National Consultant to Conduct Systematic Review of Efficacy and Safety of Fixed-dose Combination Tenofovir/Lamivudine/Dolutegravir (FDC-TLD)

USAID SUSTAINABLE FINANCING FOR HIV

Terms of Reference

National Consultant

To conduct systematic review of efficacy and safety of Fixed-dose Combination
Tenofovir/Lamivudine/Dolutegravir (FDC-TLD)

I. Background of the assignment

The USAID Sustainable Financing for HIV is a two-year project (2018-2020) in Vietnam funded by the United States Agency for International Development (USAID) and led by Abt Associates. The project started on October 1, 2018 and will end on September 30, 2020. USAID Sustainable Financing for HIV Activity is providing technical assistance to the Government of Vietnam (GVN) to complete the transition to a domestically-funded HIV program able to exceed the 9090-90 targets – 90% of people living with HIV (PLHIV) tested, 90% on anti-retroviral treatment (ART), and 90% virally suppressed – thereby achieving epidemic control. The project will provide specialized expertise to deliver targeted, innovative, evidence-based, and results-driven technical assistance designed to: 1) increase in-country capacity to self-finance and sustain HIV control efforts; and 2) strengthen government capacity on ARV supply planning, quantification, bidding, and procurement financing through the SHI fund.

Context of this assignment

Optimization of current antiretroviral drug regimens is a critical component in supporting country efforts to achieve the 90/90/90 treatment targets and epidemic control. Following 2018 WHO guidance for HIV care and treatment, the Tenofovir/Lamivudine/Dolutegravir 300/300/50 (TLD) fixed dose combination has become the preferred first-line ART option for patients in Vietnam as well developed countries. Patients on TLD have fewer side effects, and are more likely to adhere, have better treatment outcomes, and are less likely to develop resistance. Another important reason for recommending FDC-TLD is that the drug is available in a low-cost generic form in many lower-income countries as result of a licensing agreement between the Medicines Patent Pool and the drug’s developer, ViiV Healthcare.

In Vietnam, HIV patients started to receive the first SHI-covered ARVs since March, 2019. The MOH issued a TLD Market Authorization in October 2019. From January 2020 to the end of March 2020, there were about 4,797 TLD patients receiving PEPFAR-supported TLD, of which 126 were newly on ART. VAAC is planning to include TLD in the SHI drug list to ensure that HIV patients will receive SHI-covered TLD in 2022 for maintaining sustainable TLD treatment. In this context, the project will provide technical assistance to VAAC on the process to include TLD in SHI’s drug list. This consultancy will provide documentation required to complete the TLD approval process.

II. Tasks

Overall task

Support the Vietnam Authority of HIV/AIDS Control (VAAC) to review, collect and compile documents related to efficacy and safety of Fixed-dose Combination Tenofovir/Lamivudine/Dolutegravir 300/300/50mg (FDC- TLD) in order to finalize a dossier for inclusion of TLD drugs into SHI drug list, to be submitted to the Department of Health Insurance, the MOH’s relevant unit for approval.

Specific tasks

1. Systematically summarize documents, including:

• Articles published on the efficacy and safety of FDC - TLD

• Scientific reports, program reports on treatment results and safety of FDC TLD from countries around the world.

• Articles published on the efficacy and safety of DTG-containing regimens.

• Instructions on the use of TLD regimens, FDC - TLD tablets of WHO, Vietnam and other countries, recommendations from WHO for the use of TLD drugs

• Report on the FDC - TLD drugs and bioequivalence results of TLD.

• Progression of transition in TLD use in Vietnam

2. Conduct and report on systematic reviews on efficacy and safety of FDC - TLD, report bioequivalence results, scientific reports and the situation of combined use of FDC - TLD in countries around the world, progress of TLD transfer and research to assess the effectiveness and safety of FDC TLD in Vietnam.

3. After dossier submission to DHI: Support VAAC to supplement required documents related to efficacy and safety of FDC - TLD based on comments of Departments and relevant units;

4. Support VAAC to prepare contents, presentations, reports and attend technical meetings and workshops related to efficacy and safety of FDC - TLD with Drug Review and Appraisal committee, as needed.

III. Qualification requirements

• An advanced degree in medicine, pharmacology or related disciplines;

• More than 10 years of relevant work experience in the health sector;

• Strong understanding and knowledge on HIV treatment, SHI policies;

• Strong understanding and experience in conducting and reporting systematic reviews on efficacy and safety of drugs;

• Adequate knowledge and understanding of HIV/AIDS care and treatment program in Vietnam;

• Demonstrated ability to work effectively with government agencies including health and social security sectors and health facilities;

• Basic knowledge of English.

Duration: Between 15^th May to 31^th July, 2020

Note: This position is based in Hanoi, Vietnam.

To apply, please send your application documents to Ms Thanh Hien with the following email: [email protected]

Deadline: May 10, 2020

Only short-listed candidates will be contacted for interviews.