HIV update - 29th April 2015

Single-tablet regimens like Atripla no better than multiple tablets

A new analysis has put in question the value to the NHS of treatments such as Atripla, Stribild and Eviplera which combine three or more antiretroviral drugs into a single tablet. While these treatments all have excellent outcomes, they can be five times more expensive than regimens made up of multiple tablets and non-branded drugs.

As clinical outcomes are just as good with some less expensive alternatives, some doctors believe that NHS spending on single-tablet regimens cannot be justified. They acknowledge that many people living with HIV prefer single tablets and find them more convenient. However, doctors are under pressure to keep their budgets under control without reducing the quality of care.

Single-tablet regimens are more expensive because they are patented, branded products, rather than generic medicines. When a new drug is produced, it is protected by patent, which means that the pharmaceutical company which developed it has the exclusive right to sell it for 20 years. Following this, other manufacturers can produce generic versions of the drug, which have the same ingredients and quality requirements as the branded product, but are usually 80% cheaper.

In recent years, several effective and widely used antiretroviral drugs have come off patent, meaning that cheaper generic versions are available.

But pharmaceutical companies often try to extend the period of time in which they have exclusive, patented products in the market. One way they do this is by developing single-tablet regimens. For example, a drug called efavirenz was first produced in the 1990s and came off patent in 2013. But efavirenz is also an ingredient in Atripla, along with two other drugs, tenofovir and emtricitabine. This single-tablet regimen first became available in 2006 and will remain under patent for several more years.

Doctors have a choice when this is the most appropriate treatment for someone living with HIV. They could prescribe the exclusive, branded version (Atripla) at a cost of several thousand pounds per patient, per year. It has the advantage that the whole treatment is one pill a day. Or they could save several hundred pounds on each patient by prescribing the same combination of drugs as two or three separate tablets, including a generic version of efavirenz. Much bigger savings could be made by making small adjustments to the drugs prescribed, using drugs of equivalent effectiveness that are available in generic versions.

But would this mean that people would have poorer results? Would more people have trouble maintaining an undetectable viral load? Would there be more cases of drug resistance?

To answer this question, researchers searched for all randomised clinical trials which compared co-formulated tablets (containing two, three or more drugs) with regimens made up of multiple tablets. They found nine studies involving a total of around 2500 people.

They found that the clinical results were as good with multiple tablets as with co-formulations. They concluded that the benefits of single-tablet regimens have not been proven, despite the large differences in costs.

You can find out more about generic medicines in NAM’s booklet ‘Taking your HIV treatment’ and in a 2012 article from ‘HIV Treatment Update’.

Strong interest in cure research

People living with HIV have a great interest in taking part in studies towards an HIV cure, with many people aware of the risks involved and the fact that they would be unlikely to benefit personally from cure research. These are the results of an online survey conducted last year. Many readers of HIV Update were among the 982 people who took part.

This was a self-selecting sample, but nonetheless the 95% of respondents who would participate in a cure study suggests an enthusiasm for future research.

As might be expected, interest in a ‘sterilising’ cure was very strong. Over 90% of respondents said that it was very desirable that a future cure would mean that “you no longer have HIV in your body”.

But researchers are more hopeful about the possibility of developing a ‘functional’ cure, in other words one which does not eradicate the virus but which would allow someone a prolonged period with neither daily treatment nor disease progression. Over 90% of respondents were also interested in outcomes that could be associated with a functional cure: there being no risk of HIV-related health problems and no risk of passing HIV on during sex.

For example one person said:

“I would love to be able to stop taking the drugs and remain well with HIV infection under control (not necessarily HIV-free). After 15 years I may say that I am quite tired taking drugs every day.” 

Some people suggested that if the risk of HIV transmission was gone, a cure would have a social and psychological impact, as well as a medical benefit.

Many people suggested altruistic reasons for taking part in cure research, for example:

“I would happily take part in a cure study if it would benefit others. Knowing that my life would have had some purpose is worth the possible side-effects.”

Many people said they’d be willing to take risks with their own HIV treatment – including stopping it for a period – in order to take part in a cure study. But most also said that they would want to get advice from their doctor before going ahead. It’s important to weigh up the pros and cons before taking part in any research study.

For more information about taking part in research studies, read NAM’s factsheets ‘Clinical trials’ and ‘Thinking about joining a clinical trial?’

Sexually transmitted infections and infectiousness

It’s now well understood that effective HIV treatment and undetectable viral loads dramatically reduce the infectiousness of people living with HIV, making it highly unlikely that they will pass HIV on.

But there has been a concern about sexually transmitted infections (STIs). It’s been thought that an untreated STI can raise a person’s HIV viral load. Both the ‘Swiss Statement’ and its British equivalent say that the protective impact of HIV treatment on onward transmission may not apply if either partner has a sexually transmitted infection.

On the other hand, the interim results of the PARTNER study found no HIV transmissions at all from gay men taking HIV treatment – even though 16% of men in the study had sexually transmitted infections.

And now a small study has found little impact of sexually transmitted infections on viral load. The researchers looked specifically at viral loads measured in the lining of the rectum, which are relevant to the risk of HIV being passed on during anal sex without a condom.

In 21 gay men who were taking HIV treatment, all had an undetectable viral load in the rectum. Although seven of the men had rectal chlamydia or gonorrhoea at the time, they had undetectable viral loads too. The findings suggest that gonorrhoea and chlamydia have a minimal impact on onward HIV transmission.

Hepatitis C and alcohol

People living with hepatitis C have a much greater risk of going to hospital with liver problems or of death if they have a drinking problem, according to a French study.

It looked into the impact of various factors on the health of people living with hepatitis C. In particular, the researchers wanted to find out the extent to which alcohol contributes to poor health in people living with hepatitis C – and whether people without high levels of alcohol consumption have poor outcomes if infected with hepatitis C.

Between 2008 and 2012, over 100,000 people living with hepatitis C went to hospital in France. They weren’t necessarily being treated for hepatitis – they could be in hospital to give birth or after a road accident, for example.

Around one-in-five had some sort of alcohol problem. While this figure is very high, just under half of people living with hepatitis C who were in hospital for a liver-related problem had an alcohol problem. And a third of those who died had an alcohol problem.

The findings suggest that one of the most important contributions to poor health in people living with hepatitis C is heavy drinking. Stopping or cutting down on drinking may make a big difference to the health of people who have hepatitis C.

There’s more information on the impact of drinking in NAM’s factsheet ‘Alcohol’.

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