In this large study in India, NVP-based HAART, given as a FDC formulation, was shown to be safe, tolerable and effective amongst HIV-1 infected patients. Generic FDC formulations were used in all the patients in the study.
Adherence in patients showing improvement was excellent. One of the reasons may have been the use of FDC formulations, which are convenient to take. Many of the FDC formulations are available as monthly packs, which ensure supplies for patients staying away from tertiary centres and with limited access to medications. Additionally, patients paid for their own medications. Patients were screened carefully for their ability to pay before they were offered HAART. To ensure they understood, we demonstrated how to take the pills especially during the lead-in phase. Finally, we reinforced the importance of adherence at each follow-up visit.
The frequency of acute adverse events attributable to NVP was lower than in other reported studies . The frequency of rash may have been lower because of the high proportion of patients adhering to the lead-in dose of NVP while initiating therapy. Only female gender was significantly associated with higher risk of development of adverse events, while concomitant TMP-SMX and baseline CD4 counts were not.
The low frequency of hepatitis reported in our study may be attributed to the fact that screening was done only when the patients had clinical symptoms of hepatitis. Asymptomatic elevation of liver enzymes would have been missed. However, in spite of selective screening, we did not see any mortality due to hepatitis in our cohort. Hence in resource-limited settings, screening for hepatitis may be done only when clinically indicated rather than as a routine. In spite of concomitant use of ATT in some patients the incidence of hepatitis was low. This may be due to absence of rifampicin from the ATT regimen because of its potential drug interaction with NVP. We did not assess background prevalence of hepatitis viruses amongst these patients and hence we could not assess their effect on the incidence of development of hepatitis.
We have not reported the type and frequency of adverse events attributable to backbone nucleosides in our study. We will report elsewhere the prevalence of morphologic and metabolic abnormalities associated with long-term use of these regimens in our cohort.