Step-wise intervention eases diarrhoea linked to PI nelfinavir (Viracept) therapy

Nelfinavir (Viracept) is an HIV protease inhibitor that produces potent and durable activity against HIV when used in combination with other antiretroviral drugs. However, nelfinavir has also been associated with diarrhoea, a limiting side effect of the drug.

Now a simple stepwise programme can help physicians and patients manage the diarrhoea associated with nelfinavir in HIV patients, a Canadian study shows.

The programme can significantly improve symptoms and quality of life, said Anita Rachlis MD, of Sunnybrook and Women’s College Health Sciences Centre, in Toronto, Ontario, where the programme was developed. She presented the findings at the 2nd International AIDS Society Conference on HIV Pathogenesis and Treatment.

“We know that nelfinavir is associated with a lot of diarrhoea,” Dr Rachlis said, adding that a survey of eight Canadian clinics revealed “haphazard” treatment patterns. Some physicians prescribed loperamide, some calcium carbonate, and still others suggested psyllium, she said.

The diarrhoea management algorithm, Dr Rachlis said, begins with a three-day washout period in which patients stop any anti-diarrhoea medication they may be using. The idea is to avoid confounding factors and to ensure there is no cause of diarrhoea other than the nelfinavir.The washout period is followed by nutrition consultation, which may include suggestions for dietary changes. The patient may be given lactase (if lactose-intolerance is the issue) or psyllium.If previous efforts have failed, the patient is given 1,500 mg of calcium carbonate twice daily, which can be boosted to 2,500 mg if there is no relief within a few days.

The final step – if the patient still has diarrhoea – is 4 mg of loperamide once daily, plus 2 mg additional doses at the patient’s discretion (to a maximum of 16 mg per day.)

The study enrolled 18 patients, Dr Rachlis said, which was fewer than expected, possibly because some potentially eligible patients switched medications, while others may have found their own way of managing diarrhoea.

The study showed statistically significant reductions in frequency of bowel movements, as well as statistically significant improvements in stool consistency, Dr Rachlis said. As well, a quality of life follow-up after nine weeks of the programme showed significant improvements in such measures as dysphoria, overall function, worry over disclosure of HIV status, sexual function, and worries about medication.

Dr Rachlis concluded that the study had found “an algorithm that patients can actually use to deal with diarrhoea related to nelfinavir.”

Rachlis A et al. Step-wise intervention for the management of nelfinavir-associated diarrhoea. 2nd IAS Conference on HIV Pathogenesis and Treatment, 13-16 July 2003, Paris. Abstract 747.

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