{"doi":"10.1093/cid/ciaa028","title":"Safety and Efficacy of Starting Antiretroviral Therapy in the First Week of Life","abstract":"BACKGROUND: Early antiretroviral therapy (ART) is recommended for infants with human immunodeficiency virus (HIV) infection. However, few antiretroviral options are available for neonates. METHODS: The Early Infant Treatment Study in Botswana tested HIV-exposed infants within 96 hours of birth, and HIV-infected infants started nevirapine (NVP) 6 mg/kg twice daily, zidovudine (ZDV), and lamivudine (3TC) at age < 7 days. NVP trough concentrations were tested at 1 and 2 weeks. NVP was switched to ritonavir-boosted lopinavir (LPV/r) at week 2, 3, 4, or 5 according to delivery gestational age. RESULTS: Forty HIV-infected infants started ART at median age 2 days (range, 1-5 days). NVP trough concentrations were highly variable and below therapeutic target (3000 ng/mL) for 50% of 2-week measurements; concentrations did not correlate with viral decline at weeks 2, 4, or 12. Two deaths unrelated to ART occurred through 24 weeks. Only 1 unscheduled treatment modification was required. Within 4 weeks of transition to LPV/r, 9 (22.5%) had transient HIV RNA increases, likely due to poor LPV/r palatability. At 12 weeks, 22 (55%) of 40 were <40 copies/mL (93% <400 copies/mL); by 24 weeks, 27 of 38 (71%) were < 40 copies/mL (84% < 400 copies/mL). HIV-1 RNA response at 12 and 24 weeks did not differ by baseline HIV RNA or other factors. CONCLUSIONS: NVP/ZDV/3TC started in the first week of life was safe and effective, even when trough NVP levels were below target. Transient viral increases occurred following transition to LPV/r, but by 12 and 24 weeks most children achieved and maintained viral suppression. CLINICAL TRIALS REGISTRATION: NCT02369406.","journal":"Clinical Infectious Diseases","year":2020,"id":100461,"datarank":1.0132625801711648,"base_score":3.367295829986474,"endowment":3.367295829986474,"self_citation_contribution":0.5050943744979712,"citation_network_contribution":0.5081682056731935,"self_endowment_contribution":0.5050943744979712,"citer_contribution":0.5081682056731935,"corpus_percentile":null,"corpus_rank":null,"citation_count":28,"citer_count":15,"citers_with_citation_signal":12,"citers_with_endowment":12,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9675,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02369406"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":493415,"name":"Gbolahan Ajibola","orcid":"0000-0002-5408-4823","position":1,"is_corresponding":false},{"id":271745,"name":"Kara Bennett","orcid":"0000-0002-9465-8983","position":2,"is_corresponding":false},{"id":330622,"name":"Edmund V. Capparelli","orcid":"0000-0002-1630-0505","position":3,"is_corresponding":false},{"id":349137,"name":"Patrick Jean‐Philippe","orcid":null,"position":4,"is_corresponding":false},{"id":425983,"name":"Sikhulile Moyo","orcid":"0000-0003-3821-4592","position":5,"is_corresponding":false},{"id":494572,"name":"Terence Mohammed","orcid":null,"position":6,"is_corresponding":false},{"id":493416,"name":"Oganne Batlang","orcid":"0000-0003-1186-2979","position":7,"is_corresponding":false},{"id":493417,"name":"Maureen Sakoi","orcid":"0009-0008-5222-7756","position":8,"is_corresponding":false},{"id":257497,"name":"Shahin Lockman","orcid":"0000-0002-5384-9716","position":9,"is_corresponding":false},{"id":393322,"name":"Joseph Makhema","orcid":"0000-0003-0017-2438","position":10,"is_corresponding":false},{"id":108393,"name":"Mathias Lichterfeld","orcid":"0000-0001-9865-8350","position":11,"is_corresponding":false},{"id":69665,"name":"Daniel R. Kuritzkes","orcid":"0000-0001-6196-5883","position":12,"is_corresponding":false},{"id":65752,"name":"Michael D. Hughes","orcid":"0000-0001-8562-2316","position":13,"is_corresponding":false},{"id":431953,"name":"Roger Shapiro","orcid":"0000-0002-4832-6275","position":14,"is_corresponding":false},{"id":493414,"name":"Kenneth Maswabi","orcid":"0000-0002-7944-4637","position":0,"is_corresponding":true}],"reference_count":31,"raw_metadata":null,"created_at":"2026-07-18T22:39:01.863288Z","pmid":"31927562","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}