Nelfinavir (Viracept) recalled due to contamination

The protease inhibitor, nelfinavir (Viracept) has been recalled in the UK and Europe because some batches of the drug became accidentally contaminated during manufacture by large amounts of a chemical linked with cancer. 

The recall affects all batches of the drug, and anybody in the UK and Europe who is taking nelfinavir must contact their HIV clinic immediately so they can be offered an alternative treatment. The recall does not affect nelfinavir in the US, Canada and Japan.

It is thought that contamination occurred in late 2006. There were six reports from Spain and France of the drug having a ‘foul odour’.

Few people in the UK take nelfinavir. It is less powerful than the newer ritonavir-boosted protease inhibitors. It is relatively easy for HIV to become resistant to nelfinavir if a person does not take at least 95% of their doses at the right time and in the right way. However, a small number of people have been successfully taking nelfinavir for years. It is known to be a safe drug (its most significant side-effects being diarrhoea and an increase in blood fats) and is used in pregnancy and for people who need emergency post-exposure prophylaxis (PEP) after potential exposure to HIV.

HIV and hepatitis

Thanks to potent anti-HIV therapy, many people with HIV are able to live much longer and healthier lives. Indeed, doctors are now so optimistic about the effectiveness and safety of currently available anti-HIV drugs that they are hopeful that people with HIV will be able to live a more or less normal lifespan. 

But some people with HIV do still become ill and even die. The causes of illness and death for people with HIV have changed since effective anti-HIV treatment became available and traditional AIDS-defining illness now account for only a small proportion of illness and mortality seen in people with HIV.

One of the main reasons why people with HIV now become unwell or even die is liver disease. This is because many people with HIV are also infected with hepatitis B or hepatitis C. The life expectancy for HIV-positive people who have long-term coinfection with either (or both) of these viruses is somewhat less than people who only have HIV.

Doctors are doing a lot of work to try and see how best to care for people coinfected with HIV and hepatitis, and there was an important meeting of experts from around the world last week where some of the latest research findings were presented.

HIV treatment in children

Since effective anti-HIV treatment became available, there has been a significant fall in the amount of illness and death caused by HIV seen in HIV-positive children.

But fewer drugs are available to treat HIV-positive children than are available for adults. Furthermore, the clinical trials that lead to the approval of the currently available anti-HIV drugs were conducted in adults, so a lot less is known about the effectiveness of treatment in children, the right doses of drugs to use, and the long-term benefits and risk of HIV treatment for children.

Now a small study has found that many children treated with efavirenz (Sustiva) have such low levels of the drug in their blood that there is a risk of resistance to the drug developing.

The children all weighed over 10kg and were aged between two years three months and 15 years. They received the appropriate weight-adjusted dose of efavirenz.

The researchers who conducted the study are calling for larger studies to be urgently undertaken to determine the safe dose of efavirenz in children.

HIV treatment during pregnancy

A mother can pass on HIV to her baby, but it is possible to reduce the risks of mother-to-child transmission of HIV to very low levels by the appropriate use of anti-HIV drugs during pregnancy, by having a caesarean delivery if the mother has a detectable viral load, and, in countries like the UK where there are safe alternatives, by not breastfeeding.

The anti-HIV drug nevirapine (Viramune) is often used during pregnancy. In the UK and similar countries, nevirapine should only be used as part of a combination of anti-HIV drugs. In countries where HIV treatment is difficult to obtain, pregnant women are sometimes given a single dose of nevirapine during labour. But this can lead to resistance to nevirapine developing and the drug should never be used in this way in the UK.

Nevirapine can also cause side-effects, the most notable being liver problems and rash. To reduce the risk of these occurring, the drug should not be given to women with a CD4 cell count of 250 or above.

A new study has shown that anti-HIV treatment that includes nevirapine achieves a rapid fall in viral load. The European study also found that women from West Africa experienced rapid falls in their viral load when treated during pregnancy.

The study compared rates of viral load decline between women taking nevirapine and nelfinavir, an alternative drug often used during pregnancy. The results of the study favoured nevirapine and the researchers “strongly suggest that an antiretroviral therapy-naïve woman with a CD4 cell count below 250 should begin nevirapine-based rather than nelfinavir-based antiretroviral therapy.” But given the recall of nelfinavir in the UK and Europe due to contamination, the findings of this study have rather been overtaken by events.

copy of copy of copy of New from NAM