My name is Jacqueline Patterson and I manage the HIV/AIDS Programs Portfolio for Interchurch Medical Assistance, which is a member of the Catholic Relief Services Consortium, one of the 4 awardees of the PEPFAR ART Initiative.

I appreciate you giving me this bit of time to bring some voices from FDC utilizing facilities into the proceedings. I’d just like to read a brief statement comprised of comments from our field partners.

The organizations within CRS and I.M.As collective Membership are currently providing ART treatment to thousands of people throughout Africa and the Caribbean through hundreds of affiliated Mission hospitals and clinics.

From our initial survey, completed in preparation for the proposal for the PEPFAR ART award, we learned that the majority of our partners and affiliated institutions are currently using FDC ARVs in the provision of treatment.

Under the PEPFAR initiative CRSC was awarded $24.7 million in Year I to scale up existing services and provide treatment to 14,900 people in 9 countries. As current PEPFAR guidelines dictate that we cannot use FDCs due to regulatory issues, our partners were interested in logging their concerns at this forum about the issue of broadening access to FDCs.

Therefore, I would like to offer comments coming directly from out affiliated hospitals, clinics and partners including the Christian Health Associations in our focal countries as well as sharing excepts from comments by clinician representatives at the February meeting in Brackenhurst Kenya, of the Christian Medical and Dental Association.

• We are currently using FDCs, following our national guidelines/protocols in accordance with WHO prequalification standards. Therefore, Policies restricting the use of FDCs result in changing of our regimens and will place us out of compliance with our governmental policies.

• Our patients on Fixed Dose Combination-based protocols at facilities such as Muheza and Selian Hospitals in Tanzania, CCAP Hospitals in Malawi, Kijabe Hospital in Kenya are experiencing positive outcomes that have been well-documented. Our experiences bear out the quality of these products.

• We appreciate any initiative that results in an expedited process for making FDCs an approved drug for widespread use, including under PEPFAR.

• FDCs must be an option for our hospitals, though we certainly acknowledge that need and utility of individual component-based regimens.

• We are concerned that the pill burden that will result from removal of FDCs from our arsenal will result in our patients having a difficult time keeping up with their regimens.

• With non-FDC regimens, there is a significant risk of sharing of pills among family members as per a prevailing cultural sense of community

• Adherence will suffer greatly as a result of pill burden and the sharing of pills and resistance will result.

• With the onset of resources from the Global Fund, Clinton Foundation, World Bank, national programs, etc, our already over-taxed institutions will suffer under the onerous management burden due to multiple programs with different drug requirements/allowances.

• In addition to the institutional challenges, volunteer community workers will have to guide already overwhelmed families with different people using different pills with different instructions.

• Due to the lower pricing of FDCs, we can treat up to 4 times more people that we would be able to treat with non-FDC/branded drugs.

• What will happen at the end of the 5-year term of the PEPFAR initiative after we’ve all changed out protocols and practices to comply with regulations excluding FDCs and requiring high-priced regimens and the resources are withdrawn?