Regulars: Letters

Human papilloma virus (HPV) vaccination for HIV-positive men

Dear Sir
The October 2007 Positive Nation included an article by Freedom Health about human papilloma virus (HPV) vaccination for HIV-positive men.

It is necessary to clarify some important issues about HPV vaccination that the Freedom Health article did not cover.

HPV vaccines are currently only licensed for women and it is only recommended that they should be provided to adolescent girls.
There are important reasons why this is the case.

We do not yet know if HPV vaccination is even safe in men or people with HIV. There are no results from clinical trials to show this. Nor is it known if these vaccines work in men. All the trial results so far are from studies that were conducted in women.

The currently available HPV vaccines do not work as well if women are already infected with the strains of HPV they are designed to protect against. They appear to reduce the risk of developing anal or cervical cancer in women already infected with these strains, but show very little protective effect against cancers caused by other strains of HPV.

HPV infection is very widespread in people with HIV. Research suggests that between 95% - 40% of HIV-positive gay men are infected with HPV. There are many different strains of HPV, some of which can lead to cancer and are not covered by the HPV vaccines.
Rates of anal and cervical cancer are higher in people with HIV than in the general population. These cancers have become more common since effective anti-HIV treatment became available. This is because people with HIV are living long enough for their infection with HPV to lead to cancerous cell changes in the anus or cervix.

But it is important to remember that both anal and cervical cancer are quite rare in people with HIV. Very few people with HIV, even if they are infected with potentially cancer-causing strains of HPV, go on to develop anal or cervical cancer. Regular monitoring by your doctor (although there is isn’t yet a consensus about the value of PAP smears for anal HPV infections), the use of anti-HIV therapy, and prompt treatment for any anal or cervical cell changes caused by HPV are the most effective strategies for dealing with disease caused by HPV.

It’s also worth noting that studies have shown that condoms provide a much higher level of protection against infection with HPV than was previously thought, and that consistent condom use helped clear HPV infection in people already infected with the virus.

The HPV vaccinations may well be shown to be safe for use in men and people with HIV. They might be shown to help prevent infection with the cancer-causing strains of HPV in men and HIV-positive individuals who aren’t already infected with them. But at the moment, we just do not know if this is the case. Men and people with HIV who are paying for off-label HPV vaccination are, in effect, taking part in an unofficial clinical trial at considerable personal expense, with none of the safeguards and protections offered by a proper trial.

Keith Alcorn, senior editor
Edwin J Bernard, editor, HIV Treatment Update
Michael Carter, editor, news and patient information
NAM, Lincoln House ,1 Brixton Road
London. SW9 6DE

Freedom Health Replies
I am glad that Alcorn, Bernard and Carter found the article on HPV of interest. It is important to have debate around this issue.

I was careful to point out some vital features. Namely, the vaccine is currently licensed for use in females; that condoms represent an effective though not complete avoidance mechanism; that HIV positive people, irrespective of gender, are more likely to develop anal malignancy than the general population; that the vaccine is not live and consequently should be safe in HIV positive people.

Alcorn et al state that we do not know if these vaccines work in males and go on to say that all trial results are from studies conducted in women. Erudite individuals involved in oncology and public health across the world are of the view that since males are the vectors of HPV related disease, males should be immunised against HPV in order to prevent spread. Given that these are experts in the appropriate malignancies I am more persuaded by their view than that of Alcorn et al. Males in the form of male children were involved in the initial studies. The drug company concerned is conducting studies in males. A number of factors operate in terms of the licensing and approval procedures. Economics and political acceptability are pre-eminent. Males are difficult to persuade to accept health interventions, especially if the benefits are not immediately apparent to them.

Anal malignancy in males who have receptive anal sex occurs at the same rate as the rate which triggered the cervical screening programme in females many years ago. Whilst Alcorn et al may be unconcerned, the gynaecological oncology community around the world did not agree when they launched the cervical screening campaign many years ago. Anal cancer rates in HIV positive gay males is estimated to be of the order of 70 to 100/100,000.
Certainly we need studies to define further the benefits in males and in people with HIV.

For the first time ever though, we have a vaccine which is thoroughly effective in females in preventing ano-genital malignancy with no plausible reason why this may not afford the same protection to males and importantly to others they may have sex with. To fail to offer the vaccine would be akin to fiddling whilst Rome burns. To suggest that offering fully informed males a vaccine which is already proven to prevent ano-genital malignancies is akin to a clinical trial is nonsense.

