Health alert issued over HIV drug combination
January 28, 2004
The World Health Organisation (WHO) has alerted the Government Analyst Food and Drug Department to the high virological failure in HIV patients treated with combinations of antiretroviral agents, Didan-osine, Lamivudine and Tenofovir.
A release from the analyst department said the WHO statement comes in the wake of a similar public statement issued earlier for triple combinations containing Abacavir, Lamivudine and Tenofovir.
According to the release, preparations containing Tenofovir are not registered for use in Guyana. However, since illegal supplies of the drug may be available locally, it is important for patients and medical practitioners to be alerted to the possible virological failure.
The WHO alert said the European Medicines Eval-uation Agency (EMEA) issued a public statement based on the observations from a clinical study of treatment-naĆ¯ve HIV-infected patients receiving a one-daily triple combination containing Tenofovir (Viread, TDF), Lamivudine, (Epivir, 2TC) and Didanosine enteric coated beadlets (Videx EC, ddI EC). The alert says the precise nature of the interaction leading to non-response is unknown. However, this will be further investigated.
In the interim, physicians are advised not to start treatment-naĆ¯ve or treatment-experienced HIV patients on a new therapeutic regimen containing Tenofovir in combination with Didanosine and Lamivudine; patients already on therapy with the above combination should be frequently monitored with a sensitive viral load test and considered for modification of therapy at the first sign of viral load increase; and patients currently using the above combination regimen should inform their doctor immediately.
The department said it would keep the public informed on any new developments that may arise from ongoing studies.