Author: Mohsen Shahmanesh

Antiretroviral prophylaxis: a defining moment in HIV control

According to an editorial by Salim Abdool Karim in the Lancet  a defining moment in the global AIDS response has been reached. The discourse is no longer about HIV prevention or HIV treatment; it is now about HIV control through the implementation of antiretroviral treatments as key components of combination interventions.

Barely a year ago, visions of HIV control would have been considered far-fetched. The impetus for this change in mindset, which has been building since the XVIII International AIDS Conference in Vienna last year, emanates from the compelling evidence that antiretroviral drugs prevent HIV infection in the general heterosexual population, which is released this week and presented at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome by the Partners PrEP and Botswana TDF2 trials.

The Partners PrEP trial, involving 4758 HIV discordant couples from Kenya and Uganda, found that daily oral tenofovir disoproxil fumarate (TDF) and TDF-emtricitabine reduced HIV transmission by 62% and 73%, respectively. The Bostwana TDF2 trial, in 1200 heterosexual men and women from the general population, found that daily oral TDF-emtricitabine reduced HIV transmission by 63%.

Both these are of a similar order of magnitude to that seen with male circumcision and is probably caused by a significant reduction of HIV in the genital tract.

see fig 1 for comparison between different prevension strategies

Several issues were raised by the authors that need further research. There is now no doubt that antiretroviral drugs prevent HIV infection. However, important scientific questions remain. Does the inclusion of emtricitabine in pre-exposure prophylaxis (PrEP) formulations provide sufficient additional benefit to warrant the additional costs and side-effects? Are levels of effectiveness and safety similar for daily use and use-with-sex of PrEP? Do the safety, effectiveness, cost, and acceptability profiles of oral and topical PrEP merit implementation of both formulations? Does PrEP lead to masking of HIV acquisition that is then revealed once PrEP is withdrawn?

Ghost authorship of scientific articles is very common

According to recent study by Wislar and colleagues appearing in the BMJ 21% of scientific papers published in reputable ‘high impact’ biomedical journals are either written by an unnamed ‘ghost’ author and then attributed to someone as honorary author (8%) or has had the names of authors that had nothing to do with the study (18%), or both. There was however a significant decline from a survey carried out in 1996 using an identical questionnaire which showed a prevalence of ghost or honorary authorship of 29%.

Over the last twelve years honorary authorship had not significantly changed overall, although it was significantly higher for research articles as opposed to review articles or editorials. Ghost authorship showed a small but significant fall over the two periods under study.

The journals that were investigated by the present study were all English language with high impact factors in 2008: Annals of Internal Medicine, JAMA, Lancet, Nature Medicine, New England Journal of Medicine, and PLoS Medicine. 

As the authors state ‘inappropriate authorship remains a problem, although the more serious ghost authorship may be declining’.

UK NHS finally accepts to use quadrivalent HPV vaccine in girls

From next September girls in the United Kingdom being vaccinated against human papillomavirus (HPV) will receive Gardasil, the vaccine that protects against genital warts as well as cervical cancer.

The Joint Committee on Vaccination and Immunisation recommended that the HPV vaccine should be offered routinely to girls aged 12 to 13 years and in a catch-up programme to those up to 18 years of age. Since then, 1.5 million young women and girls have been protected.

GlaxoSmithKline, which has been providing the Cervarix vaccine to the UK’s HPV vaccination programme since it launched in September 2008, said in a statement that it did not take part in the latest tendering exercise to provide a vaccine for the programme because the government made it clear that it wanted to protect girls against the types of HPV that caused cervical cancer and those that caused genital warts.

Gardasil, which is supplied by Sanofi Pasteur MSD, protects against HPV types 16 and 18, which cause 70% of cervical cancers, and HPV 6 and 11, which are responsible for nine in 10 cases of genital warts. Cervarix protects against HPV types 16 and 18.

When the UK programme launched, health campaigners criticised the choice of Cervarix as being short sighted and a missed opportunity (BMJ 2008;336:a451, doi:10.1136/bmj.a451)

Worldwide Gardasil has been the vaccine of choice. It has been selected by health authorities in the United States, Australia, New Zealand, Canada, Switzerland, Italy, Spain, and Sweden for regional or national vaccination programmes against cervical cancer.

