Clinical Trials

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Browsing Clinical Trials by Subject "InSTIs, pregnant women, viral load, efficacy and safety"

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    Efficacy and Safety Profile of Integrase Strand Transfer Inhibitors (InSTIs) for treatment of HIV in Pregnant Women: Systematic Review and Meta-Analysis
    (Addis Abeba University, 2020-07) Getachew, Hiwot; Woldeamanuel, Yimtubezinash(Dr. ); Makonnen, Eyasu(Prof.)
    Background: Integrase strand transfer inhibitors (InSTIs) are the most recent class of drugs approved on the basis of their efficacy and safety profiles (16). Dolutegravir and elvitegravir are considered US Food and Drug Administration pregnancy category B; while raltegravir belongs to category C. Objective: To assess the efficacy and safety profile of Integrase Strand Transfer Inhibitors drugs for treatment of HIV in Pregnant Women Method: Literature search strategies were done using medical subject headings (MeSH) and text words related to InSTIs drugs and pregnancy. Pubmed, EMBASE, Web of Science, Science Direct, Henari, and the Cochrane Central Register of Controlled Trials and other databases were searched. The estimated effect (Relative Risks) and associated 95% confidence intervals for the reduction of HIV RNA viral load were meta-analyzed using a DerSimonian– Laird randomeffects model (25). Statistical analysis was performed using RevMan 5.3 software. Result: Based on our systematic review and meta-analyses data, treatment with InSTIs based ART regimens showed to be more beneficial for HIV positive pregnant women compared to other currently used treatment strategies. Both preterm delivery and proportion of infants with Small for Gestational Age didn’t show statistically significant association with the use of InSTIs (risk ratio 0.82, 95% CI 0.60–1.13, I 2 =0%) and (risk ratio 0.90, 95% CI 0.58–1.40, I =0%) respectively. DTG based ART showed a lowered maternal serious adverse event compared to current treatment regimen (risk ratio 1.94, 95% CI 1.13–3.32, I 2 =0%). Conclusion: We suggest use of DTG based ART regimen to be preferred first line choice for HIV positive pregnant women, if the pregnancy is confirmed already past 8 weeks of gestation. Although further investigation is necessary about safety data, we suggest InSTI drugs, especially RAL, can be safely used during pregnancy particularly in late presenter pregnant women or as an intensification strategy. Because of the short and long-term consequences of adverse events seen in infants, particularly preterm birth and SGA, future studies need to assess the safety profile of DTG for infants and explore potential mechanisms of adverse outcomes. 2