Dr Séan Cummings MBBS DRCOG DFFP LLM MRCGP
Freedom Health Website:
Human papilloma virus (HPV) vaccination for
HIV-positive men

Dear Sir
The October 2007 Positive Nation included an article by Freedom Health about human papilloma virus (HPV) vaccination for HIV-positive men.

It is necessary to clarify some important issues about HPV vaccination that the Freedom Health article did not cover.

HPV vaccines are currently only licensed for women and it is only recommended that they should be provided to adolescent girls.
There are important reasons why this is the case.

We do not yet know if HPV vaccination is even safe in men or people with HIV. There are no results from clinical trials to show this. Nor is it known if these vaccines work in men. All the trial results so far are from studies that were conducted in women.

The currently available HPV vaccines do not work as well if women are already infected with the strains of HPV they are designed to protect against. They appear to reduce the risk of developing anal or cervical cancer in women already infected with these strains, but show very little protective effect against cancers caused by other strains of HPV.

HPV infection is very widespread in people with HIV. Research suggests that between 95% - 40% of HIV-positive gay men are infected with HPV. There are many different strains of HPV, some of which can lead to cancer and are not covered by the HPV vaccines.
Rates of anal and cervical cancer are higher in people with HIV than in the general population. These cancers have become more common since effective anti-HIV treatment became available. This is because people with HIV are living long enough for their infection with HPV to lead to cancerous cell changes in the anus or cervix.

But it is important to remember that both anal and cervical cancer are quite rare in people with HIV. Very few people with HIV, even if they are infected with potentially cancer-causing strains of HPV, go on to develop anal or cervical cancer. Regular monitoring by your doctor (although there is isn’t yet a consensus about the value of PAP smears for anal HPV infections), the use of anti-HIV therapy, and prompt treatment for any anal or cervical cell changes caused by HPV are the most effective strategies for dealing with disease caused by HPV.

It’s also worth noting that studies have shown that condoms provide a much higher level of protection against infection with HPV than was previously thought, and that consistent condom use helped clear HPV infection in people already infected with the virus.

The HPV vaccinations may well be shown to be safe for use in men and people with HIV. They might be shown to help prevent infection with the cancer-causing strains of HPV in men and HIV-positive individuals who aren’t already infected with them. But at the moment, we just do not know if this is the case. Men and people with HIV who are paying for off-label HPV vaccination are, in effect, taking part in an unofficial clinical trial at considerable personal expense, with none of the safeguards and protections offered by a proper trial.

Keith Alcorn, senior editor
Edwin J Bernard, editor, HIV Treatment Update
Michael Carter, editor, news and patient information
NAM, Lincoln House ,1 Brixton Road
London. SW9 6DE

Freedom Health Replies
I am glad that Alcorn, Bernard and Carter found the article on HPV of interest. It is important to have debate around this issue.

I was careful to point out some vital features. Namely, the vaccine is currently licensed for use in females; that condoms represent an effective though not complete avoidance mechanism; that HIV positive people, irrespective of gender, are more likely to develop anal malignancy than the general population; that the vaccine is not live and consequently should be safe in HIV positive people.

Alcorn et al state that we do not know if these vaccines work in males and go on to say that all trial results are from studies conducted in women. Erudite individuals involved in oncology and public health across the world are of the view that since males are the vectors of HPV related disease, males should be immunised against HPV in order to prevent spread. Given that these are experts in the appropriate malignancies I am more persuaded by their view than that of Alcorn et al. Males in the form of male children were involved in the initial studies. The drug company concerned is conducting studies in males. A number of factors operate in terms of the licensing and approval procedures. Economics and political acceptability are pre-eminent. Males are difficult to persuade to accept health interventions, especially if the benefits are not immediately apparent to them.

Anal malignancy in males who have receptive anal sex occurs at the same rate as the rate which triggered the cervical screening programme in females many years ago. Whilst Alcorn et al may be unconcerned, the gynaecological oncology community around the world did not agree when they launched the cervical screening campaign many years ago. Anal cancer rates in HIV positive gay males is estimated to be of the order of 70 to 100/100,000.
Certainly we need studies to define further the benefits in males and in people with HIV.
For the first time ever though, we have a vaccine which is thoroughly effective in females in preventing ano-genital malignancy with no plausible reason why this may not afford the same protection to males and importantly to others they may have sex with. To fail to offer the vaccine would be akin to fiddling whilst Rome burns. To suggest that offering fully informed males a vaccine which is already proven to prevent ano-genital malignancies is akin to a clinical trial is nonsense.

Dr Séan Cummings MBBS DRCOG DFFP LLM MRCGP Freedom Health Website: www.freedomhealth.co.uk

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