Research from Australia has shown that cases of genital warts have nearly disappeared since 2007 when the national vaccination programme against cervical cancer using Gardasil was introduced (Sexually Transmitted Infectionsdoi:10.1136/sextrans-2011-050234). The study found that new diagnoses of genital warts among women under 21 years attending a sexual health centre in Melbourne fell from 18.6% in 2007-8 to 1.9% in 2010-11 and in heterosexual men aged under 21 from 22.9% to 2.9%. During the period before the introduction of the vaccination programme, new cases of genital warts rose by 1.8%.

Universities under attack: a warning by former president of the British Academy

Fellow of All Souls College, Oxford and former President of the British Academy, Sir Keith Thomas and Professor Michael Wood who teaches English at Princeton spoke at the Universities Under Attack a conference sposored by the London Review on November 26, 2011 at King’s College London. In his talk Keith Thomas pointed out that ‘confronted by the philistinism on the scale of the Browne report and the goverment’s White Paper’ we can look to neither the present government, committed as it is to the university system as a market, not the labour in power or in opposition, nor Hefce, or the research councils, or the law courts, the vice-chancelors, or even the academic profession as a whole to come up with a solution.

Thomas then goes on to suggest some alternative ways forward on tuition fees and the Resarch Excellence Framework (REF) formerly the RAE, and called on the universities to collecively and publicy repudiate the ‘repugnant phiosophy underlying the Browne report and the White Paper by reaffirming what they stand for the correct reletinhip tp students on ghe one hand and the governmemt on the other.’

Wood gave the view from the other side of the pond that those who think that the ‘supposedly unpractical side of higher education (such as, say, the teaching of Sanscrit) are a luxury for which the state has no responsibility are right in a quite wretched way. They won’t have to pay for them. But their children will, and so will ours – and not with money.’

Use of human papillomavirus (HPV) vaccine causes dramatic fall in genital warts

An important new study by a team of researchers working in a sexual health clinic in Melbourne, Australia has shown that 4 years after a government funded program of vaccinating girls and women aged 12-18 there was a dramatic decline in new cases of genital warts in heterosexual women and also of men with a new diagnosis of genital warts. Cases of genital warts attending the Melbourne Sexual Health Centre fell from 18.6% of all new diagnosis in women under 21 in 2007-2008  to 1.9% in 2010-2011. Interestingly there was a similar dramatic fall in new cases of genital warts in men under 21 over the same time period from 22.9% to 2.9%. The odds ratio per year for diagnosis of genital warts that was adjusted for number of sexual partners from July 2007 until June 2011 in women <21 years was 0.44 (95% CI 0.32 to 0.58) and in heterosexual men aged <21 was 0.42 (95% CI 0.31 to 0.60)  – a fall of over 55% in both sexes.

There was no drop in the incidence of new genital warts diagnosis in women aged over 30 or in men who have sex with men adding weight to the authors’ conclusions that the fall in new wart cases in younger men and women was a consequence of vaccination. It is argued that a reduction in new infections in young women had resulted in a reduced pool of infection and hence also caused a similar drop in their male sexual partners.

The Australian government was providing the vaccine free to all girls and women aged 12-18 from 2007 until the end of 2009. Since then free vaccine has been only offered girls aged 12-13.  The vaccine used in Australia contains antigens from HPV 6 and 11 which are the commonest HPV genotypes associated with genital warts as well as HPV 16 and 18 associated with cervical cancer.

Unfortunately the quadrivalent vaccine is not the one chosen for use by the Department of Health in the UK. A recent study which we reported earlier showed that the quadrivalent vaccine is more cost effective than the bivalent vaccine currently recommended for use in the UK.

 

WHO asks for 16 days of activism against gender violence

According to the World Health Organisation 1 in 4 women worldwide are physically or sexually abused during pregnancy, usually by her partner. The WHO multi-country study on women’s health and domestic violence against women has highlighted the extent of violence by intimate partners against women across a wide range of societies. WHO has asked for 16  days leading up to December 10, International Human Rights Day, for global activism to counter violence perpetuated against women.

