira

Dr Andreas Jahn, Dr Zengani Chirwa, Dr Erik Schouten

HIV and AIDS DepartmentMinistry of Health

Malawi

WHO antiretroviral Therapy Guidelines for Adults and Adolescents (2009)

Feasibility appraisal of proposed changes in Malawi

Malawi

• Population 15 million• Adult HIV Prevalence 11% (15-49)• 960,000 people living with HIV• 306,000 people in need of treatment

(based on CD4 of 250) • Heavily single donor dependent (GF)• Health System is heavily compromised

(resource limited)

ART scale up Plan 2006-2010Based on realities - a public health approach:

• Simple – One regimen for all (adults, children, pregnant women)– Not dependent on laboratory monitoring or CD4 count– Simple drug supply management (kit system, special packaging)

• Standardised – Case finding (HTC/PITC) - STD Treatment regimen– STD Training - Guidelines– STD Reporting - Supervision and monitoring

• Inclusive – All providers (government, mission, NGO, Private for profit)

involved in the development of protocols, guidelines, scale up plans, M&E tools, reporting, etc.

• Tasks shifting & decentralization of services• Strong emphasis on M & E and supervision

People on ART by provider (June 2009)

MOH, 44%

MOH / NGO, 24%

Mission, 19%

Indep NGO, 8%

Army / police, 2%

Private, 3% Other (para) statal, 1.0%

Achievements up till end June 2009

• 234,395 people ever initiated on ART• 169,965 people alive and on treatment

– (55% coverage based on CD4 cut-off of 250cells/mm³)

• ART services in over 224 static health facilities & 96 mobile/outreach sites in the country

• Access: 60% female, 9% children (<15y)• ART Regimen:

– 93% on 1st line ART: d4T+3TC+NVP (Triomune)– 7% on one of the alternative 1st lines: AZT, EFV– <1% on 2nd line: TDF+AZT+3TC+LPV/r

WHO proposed changes in ART guidelines in RLS

1. Earlier ART initiation:– Initiation of ART at CD4 count of <350 for those in WHO stage

1 or 2

2. Regimen change: – Transitioning to more efficacious regimens with fewer side

effects i.e. TDF and/or AZT– Phasing out d4T

3. Regular CD4 / viral load monitoring for treatment failure

• What is the likely impact at the national programme level of the proposed new ART recommendations (risk-benefits, acceptability, cost/financial implications and feasibility)

Methodology

• Qualitative and quantitative study– Desk appraisal, literature review of ART scale-up in

Malawi: achievements, evaluation reports reviewed– Semi-structured interviews using questionnaire

(stakeholders, implementers, key informants etc)– Data collection and analysis from selected sites– Literature review of papers from other regional

countries– Local short term consultant engaged with WHO

support

• Consultative meeting with key stakeholders to review findings 29-30th September 2009

Earlier ART Initiation issues

2) Earlier start of ART (higher CD4 count threshold ) can not be done using the current first line (d4T based) ART regimen due to the toxicity of the regimen.

• Basic principles developed in Malawi’s 2006-2010 scale up plan for choosing a first line regimen are still valid

Basic principles for choosing the first line regimen : Public health approach

• Need for standardized treatment regimen across the country in all patient groups (including pregnant women). Makes prescribing easy and hence allows for task shifting

• Ease of administration (FDC, low pill burden, can be taken irrespective of food intake) will promote adherence

• Standardized regimen simplifies guidelines, training curricula and the actual training

• Also simplifies quantification & forecasting, procurement and storage

• Cost

Earlier ART Initiation findings

• Most ART sites in Malawi do not have CD4 count capacity (42/224 static sites) and most (67%) of people start ART on the basis of clinical staging

• The quality of CD4 count test being performed is sometimes questionable (QC reports consistently indicate that a third of CD4 counts are outside 2 standard deviations)

CD4 count at first visit for eligibility assessment

CD4 count Lighthouse CD4 count Thyolo<100 1,452 36% <200 1,868 43%<250 1,383 34% <250 467 11%<350 465 12% <350 631 14%≥350 717 18% ≥350 1,418 32%∆ 17% ∆ 26%

The number of people eligible for treatment would increase by 17% and 26% (average 21%) in the 2 clinics/districts respectively if CD4 ≤ 350 became an inclusion criterion.

