Question
What side effects are associated with Kivexa plus Kaletra?
7 August 2007. Related: All topics, Side effects, Starting treatment.
I am starting my combination therapy in a couple of weeks, as my CD 4 has dropped.
I was wondering if you can give me any advice as to what side effects I can expect and how to manage them successfully. I am starting on Kivexa and Kaletra.
I am also starting University 3 weeks after the initial starting date of the medication, I do not wish to let them know that i am HIV-positive but how do I explain any prolonged side effects. Any help that you can offer will be gratefully received.
You have helped me before with questions and I respect your advice.
Many thanks and kindest regards
Answer
Hi
For the first few weeks, most people report general side effects until your body gets used to treatment. This can include nausea and tiredness and are associated with most combinations, but which also generally improve fairly quickly.
Kivexa is a fixed dose combination of 3TC and abacavir.
3TC is unlikely to give you any side effects (very rarely it can cause hair loss).
Abacavir is associated with a hypersensitivity reaction, BUT in the UK, most clinics can now use a genetic test called HLA-B*5701 before someone starts abacavir treatment to see if you are a risk of this side effect. The test is cheap and accurate, so it is worth checking that you were given this.
Kaletra (lopinavir/ritonavir) is a twice-daily protease inhibitor. Main early side effects include diarrhoea (which can usually be managed by imodium (loperamide), nausea and blood lipid changes (increases in cholesterol and triglycerides).
Whatever combination you use, if it causes problems, then there are plenty of other options to switch to, and you shouldn’t put up with any combination that is too difficult. So, one thing I’d say is that you shouldn’t put up with any ‘prolonged’ side effects because there are other options.
One aspect of treatment that you may want to consider, is whether a once-daily combination would be easier for your university life, especially if you have long or unpredictable hours, and if don’t want to take meds at college.
Although abacavir and 3TC are once-daily drugs, Kaletra needs to be taken every 12 hours. If this gets difficult, or if you have side effects on your first combination, talk to your doctor about atazanavir/ritonavir. This is a once-daily protease inhibitor that uses a lower dose of ritonavir than Kaletra to boost the main protease inhibitor.
There is more information on managing side effects in the i-Base Guide to Avoiding and Managing Side Effects.
Thanks for your comment. This is something where the regulatory agencies in Europe and the US do not agree.
Although Abbott applied for a once-daily license in Europe at the same time as it applied in the US, it is not clear why this was not granted by the European regulatory agency.
The two main studies that comparing once-daily to twice-daily Kaletra both found that twice daily was better. One included 38 people which showed that the drug levels at the end of the once-daily dose were more variable and also much lower than the twice-daily group. Even though the results were similar in terms of people getting undetectable viral load, this is much too small a study to change a drugs dosing.
The larger study carried out in Brazil, with tenofovir and FTC as background nukes, found that once-daily was less effective in people who started treatment with viral load over 100,000 copies/mL.
It also found that side effects (mainly diarrhoea) were twice as frequent when taking Kaletra once-daily: 57% vs 35% for all side effects and 16% vs 5% for the risk of more serious side effects (graded moderate or higher).
This higher risk of side effects is included in the US product label.
There have not been any studies that compare the earlier version of Kaletra capsules once-daily to the new formulation tablets taken once daily.
Kaletra is approved for once-daily use in the US for treatment-naive patients. The new tablet formulation also has less GI side effects compared to the older gel capsules.