UK-CAB 3: HIV, Pregnancy and Maternal Health

Friday 25 October 2002

Notes for the meeting

Introduction to meeting and speakers
Reading material
Background information – Boehringer Ingelheim
Agenda for Meeting

Transcriptions from the meeting:

Summary report from the meeting
Karen Beckerman : HIV, Pregnancy and Maternal Heath

Powerpoint slides:

HIV, Pregnancy and Maternal Heath – Karen Beckerman

Boehringer (4 powerpoint files)

 

  1. tipranavir trials [468kb]
  2. tipranavir resistance [696kb]
  3. tipranavir clinical data [444kb]
  4. nevirapine side effect management [Awaiting arrival]

1). Introduction to meeting and speakers

The training sessions for the third CAB meeting were the results of the questionnaire sent round to the group by email. We had about 20 replies within the week and HIV pregnancy was well in the lead, and we thought including a talk on the sperm-washing and fertility clinic at the Chelsea and Westminster Hospital would be very important in this context.

Combination therapy, activism, statistics, co-infection and drug development were then the most popular and will follow in future meetings.

We are very fortunate to have presentations from leading researchers.

Dr Karen Beckerman

Dr Karen Beckerman is assistant professor of obstetrics and gynaecology at New York University and director of obstetrics at Bellevue Hospital, New York. She is also one of the most experienced obstetricians for treating HIV-positive women through pregnancy using combination therapy.

Over 4 years ago at the World AIDS Conference in Geneva she reported that reducing viral load to undetectable levels using HAART had reduced transmission rates to approaching 0% at the Bay Area Clinic in San Francisco in over 70 pregnancies.

This was the lowest transmission rate that had then been reported, and most studies during pregnancy until that time had also primarily focussed more on reducing the risk of transmission than primarily on the mothers health. To some extent this still continues today in some cases.

She also reported that routine elected C-section delivery for HIV-positive mothers added no additional benefit to either the mother or babys’ health – although she argues that as will all other aspects of her care, this choice should be made by the mother in association with her healthcare team.

Both these issues are particularly relevant for us as advocates in the UK, where C-section is still routinely recommended even when this is not the mothers first preference. Use of AZT monotherapy or dual therapy with AZT/3TC is sometimes also still recommended despite the high risk of the mother developing resistance to these drugs.

Although single-dose nevirapine given to both the mother and baby prior to delivery and after birth reduced the risk of transmission (from 26 to 13% in the much publicised HIVNET 012 study, Dr Beckerman argues that adopting this treatment in an inappropriate and very short sighted approach. It is bad for the mothers health, with a high risk of developing resistance to NNRTIs – drugs that are also most likely to be included in the first HAART regimens to be available in Africa (either by price reductions or in a generic formulation).

Leila Frodsham

Leila Frodsham clinical research fellow at the Chelsea and Westminster Hospital in London’s assisted conception unit, where she is mainly involved with positive women.

This is the only clinic in the UK offering these services to HIV-positive people (where either or both partners are HIV-positive). The sperm-washing clinic was developing in consultation with Dr Semprini in Italy who developed this technique which has resulted in successful delivery around 600 HIV-negative babies.

2. Reading material

The following reading was posted out (electronic copies not available or on-line as far as yet).

  1. IAS Pregnacy guidelines (Beckerman)
  2. AIDS Reader article on spermwashing

3. Background information:

Boehringer Ingelheim (BI)

Boehringer Ingelheim is the German owned pharmaceutical company mainly know for developing and marketing of nevirapine.

Nevirapine was actually first studies in the early 90s but development was suspended due to the limited effect on viral load and very early development of resistance – this was before the importance of using triple combinations had been established.

Over a year ago they also purchased tipranavir from Pharmacia and Upjohn. Early studies showed that the tipranavir has a very strong resistance profile against HIV that is resistant to current PIs – and the development and access to tipranavir is very important for people needing salvage therapy.

Most of the inherited studies and data from Pharmacia was either poorly designed or unusable and was complicated by different formulations (original studies required around 30 tablets a day and the pill count was linked to poor adherence and unclear results).

As producers of nevirapine BI have established an international drug donation programme for use in pregnancy (most publicised in relation to South Africa), and given the focus of today meeting it seemed appropriate and lucky that we are able to meet with Dr Hubert Bland, Dr Kevin Curry and Dr Michael McKenna from their medical team, and Kristi Pitt who many of you already know from her role as Community Liaison.

4. Agenda for meeting

8.30-9.00 Registration
9.00-9.30 Introduction to the day
9.30-11.00 HIV, Pregnancy and Maternal Health Dr Karen Beckerman
11.00-11.30 Break
11.30-12.30 HIV Sub-fertility and Spermwashing Dr Leila Frodsham
12.30-14.00 Lunch
14.00-16.00 Boehringer:
Introduction to BI
Tipranavir (Development programme, clinical studies, expanded access programme etc)
Nevirapine – management of toxicity (rash and hepatic toxicity)
Nevirapine use in pregnancy and international programme
Drugs in development: HCV protease inhibitor
16.00-16.15 Break
16.15-17.00 Internal (Feedback, conference reports, next meeting etc)

 

Financial support

The UK-CAB receives unrestricted funding from some pharmaceutical companies towards the direct costs of holding four meetings each year. This funding supports the travel and accommodation costs for members to attend from outside London, plus the cost of catering.

The content, programme and agenda for meetings is decided by the UK-CAB steering group in consultation with the wider membership. Funding is unconnected to meeting content.

We believe that manufacturers who currently develop and market medicines have a responsibility to actively engage with advocacy organisations and that HIV positive people and their advocates should be able to directly question manufacturers about the safety and efficacy of their products and proposals for future research.

For a list of companies that support the UK-CAB please see the “about us” page.

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Published: October 25, 2002
Last edited: August 15, 2013