Raltegravir versus lopinavir/ritonavir for treatment of HIV-infected late-presenting pregnant women

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.

British HIV Association guidelines for the management of HIV in pregnancy and postpartum 2018

“…A pilot study in 40 women demonstrated that initiation of raltegravir‐based therapy, compared to lopinavir/r‐based therapy, resulted in significantly more women with undetectable viral load <50 HIV RNA copies/mL at delivery and a faster median time to viral load reduction to <50 HIV RNA copies/mL of 44 days in the raltegravir arm and 69 days in the lopinavir/r arm . Adverse event incidence rates were also lower in the raltegravir arm.…”

Effectiveness and safety of integrase inhibitors in HIV-infected pregnant women followed up in the Madrid Cohort

“…RAL has been the most frequently used INI, with demonstrated utility in patients with late diagnosis in pregnancy due to its good placental transfer, as well as in pregnant women with resistant viruses to first-line drugs [2][3][4][5]10,11], being currently the preferred INI in pregnancy [3].…”

“…Mother-to-child transmission (MTCT) is the main way of HIV infection in childhood [1]. Despite the great advances in its prevention, especially in the treatment of pregnant women with antiretroviral therapy (AT), currently there is still ongoing perinatal transmission [2], mainly in children of mothers with poor viral load (VL) control during pregnancy or with late diagnosis [3].…”

“…The risk of MTCT mainly depends on the gestational age at which AT is initiated and the maternal plasma VL at the time of delivery [2,4,5], and therefore achieving virological suppression previously, is the main objective of AT during pregnancy [2,[6][7][8][9].…”

Computational screening of phytocompounds from Moringa oleifera leaf as potential inhibitors of SARS-CoV-2 Mpro

“…Anti-viral drugs such as Raltegravir, Lopinavir-Ritonavir, Maraviroc, Nel navir and Tipranavir were also screened for tracing possible interaction with M pro . Raltegravir (-7.2 kcal/mol) is an anti-retroviral drug, used along with other drugs to relieve the HIV infection [44]. Lopinavir-Ritonavir (-7.7 kcal/mol) is a combination of two medications; lopinavir and ritonavir, used to control HIV/AIDS infection [45].…”