0

100,000

200,000

300,000

400,000

500,000

600,000

4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

# of patients alive on ART # of patients alive on ART (new)# in need of ARTPoly. (# of patients alive on ART )

Consequences of early initiation of ART

• The number of people starting ART will increase by 30-40% by 2014 (230,000-355500 using EPP projections) with the following consequences:– New guidelines and curricula need to be

produced– In-service/refresher training of current staff– Additional staff & ART sites will be required– Additional costs (lab & drugs)– Risk of reintroducing waiting lists (cause of

current clients becoming immediately eligible)

Additional staff

• Data from 138 ART sites in the public sector. By end of June 2009: 123,108 patients alive and on ART (531 clinician and 660 nurses days per week)

• On the basis of 180 days work in the clinic per year:– 1.25 clinician per 1000 people on ART– 1.55 nurse per 1000 people on ART

• 476 FTE health staff needed for 170,000 people on ART• In the current scale up: 30 additional health staff (FTE)

needed every quarter• With the increase in number of people starting ART there is

a need of an additional 780 FTE Health Workers by 2014

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20

40

60

80

100

120

140

160

180

200

2009 2010 2011 2012 2013 2014

US

$ (

mil

lio

n)

Costs per Annum for Different Scenarios

GOM contribution to health

current scale up

early start

early start (AZT NVP)

early start (TFD EFV)

Additional costs

• An earlier start and change in ART regimen will increase the costs of the ART programme by 50 – 100% (depending on choice of regimen: AZT vs TDF)

• The additional costs to change from d4T+3TC+NVP to a TDF+3TC/FTC+EFV regimen (while leaving other costs unchanged) for the period up to 2014 is estimated at US$ 100 million (US$ 50 m for AZT based regimen)

Treatment failure

6) - Laboratory monitoring (6 monthly) for suspected treatment failure based on CD4 count will entail 200,000 more tests per year. Currently only 80,000 tests done per year for screening mainly.

- Lab staff need to be recruited and /or trained on use of CD4 machines

- CD4 machines (currently 42 functional machines in country) need to be purchased and sample transportation strenghthened

Treatment Failure

• - The roll out of routine VL testing at 6 months (for adherence) and on an annual basis (for resistance) needs to be considered. However, the current capacity in country for VL is approximately 20,000 tests per year(4 DNA-PCR machines with current lab staff) and this will need to be increased to 200 – 400,000 tests per year.

Discussion

• The decision to change the CD4 threshold and the first line regimen should take into account the capacity in the health system:

- limited logistics and drug procurement & storage management capacity,

- limited HR & laboratory capacity,

- limited funding options

Recomendations

• A phased approach may be feasible for a RLS like Malawi, that is implementing the recommendations in phases e.g. change the regimen first then implement earlier initiation at the threshold of 350 or vice-versa

• Starting new patients with Triomune for 3-6 months and then changing to more efficacious regimens (before they develop side effects)

Recommendations cont’dAdvantages:

- will enable sites with limited Lab to continue scale up as well as new rural sites to be established (while health systems strengthening takes place)

- Will raise Hb in patients with baseline anemia and enable administration of AZT based regimen at 3-6 months (if AZT is the option)

- Will minimize wastage of current D4T

Recommendations

• Need to explore point of care CD4 as an option for rapid scale up of CD4 capability

to enable early initiation of ART using CD4 • For ART failure monitoring it may be more

feasible to roll out routine Viral Load monitoring than CD4 due to availability of DBS

Conclusion

• Resource limited countries are encouraged to conduct some form of feasibility appraisal to assist them adapt the new recommendations

• Adaptation may be done in phases where resources are limited

• Transition from d4T can also be done in phases

Conclusion

• Cost of TDF is expected to come down further

• When comparing cost of TDF vs AZT, cost of side effects monitoring & treatment should be taken into consideration (e.g. Anemia)

I thank you

Dr Zengani Chirwa - T/A Care, Treatment & Support, MOH, Malawi

Aknowledgements:World Health Organization

Ministry of Health

District health Officers

HIV & AIDS department - staff

I-TECH/CDC

Clinton Foundation Health Access Initiative