IAS: Lack of data on men with weak immune systems weakens study comparing safety of circumcision in HIV-positive and HIV-negative men

Circumcision is equally safe in HIV-positive and HIV-negative men, according to data from Uganda presented to the 4^th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Sydney on July 25^th.

Investigators found that there were near-identical rates of adverse-events in HIV-positive and HIV-negative men undergoing surgical circumcision by a trained medical practitioner. More HIV-positive men, however, had not fully healed 30 days after their operation.

But it's questionable just how valid the findings of the study are. One of the world’s leading public health experts, Dr Kevin de Cock, head of the World Health Organization's HIV programme, expressed some severe doubts about the design of the study. He suggested that the study had not been a true comparison of the safety of circumcision in HIV-positive and HIV-negative men because HIV-positive men with CD4 cell counts below 350 cells/mm³ were excluded.

Three randomised controlled trials in Africa have demonstrated that circumcision can reduce HIV incidence. There are low rates of post-operative complications (2% - 10%) after adult circumcision, provided that the procedure is undertaken by trained medical practitioners in sterile conditions. However, there are few data on the safety of circumcision in HIV-positive individuals. It is possible that, because of weakened immunity HIV-positive individuals may have a higher risk of post-operative infection or a slower rate of healing.

To address this and other questions, researchers in Rakai, Uganda analysed data from two large circumcision trials. One involved over 2,000 HIV-negative men, the second 420 HIV-positive men.

Dr Godfrey Kigozi of Uganda's Rakai Health Sciences Programme presented data to the Sydney conference comparing adverse events, resumption of sexual activity post-circumcision and speed of healing in HIV-positive and HIV-negative men. Follow-up was performed at days one, seven days and 30 days after circumcision.

To be included in the study, HIV-positive men were required to have well-preserved immune function, with a CD4 cell count above 350 cells/mm³.

The baseline characteristics of the two groups differed, with HIV-positive men being older, having more sexual partners, using condoms less frequently and reporting higher rates of symptoms of sexually transmitted infections (all p < 0.001).

Following surgery, the rate of adverse events requiring treatment was similar between the two groups, 3.2% for HIV-positive men and 3.6% for HIV-negative men. The most common events were infections, with moderate-to-severe infections affecting 2.0% of the seropositive group and 2.1% of the seronegative group. Statistical analysis did not reveal any significant sociodemographic or behavioural factors or STI symptom that correlated with these adverse events. There was a trend, in both HIV-positive and HIV-negative men, for post-circumcision adverse events to be associated with the resumption of sexual activity before full healing had been achieved.

While event rates were similar, the two groups differed in the proportion healed by day 30. Among the HIV-positive group, 71.1% had healed one month after surgery, compared with 80.7% among the HIV-negative group. This difference was statistically significant (p < 0.01).

On the basis of these findings, the researchers concluded “overall, the safety of circumcision was comparable in HIV-positive and HIV-negative men, although there was somewhat slower wound healing among the HIV-infected participants.”