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October 11, 2020
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Patients with HIV and four-class drug resistance have high disease burden

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Patients with four-class drug-resistant HIV have a high burden of disease and “worrying” rate of malignancies, according to findings published in Open Forum Infectious Diseases.

Around 25% develop a clinical event or death within 4 years, researchers from Italy reported.

HIV clinical events
Source: Galli L, et al. Open Forum Infect Dis. 2020;doi:10.1093/ofid/ofaa456.

“Because of the high burden of disease in people living with HIV (PLWH) with 4-class drug-resistant (4DR) virus, close prevention and monitoring interventions are highly recommended, especially in people with a history of clinical events and low CD4+/CD8+ ratio,” the researchers wrote. “In PLWH with 4DR virus, efforts to favor access to drugs with new mechanisms of action are also urgently needed in order to achieve undetectable HIV-RNA load, preserve immune system, prevent clinical progression and ultimately improve quality of life.”

The researchers examined patient data from 148 PLWH with documented resistance to four drugs — nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs) and integrase strand transfer inhibitor (INSTI) — via the PRESTIGO Registry. They analyzed the incidence of death, various clinical events and the burden of disease, which they defined as the occurrence of new events, including AIDS or non-AIDS-defining events or death.

Among the 148 patients, 38 patients experienced 62 new events or died (incidence rate [IR] = 9.12/100 person-years of follow-up [PYFU]; 95% CI, 6.85-11.39). The new events included 12 deaths, 18 AIDS-defining events and 32 non-AIDS-defining events. Cumulative death incidence across 4 years was 6% (95% CI, 3%-13%). The risk for death or new clinical events was higher among PLWH with pervious clinical events (adjusted HR = 2.67; 95% CI, 1.07-6.67).

The authors said the study’s major limitations included the absence of a control group.

“Although, clinical records were carefully monitored, we cannot exclude a potential underestimation of clinical events, especially of non-AIDS-related events and mortality for which a link with the national death registry is not available in Italy,” the researchers wrote. “Another issue is related to the recent establishment of the PRESTIGIO Registry: Recorded people are those who survived a previous potentially fatal event and, for this reason, we might have underestimated the true incidences of AIDS-, non-AIDS-related events and death.”