Six months of DOT achieves undetectable HIV viral load in both genital tract and plasma

Michael Carter
Estimated reading time 3 minutes
This article is more than 21 years old.

Directly observed antiretroviral therapy was successful at reducing HIV viral load in both plasma and the genital tract to below the limit of detection in six women with a history of drug abuse and poor adherence in a small study published in the September 5th edition of AIDS.

The investigators suggest that their study provides proof of concept that women with adherence difficulties can benefit from directly observed HAART. Another recently published small study showed that six weeks of directly observed HAART could yield improvements in viral load and CD4 cell count lasting six months (link below).

A total of eleven HIV-positive women with a history of drug use and poor adherence were recruited to the study. Their HAART regimens consisted of d4T, 3TC, and ddI, plus either efavirenz or saquinavir boosted by ritonavir.

Glossary

plasma

The fluid portion of the blood.

directly observed therapy (DOT)

When a health care professional watches as a person takes each dose of a medication, to verify that all doses are taken as prescribed.

chlamydia

Chlamydia is a common sexually transmitted infection, caused by bacteria called Chlamydia trachomatis. Women can get chlamydia in the cervix, rectum, or throat. Men can get chlamydia in the urethra (inside the penis), rectum, or throat. Chlamydia is treated with antibiotics.

boosting agent

Booster drugs are used to ‘boost’ the effects of protease inhibitors and some other antiretrovirals. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels. Without the boosting agent, the prescribed dose of the primary drug would be ineffective.

loss to follow up

In a research study, participants who drop out before the end of the study. In routine clinical care, patients who do not attend medical appointments and who cannot be contacted.

Each woman was visited by an outreach worker daily when anti-HIV medications were provided. At baseline, and months one, three and six, the women provided cervicovaginal lavage (CVL) and blood samples for HIV viral load testing. The CVL was also screened for sexually transmitted infections and semen.

Only six women recruited to the study remained on it for six months. One woman died before starting the study, one woman was excluded after gentoyping revealed she was resistant to the study medications, and three women were lost to follow-up.

CVL viral load ranged from 80,000 copies/mL to below 400 copies/mL at baseline. By month three, all women had a CVL viral load below 400 copies/mL.

Plasma viral load at baseline was between 2,000 copies/mL and 800,000 copies/mL, and all six women who completed the six months of the study had a viral load below 400 copies/mL by month six.

CD4 cell count also increased by a mean of 76 cells/mm3 after six months of directly observed HAART.

No cases of gonorrhoea, chlamydia, or trichomoniasis were diagnosed, although there were eight cases of vaginal thrush and five cases of bacterial vaginosis. These were not associated with a rebound in CVL viral load.

”These results show that some women with a history of poor adherence and active substance abuse can realize significant benefits from antiretroviral therapy through a programme of outreach and DOT…with decreases in both CVL and plasma HIV” viral loads conclude the investigators. They acknowledge the small size of their study and limited duration of follow-up. Nevertheless they believe that their study provides proof of concept that directly observed HAART can be effective. They call for larger studies to confirm their findings.

Further information on this website

Six weeks of DOT can yield CD4 increases and fall in HIV viral load lasting six months - news story

Adherence - factsheet

Adherence tips - factsheet

Late/missed doses - factsheet

Adherence - booklet in the information for HIV-positive people

References

Harwell JL et al. Directly observed antiretroviral therapy to reduce genital tract and plasma HIV-1 RNA in women with poor adherence. AIDS 17: 1990 - 1992, 2003.

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