Other short reports from BHIVA:

HIV and transgender care; HIV positive kidney transplants; Exclusion of HIV positive people from lymphoma research; Meta-analysis of randomised studies of FDCs; HIV seroreversion in UK children; Informed consent and patient information.

Simon Collins, HIV i-Base

Short summaries of other studies are included below.

HIV and transgender care

For the first time at a BHIVA conference the programme included a lecture, now online as a webcast, that addressed the management needs of HIV positive transgender patients.

The presentation by Asa Radix from the Callen-Lorde community Centre in New York was especially well timed as in 2015 the NHS is at last starting to adopt a non-binary gender approach that might finally end the exclusion of transgender people from public health statistics.

Ref: Radix A. HIV and vulnerable populations: transgender medicine. Invited lecture. 21st Annual Conference of the British HIV Association (BHIVA), 21–24 April 2015, Brighton.

http://www.bhiva.org/150424AsaRadix.aspx (webcast)

http://www.bhiva.org/documents/Conferences/2015Brighton/Presentations/150424/AsaRadix.pdf (PDF slides)

Tacrolimus-based immunosuppression for HIV positive kidney transplant recipients

A UK study of HIV positive kidney transplant recipients reported significantly better outcomes when tacrolimus (Tac)-based immunosuppression was used compared to ciclosporin (CsA).

Data on allograft rejection (AR) was available for 79/85 renal transplants in HIV positive people carried out between 2005 and 2013, with 32/79 using CsA) and 45/79 using Tac).

Demographics included mean age 44.8 years, 75% black ethnicity, median CD4 cell count 277 cells/mm³ and that 97% had viral load <200 copies/mL.

Using logrank tests to compare survival and Cox proportional hazard models for AR, cumulative incidence of AR at 1 year was 57% and 20% among patients who started CsA and Tac respectively (p=0.002), with choice of immunosuppressant being the only significantly associated factor (HR 0.30: 95% CI: 0.13 to 0.67, p=0.003).

Overall one-year patient and graft survival were 97.3% and 94.6% respectively. AR was observed in 28 patients (36%), with a median time from transplant of 2.6 months (IQR: 0.5, 5.9 months).

The researchers commented that not using protease-based combinations enabled the safer use of Tac.

Ref: Gathogo E et al. Risk factors for acute allograft rejection in HIV-positive kidney transplant recipients. 21st Annual Conference of the British HIV Association (BHIVA), 21–24 April 2015, Brighton. Oral abstract O23.

http://www.bhiva.org/150423EstherGathogo.aspx (webcast)

http://www.bhiva.org/documents/Conferences/2015Brighton/Presentations/150423/EstherGathogo.pdf (PDF slides)

Exclusion of HIV positive people from experimental studies for lymphoma research

Although HIV does not affect the prognosis for Hodgkin lymphoma or non-Hodgkin lymphoma, the incidence of both cancers in significantly higher in HIV positive people compared to general population.

This makes the opportunity to enrol in studies for new treatments especially important. Although historically HIV was an exclusion criterion in the pre-ART era, there is now little rationale for excluding HIV positive people from clinical research studies that are not exclusively designed for HIV. Most HIV positive people are able to achieve undetectable viral load and the choice of ART enables combinations that minimise the risk of interactions with chemotherapy for lymphoma.

A review of current UK studies found that only 14/46 interventional studies with eight classes of compounds were open to HIV positive people. IRequests to see complete protocols were only provided for 8/32 studies although researchers from a further four studies responded to questions.

In no case was the exclusion of PLWH explicitly justified in the protocol. Following review of the trial protocols or published data on novel agents, there was a biologically valid reason for excluding PLWH for 1 trial and a possible valid reason for one further study. Choice of ART would be able to overcome potential for drug interactions in the 28/32 where this might be a theoretical concern.

Reference:

Venturelli S et al. The exclusion of people living with HIV (PLWH) from clinical trials in lymphoma: prejudice or justified? 21st Annual Conference of the British HIV Association (BHIVA), 21–24 April 2015, Brighton. Oral abstract O21.

http://www.bhiva.org/150423SerenaVenturelli.aspx (webcast)

http://www.bhiva.org/documents/Conferences/2015Brighton/Presentations/150423/SerenaVenturelli.pdf (PDF slides)

Meta-analysis of randomised studies finds no higher risk of viral failure in fixed-dose combinations compared to separate drugs

A new meta-analysis from Andrew Hill and colleagues of nine open-label randomised studies in over 2500 patients reported few significant differences between use of fixed-dose combination (FDCs) and separately dosed combinations. Most of these studies (7/9) were switch studies in people who were virally suppressed.

However, FDCs had small but significant benefits for two endpoints. For the switch equals failure endpoint FDC had a 3% lower risk of failure (95% C.I. 0 to -5%, p=0.05) and for the 95% adherence endpoint FDCs had a 5% higher rate of success (95% C.I. 1% to 9%, p=0.007).

Reference:

Hill A et al. No difference in risk of virological failure between antiretroviral treatments using co-formulated versus individual drugs: Meta-analysis of 9 randomised trials in 2,568 patients. 21st Annual Conference of the British HIV Association (BHIVA), 21–24 April 2015, Brighton. Oral abstract O10.

http://www.bhiva.org/150423AndrewHill.aspx (webcast)

http://www.bhiva.org/documents/Conferences/2015Brighton/Presentations/150423/AndrewHill.pdf (PDF slides)

Phenomenon of seroreversion in UK children started on early ART after birth

A retrospective analysis from five paediatric centres in the UK reported that seroreversion was identified in 10/398 (2.5%) children: 6 male and 4 female.

Median age at HIV diagnosis was 0.2 years (range 0 to 0.3) and ART was started at median age of 0.3 years (range 0 to 0.4).

All were still alive and on ART at last follow-up. Median age was 9.4 years (range 2.0 to 14.3]. Median CD4 count was 1112 cells/mm3 (429 to 1501). Importantly, 9 children had viral load suppressed to <50 copies/mL and one had a low level viral load of 230 copies/mL.

In this first study of seroreversion in children in the UK, the researchers were unable to comment on whether this phenomenon related to differences in HIV reservoirs or genetic factors.

Patel A et al. To determine the prevalence of HIV seroreversion across 5 collaborating paediatric HIV centres in the UK. 21st Annual Conference of the British HIV Association (BHIVA), 21–24 April 2015, Brighton. Oral abstract O26.

http://www.bhiva.org/150424AmiePatel.aspx (webcast)

http://www.bhiva.org/documents/Conferences/2015Brighton/Presentations/150424/AmiePatel.pdf (PDF slides)

Informed consent and patient information are too difficult for most people to easily understand

Activists at HIV i-Base analysed a range of patient information leaflets (PiLs) used as part of the informed consent process for nine ongoing studies. They reported that all document were written to a higher level of literacy to that recommended in NHS guidelines.

The study explained how readability results are easy to calculate and included information on how to produce information that would be easily read by a larger percentage of people. Results were compared to community produced PiLs for documents of similar length and complexity.

Reference:

Collins S et al. Patient information leaflets (PILs) currently require graduate-level reading skills equivalent to The Guardian or The Telegraph. 21st Annual Conference of the British HIV Association (BHIVA), 21–24 April 2015, Brighton. Oral abstract O4.
http://www.bhiva.org/150422SimonCollins.aspx (webcast)
http://www.bhiva.org/documents/Conferences/2015Brighton/Presentations/150422/SimonCollins.pdf (PDF slides)