Monitoring side effects in resource limited countries

Immediately prior to the Lipodystrophy Workshop, the Forum for Collaborative HIV Research (FCHR) organised a roundtable discussion to focus on side effects in resource-limited settings. A report from this meeting was included in the programme of the main Workshop, and was given by Veronica Miller, the director of the Forum. [1]

Nearly two million people receive ARV thanks to recent treatment access programmes. The majority receive drugs for which the side-effects are well described, but which are no-longer recommended as first-line therapy in US treatment guidelines. The lack of information on safety and tolerability from these rollout problems is disturbing. Studies reported at medical conferences are largely from smaller single investigator sites. Virologic and clinical results are optimistic, but the side-effects generally also reflect earlier use of these treatments in the economically developed countries. There is certainly no indication that treatments should be any safer in these programmes than in a Western setting. In fact, the likelihood is a higher incidence of toxicity, driven by patients starting treatment at more advanced disease stage when tolerability is worse. This may be complicated by overlapping of side effects with symptoms of other illnesses, and by a healthcare workers who have less experience in the use of HAART.

In the case of stavudine, the side effects are often irreversible (lipoatrophy, neuropathy and lactic acidosis), and so problematic that the drugs are rarely used in Western countries. This may also become the case with AZT, as anaemia frequently complicates use of AZT as an alternative first-line choice. Many doctors and advocates recognise the importance of switching away from d4T in resource-limited settings. However, this is unlikely to occur given the additional cost, unless there are adequate data. A proposal to start collecting data now, even while advocating for change, will provide the necessary support for the range of healthcare providers funders, governments and healthcare systems to justify additional costs for safer and more tolerable treatment.

WHO and the Global Fund were invited to the meeting but did not attend. The concern was also expressed that the goal of numbers on treatment now drives access programmes both on national and international agendas, at the expense of individual patient care. Speakers at both meetings highlighted the importance of including data and safety provision within all programmes and of funders including PEPFAR and GFATM recognising and supporting this. Lipoatrophy and neuropathy are stigmatizing and debilitating no matter which country you receive your treatment in. Fatal side-effects including lactic acidosis and hepatic failure will similarly contribute to undermining the benefits that ARV treatment undoubtedly provides. Using treatment with high levels of toxicity will only build problems for the future. No-one expects any of the corrective procedures to ever become available. These patients trust their doctors, just like patients in the West. Collecting accurate data on the incidence of side effects in roll-out programmes will also provide a clearer picture of the overall benefits over the risks for the majority of people who use ARV treatment.

The Forum meeting included presentations on the importance of long-term monitoring, regulatory considerations, agreements on standardisation on the way that data will be collected and use of both traditional and newer technologies (SMS, mobile phone, and internet).

Slide presentations are already posted to the FCHR website and a full report form the meeting will follow: