Second-Line Switch to Dolutegravir for Treatment of HIV Infection.

BACKGROUND: Data to inform the switch from a ritonavir-boosted protease inhibitor (PI) to dolutegravir in patients living with human immunodeficiency virus (HIV) infection who do not have genotype information and who have viral suppression with second-line therapy containing a ritonavir-boosted PI have been limited. METHODS: In a prospective, multicenter, open-label trial conducted at four sites in Kenya, we randomly assigned, in a 1:1 ratio, previously treated patients without genotype information who had viral suppression while receiving treatment containing a ritonavir-boosted PI to either switch to dolutegravir or continue the current regimen. The primary end point was a plasma HIV type 1 RNA level of at least 50 copies per milliliter at week 48, assessed on the basis of the Food and Drug Administration snapshot algorithm. The noninferiority margin for the between-group difference in the percentage of participants who met the primary end point was 4 percentage points. Safety up to week 48 was assessed. RESULTS: A total of 795 participants were enrolled, with 398 assigned to switch to dolutegravir and 397 assigned to continue taking their ritonavir-boosted PI; 791 participants (397 in the dolutegravir group and 394 in the ritonavir-boosted PI group) were included in the intention-to-treat exposed population. At week 48, a total of 20 participants (5.0%) in the dolutegravir group and 20 (5.1%) in the ritonavir-boosted PI group met the primary end point (difference, -0.04 percentage points; 95% confidence interval, -3.1 to 3.0), a result that met the criterion for noninferiority. No mutations conferring resistance to dolutegravir or the ritonavir-boosted PI were detected at the time of treatment failure. The incidence of treatment-related grade 3 or 4 adverse events was similar in the dolutegravir group and the ritonavir-boosted PI group (5.7% and 6.9%, respectively). CONCLUSIONS: In previously treated patients with viral suppression for whom there were no data regarding the presence of drug-resistance mutations, dolutegravir treatment was noninferior to a regimen containing a ritonavir-boosted PI when the patients were switched from a ritonavir-boosted PI-based regimen. (Funded by ViiV Healthcare; 2SD ClinicalTrials.gov number, NCT04229290.).

Preconception Care Uptake and Immediate Outcomes among Discordant Couples Accessing Routine HIV Care in Kenya.

INTRODUCTION: A large proportion of new HIV infections occur within discordant partnerships making discordance a significant contributor to new HIV infections in Africa. Despite the role of preconception care for HIV discordant couples, there is little data on fertility desire and preconception care uptake. This study aimed at documenting fertility desire (desire to conceive), determining the uptake of preconception care, identifying HIV prevention strategies used during preconception care, and determining immediate conception outcomes among HIV discordant couples in Kenya. METHODS: We retrospectively extracted electronic medical record data on discordant couples at an HIV care discordant couples' clinic. We included data on couples who expressed a desire to conceive and were offered preconception care and followed up for 29 months. We collected data on sociodemographic characteristics, preconception prevention methods, and associated outcomes. RESULTS: Among couples, with male HIV-positive partners, there was a twofold likelihood of accepting preconception services (OR = 2.3, CI 95% (1, 1, 5.0)). A shorter discordant union was independently associated with the uptake of preconception services (OR = 0.92, CI 95% (0.86, 0.98)). The most used prevention intervention (38.5%) among discordant couples was a combination of pre-exposure prophylaxis (PrEP) by the uninfected partner, alongside HAART by the partner living with HIV. Pregnancy rates did not significantly (p = 0.06) differ among those who took up preconception care versus those who did not. HIV-negative partners of couples who declined preconception care had a significantly (p = 0.04) higher attrition from clinic follow-up. One confirmed seroconversion occurred; an HIV incidence rate of 0.19 per 100 person-years. CONCLUSION: The study demonstrates the feasibility of implementing safe and effective preconception servicesas part of routine HIV care for discordant couples living in low resource settings. The provision and the utilisation of safer conception services may be hindered by the poor retention to follow-up and care of HIV-negative partners. This challenge may impede the expected benefits of preconception care as an HIV prevention intervention.