AIDS Alert International

Study finds excellent clinical ART responses from Kenyans

Toxicities were top reason for switch

A new study found that 1,286 HIV patients in Kenya had excellent clinical and immunologic responses to antiretroviral therapy (ART), but they also switched regimens frequently.1

"We found significant improvements in clinical and immunological status after 12 months on therapy, with a marked decrease in HIV/AIDS-related symptoms and a significant increase in CD4 count, which was 121 cells/mm3 at baseline and 208 cells/mm3 at 12 months," says Claudia Hawkins, MD, an investigator on the study who is with the division of infectious diseases at Northwestern University, Feinberg School of Medicine in Chicago, IL.

Women accounted for 59.1 percent of the people enrolled in the study, and 62.1 percent of the participants had started on an ART regimen of stavudine, lamivudine, and nevirapine.1

The median duration on ART was 11.6 months, and the participants had significant improvements in clinical and immunologic status after 12 months of therapy.1

Investigators found that 54.5 percent of patients made changes in their ART, and the cumulative incidence of switching ART at 12 months was 78.4 percent.1

"These switches were higher than anticipated, although most switches were within class switches for reasons of toxicity and tuberculosis co-infection," Hawkins says.

Antiretroviral toxicity affected 40.6 percent of the patients and tuberculosis treatment interactions impacted 28.1 percent of the patients who switched regimens.1

"D4T related neuropathy accounted for a substantial proportion of toxicity in our cohort and presumably switches in therapy," Hawkins says. "Alternatives to D4T should, therefore, be considered for use in first-line regimens, particularly if the goal is to minimize switches to second-line therapy."

The most frequent toxicity reported was peripheral neuropathy among 20.7 percent of the patients.1

Investigators also found that a lower baseline CD4 count was a significant predictor of toxicity, Hawkins says.

"We also suspect there was some difficulty discerning toxicities from symptoms related to poor immunological status," she adds.

The study had a large loss to follow-up rate, which is not unique to this cohort, Hawkins notes.

"It suggests the need for more active patient tracking systems such as those with home-based care," she adds.

Overall, the research demonstrated that a large scale antiretroviral treatment program could be a success, and it highlighted the components that are needed to achieve success, Hawkins says.

For example, antiretroviral programs in sub-Saharan Africa will need to include good patient tracking systems, free and sustainable drug supplies, optimal antiretroviral treatment regimens, and more effective patient monitoring, including better toxicity detection and management and diagnosis of opportunistic infections, Hawkins says.

"This research demonstrates that provision of antiretroviral therapy to HIV-infected populations in sub-Saharan Africa is quite feasible as long as there is close monitoring of patients to ensure durability of first-line ART," Hawkins says.

"This is particularly the case where access to second line therapy is limited," she adds. "As noted in our study, some individuals may require closer monitoring after initiation of ART, particularly those with lower baseline CD4 counts."

Reference:

  1. Hawkins C, et al. Antiretroviral durability and tolerability in HIV-infected adults living in urban Kenya. JAIDS. 2007;45:304-310.

Phase I Trials of Preventative HIV/AIDS Vaccines Worldwide (August 2007)