FY08 Collaborative Uganda n PHE- UG.08.0202: Multi-country CT HIV Counseling and Testing to Optimize

Patient Enrollment in HIV Care and Treatment

Strengthening Test Acceptance and Treatment Uptake Study (STATUS) Project is a multi-country HIV

Counseling and Testing public health evaluation is proposed to determine whether HIV Counseling and

testing (HCT) can be provided to a large percentage of persons in outpatient departments, and if this venue

can be used to efficiently identify HIV infected patients early in the course of HIV disease. Additionally, the

study will evaluate three models of HIV testing and counseling in outpatient departments to determine the

most effective model across countries to increase testing uptake and linkage to care and treatment services

for those who test HIV positive.

Despite the central importance of HIV testing and counseling (HTC) in achieving the above goals, it is

estimated that just 10% of people in low and middle income countries have ever been tested for HIV. Due

to these low rates of testing, many HIV positive people learn their status too late to take advantage of

available services. Health facilities are optimal places to counsel and test people who do not know their HIV

status, although studies have shown that opportunities to diagnose people in these settings are being

missed. When HIV testing is offered and provided in health facilities, evidence has shown that test

acceptance is high.

New/Continuing Activity: New Activity

Continuing Activity:

Program Budget Code: 15 - HTXD ARV Drugs

Total Planned Funding for Program Budget Code: $38,662,390

Total Planned Funding for Program Budget Code: $0

Program Area Narrative:

The procurement and distribution of antiretroviral drugs (ARVs) is a critical component of PEPFAR Uganda which supports the

Ministry of Health (MOH) National Plan for the roll-out of ARV treatment. The ongoing focus areas of the ARV Drugs Program are

to: a) continue working within the Ugandan Three-Year National Plan for Procurement of Essential Medicines and Health Supplies

(EMHS); b) strengthen the Government of Uganda (GOU) capacity for timely procurement, distribution, monitoring and quality

assurance; and c) support the provision of appropriate and adequate HIV/AIDS related drugs and commodities to treatment

partners.

USG will continue to leverage other donor resources for drugs including the Global Fund for AIDS, TB and Malaria (GFATM),

pediatric and second line drugs donated through the Clinton Foundation, as well as other donations to increase the number of

individuals receiving ART. The Clinton Foundation will continue to provide pediatric drugs through 2010, but will discontinue adult

second-line drugs at the end of 2009. By the end of September 2008, 130,837 individuals in Uganda were currently receiving ARV

treatment with direct USG support, and an additional 12,700 were indirectly supported through USG inputs in national logistics

systems, training, quality assurance and policy.

New in FY08 was the establishment of a local Ugandan pharmaceutical manufacturing firm, made possible through a private-

public partnership initiative between the GOU, Quality Chemicals Limited, and Cipla India. Local production of anti-malarial and

ARV drugs is expected to start later this calendar year. This firm is currently undergoing FDA and WHO assessment for approval.

If approved, this initiative is anticipated to significantly increase access to ART through reduced costs of ARV drugs and

elimination of long lead times. Supplemental drug supplies have already been delivered by Cipla/India. For FY08/09, the GOU has

committed up to $40 million towards the purchase of ARV and anti-malarial drugs from Quality Chemicals.

The National Three-Year Rolling Procurement Plan

In 2007, the MOH Medicines and Health Supplies Technical Working Group developed a National "Three-year Rolling

Procurement Plan for Essential Medicines and Health Supplies" for FY06/07-2008/09 (EMHS). Although this plan is in place, it is

not yet fully functional. All development partners, including USG and its implementing partners, are to share their procurement

plans with MOH and these are consolidated annually into one national procurement plan. The plan is intended to identify all

projected procurements of health and HIV/AIDS commodities by organizations and donors so that MOH can coordinate and

systematically address gaps in a timely manner. Currently, Supply Chain Management Systems (SCMS) is providing assistance

to MOH and PEPFAR partners in forecasting and quantifying ARV drug needs.

Procurement Mechanisms

To respond to Uganda's ARV requirement, four PEPFAR procurement mechanisms are in place: the AIDS Relief Project, SCMS,

Joint Clinical Research Center (JCRC), and Medical Access. (The latter two pre-date PEPFAR). These different procurement

mechanisms provide the flexibility to service the individual needs of MOH and partner treatment sites. PEPFAR drugs provide a

buffer when MOH sites experience stock outs of ARV drugs.

