The study's results – reported by Doctor Anne Goldfeld of the Children's Hospital Boston and the CAMELIA (Cambodian Early versus Late Introduction of Antiretrovirals) study team – definitively show that immunosuppressed HIV-TB co-infected patients should be started on ART rapidly at two weeks after beginning TB therapy. At the same time, the results strongly suggest that the World Health Organisation (WHO) should be more aggressive in its recommendations for treating such patients.
A collaboration of Cambodian, French, and American physicians and researchers, the CAMELIA trial set out to settle a long-standing debate in the medical community over the relative timing of antiretroviral (ART) and anti-TB treatment regimens in co-infected patients. Some have advocated for delaying ART for upwards of two months after initiating anti-TB treatment, arguing that the toxicity of and difficulties in adhering to the two regimens (which together require patients to take seven pills every day), as well as the risk of severe inflammation as the immune system rebounds from HIV's suppressive influence, create undue burden on patients.
Those supporting early initiation of ART note that rapid restoration of immune function bolsters the effects of anti-TB treatment. "Tuberculosis claims the lives of more than half a million people with HIV worldwide every year," said Goldfeld. "This is a tragedy, because TB is completely curable when diagnosed and treated properly even in a patient with advanced HIV, especially if the patient also receives anti-retroviral therapy."
Upon enrolment in the CAMELIA trial, all participants started standard treatment for TB, followed either two weeks or two months later by ART. Patients, all of whom had very weak immune systems, were seen at one of five study sites across Cambodia and followed for as long as four and a half years. By the time enrolment closed, 661 patients had been recruited into the study.
The study was also remarkable for its successful level of follow up: Of the trial's 661 participants, only 12 were lost to follow-up over the study period, and participants only missed less than one per cent of the study's 8,955 scheduled visits.
"When we started, there was no research infrastructure for conducting such a trial in Cambodia. ART was just being introduced into the country, and HIV and TB were not being treated in an integrated fashion," Goldfeld said. "As side benefits, over the course of the study we helped to establish a centre of excellence for HIV and TB care, and a centre for treating children with HIV. We also created a national framework in Cambodia for treating patients with multi-drug resistant TB, which is now being replicated in Ethiopia."
MEDICA.de; Source: Children's Hospital Boston