Protocol for Active Safety Monitoring of a Dolutegravir-Based Antiretroviral Regimen in Mozambique

Introduction
Dolutegravir-based antiretroviral therapy (ART) is increasingly being used as the preferred first-line regimen for the treatment of HIV in low-income and middle-income countries. The National Program for the Control of STI/HIV/AIDS in Mozambique has planned a phased introduction of the tenofovir/lamivudine/dolutegravir (TLD) regimen. In 2019, concerns about a potential safety signal identified with dolutegravir identified in the results of the Tsepamo study, conducted in Botswana, led the National Directorate of Pharmacy and the National Program for the Control of STI/HIV/AIDS to establish an active pharmacovigilance surveillance system among newly placed patients on a TLD regimen. This activity aims to establish an active pharmacovigilance system to monitor adverse events in patients on a TLD regimen to support the effectiveness of Mozambique’s public health programmes in improving the process of care and treatment outcomes for people with HIV/AIDS.

Methods and analysis
This is a prospective, non-interventional, descriptive cohort study to monitor HIV patients managed with TLD at 10 sentinel health centres in Mozambique. The cohort consists of HIV-infected patients commencing treatment with TLD, either as treatment naïve patients or switched from other ART regimens. Patients have monthly routine follow-up visits for the first 3 months after starting HIV treatment with TLD, and subsequently every 3 months for a total period of 1 year. Patients are monitored to identify possible adverse events during the follow-up period. The intended size of the cohort is 3000 patients.

Protocol for Active Safety Monitoring of a Dolutegravir-Based Antiretroviral Regimen in Mozambique

By Merana Mussá, Irénio Gaspar, Luisa Namburete, Tânia Vuyeya Sitoie, Aleny Couto, Jamal Mario Paulino, Abrao Lemos, Stefia Vilanculos, Comfort Kunak Ogar, Denylson Namburete, Eunice Dias Seni, Tamara Hafner, Andy Stergachis