JCRC and AIDS Relief/ Catholic Relief Services Consortium directly procure ARVs from manufacturers and deliver them to

designated sites throughout the country. JCRC also supplies ARVs to USG Department of Defense and Walter Reed supported

ART sites, and responds to emergency ARV stock outs at MOH sites. Medical Access, Limited is a non-profit local Ugandan NGO

that was formed under the Ugandan Drug Access Initiative in 1998. Medical Access procures and distributes drugs for the

following USG partners: Mildmay, The AIDS Support Organization (TASO), Mulago Mbarara Joint AIDS Program (MJAP), Rakai

Health Sciences Program, Baylor Uganda / PIDC, and Reach-Out, Mbuya. SCMS procures ARVs and HIV/AIDS commodities for

the Inter-religious Council of Uganda (IRCU), the Northern Uganda Malaria, AIDS, and TB (NUMAT) project and will procure for

three new district-based HIV/AIDS programs.

In FY09, USG with continue strengthening the national procurement system through technical assistance and training. Recently,

Crown Agents was awarded the contract as the third party procurement agent for GFATM commodities. USG, through

participation in the MOH medicines technical workgroup, will ensure close coordination between Crown Agents and the other

procurement mechanisms.

Ongoing challenges in the national system include:

1) ARV drug stock-outs at GFATM-supported sites. The 2007 the Uganda Service Provision Assessment survey showed that 83

percent of hospitals and 74 of Health Center (HC) IV facilities had a stock out of first line adult regimen in the previous six months.

Reasons for stock outs included GFATM funding delays, late delivery of drugs, and delayed forecasting. (Only two-thirds of sites

submit the required bimonthly reports and orders for ARVs).

2) A series of assessments of the National Medical Stores (NMS) identified key issues that have contributed to inadequate

performance. These include critical lack of finances due to lack of capital, delayed payment from customers, insufficient

personnel, and the burden of managing third party commodities, inefficient management information systems, limited

warehousing, and an aging transportation fleet.

3) The MOH Pharmacy Division and AIDS Control Program are responsible for forecasting, procurement planning, and

management of the ARV logistics information system, monitoring stock levels, and coordinating with the NMS to ensure timely

distribution. Budget constraints and limited staff and office space have delayed the full transfer of logistics management to the

national program. A demonstrated commitment from the MOH to provide resources is needed so that USG technical assistance is

fully realized.

FY09 Identified Focus Areas

In order to plan for FY09, the USG Country Team carried out a program review of the USG treatment portfolio; conducted field

visits to implementing partner sites; participated in the National ART Committee that revised the National Treatment Guidelines;

held a stakeholders consultative meeting; and performed a critical analysis of the FY08 Semi-Annual Program Results. These

planning exercises resulted in the identification of three major focus areas for FY09:

1) Continue to provide technical assistance to strengthen national forecasting and procurement capability and continue to work

within the Ugandan National Three-Year Procurement Plan for Essential Medicines and Health Supplies to enable the government

to develop and maintain the capacity for long-range planning, thereby preventing ARV stock outs and emergency procurements.

In addition, continue support to the NMS to strengthen their warehousing, management information systems and distribution

operations.

2) Maintain support to the National Drug Authority to enable them to implement quality assurance procedures and monitor

acceptability of ARV drugs.

3) Build capacity of district health offices and ART health facilities in ARV logistics management through training, technical

assistance and support supervision.

Product/Drug Selection and Treatment Policy

The National ART Treatment Guidelines were revised (June 2008). The new recommendations include:

1) Phase out stavudine (D4T) as a first line drug due to toxicity. The USG-supported PHE, Home Based AIDS Care (HBAC),

demonstrated that D4T-associated neuropathy occurred in an estimated 36% of patients in a cohort of 1,000 over 3 years; 9%

required drug switches due to D4T side effects; and D4T associated lactic acidosis was responsible for several fatalities and

significant lipodystrophy.

