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

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.

Survival Estimates and Mortality Risk Factors in a Cohort of HIV Vertically Infected Individuals in Salvador, Brazil.

BACKGROUND: There are few data on long-term survival of Brazilian children with vertically acquired HIV infection. We assessed survival, mortality risk factors and response to antiretroviral therapy (ART). We compared children with early and late access to care. METHODS: We used Kaplan-Meier survival curves with Log-rank tests to compare survival time and mortality rates of 245 HIV vertically infected children admitted for care during 2002-2014. RESULTS: Total follow-up sum was 1584.4 person-years. Overall survival was 83.9%. Median age at start of ART was 51.6 (18.0-94.2) months, and median age at death was 8.2 (1.7-10.1) years (mortality rate: 1.7/100 person-years). Pneumonia and sepsis were the main causes of death. Male gender, viral load (VL) ≥100,000 copies, severe immunosuppression, moderate/severe symptoms and history of opportunistic infection were associated with higher mortality in bivariate analysis. Only severe symptoms remained associated in multivariate analysis (P = 0.03). There was no difference in mortality in early compared to late access group. Overall, 217 patients received ART; 192 had a recent VL, of which 116 (59.8%) had ≤400 copies. Variables associated with therapeutic failure were as follows: VL ≥100,000 copies, less immune suppression, age <12 months at admission and age <3 years at ART start. CONCLUSIONS: We have a high mortality rate in comparison with developed countries. Although early access did not impact mortality, we detected a trend in favor of early treatment as a protecting factor against mortality. We need to increase adherence to care and treatment, and better drugs to optimize outcomes.