Although there were a smattering of sessions live from Berlin, Germany, the conference was yet again a largely virtual one, with COVID-19 inevitably high on the agenda.
COVID-19 in people with HIV
Silvia Bertagnolio (WHO, Switzerland) presented clinical characteristics and prognostic factors for people living with HIV and hospitalised with COVID-19 in 24 countries. The study included data for 168 649 people hospitalised with COVID-19, 15 522 of whom were living with HIV. 36·2% of people with HIV had severe or critical illness at presentation, and 23·1% of those with known outcomes died in hospital: HIV infection was associated with increased risk of in-hospital mortality after adjusting for age, gender, disease severity, and comorbidities burden (adjusted hazard ratio 1·30, 95% CI 1·24–1·36). These findings support WHO's recent call for people living with HIV to be prioritised for SARS-CoV-2 vaccines (PEBLB20).
HIVDR in diagnoses on PrEP
HIV drug resistance (HIVDR) monitoring in pre-exposure prophylaxis (PrEP) roll-out could maintain antiretroviral treatment and prevention options. Urvi Parikh (University of Pittsburgh, USA) reported results of HIVDR monitoring among users of PrEP with tenofovir disoproxil fumarate and emtricitabine who became HIV positive after PrEP initiation. The study is part of the Global Evaluation of Microbicide Sensitivity project, which monitors HIVDR among 104 000 people on PrEP roll-out programmes in Eswatini, Kenya, South Africa, and Zimbabwe. 229 people seroconverted between December 2017 and June 2021, 208 (91%) provided blood samples. Participants were mostly young women aged 16–24 years. 58% of participants were on PrEP for more than 3 months before seroconverting. 118 samples were successfully sequenced: 65 (55%) had no resistance mutations, 26 (22%) had resistance mutations not associated with PrEP, and 27 (23%) had PrEP-associated mutations (Lys65Arg, Lys70Glu, and Met184Ile/Val). 14 (78%) of 18 samples with PrEP-related resistance had drug levels associated with high adherence (OALC01LB02).
The next long-acting antiretroviral?
The capsid inhibitor lenacapavir seems safe and efficacious for HIV treatment when given as twice yearly subcutaneous injections according to 28-week results of the CALIBRATE trial (NCT04143594) presented by Samir Gupta (Indiana University, USA). The phase 2 trial compared subcutaneous lenacapavir injections every 26 weeks with oral daily lenacapavir (both in combination with other antiretroviral agents) or oral daily bictegravir with tenofovir alafenamide and emtricitabine. Lenacapavir regimens led to no study drug-related serious adverse events and only mild or moderate injection site reactions. High rates of viral suppression were seen in all arms; however, there was one case of drug resistance in one of the subcutaneous lenacapavir arms. Of the 182 participants, across all arms, only 7% were women and further studies into lenacapavir will need to recruit more women. Gupta said that trials of lenacapvir in combination with islatravir as a long-acting injectable antiretroviral therapy are worth pursuing (OALB0302).
High adherence to ring and PrEP
Interim results from the REACH (MTN-034) study show adherence, acceptability, and safety of dapivirine vaginal ring and oral PrEP use among adolescent girls and young women. Gonasagrie Nair (Stellenbosch University, South Africa) reported results of the randomised, crossover, open-label trial, which assigned participants to either the monthly dapivirine ring or daily oral PrEP with tenofovir disoproxil fumarate and emtricitabine. 247 participants (average age 18 years) were enrolled across four sites in South Africa, Uganda, and Zimbabwe. Rates of adverse events of grade 2 or higher were similar among ring users (78%) and oral PrEP users (77%). High adherence was recorded in 50·2% of timepoints for ring users and 22·4% for oral PrEP users—higher than in previous studies. Acceptability by self-report was higher for the dapivirine ring (88·5%) than for oral PrEP (63·9%) OALC01LB01.
No Data No More
A group of trans activists launched No Data No More: a Manifesto to Align HIV Prevention Research with Trans and Gender Diverse Realities during the IAS Conference. The manifesto challenges those working in HIV prevention research to do better in representation of trans and gender diverse identities at every stage, from study design to results dissemination. JD Davids, Max Appenroth, Tshepo Ricki Kgositau Kanza, Lee-Ann van der Merwe highlighted the importance of involving trans people fundamentally in research, rather than token inclusion and reporting data more completely and with nuance that better reflects the diversity and reality of gender identities and behaviours. Davids highlighted that for trans masculine people, PrEP with tenofovir alafenamide and emtricitabine was not approved, because studies had not reported data for trans men. “A lack of data doesn't mean we are not at risk”, said Appenroth.