Safety and Efficacy of Fixed Drug Combination Tenofovir, Lamivudine and Efavirenz to Prevent Transmission of HIV

Introduction: Mother-to-child transmission of HIV can occur during pregnancy, labour, or breastfeeding. The first-line regimen for prophylaxis in HIV infected pregnant women is combination of Tenofovir, Lamivudine and Efavirenz (TLE). Aim: To evaluate the safety and efficacy of the TLE regimen in the Prevention of Mother-To-Child Transmission (PMTCT) of HIV. Materials and Methods: The present hospital-based, retrospective cohort study was conducted at ART center, PPTCT center, and Department of Medicine, SP Medical College, Bikaner from July 2016 to June 2019. HIV positive gravidas, on triple-drug regimen TLE (Tenofovir 300 mg, Lamivudine 300 mg, Efavirenz 600 mg) before conception and, those detected HIV reactive antenatally during study period were included in this study and started on TLE regimen. After delivery, these newborns were given syrup Nevirapine as per the Prevention of Parent to Child Transmission (PPTCT) guidelines. Infants were tested with Rapid test and PCR for HIV, at six weeks, six months, 12 months, and 18 months of life. Results: Out of 87 pregnant women, enrolled and delivered at the study institute, 85 were live births and two were stillbirths. Out of 85 live-born babies, four have died during infancy and two were lost to follow-up despite repeated counselling. Five babies were referred to nearby Anti-Retroviral Therapy (ART) centers. So, the study followed 74 babies out of which one girl child was found to be positive for HIV-1 at 18 months of age (transmission rate of HIV was 1.35 and efficacy of TLE 98.65%). No major adverse effects of TLE were noted and all women continued TLE. Conclusion: The use of a triple-drug regimen (TLE) declined the risk of transmission of HIV from mother-to-child at negligible level, without drug resistance and with safety and tolerability as compared to single drug.