Second-line ART patients reach viral re-suppression following intensified adherence support

Sixty-seven per cent of all patients who were experiencing treatment failure on second-line antiretroviral therapy (ART) achieved viral re-suppression after intensified adherence support was provided, according to a study presented at the 7^th South African AIDS Conference by Dr Vivian Cox from Médecins Sans Frontières (MSF/Doctors Without Borders) in Khayelitsha, a large informal settlement situated 40km outside of Cape Town in South Africa.

The study examined the viral re-suppression rates over time of 111 people who were on protease inhibitor-based second-line ART, with a viral load of more than 400 copies/ml. Of the 67% (71 of 111) of those who reached viral re-suppression, 46% (51 of 111) reached viral re-suppression at first follow-up viral load test. People in this group were three times more likely to remain virally re-suppressed, compared to those who reached viral re-suppression later (aHR 3.15, 95% CI: 2.2-4.4, p<0.0001), when adjusted for age, gender, year of ART start and time on ART). Twenty-one per cent (12 of 56) and 20% (8 of 40) reached virological re-suppression at second and third follow-up viral load test respectively.

The median age of those included in the study was 36.1 years (IQR: 31.5-40.4), of whom 73% (81 of 111) were female. The median time on ART at enrolment was 5.1 years (IQR: 4.1-6.9) and the median time on second-line ART at enrolment was 1.8 years (IQR: 1.0-3.0).

Seventy-seven per cent (n = 81) remained in care during the study period; 4% (n = 4) died and 17% (n = 19) were lost to follow-up.

Virological failure may be caused by a number of factors, including having baseline drug resistance before starting treatment, the development of drug resistance during treatment, length of time on treatment and poor adherence.

In February 2012, MSF partnered with the Western Cape Department Health to pilot a ‘risk of treatment failure’ intervention at a large community health centre in Khayelitsha. Ubuntu Clinic provides ART to 8552 people, of whom approximately 11.5% are currently receiving second-line treatment. Forty per cent of these have a high viral load, of which 5% are caused due to drug resistance.

The adherence support intervention includes identifying patients with a viral load measurement of greater than 400 copies/ml. Their folders are flagged and separated by reception staff who check the most recent viral load result (either manually or through the clinic’s electronic medical system) and place a red sticker on the patient’s folder. If the patient achieves viral re-suppression, a green sticker is placed over the red one.

These patients are then referred to ART support groups with a specific focus on adherence, run by a lay counsellor. The adherence support group is held on the same day as the clinical consultation (for patient convenience and to improve retention), where common adherence difficulties are discussed and treatment myths (such as not being able to take ART when drinking alcohol) are addressed. Adherence support group members are encouraged to motivate and support each other and when a member reaches viral re-suppression, it is celebrated.

Combined clinical and adherence consultations are facilitated by a nurse, where structured adherence support sessions are held, with an emphasis on the correlation between adherence and viral load result. The nurse discusses a medication schedule to fit into the routine of the patient’s daily life, allowing flexibility where appropriate; where and how to keep extra or emergency doses ART on hand; a simple reminder strategy; a plan for taking ART when using substances or experiencing depression; and an alternative plan for getting to clinic appointments and a plan for vacations and out-of-town trips.

In cases where people had repeated high viral load test results, genotyping to determine resistance would be conducted and patients would be switched to third-line ART.

“The main concern with people failing second-line should be adherence support, not the risk that they may have developed drug resistance to their regimen. National guidelines for structured adherence support are urgently needed,” urged Dr Cox. Adherence strategies increase the durability of second-line ART, decrease the need for costly third-line regimens and prevent unnecessary genotyping tests.