Does 'real world' study cast doubt on use of HIV treatment as prevention?

Treatment with antiretroviral drugs did not reduce the rate of HIV transmission in serodiscordant heterosexual couples in the Henan province of China, investigators report in the October edition of the Journal of Acquired Immune Deficiency Syndromes.

The transmission rate in couples where the HIV-infected partner was taking antiretroviral treatment was 5% compared to a rate of 3% in other couples.

In an accompanying editorial, Dr Myron Cohen says that the results “demand a giant pause” and show that the ability of HIV treatment to reduce the risk of transmission outside the setting of clinical studies is uncertain.

However, the investigators note that the high transmission rate seen in couples where HIV treatment was used could be due to poor adherence. A separate study showed that 66% of patients in Henan province had sub-optimal adherence to their HIV treatment six months after starting HIV treatment.

Henan province has a high number of HIV infections due to unsanitary procedures for collecting commercial blood donations. Thousands became infected with HIV after selling blood at clinics with poor infection control methods.

The quality of HIV care in some parts of China has been questioned, owing to high rates of treatment failure and drug resistance reported in the country compared to treatment programmes in Africa and Latin America. China Daily reported in 2004 that many patients stopped taking antiretroviral drugs after a few months due to a lack of attention to side-effects by health care professionals.

The study published this week involved 1927 serodiscordant couples. HIV incidence was retrospectively monitored between early 2006 and the end of 2008. Individuals were interviewed about their HIV risk behaviour.

The patients contributed a total of 4918 person-years of follow-up (median, 2.8 years). There were 84 seroconversions (4%). This provided an incident rate of 1.71 per 100 person-years.

Sex in the previous three months was reported by 91% of couples where transmission occurred compared to 83% of those where it did not (p < 0.05).

More frequent sexual intercourse was also associated with an increased risk of transmission. The transmission rate was five times higher in couples having sex four times or more a month than in couples where intercourse was less frequent (RR = 5.24, 95% CI, 2.55-10.77).

Consistent condom use was reported by 93% of couples. Not using condoms was significantly associated with an increased risk of transmission (RR = 8.42; 95% CI, 4.83-14.67).

Only seven individuals reported extra-marital sex, and one of these seroconverted. Only one patient reported injected drug use, but this individual did not contract HIV. None of the men surveyed reported sex with another man.

A total of 1369 patients (80%) were taking HIV therapy. There was no significant difference in the transmission rate between couples where antiretroviral therapy was used and those where it was not (5% vs. 3%). No information was provided about viral load.

However, the investigators did find that the 266 patients who had switched antiretroviral therapy were less likely to transmit the virus to their partners than the patients who remained on the same regimen for the duration of the study (RR, 2.66; 95% CI, 1.15-6.15).

Finally, the investigators found that poor psychological functioning was associated with an increased risk of seroconversion.

“The incident rate from our study is similar to the incident rate of 2.3 per 100 person-years reported among a cohort of injecting drug users from a high prevalence region in southwestern China”, comment the investigators. They add: “This suggests that HIV-negative spouses living in serodiscordant relationships…could be considered one of China’s high-risk groups.”

Dr Cohen suggests that the study could have wider implications, and should cause those who advocate the use of treatment as prevention to “pause”.

“Will ART suppress transmission of HIV under ‘real life’ conditions?”, he asks, “it seems wise to try and answer this question before we fully deploy a ‘Test and Treat strategy’, expecting to detect a benefit to the general population.”

However, increasing the number of patients taking HIV therapy in routine care has already been credited with falls in HIV incidence in San Francisco and British Columbia.