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Diarrhea is a well-documented adverse effect associated with protease inhibitor therapy. The effective management of diarrhea is critical not only in improving patient quality of life, but also in minimizing non-adherence to antiretroviral therapy which can ultimately contribute to the development of resistance and therapeutic failure.

The Role of Calcium Supplements in the Treatment of Nelfinavir-Induced Diarrhea1 Perez-Rodriguez et al. studied the use of various brands of calcium supplements in the treatment of nelfinavir (NFV)-induced diarrhea in an open label prospective trial of 24 HIV+ patients currently experiencing diarrhea while on NFV. Patients were asked to complete a survey prior to initiating therapy with calcium 500 mg taken twice daily with their NFV dose. After a minimum of 48 hours, patients were again asked to complete a survey regarding any change in bowel movements. The surveys required patients to grade their diarrhea as follows: grade 0 = normal, grade 1 = mild (1-3 loose stools per day), grade 2 = moderate (4-7 loose stools per day), grade 3 = severe (>7 loose stools per day). The average diarrhea grade before treatment with calcium was 1.58. This improved to an average grade of 0.33 after treatment with calcium. 100% of study participants described their diarrhea as "dramatically improved" post calcium treatment. No adverse effects secondary to the use of calcium supplementation were noted.

In order to assess the potential of calcium supplements to interfere with the absorption of NFV, Perez-Rodriguez et al.2 conducted an open label, randomized pharmacokinetic study in 16 HIV+ patients currently taking a regimen containing NFV 1250 mg bid along with 500 mg calcium supplements bid. Eight patients were administered Os-Cal brand calcium supplement (calcium carbonate) and eight patients were given generic brand calcium. Data are available for 15 subjects. When comparing the two calcium arms and a historic control group (NFV 1250 mg bid + 3TC + d4T), no significant difference (p>0.05) in the concentrations of NFV was found at the three time points measured (pre-dose, 2 hours post-dose and 4 hours post-dose). The combination of NFV and calcium was well-tolerated with no adverse events reported and no pharmacokinetic interaction found between calcium and NFV.

Summary
In summary, the use of calcium supplements may be a viable, effective and inexpensive option in the management of NFV-induced diarrhea. This combination does not appear to be associated with negative pharmacokinetic consequences and appears to be well-tolerated.

References:
1. Perez-Rodriguez E, Gonzalez L, Kopp B. The role of calcium supplements in the treatment of nelfinavir-induced diarrhea. 39th Interscience Conference on Antimicrobial Agents and Chemotherapy 1999; San Francisco, CA.
 
2. Perez-Rodriguez E, Kopp Hutzler B, Norton S, Hsyu PH. Pharmacokinetic interactions between nelfinavir and calcium supplements. AIDS 2000;14(Suppl 4).

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