Lack of funding causes Global Fund to suspend funding for projects on AIDS, Tuberculosis and Malaria until 2014

On the eve of World AIDS Day on December 1, the Global Fund to Fight AIDS, Tuberculosis and Malaria has for the first time in its decade-long existence suspended all new grants because of lack of funding. According to the fund director Christoph Benn the Fund has to date distributed US$8.5 bn (6.4 bn Euros, 5.5 bn GBP) on projects worldwide, and promised a further US$1.5 for the next two years.

the Fund is also concerned that it might not be able to meet its target of increasing funding to scale up services in poorer countries. Thus the fund will attempt to guarantee continued funding for those already on treatment but will not provide funding for treating new cases. This is a major setback for the millennium project to have 3.5 million people with advanced HIV receiving anti-retroviral drugs by 2015. Mike Mandelbaum, executive of the charity TB Allert, talking to the BMJ, spoke of ‘catastrophic effect’ of reduced funding leading to ‘many avoidable deaths’. Similar concerns were raised by Awa Marie Coll-Seck of the Roll Back Malaria partnership who warned of losing ‘the tremendous gains made in malaria control in recent years’. Malaria remains the top cause of death globally.

BMJ 2011:343:d7755

STIRF funds new research on chlamydia and gonorrhoea

Chlamydia and gonorrhoea are the most common treatable bacterial sexually transmitted infections diagnosed within theUnited Kingdom. Most sexual health clinics now use Nucleic Acid Amplification based Tests (NAATs), which test for DNA sequences particular to the organism in question, to diagnose these infections.

These tests are highly sensitive and specific but can remain positive for a while after the infection is successfully treated with antibiotics. This is because NAAT tests, unlike bacterial culture, do not distinguish between live and dead organisms. This means that if individuals are retested too soon after completing treatment, their test result will still be positive from the initial treated infection. We do not know for how long this will be the case, making interpretation of repeat tests difficult.

This is particularly important in clinical practice, where where a test of cure is recommended, such as in pregnancy and after gonorrhoea. The research will allow better interpretation of test of cure results, thereby avoiding the need to retreat individuals and their partners with antibiotics unnecessarily.

The proposed project will follow up individuals known to have chlamydia or gonorrhoea who have been treated as per national guidelines and then retested every week (using NAAT tests) for the initial infection until this is no longer detected. Non-compliance and possible re-infection will be ruled out through structured questionnaires during the follow up period.

This is a collaborative study in conjunction with centres in London. STIRF will be funding the part of the study to be performed in Manchester.

Title of project: Testing for chlamydia and gonorrhoea: persistence of a positive test result after successful treatment.

Lead researcher:   Dr Gabriel Schembri

Place of Research: Manchester Centre for Sexual Health, Manchester Royal Infirmary.

Collaborating Centres: Sexual health centres in London

Proposed Duration of Study: One year

Funding from STIRF: £27,000 (subject to satisfactory report at six months)

 

How to apply for research funds from STIRF

Application for Research Funds from STIRF

Conditions and regulations

Sexually Transmitted Infections Research Foundation (STIRF) was set up to pump prime research projects relating to the epidemiology, pathophysiology, management, and health care delivery of sexually transmitted infections and HIV in the East and West Midlands. In 2010 the North East and North West Regions were added.

Before filling the application form for funding from STIRF please read the following conditions, which should be met before applications are considered.

1. The following fields of research will be considered in relation to STIs and HIV

  • Epidemiology of HIV and other sexually transmitted diseases
  • Research on HPV and other sexually transmissible malignancies
  • Health care delivery including views of clients
  • Issues relating to deprived or marginalised communities.
  • Pathophysiology of diseases and syndromes
  • Inter-relationship between diseases
  • Treatment modalities
  • Complications of treatment and co-morbidities

2. Applicants should be working in the NHS or universities within the East and West Midlands and the North East and North West Regions of the United Kingdom. Applicants from non-NHS and non-academic settings within the same geographical locations will also be considered.

3. Applicants should ensure that sponsorship of the project, including adherence to the NHS Research Governance Guidelines, is provided by the host institution.

4. Applications should not exceed £50,000 in the first year. Depending on satisfactory reports a further £25,000 may be available for the second year. Joint funding with other grant giving bodies will be considered.

5. Detailed justification for costs should be made on the application form

6. Overhead costs be should be limited to 15% of salary costs within any proposal.

7.  Funding will be paid quarterly in arrears dependent on satisfactory progress

8. A brief (2 page) CV should be attached.

Please note that we are less likely to fund researchers who have successfully received funds from STIRF in the recent past

To apply fill download the Application form complete and send it by email with the other required documents to stirfweb@gmail.com or post to

STIRF, c/o Dr Shahmanesh, Whittall Street Clinic, Whittall Street, Birmingham B4 6DH

Deadline for receiving applications in the 2015 round is March 31, 2015