Raltegravir versus lopinavir/ritonavir for treatment of HIV-infected late-presenting pregnant women. Issue 3 (4th May 2018)

• Record Type: Journal Article
• Authors: Brites, Carlos; Nóbrega, Isabella; Luz, Estela; Travassos, Ana Gabriela; Lorenzo, Cynthia; Netto, Eduardo M.
• Is Part Of: HIV clinical trials. Volume 19:Issue 3(2018)
• Page Start: 94
• Page End: 100
• Publication Date: 2018-05-04
• Subjects: Raltegravir -- Lopinavir/ritonavir -- HIV-1 -- Pregnant women -- Mother-to-child-transmission; HIV Infections -- Chemotherapy -- Periodicals; AIDS (Disease) -- Chemotherapy -- Periodicals; HIV Infections -- Research -- Periodicals; AIDS (Disease) -- Research -- Periodicals; 616.979206105
• DOI: 10.1080/15284336.2018.1459343
• Languages: English
• ISSNs: 1528-4336

Abstract

Abstract : Background: Late-presenting pregnant women pose a challenge in the prevention of HIV-1 mother-to-child-transmission. We compared the safety and efficacy of raltegravir and lopinavir/ritonavir for this population. Methods: We did a single-center, pilot, open-label, randomized trial in Brazil ( N = 44). We randomly allocated late-presenting HIV-infected pregnant women (older than 18 years with a plasma HIV-1 RNA >1000 copies/mL) to receive raltegravir 400 mg twice a day or lopinavir/ritonavir 400/100 mg twice a day plus zidovudine and lamivudine (1:1). The primary endpoint was virological suppression at delivery (HIV-1 RNA <50 copies per mL), in all patients who received at least one dose of study drugs (modified intention-to-treat analysis). Missing information was treated as failure. We assessed safety in all patients. Results: We enrolled and randomly assigned treatment to 33 patients (17 in raltegravir group) between June 2015 and June 2017. The study was interrupted by the IRB because a significant difference between arms was detected in an interim analysis. All patients completed follow up at delivery. At delivery, virological suppression was achieved by 13/17 (76.5%) of patients in raltegravir group, versus 4/16 (25.0%) in lopinavir/ritonavir group (RR 3.1, 95% CI: 1.3–7.4). Patients in raltegravir group had significantly higher proportion of virological suppression at 2, 4, and 6 weeks than lopinavir/ritonavir group. Adverse events were most of mild intensity, but patients in lopinavir/ritonavir group had significantly more gastrointestinal adverse events. There was neither discontinuation nor deaths in this trial. Conclusion: Raltegravir might be a first-line option for treatment of HIV-infected late-presenting pregnant women.