2) The recommended Initial Treatment Regimens now include one of the following NRTI combinations: zidovudine and lamivudine

(ZDV +3TC); Tenofovir and lamivudine (TDF + 3TC); Tenofovir and Emtricitabine, called Truvada (TDF + FTC); stavudine and

lamivudine (D4T + 3TC) only as a last option; plus either efavirenz (EFV) or nevirapine (NVP).

3) ART eligibility criteria have been revised to include all adults and older children with a CD4 count less than 250 cells/mm3,

women and TB co-infected patients with CD4less than 350 cells/mm3, and infants less than 12 months with HIV infection.

In compliance with these guidelines, USG will make use of the recommended first line regimens. TDF combinations have a low

toxicity profile, can be used safely in pregnancy and concurrently with TB medication, and are dosed once-a-day, potentially

improving adherence. In addition, using TDF in a first-line regimen reserves thymidine analogues (ZDV) and protease inhibitors

(PIs) for second line therapy. Despite these advantages, one of the most commonly procured first line drugs (SCMS) is the triple

fixed dose combination (FDC) of ZDV+3TC+NVP, because of the cost difference between generic Duovir ($13.38/month), versus

Truvada ($26.25/month) plus NVP ($3.40/month) or EFV ($11.72/month). Truvada is used as a first-line regimen for those

patients who cannot be started on ZDV, as well as a second-line regimen. The MOH in October 2008 recommended changing

patients at MOH supported sites who are on Truvada to generic TDF+3TC ($13.25/month), also based on cost considerations.

Given these recommendations, USG supported patients may also be started on TDF+3TC rather than Duovir or Truvada in order

to benefit from the advantages of using TDF. TDF and FTC are not available as single generic drugs. It should be noted that the

US HHS recommendations Truvada for first line drug initiation in the US.

Kaletra syrup and heat-stable Alluvia are also purchased for initiation of pediatric patients, and for second-line treatment of adults,

respectively. Significant progress has been made is using generic formulations. The vast majority of drugs procured are now

generics; only Truvada, TDF single dose, and PIs remain as non-generic formulations.

An increase in the number of patients who can be placed on ART may be constrained in future years by flat-lined funding as the

number of patients who require second-line therapy increases. Given that almost all drugs are now generic, with the exception of

PIs, TDF, and Truvada, it is unlikely that significant decreases in drug costs will occur. In addition, the WHO recommendations for

initiation of ART are for adults with CD4 <350 CD4 cells/mm3, rather than the current MOH guideline of CD4 <250 cells/mm3. If

MOH changes its recommendations, then the number who need to be initiated on treatment will increase.

Quality Assurance

USG is providing technical support to the National Drug Authority (NDA) to strengthen information systems, provide equipment

and training to expedite drug registration, and to renew and facilitate quality testing of ARVs on arrival into the country. Eight

computers have been procured, and internet connectivity will be established at headquarters and regional centers. NDA is

currently awaiting delivery of additional machines to expand their testing capacity. To date, they have tested 34 batches of ARV

drugs among the 46 received. USG also provides technical and financial support to NDA to establish a system for monitoring and

reporting drug adverse events (pharmacovigilance). The first pharmacovigilance center is being established in Fort Portal in the

next few months. Guidelines for reporting adverse events and a pharmacovigilance bulletin have been developed for healthcare

personnel to record and report to NDA. To date, 9 reports have been received through spontaneous reporting through clinical

trials, and 13 received at the regions. Pharmacovigilance sensitization meetings have been conducted for 111 private pharmacies

and clinic owners.

FY09 Targets

USG plans to directly support 155,519 people including 12,735 children with ART in FY09. This represents an increase in the

number of people requiring antiretroviral therapy. The overall cost of ARV drug regimens will increase due to the changes in the

drug combinations that are now officially recommended for first line treatment. However, when TDF goes off patent, there may be

a reduction in overall costs. The total estimated cost of ARV drugs supported by PEPFAR will be $39 million. Since 2004,

treatment partners have maintained a three-month buffer stock of medications, which greatly assisted the national program in

overcoming stock-outs due to unanticipated and problematic disruptions in GFATM funding. USG will continue to support a three-

month buffer supply, and a special provision to procure ARVs in the event of other emergency needs at MOH-supported facilities.

Table 3.3.15: